{ "$schema": "https://goal.md/peptides/catalog.schema.json", "catalogVersion": "1.0.0", "publisher": { "name": "GOAL.MD", "url": "https://goal.md" }, "scope": "Education-only reference facts for peptide ingredient pages that have completed physician and compliance review and have been explicitly released for publication. Not a product feed, not an offer, and not clinical guidance.", "usageNotes": [ "Regulatory labels are per ingredient and must not be summarised as FDA approval.", "Compounded preparations are not FDA-approved.", "This catalog carries no pricing, dosing, sourcing, or availability information, and none may be inferred from it.", "Draft, in-review, and unreleased records are absent by design, so absence from this file is not evidence about a substance." ], "entryCount": 20, "contentHash": "v1-fd338c65ad1c2461", "entries": [ { "slug": "5-amino-1mq", "canonicalName": "5-Amino-1MQ", "aliases": [ "5-amino-1-methylquinolinium" ], "aliasPaths": [ "/peptides/5-amino-1-mq", "/peptides/amino-1mq" ], "category": "metabolic", "categoryLabel": "Metabolic and mitochondrial", "regulatoryStatus": "investigational", "regulatoryLabel": "Investigational", "regulatoryMeaning": "This substance is studied in research settings. It is not an FDA-approved drug product, and its use outside research is not an established standard of care.", "approvedIndication": "", "evidenceTier": "none-published", "evidenceTierMeaning": "No published controlled human trials were identified for the uses discussed here.", "summary": "5-Amino-1MQ is a synthetic small molecule studied as an inhibitor of the enzyme NNMT (nicotinamide N-methyltransferase), which sits at a crossroads of cellular energy metabolism. It is frequently sold alongside peptides in research-chemical marketplaces, but chemically it is not a peptide at all, and that distinction affects how it is manufactured, analyzed, and regulated. Research to date is almost entirely limited to cultured cells and rodents. No published human trial data establish safety or benefit in people.", "canonicalUrl": "https://goal.md/peptides/5-amino-1mq", "lastReviewed": "2026-08-13", "reviewers": [ { "name": "Michael Fitch, MD", "credential": "MD", "role": "medical", "reviewedAt": "2026-08-13" }, { "name": "Michael Mimlitz, MD", "credential": "MD", "role": "compliance", "reviewedAt": "2026-08-13" } ], "citations": [ { "title": "Selective and membrane-permeable small molecule inhibitors of nicotinamide N-methyltransferase reverse high fat diet-induced obesity in mice", "publisher": "Biochem Pharmacol (PubMed)", "url": "https://pubmed.ncbi.nlm.nih.gov/29155147/", "identifier": "PMID 29155147", "published": "2018 Jan", "sourceType": "preclinical", "supports": "Original NNMT inhibitor work in diet-induced obesity, the source of the metabolic claims and the basis for stating this is a small molecule rather than a peptide." }, { "title": "Glucose availability regulates nicotinamide N-methyltransferase expression in adipocytes", "publisher": "Life Sci (PubMed)", "url": "https://pubmed.ncbi.nlm.nih.gov/32112869/", "identifier": "PMID 32112869", "published": "2020 May 1", "sourceType": "preclinical", "supports": "Regulation of NNMT expression in adipocytes, cited for mechanism context." }, { "title": "Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act", "publisher": "U.S. Food and Drug Administration", "url": "https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act", "identifier": "", "published": "", "sourceType": "fda-regulatory", "supports": "Current status of the substance for compounding under section 503A." }, { "title": "Compounding and the FDA: Questions and Answers", "publisher": "U.S. Food and Drug Administration", "url": "https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers", "identifier": "", "published": "", "sourceType": "fda-regulatory", "supports": "The statement that compounded preparations are not FDA-approved." } ], "relatedUrls": [ "https://goal.md/peptides/epitalon", "https://goal.md/peptides/mots-c" ] }, { "slug": "aod-9604", "canonicalName": "AOD-9604", "aliases": [ "hGH Fragment 176-191" ], "aliasPaths": [ "/peptides/aod9604" ], "category": "metabolic", "categoryLabel": "Metabolic and mitochondrial", "regulatoryStatus": "investigational", "regulatoryLabel": "Investigational", "regulatoryMeaning": "This substance is studied in research settings. It is not an FDA-approved drug product, and its use outside research is not an established standard of care.", "approvedIndication": "", "evidenceTier": "early-limited", "evidenceTierMeaning": "Human research exists but is early, small, or narrow in scope, so conclusions about general use are premature.", "summary": "AOD-9604 is a fragment of the human growth hormone molecule, corresponding to amino acids 176 to 191, that was specifically developed and tested as a potential treatment for obesity. Human clinical trials conducted for that purpose did not demonstrate a meaningful weight-loss or fat-loss effect at the exposures studied, and the substance was not approved as a result. It is not an FDA-approved drug product, and its history is a useful, direct illustration of how a peptide can advance through human testing and still fail to show worthwhile benefit. This page states that outcome plainly rather than treating AOD-9604 as an open or promising question.", "canonicalUrl": "https://goal.md/peptides/aod-9604", "lastReviewed": "2026-08-13", "reviewers": [ { "name": "Michael Fitch, MD", "credential": "MD", "role": "medical", "reviewedAt": "2026-08-13" }, { "name": "Michael Mimlitz, MD", "credential": "MD", "role": "compliance", "reviewedAt": "2026-08-13" } ], "citations": [ { "title": "Increase of fat oxidation and weight loss in obese mice caused by chronic treatment with human growth hormone or a modified C-terminal fragment", "publisher": "Int J Obes Relat Metab Disord (PubMed)", "url": "https://pubmed.ncbi.nlm.nih.gov/11673763/", "identifier": "PMID 11673763", "published": "2001 Oct", "sourceType": "preclinical", "supports": "Animal data on fat oxidation and weight loss, the origin of the fat-loss claims made for this fragment." }, { "title": "AOD-9604 Metabolic", "publisher": "Curr Opin Investig Drugs (PubMed)", "url": "https://pubmed.ncbi.nlm.nih.gov/15134286/", "identifier": "PMID 15134286", "published": "2004 Apr", "sourceType": "narrative-review", "supports": "Development-stage review of AOD-9604 as an investigational metabolic agent." }, { "title": "Detection and in vitro metabolism of AOD9604", "publisher": "Drug Test Anal (PubMed)", "url": "https://pubmed.ncbi.nlm.nih.gov/25208511/", "identifier": "PMID 25208511", "published": "2015 Jan", "sourceType": "analytical", "supports": "Analytical detection and in vitro metabolism work, cited for the absence of positive human outcome trials." }, { "title": "Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act", "publisher": "U.S. Food and Drug Administration", "url": "https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act", "identifier": "", "published": "", "sourceType": "fda-regulatory", "supports": "Current status of the substance for compounding under section 503A." }, { "title": "Compounding and the FDA: Questions and Answers", "publisher": "U.S. Food and Drug Administration", "url": "https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers", "identifier": "", "published": "", "sourceType": "fda-regulatory", "supports": "The statement that compounded preparations are not FDA-approved." } ], "relatedUrls": [ "https://goal.md/peptides/cjc-1295", "https://goal.md/peptides/ipamorelin", "https://goal.md/peptides/tesamorelin" ] }, { "slug": "bpc-157", "canonicalName": "BPC-157", "aliases": [ "Body Protection Compound-157", "PL 14736" ], "aliasPaths": [ "/peptides/body-protection-compound-157", "/peptides/bpc157" ], "category": "repair", "categoryLabel": "Tissue and gut signalling", "regulatoryStatus": "investigational", "regulatoryLabel": "Investigational", "regulatoryMeaning": "This substance is studied in research settings. It is not an FDA-approved drug product, and its use outside research is not an established standard of care.", "approvedIndication": "", "evidenceTier": "none-published", "evidenceTierMeaning": "No published controlled human trials were identified for the uses discussed here.", "summary": "BPC-157 is a synthetic peptide derived from a fragment of a protein found in gastric juice, studied almost exclusively in animal and cell models of tissue and gut signalling. It is not an FDA-approved drug product, and in 2023 the FDA identified it as a bulk substance raising significant safety concerns for compounding, which limits how it can lawfully be prepared. Enthusiasm for BPC-157 online is driven overwhelmingly by preclinical findings and anecdote rather than by controlled human trials. Patients who ask about it should understand that its popularity currently exceeds the strength of its human evidence base by a wide margin.", "canonicalUrl": "https://goal.md/peptides/bpc-157", "lastReviewed": "2026-08-13", "reviewers": [ { "name": "Michael Fitch, MD", "credential": "MD", "role": "medical", "reviewedAt": "2026-08-13" }, { "name": "Michael Mimlitz, MD", "credential": "MD", "role": "compliance", "reviewedAt": "2026-08-13" } ], "citations": [ { "title": "BPC 157 for Acute Hamstring Muscle Strain Repair (Phase 2, Recruiting)", "publisher": "U.S. National Library of Medicine, ClinicalTrials.gov", "url": "https://clinicaltrials.gov/study/NCT07437547", "identifier": "NCT07437547", "published": "2026-02-02", "sourceType": "trial-registry", "supports": "The first registered phase 2 human trial, cited to show human study is only now beginning." }, { "title": "Multifunctionality and Possible Medical Application of the BPC 157 Peptide-Literature and Patent Review", "publisher": "Pharmaceuticals (Basel) (PubMed)", "url": "https://pubmed.ncbi.nlm.nih.gov/40005999/", "identifier": "PMID 40005999", "published": "2025 Jan 30", "sourceType": "narrative-review", "supports": "Review of proposed mechanisms and patent activity, cited as the source of mechanism claims that remain preclinical." }, { "title": "Emerging Use of BPC-157 in Orthopaedic Sports Medicine: A Systematic Review", "publisher": "HSS J (PubMed)", "url": "https://pubmed.ncbi.nlm.nih.gov/40756949/", "identifier": "PMID 40756949", "published": "2025 Nov", "sourceType": "narrative-review", "supports": "Systematic review of the orthopaedic sports medicine literature, cited for the near-absence of controlled human evidence." }, { "title": "Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks", "publisher": "U.S. Food and Drug Administration", "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks", "identifier": "", "published": "", "sourceType": "fda-regulatory", "supports": "FDA's identification of BPC-157 as a bulk substance that may present significant safety risks in compounding." }, { "title": "Compounding and the FDA: Questions and Answers", "publisher": "U.S. Food and Drug Administration", "url": "https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers", "identifier": "", "published": "", "sourceType": "fda-regulatory", "supports": "The statement that compounded preparations are not FDA-approved." } ], "relatedUrls": [ "https://goal.md/peptides/ghk-cu", "https://goal.md/peptides/kpv", "https://goal.md/peptides/tb-500" ] }, { "slug": "cjc-1295", "canonicalName": "CJC-1295", "aliases": [ "CJC-1295 with DAC", "CJC-1295 without DAC", "Modified GRF 1-29" ], "aliasPaths": [ "/peptides/cjc-1295-dac", "/peptides/cjc1295" ], "category": "growth-hormone", "categoryLabel": "Growth hormone axis", "regulatoryStatus": "investigational", "regulatoryLabel": "Investigational", "regulatoryMeaning": "This substance is studied in research settings. It is not an FDA-approved drug product, and its use outside research is not an established standard of care.", "approvedIndication": "", "evidenceTier": "early-limited", "evidenceTierMeaning": "Human research exists but is early, small, or narrow in scope, so conclusions about general use are premature.", "summary": "CJC-1295 is a synthetic analogue of growth hormone-releasing hormone (GHRH) studied for its potential to stimulate growth hormone release. It exists under two related names describing different chemical formulations, one with a drug affinity complex (DAC) and one without, often called Modified GRF 1-29; this is a naming and formulation distinction, not a statement about how either is used. Neither form is an FDA-approved drug product, and human evidence for either remains limited. This page explains the naming clearly and separates it from any claim of approval or established benefit.", "canonicalUrl": "https://goal.md/peptides/cjc-1295", "lastReviewed": "2026-08-13", "reviewers": [ { "name": "Michael Fitch, MD", "credential": "MD", "role": "medical", "reviewedAt": "2026-08-13" }, { "name": "Michael Mimlitz, MD", "credential": "MD", "role": "compliance", "reviewedAt": "2026-08-13" } ], "citations": [ { "title": "A Study to Evaluate CJC 1295 in HIV Patients With Visceral Obesity (Phase 2, Terminated)", "publisher": "U.S. National Library of Medicine, ClinicalTrials.gov", "url": "https://clinicaltrials.gov/study/NCT00267527", "identifier": "NCT00267527", "published": "2005-12", "sourceType": "trial-registry", "supports": "The terminated phase 2 HIV visceral obesity study, cited for the absence of a completed outcome program." }, { "title": "Prolonged stimulation of growth hormone (GH) and insulin-like growth factor I secretion by CJC-1295, a long-acting analog of GH-releasing hormone, in healthy adults", "publisher": "J Clin Endocrinol Metab (PubMed)", "url": "https://pubmed.ncbi.nlm.nih.gov/16352683/", "identifier": "PMID 16352683", "published": "2006 Mar", "sourceType": "human-trial", "supports": "Randomized human data showing prolonged GH and IGF-1 elevation after CJC-1295 administration." }, { "title": "Once-daily administration of CJC-1295, a long-acting growth hormone-releasing hormone (GHRH) analog, normalizes growth in the GHRH knockout mouse", "publisher": "Am J Physiol Endocrinol Metab (PubMed)", "url": "https://pubmed.ncbi.nlm.nih.gov/16822960/", "identifier": "PMID 16822960", "published": "2006 Dec", "sourceType": "preclinical", "supports": "Preclinical characterization of once-daily long-acting GHRH analog dosing." }, { "title": "Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act", "publisher": "U.S. Food and Drug Administration", "url": "https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act", "identifier": "", "published": "", "sourceType": "fda-regulatory", "supports": "Current status of the substance for compounding under section 503A." }, { "title": "Compounding and the FDA: Questions and Answers", "publisher": "U.S. Food and Drug Administration", "url": "https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers", "identifier": "", "published": "", "sourceType": "fda-regulatory", "supports": "The statement that compounded preparations are not FDA-approved." } ], "relatedUrls": [ "https://goal.md/peptides/aod-9604", "https://goal.md/peptides/ipamorelin", "https://goal.md/peptides/tesamorelin" ] }, { "slug": "dsip", "canonicalName": "DSIP (Delta Sleep-Inducing Peptide)", "aliases": [ "DSIP peptide", "Delta sleep-inducing peptide" ], "aliasPaths": [ "/peptides/delta-sleep-inducing-peptide" ], "category": "cognitive", "categoryLabel": "Cognition, sleep, and mood", "regulatoryStatus": "investigational", "regulatoryLabel": "Investigational", "regulatoryMeaning": "This substance is studied in research settings. It is not an FDA-approved drug product, and its use outside research is not an established standard of care.", "approvedIndication": "", "evidenceTier": "case-reports-only", "evidenceTierMeaning": "Human information is limited to case reports or uncontrolled observations, which cannot establish benefit.", "summary": "Delta sleep-inducing peptide, or DSIP, is a short peptide first isolated from the blood of rabbits in the 1970s during studies of sleep induction, a discovery that gave it a name suggesting a sleep-promoting function it has not been shown to reliably reproduce in humans. It is not an FDA-approved drug product, and despite decades of subsequent research, the human sleep evidence is inconsistent and largely limited to small, older studies. Patients often ask about DSIP assuming its name reflects an established mechanism, when in fact the name reflects a single historical animal observation. Understanding that history is essential to interpreting any claim made about this peptide today.", "canonicalUrl": "https://goal.md/peptides/dsip", "lastReviewed": "2026-08-13", "reviewers": [ { "name": "Michael Fitch, MD", "credential": "MD", "role": "medical", "reviewedAt": "2026-08-13" }, { "name": "Michael Mimlitz, MD", "credential": "MD", "role": "compliance", "reviewedAt": "2026-08-13" } ], "citations": [ { "title": "Delta sleep-inducing peptide (DSIP): a still unresolved riddle", "publisher": "J Neurochem (PubMed)", "url": "https://pubmed.ncbi.nlm.nih.gov/16539679/", "identifier": "PMID 16539679", "published": "2006 Apr", "sourceType": "narrative-review", "supports": "Review describing DSIP's unresolved identity and mechanism." }, { "title": "Study of delta sleep-inducing peptide efficacy in improving sleep on short-term administration to chronic insomniacs", "publisher": "Int J Clin Pharmacol Res (PubMed)", "url": "https://pubmed.ncbi.nlm.nih.gov/3583493/", "identifier": "PMID 3583493", "published": "1987", "sourceType": "human-trial", "supports": "The small controlled human insomnia study, cited as the limited and dated human evidence." }, { "title": "Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act", "publisher": "U.S. Food and Drug Administration", "url": "https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act", "identifier": "", "published": "", "sourceType": "fda-regulatory", "supports": "Current status of the substance for compounding under section 503A." }, { "title": "Compounding and the FDA: Questions and Answers", "publisher": "U.S. Food and Drug Administration", "url": "https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers", "identifier": "", "published": "", "sourceType": "fda-regulatory", "supports": "The statement that compounded preparations are not FDA-approved." } ], "relatedUrls": [ "https://goal.md/peptides/selank", "https://goal.md/peptides/semax" ] }, { "slug": "epitalon", "canonicalName": "Epitalon", "aliases": [ "Epithalon", "epitalon tetrapeptide" ], "aliasPaths": [ "/peptides/epithalon" ], "category": "longevity", "categoryLabel": "Longevity research", "regulatoryStatus": "investigational", "regulatoryLabel": "Investigational", "regulatoryMeaning": "This substance is studied in research settings. It is not an FDA-approved drug product, and its use outside research is not an established standard of care.", "approvedIndication": "", "evidenceTier": "case-reports-only", "evidenceTierMeaning": "Human information is limited to case reports or uncontrolled observations, which cannot establish benefit.", "summary": "Epitalon is a synthetic tetrapeptide modeled on a substance isolated from the pineal gland, studied for decades primarily by a small group of researchers investigating pineal biology, telomerase activity, and aging in animal and limited human cohorts. The literature discussing it is notable for its age and its concentration among a small number of research groups rather than broad, independent replication. It is not an approved product, and describing it as capable of slowing biological aging goes beyond what this literature can support.", "canonicalUrl": "https://goal.md/peptides/epitalon", "lastReviewed": "2026-08-13", "reviewers": [ { "name": "Michael Fitch, MD", "credential": "MD", "role": "medical", "reviewedAt": "2026-08-13" }, { "name": "Michael Mimlitz, MD", "credential": "MD", "role": "compliance", "reviewedAt": "2026-08-13" } ], "citations": [ { "title": "Epithalon decelerates aging and suppresses development of breast adenocarcinomas in transgenic her-2/neu mice", "publisher": "Bull Exp Biol Med (PubMed)", "url": "https://pubmed.ncbi.nlm.nih.gov/12459848/", "identifier": "PMID 12459848", "published": "2002 Aug", "sourceType": "preclinical", "supports": "Transgenic mouse aging and tumor data, the origin of the longevity claims made for this tetrapeptide." }, { "title": "Overview of Epitalon-Highly Bioactive Pineal Tetrapeptide with Promising Properties", "publisher": "Int J Mol Sci (PubMed)", "url": "https://pubmed.ncbi.nlm.nih.gov/40141333/", "identifier": "PMID 40141333", "published": "2025 Mar 17", "sourceType": "narrative-review", "supports": "Current overview of epitalon bioactivity, cited for the state of the evidence base." }, { "title": "Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act", "publisher": "U.S. Food and Drug Administration", "url": "https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act", "identifier": "", "published": "", "sourceType": "fda-regulatory", "supports": "Current status of the substance for compounding under section 503A." }, { "title": "Compounding and the FDA: Questions and Answers", "publisher": "U.S. Food and Drug Administration", "url": "https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers", "identifier": "", "published": "", "sourceType": "fda-regulatory", "supports": "The statement that compounded preparations are not FDA-approved." } ], "relatedUrls": [ "https://goal.md/peptides/5-amino-1mq", "https://goal.md/peptides/mots-c" ] }, { "slug": "ghk-cu", "canonicalName": "GHK-Cu (Copper Tripeptide-1)", "aliases": [ "Copper tripeptide", "Copper tripeptide-1", "GHK-Cu" ], "aliasPaths": [ "/peptides/copper-tripeptide-1", "/peptides/ghk-copper" ], "category": "skin", "categoryLabel": "Skin and cosmetic", "regulatoryStatus": "cosmetic-topical", "regulatoryLabel": "Cosmetic or topical context", "regulatoryMeaning": "This ingredient appears mainly in cosmetic or topical formulations. Cosmetic ingredients are not reviewed by the FDA for medical benefit.", "approvedIndication": "", "evidenceTier": "early-limited", "evidenceTierMeaning": "Human research exists but is early, small, or narrow in scope, so conclusions about general use are premature.", "summary": "GHK-Cu is a naturally occurring copper-binding tripeptide most commonly encountered as an ingredient in topical cosmetic products marketed for skin appearance. Its presence in a cosmetic formulation reflects FDA oversight of ingredient safety and labeling, not FDA review of whether the product delivers the cosmetic benefit advertised. Most published research is laboratory-based or comes from small, often industry-funded human studies of specific formulations, so results from one product cannot be assumed to apply to another. Injectable use of GHK-Cu is a materially different and separately regulated matter from topical cosmetic use and is not addressed by cosmetic research.", "canonicalUrl": "https://goal.md/peptides/ghk-cu", "lastReviewed": "2026-08-13", "reviewers": [ { "name": "Michael Fitch, MD", "credential": "MD", "role": "medical", "reviewedAt": "2026-08-13" }, { "name": "Michael Mimlitz, MD", "credential": "MD", "role": "compliance", "reviewedAt": "2026-08-13" } ], "citations": [ { "title": "Topical GHK-Cu Gel for Acute Skin Wound Healing (Phase 2, Recruiting)", "publisher": "U.S. National Library of Medicine, ClinicalTrials.gov", "url": "https://clinicaltrials.gov/study/NCT07437586", "identifier": "NCT07437586", "published": "2026-02-02", "sourceType": "trial-registry", "supports": "Registered phase 2 topical wound-healing trial, cited to show current human study is early." }, { "title": "GHK Peptide as a Natural Modulator of Multiple Cellular Pathways in Skin Regeneration", "publisher": "Biomed Res Int (PubMed)", "url": "https://pubmed.ncbi.nlm.nih.gov/26236730/", "identifier": "PMID 26236730", "published": "2015", "sourceType": "narrative-review", "supports": "Review of GHK activity across skin regeneration pathways, the basis of the mechanism section." }, { "title": "Regenerative and Protective Actions of the GHK-Cu Peptide in the Light of the New Gene Data", "publisher": "Int J Mol Sci (PubMed)", "url": "https://pubmed.ncbi.nlm.nih.gov/29986520/", "identifier": "PMID 29986520", "published": "2018 Jul 7", "sourceType": "narrative-review", "supports": "Gene-expression review of GHK-Cu regenerative and protective actions." }, { "title": "FDA Authority Over Cosmetics: How Cosmetics Are Not FDA-Approved, but Are FDA-Regulated", "publisher": "U.S. Food and Drug Administration", "url": "https://www.fda.gov/cosmetics/cosmetics-laws-regulations/fda-authority-over-cosmetics-how-cosmetics-are-not-fda-approved-are-fda-regulated", "identifier": "", "published": "", "sourceType": "fda-regulatory", "supports": "The distinction between a regulated cosmetic ingredient and an FDA-approved drug." }, { "title": "Compounding and the FDA: Questions and Answers", "publisher": "U.S. Food and Drug Administration", "url": "https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers", "identifier": "", "published": "", "sourceType": "fda-regulatory", "supports": "The statement that compounded preparations are not FDA-approved." } ], "relatedUrls": [ "https://goal.md/peptides/bpc-157", "https://goal.md/peptides/tb-500" ] }, { "slug": "igf-1-lr3", "canonicalName": "IGF-1 LR3", "aliases": [ "Long R3 IGF-1", "insulin-like growth factor 1 LR3 analogue" ], "aliasPaths": [ "/peptides/igf1-lr3", "/peptides/long-r3-igf-1" ], "category": "growth-hormone", "categoryLabel": "Growth hormone axis", "regulatoryStatus": "investigational", "regulatoryLabel": "Investigational", "regulatoryMeaning": "This substance is studied in research settings. It is not an FDA-approved drug product, and its use outside research is not an established standard of care.", "approvedIndication": "", "evidenceTier": "none-published", "evidenceTierMeaning": "No published controlled human trials were identified for the uses discussed here.", "summary": "IGF-1 LR3 is a laboratory-engineered analogue of insulin-like growth factor 1, modified to resist degradation for use as a research reagent in cell culture, not as a therapeutic product. It is not an approved product for human use, and it should not be treated as a variant of an approved medicine. Because it acts on growth factor signalling, it raises genuine concerns about effects on cell proliferation and about severe blood sugar drops, concerns that are taken seriously in the scientific literature on IGF-1 biology generally. There is no controlled human trial establishing a safety profile for this specific analogue.", "canonicalUrl": "https://goal.md/peptides/igf-1-lr3", "lastReviewed": "2026-08-13", "reviewers": [ { "name": "Michael Fitch, MD", "credential": "MD", "role": "medical", "reviewedAt": "2026-08-13" }, { "name": "Michael Mimlitz, MD", "credential": "MD", "role": "compliance", "reviewedAt": "2026-08-13" } ], "citations": [ { "title": "INCRELEX (mecasermin injection) prescribing information", "publisher": "U.S. National Library of Medicine, DailyMed", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d5b2b0e1-c523-468d-9a0b-4ae4e4a8dbce", "identifier": "DailyMed setid d5b2b0e1-c523-468d-9a0b-4ae4e4a8dbce", "published": "", "sourceType": "fda-label", "supports": "The FDA-approved IGF-1 product (mecasermin) and its narrow indication, boxed warning, and hypoglycemia monitoring requirements, cited to distinguish it from LR3 research material." }, { "title": "Mecasermin", "publisher": "BioDrugs (PubMed)", "url": "https://pubmed.ncbi.nlm.nih.gov/18481900/", "identifier": "PMID 18481900", "published": "2008", "sourceType": "narrative-review", "supports": "Clinical profile of mecasermin, the approved recombinant IGF-1." }, { "title": "Recombinant expression of IGF-1 and LR3 IGF-1 fused with xylanase in Pichia pastoris", "publisher": "Appl Microbiol Biotechnol (PubMed)", "url": "https://pubmed.ncbi.nlm.nih.gov/37261455/", "identifier": "PMID 37261455", "published": "2023 Jul", "sourceType": "preclinical", "supports": "Recombinant expression work on LR3 IGF-1, cited for the fact that LR3 is a research reagent variant." }, { "title": "Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks", "publisher": "U.S. Food and Drug Administration", "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks", "identifier": "", "published": "", "sourceType": "fda-regulatory", "supports": "FDA bulk-substance safety risk listing relevant to IGF-1 analogs in compounding." }, { "title": "Compounding and the FDA: Questions and Answers", "publisher": "U.S. Food and Drug Administration", "url": "https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers", "identifier": "", "published": "", "sourceType": "fda-regulatory", "supports": "The statement that compounded preparations are not FDA-approved." } ], "relatedUrls": [ "https://goal.md/peptides/5-amino-1mq", "https://goal.md/peptides/mots-c" ] }, { "slug": "ipamorelin", "canonicalName": "Ipamorelin", "aliases": [ "Ipamorelin acetate" ], "aliasPaths": [ "/peptides/ipamorelin-peptide" ], "category": "growth-hormone", "categoryLabel": "Growth hormone axis", "regulatoryStatus": "investigational", "regulatoryLabel": "Investigational", "regulatoryMeaning": "This substance is studied in research settings. It is not an FDA-approved drug product, and its use outside research is not an established standard of care.", "approvedIndication": "", "evidenceTier": "case-reports-only", "evidenceTierMeaning": "Human information is limited to case reports or uncontrolled observations, which cannot establish benefit.", "summary": "Ipamorelin is a synthetic peptide studied as a selective growth hormone secretagogue, meaning it is proposed to stimulate growth hormone release without the broader hormonal effects seen with some older secretagogues. It is not an FDA-approved drug product, and its position in the compounding market has been directly shaped by FDA decisions about which bulk drug substances compounding pharmacies may legally use. Those decisions have changed over time, so any statement about current compounding availability needs verification rather than assumption. This page focuses on that regulatory reality alongside what is and is not known from the research.", "canonicalUrl": "https://goal.md/peptides/ipamorelin", "lastReviewed": "2026-08-13", "reviewers": [ { "name": "Michael Fitch, MD", "credential": "MD", "role": "medical", "reviewedAt": "2026-08-13" }, { "name": "Michael Mimlitz, MD", "credential": "MD", "role": "compliance", "reviewedAt": "2026-08-13" } ], "citations": [ { "title": "Safety and Efficacy of Ipamorelin Compared to Placebo for the Recovery of Gastrointestinal Function (Phase 2, Completed)", "publisher": "U.S. National Library of Medicine, ClinicalTrials.gov", "url": "https://clinicaltrials.gov/study/NCT01280344", "identifier": "NCT01280344", "published": "2011-04", "sourceType": "trial-registry", "supports": "The completed phase 2 program in postoperative gastrointestinal recovery, which did not lead to approval." }, { "title": "Pharmacokinetic-pharmacodynamic modeling of ipamorelin, a growth hormone releasing peptide, in human volunteers", "publisher": "Pharm Res (PubMed)", "url": "https://pubmed.ncbi.nlm.nih.gov/10496658/", "identifier": "PMID 10496658", "published": "1999 Sep", "sourceType": "human-trial", "supports": "Human pharmacokinetic-pharmacodynamic data in healthy volunteers, the basis for saying human exposure data exist but outcome data do not." }, { "title": "Ipamorelin, the first selective growth hormone secretagogue", "publisher": "Eur J Endocrinol (PubMed)", "url": "https://pubmed.ncbi.nlm.nih.gov/9849822/", "identifier": "PMID 9849822", "published": "1998 Nov", "sourceType": "preclinical", "supports": "Original characterization of ipamorelin as a selective growth hormone secretagogue (preclinical)." }, { "title": "Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act", "publisher": "U.S. Food and Drug Administration", "url": "https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act", "identifier": "", "published": "", "sourceType": "fda-regulatory", "supports": "Current status of the substance for compounding under section 503A." }, { "title": "Compounding and the FDA: Questions and Answers", "publisher": "U.S. Food and Drug Administration", "url": "https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers", "identifier": "", "published": "", "sourceType": "fda-regulatory", "supports": "The statement that compounded preparations are not FDA-approved." } ], "relatedUrls": [ "https://goal.md/peptides/aod-9604", "https://goal.md/peptides/cjc-1295", "https://goal.md/peptides/tesamorelin" ] }, { "slug": "kisspeptin-10", "canonicalName": "Kisspeptin-10", "aliases": [ "KP-10", "Kisspeptin" ], "aliasPaths": [ "/peptides/kisspeptin" ], "category": "hormonal", "categoryLabel": "Hormonal and sexual health", "regulatoryStatus": "investigational", "regulatoryLabel": "Investigational", "regulatoryMeaning": "This substance is studied in research settings. It is not an FDA-approved drug product, and its use outside research is not an established standard of care.", "approvedIndication": "", "evidenceTier": "early-limited", "evidenceTierMeaning": "Human research exists but is early, small, or narrow in scope, so conclusions about general use are premature.", "summary": "Kisspeptin-10 is a fragment of the kisspeptin peptide family studied for its role as an upstream trigger of the reproductive hormone cascade, sitting above GnRH, LH, and FSH release. It is not an FDA-approved drug product and no approved medicine is built on it. Researchers have used it mainly as an experimental probe to understand how the hypothalamus signals the pituitary and gonads, including in small human physiology studies. Patients typically ask about it in the context of reproductive hormone or libido-related questions, but the evidence base remains investigational and narrow.", "canonicalUrl": "https://goal.md/peptides/kisspeptin-10", "lastReviewed": "2026-08-13", "reviewers": [ { "name": "Michael Fitch, MD", "credential": "MD", "role": "medical", "reviewedAt": "2026-08-13" }, { "name": "Michael Mimlitz, MD", "credential": "MD", "role": "compliance", "reviewedAt": "2026-08-13" } ], "citations": [ { "title": "Kisspeptin Administration Subcutaneously to Patients With IHH (Phase 2, Recruiting)", "publisher": "U.S. National Library of Medicine, ClinicalTrials.gov", "url": "https://clinicaltrials.gov/study/NCT05896293", "identifier": "NCT05896293", "published": "2023-02-03", "sourceType": "trial-registry", "supports": "Registered phase 2 trial in idiopathic hypogonadotropic hypogonadism, cited as an example of current investigational use." }, { "title": "Metabolic regulation of kisspeptin - the link between energy balance and reproduction", "publisher": "Nat Rev Endocrinol (PubMed)", "url": "https://pubmed.ncbi.nlm.nih.gov/32427949/", "identifier": "PMID 32427949", "published": "2020 Aug", "sourceType": "narrative-review", "supports": "Link between energy balance and reproductive signalling." }, { "title": "Kisspeptin and neurokinin B neuroendocrine pathways in the control of human ovulation", "publisher": "J Neuroendocrinol (PubMed)", "url": "https://pubmed.ncbi.nlm.nih.gov/38404024/", "identifier": "PMID 38404024", "published": "2024 Oct", "sourceType": "narrative-review", "supports": "Kisspeptin's role in the control of human ovulation, the basis of the mechanism and research-use sections." }, { "title": "Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act", "publisher": "U.S. Food and Drug Administration", "url": "https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act", "identifier": "", "published": "", "sourceType": "fda-regulatory", "supports": "Current status of the substance for compounding under section 503A." }, { "title": "Compounding and the FDA: Questions and Answers", "publisher": "U.S. Food and Drug Administration", "url": "https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers", "identifier": "", "published": "", "sourceType": "fda-regulatory", "supports": "The statement that compounded preparations are not FDA-approved." } ], "relatedUrls": [ "https://goal.md/peptides/oxytocin", "https://goal.md/peptides/pt-141" ] }, { "slug": "kpv", "canonicalName": "KPV", "aliases": [ "Lysine-Proline-Valine peptide", "alpha-MSH C-terminal tripeptide" ], "aliasPaths": [ "/peptides/kpv-peptide" ], "category": "immune", "categoryLabel": "Immune signalling", "regulatoryStatus": "investigational", "regulatoryLabel": "Investigational", "regulatoryMeaning": "This substance is studied in research settings. It is not an FDA-approved drug product, and its use outside research is not an established standard of care.", "approvedIndication": "", "evidenceTier": "none-published", "evidenceTierMeaning": "No published controlled human trials were identified for the uses discussed here.", "summary": "KPV is the smallest active fragment of alpha-melanocyte-stimulating hormone, consisting of just three amino acids: lysine, proline, and valine. Laboratory and animal research has focused on its apparent anti-inflammatory signalling, particularly in models of intestinal inflammation, independent of the pigmentation and appetite pathways associated with full-length alpha-MSH. It is not an FDA-approved drug product, and published human data are minimal. Interest in KPV should be understood as interest in an actively researched signalling fragment, not an established anti-inflammatory therapy.", "canonicalUrl": "https://goal.md/peptides/kpv", "lastReviewed": "2026-08-13", "reviewers": [ { "name": "Michael Fitch, MD", "credential": "MD", "role": "medical", "reviewedAt": "2026-08-13" }, { "name": "Michael Mimlitz, MD", "credential": "MD", "role": "compliance", "reviewedAt": "2026-08-13" } ], "citations": [ { "title": "PepT1-mediated tripeptide KPV uptake reduces intestinal inflammation", "publisher": "Gastroenterology (PubMed)", "url": "https://pubmed.ncbi.nlm.nih.gov/18061177/", "identifier": "PMID 18061177", "published": "2008 Jan", "sourceType": "preclinical", "supports": "Mechanism of PepT1-mediated KPV uptake and reduced intestinal inflammation (preclinical)." }, { "title": "Melanocortin-derived tripeptide KPV has anti-inflammatory potential in murine models of inflammatory bowel disease", "publisher": "Inflamm Bowel Dis (PubMed)", "url": "https://pubmed.ncbi.nlm.nih.gov/18092346/", "identifier": "PMID 18092346", "published": "2008 Mar", "sourceType": "preclinical", "supports": "Anti-inflammatory activity in murine inflammatory bowel disease models." }, { "title": "Transdermal Iontophoretic Delivery of Lysine-Proline-Valine (KPV) Peptide Across Microporated Human Skin", "publisher": "J Pharm Sci (PubMed)", "url": "https://pubmed.ncbi.nlm.nih.gov/28343991/", "identifier": "PMID 28343991", "published": "2017 Jul", "sourceType": "preclinical", "supports": "Delivery research across human skin, cited for the formulation questions that remain unresolved." }, { "title": "Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act", "publisher": "U.S. Food and Drug Administration", "url": "https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act", "identifier": "", "published": "", "sourceType": "fda-regulatory", "supports": "Current status of the substance for compounding under section 503A." }, { "title": "Compounding and the FDA: Questions and Answers", "publisher": "U.S. Food and Drug Administration", "url": "https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers", "identifier": "", "published": "", "sourceType": "fda-regulatory", "supports": "The statement that compounded preparations are not FDA-approved." } ], "relatedUrls": [ "https://goal.md/peptides/bpc-157", "https://goal.md/peptides/ll-37", "https://goal.md/peptides/thymosin-alpha-1" ] }, { "slug": "ll-37", "canonicalName": "LL-37", "aliases": [ "Cathelicidin antimicrobial peptide", "hCAP-18 fragment" ], "aliasPaths": [ "/peptides/cathelicidin-ll-37", "/peptides/ll37" ], "category": "immune", "categoryLabel": "Immune signalling", "regulatoryStatus": "investigational", "regulatoryLabel": "Investigational", "regulatoryMeaning": "This substance is studied in research settings. It is not an FDA-approved drug product, and its use outside research is not an established standard of care.", "approvedIndication": "", "evidenceTier": "case-reports-only", "evidenceTierMeaning": "Human information is limited to case reports or uncontrolled observations, which cannot establish benefit.", "summary": "LL-37 is the only cathelicidin-family antimicrobial peptide produced naturally by the human body, generated by immune cells and skin as part of innate host defence against microbes. It is studied extensively in laboratory settings for its antimicrobial and immune-modulating properties, but it is not an FDA-approved drug product, and no approved therapeutic version exists. Unlike many investigational peptides discussed for enhancement or recovery, LL-37 research carries a genuine two-sided profile: the same immune-activating signalling that makes it interesting also raises real theoretical concerns about excessive inflammation and autoimmune-like activity. This page focuses on explaining that duality rather than presenting LL-37 as a benign or emerging option.", "canonicalUrl": "https://goal.md/peptides/ll-37", "lastReviewed": "2026-08-13", "reviewers": [ { "name": "Michael Fitch, MD", "credential": "MD", "role": "medical", "reviewedAt": "2026-08-13" }, { "name": "Michael Mimlitz, MD", "credential": "MD", "role": "compliance", "reviewedAt": "2026-08-13" } ], "citations": [ { "title": "The human cathelicidin LL-37--A pore-forming antibacterial peptide and host-cell modulator", "publisher": "Biochim Biophys Acta (PubMed)", "url": "https://pubmed.ncbi.nlm.nih.gov/26556394/", "identifier": "PMID 26556394", "published": "2016 Mar", "sourceType": "narrative-review", "supports": "Pore-forming antibacterial and host-cell-modulating activity of human LL-37." }, { "title": "Cathelicidins: Immunomodulatory Antimicrobials", "publisher": "Vaccines (Basel) (PubMed)", "url": "https://pubmed.ncbi.nlm.nih.gov/30223448/", "identifier": "PMID 30223448", "published": "2018 Sep 14", "sourceType": "narrative-review", "supports": "Review of cathelicidins as immunomodulatory antimicrobials, the basis of the mechanism section." }, { "title": "Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act", "publisher": "U.S. Food and Drug Administration", "url": "https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act", "identifier": "", "published": "", "sourceType": "fda-regulatory", "supports": "Current status of the substance for compounding under section 503A." }, { "title": "Compounding and the FDA: Questions and Answers", "publisher": "U.S. Food and Drug Administration", "url": "https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers", "identifier": "", "published": "", "sourceType": "fda-regulatory", "supports": "The statement that compounded preparations are not FDA-approved." } ], "relatedUrls": [ "https://goal.md/peptides/bpc-157", "https://goal.md/peptides/kpv", "https://goal.md/peptides/thymosin-alpha-1" ] }, { "slug": "mots-c", "canonicalName": "MOTS-c", "aliases": [ "MOTS-c peptide", "mitochondrial-derived peptide MOTS-c" ], "aliasPaths": [ "/peptides/mots-c-peptide", "/peptides/motsc" ], "category": "metabolic", "categoryLabel": "Metabolic and mitochondrial", "regulatoryStatus": "investigational", "regulatoryLabel": "Investigational", "regulatoryMeaning": "This substance is studied in research settings. It is not an FDA-approved drug product, and its use outside research is not an established standard of care.", "approvedIndication": "", "evidenceTier": "none-published", "evidenceTierMeaning": "No published controlled human trials were identified for the uses discussed here.", "summary": "MOTS-c is a short peptide encoded within the mitochondrial genome that has drawn research interest as a signal linking mitochondrial function to whole-body metabolism. Almost everything known about it comes from mouse and cell-culture experiments rather than from people. It is not an approved drug, and no clinical trial has established what it does when given to humans. Claims about fat loss or longevity benefit in people are not supported by the current published record.", "canonicalUrl": "https://goal.md/peptides/mots-c", "lastReviewed": "2026-08-13", "reviewers": [ { "name": "Michael Fitch, MD", "credential": "MD", "role": "medical", "reviewedAt": "2026-08-13" }, { "name": "Michael Mimlitz, MD", "credential": "MD", "role": "compliance", "reviewedAt": "2026-08-13" } ], "citations": [ { "title": "MOTS-c for Improving Insulin Sensitivity in Adults With Prediabetes and Overweight/Obesity (Phase 2, Recruiting)", "publisher": "U.S. National Library of Medicine, ClinicalTrials.gov", "url": "https://clinicaltrials.gov/study/NCT07505745", "identifier": "NCT07505745", "published": "2026-02-02", "sourceType": "trial-registry", "supports": "The registered phase 2 insulin-sensitivity trial, cited to show human testing is early and ongoing." }, { "title": "The mitochondrial-derived peptide MOTS-c promotes metabolic homeostasis and reduces obesity and insulin resistance", "publisher": "Cell Metab (PubMed)", "url": "https://pubmed.ncbi.nlm.nih.gov/25738459/", "identifier": "PMID 25738459", "published": "2015 Mar 3", "sourceType": "preclinical", "supports": "Original identification of MOTS-c and its metabolic effects in animal models." }, { "title": "The Mitochondrial-Encoded Peptide MOTS-c Translocates to the Nucleus to Regulate Nuclear Gene Expression in Response to Metabolic Stress", "publisher": "Cell Metab (PubMed)", "url": "https://pubmed.ncbi.nlm.nih.gov/29983246/", "identifier": "PMID 29983246", "published": "2018 Sep 4", "sourceType": "preclinical", "supports": "Nuclear translocation and gene-regulation mechanism under metabolic stress (preclinical)." }, { "title": "Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act", "publisher": "U.S. Food and Drug Administration", "url": "https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act", "identifier": "", "published": "", "sourceType": "fda-regulatory", "supports": "Current status of the substance for compounding under section 503A." }, { "title": "Compounding and the FDA: Questions and Answers", "publisher": "U.S. Food and Drug Administration", "url": "https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers", "identifier": "", "published": "", "sourceType": "fda-regulatory", "supports": "The statement that compounded preparations are not FDA-approved." } ], "relatedUrls": [ "https://goal.md/peptides/5-amino-1mq", "https://goal.md/peptides/epitalon", "https://goal.md/peptides/igf-1-lr3" ] }, { "slug": "oxytocin", "canonicalName": "Oxytocin", "aliases": [ "Pitocin" ], "aliasPaths": [ "/peptides/oxytocin-peptide" ], "category": "hormonal", "categoryLabel": "Hormonal and sexual health", "regulatoryStatus": "fda-approved-specific-indication", "regulatoryLabel": "FDA-approved for a specific indication", "regulatoryMeaning": "This substance has FDA approval for one or more named indications. Approval applies only to those indications and to the specific approved product, not to every use discussed on this page.", "approvedIndication": "Injectable oxytocin is FDA-approved only for specific obstetric uses, including the induction or improvement of uterine contractions when medically indicated at term, and for control of postpartum bleeding. Approval does not extend to intranasal use, to social-cognition or bonding uses, or to any wellness, mood, or sexual-health purpose.", "evidenceTier": "established-for-approved-indication", "evidenceTierMeaning": "Human evidence is well developed for a specific approved indication and does not extend to other uses.", "summary": "Oxytocin is a naturally occurring hormone and neuropeptide, and an injectable form is FDA-approved strictly for specific obstetric indications administered in a clinical setting. That approval does not extend to intranasal oxytocin sprays or to any use aimed at mood, bonding, intimacy, or general wellness, which remain the subject of investigational research rather than approved medicine. Separately from any clinical use, oxytocin has drawn substantial scientific interest for its proposed role in social bonding and trust behaviour, largely from animal studies and small human trials. Patients should understand that these are two distinct conversations: an approved obstetric drug, and an investigational research literature that has not produced an approved product for behavioural or sexual-health use.", "canonicalUrl": "https://goal.md/peptides/oxytocin", "lastReviewed": "2026-08-13", "reviewers": [ { "name": "Michael Fitch, MD", "credential": "MD", "role": "medical", "reviewedAt": "2026-08-13" }, { "name": "Michael Mimlitz, MD", "credential": "MD", "role": "compliance", "reviewedAt": "2026-08-13" } ], "citations": [ { "title": "PITOCIN (oxytocin injection, USP) prescribing information", "publisher": "U.S. National Library of Medicine, DailyMed", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6e5a66fc-e507-497c-b5ce-44a8c95898ad", "identifier": "DailyMed setid 6e5a66fc-e507-497c-b5ce-44a8c95898ad", "published": "", "sourceType": "fda-label", "supports": "The FDA-approved indication (obstetric use of injectable oxytocin), its boxed warning, and the fact that no FDA-approved intranasal oxytocin product exists." }, { "title": "Intranasal oxytocin, social cognition and neurodevelopmental disorders: A meta-analysis", "publisher": "Psychoneuroendocrinology (PubMed)", "url": "https://pubmed.ncbi.nlm.nih.gov/29032324/", "identifier": "PMID 29032324", "published": "2018 Jan", "sourceType": "systematic-review", "supports": "Meta-analysis of intranasal oxytocin and social cognition, cited for the inconsistency of effects." }, { "title": "Intranasal Oxytocin in Children and Adolescents with Autism Spectrum Disorder", "publisher": "N Engl J Med (PubMed)", "url": "https://pubmed.ncbi.nlm.nih.gov/34644471/", "identifier": "PMID 34644471", "published": "2021 Oct 14", "sourceType": "human-trial", "supports": "The large randomized phase 2 trial that found no benefit of intranasal oxytocin on social function in autism, cited against off-label behavioral claims." }, { "title": "Compounding and the FDA: Questions and Answers", "publisher": "U.S. Food and Drug Administration", "url": "https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers", "identifier": "", "published": "", "sourceType": "fda-regulatory", "supports": "The statement that compounded preparations are not FDA-approved." } ], "relatedUrls": [ "https://goal.md/peptides/kisspeptin-10", "https://goal.md/peptides/pt-141" ] }, { "slug": "pt-141", "canonicalName": "PT-141 (Bremelanotide)", "aliases": [ "Bremelanotide", "Vyleesi" ], "aliasPaths": [ "/peptides/bremelanotide", "/peptides/pt141" ], "category": "hormonal", "categoryLabel": "Hormonal and sexual health", "regulatoryStatus": "fda-approved-specific-indication", "regulatoryLabel": "FDA-approved for a specific indication", "regulatoryMeaning": "This substance has FDA approval for one or more named indications. Approval applies only to those indications and to the specific approved product, not to every use discussed on this page.", "approvedIndication": "Bremelanotide, sold as an FDA-approved product under the brand name Vyleesi, is approved specifically for acquired, generalized hypoactive sexual desire disorder in premenopausal women. Approval does not extend to men, to postmenopausal women, or to any other population or purpose.", "evidenceTier": "established-for-approved-indication", "evidenceTierMeaning": "Human evidence is well developed for a specific approved indication and does not extend to other uses.", "summary": "PT-141 is the research name for bremelanotide, a melanocortin receptor agonist, and it exists in two very different forms that patients frequently conflate. One form, marketed under the brand name Vyleesi, is FDA-approved specifically for acquired, generalized hypoactive sexual desire disorder in premenopausal women. The other, sold on the research market as PT-141, is not the approved Vyleesi product, is not FDA-approved for any use, and is not the same as a compounded preparation supervised by a pharmacist. Approval does not extend to men or to postmenopausal women under either name, and understanding this distinction is essential before considering any use.", "canonicalUrl": "https://goal.md/peptides/pt-141", "lastReviewed": "2026-08-13", "reviewers": [ { "name": "Michael Fitch, MD", "credential": "MD", "role": "medical", "reviewedAt": "2026-08-13" }, { "name": "Michael Mimlitz, MD", "credential": "MD", "role": "compliance", "reviewedAt": "2026-08-13" } ], "citations": [ { "title": "VYLEESI (bremelanotide injection) prescribing information", "publisher": "U.S. National Library of Medicine, DailyMed", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf", "identifier": "DailyMed setid f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf", "published": "", "sourceType": "fda-label", "supports": "The FDA-approved indication (acquired, generalized hypoactive sexual desire disorder in premenopausal women), dosing limits, contraindications, and blood-pressure warnings quoted on this page." }, { "title": "Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials", "publisher": "Obstet Gynecol (PubMed)", "url": "https://pubmed.ncbi.nlm.nih.gov/31599840/", "identifier": "PMID 31599840", "published": "2019 Nov", "sourceType": "human-trial", "supports": "The two randomized phase 3 trials supporting approval." }, { "title": "Safety Profile of Bremelanotide Across the Clinical Development Program", "publisher": "J Womens Health (Larchmt) (PubMed)", "url": "https://pubmed.ncbi.nlm.nih.gov/35147466/", "identifier": "PMID 35147466", "published": "2022 Feb", "sourceType": "human-trial", "supports": "Pooled safety profile across the clinical development program, the source of the nausea and blood-pressure figures." }, { "title": "Small Effects, Questionable Outcomes: Bremelanotide for Hypoactive Sexual Desire Disorder", "publisher": "J Sex Res (PubMed)", "url": "https://pubmed.ncbi.nlm.nih.gov/36809187/", "identifier": "PMID 36809187", "published": "2024 May", "sourceType": "narrative-review", "supports": "Critical appraisal describing the small effect sizes, cited so benefit is not overstated." }, { "title": "Compounding and the FDA: Questions and Answers", "publisher": "U.S. Food and Drug Administration", "url": "https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers", "identifier": "", "published": "", "sourceType": "fda-regulatory", "supports": "The statement that compounded preparations are not FDA-approved." } ], "relatedUrls": [ "https://goal.md/peptides/kisspeptin-10", "https://goal.md/peptides/oxytocin" ] }, { "slug": "selank", "canonicalName": "Selank", "aliases": [ "Selank peptide", "Tuftsin analogue" ], "aliasPaths": [ "/peptides/n-acetyl-selank" ], "category": "cognitive", "categoryLabel": "Cognition, sleep, and mood", "regulatoryStatus": "investigational", "regulatoryLabel": "Investigational", "regulatoryMeaning": "This substance is studied in research settings. It is not an FDA-approved drug product, and its use outside research is not an established standard of care.", "approvedIndication": "", "evidenceTier": "early-limited", "evidenceTierMeaning": "Human research exists but is early, small, or narrow in scope, so conclusions about general use are premature.", "summary": "Selank is a synthetic peptide derived from tuftsin, an immune-signalling peptide fragment, and has been studied predominantly by Russian researchers for anxiety-related outcomes. It holds a Russian medicine registration for anxiety indications, a status specific to that country's regulatory process and not recognized by or transferable to the FDA. Patients typically raise Selank in the context of stress and anxiety rather than cognition broadly. The available human evidence remains concentrated in a small number of research groups and has not been independently replicated at scale under modern international trial standards.", "canonicalUrl": "https://goal.md/peptides/selank", "lastReviewed": "2026-08-13", "reviewers": [ { "name": "Michael Fitch, MD", "credential": "MD", "role": "medical", "reviewedAt": "2026-08-13" }, { "name": "Michael Mimlitz, MD", "credential": "MD", "role": "compliance", "reviewedAt": "2026-08-13" } ], "citations": [ { "title": "Selank Administration Affects the Expression of Some Genes Involved in GABAergic Neurotransmission", "publisher": "Front Pharmacol (PubMed)", "url": "https://pubmed.ncbi.nlm.nih.gov/26924987/", "identifier": "PMID 26924987", "published": "2016", "sourceType": "preclinical", "supports": "Effects on genes involved in GABAergic neurotransmission, the basis of the mechanism section." }, { "title": "Peptide Selank Enhances the Effect of Diazepam in Reducing Anxiety in Unpredictable Chronic Mild Stress Conditions in Rats", "publisher": "Behav Neurol (PubMed)", "url": "https://pubmed.ncbi.nlm.nih.gov/28280289/", "identifier": "PMID 28280289", "published": "2017", "sourceType": "preclinical", "supports": "Anxiolytic effects in a rat chronic-stress model, cited as preclinical rather than human evidence." }, { "title": "Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act", "publisher": "U.S. Food and Drug Administration", "url": "https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act", "identifier": "", "published": "", "sourceType": "fda-regulatory", "supports": "Current status of the substance for compounding under section 503A." }, { "title": "Compounding and the FDA: Questions and Answers", "publisher": "U.S. Food and Drug Administration", "url": "https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers", "identifier": "", "published": "", "sourceType": "fda-regulatory", "supports": "The statement that compounded preparations are not FDA-approved, and that a drug registered only outside the United States is not FDA-approved." } ], "relatedUrls": [ "https://goal.md/peptides/dsip", "https://goal.md/peptides/semax" ] }, { "slug": "semax", "canonicalName": "Semax", "aliases": [ "ACTH(4-10) analogue", "Semax peptide" ], "aliasPaths": [ "/peptides/n-acetyl-semax" ], "category": "cognitive", "categoryLabel": "Cognition, sleep, and mood", "regulatoryStatus": "investigational", "regulatoryLabel": "Investigational", "regulatoryMeaning": "This substance is studied in research settings. It is not an FDA-approved drug product, and its use outside research is not an established standard of care.", "approvedIndication": "", "evidenceTier": "early-limited", "evidenceTierMeaning": "Human research exists but is early, small, or narrow in scope, so conclusions about general use are premature.", "summary": "Semax is a synthetic peptide derived from a fragment of adrenocorticotropic hormone (ACTH) that has been studied in Russia for decades and is registered there as a medicine for certain neurological indications. It is not an FDA-approved drug product in the United States, and its Russian registration does not establish safety or effectiveness under US regulatory standards. Patient interest generally centers on attention, mental fatigue, and stress recovery. The English-language human evidence base is thin compared to the Russian literature, and independent replication under modern trial standards is limited.", "canonicalUrl": "https://goal.md/peptides/semax", "lastReviewed": "2026-08-13", "reviewers": [ { "name": "Michael Fitch, MD", "credential": "MD", "role": "medical", "reviewedAt": "2026-08-13" }, { "name": "Michael Mimlitz, MD", "credential": "MD", "role": "compliance", "reviewedAt": "2026-08-13" } ], "citations": [ { "title": "Semax and Pro-Gly-Pro activate the transcription of neurotrophins and their receptor genes after cerebral ischemia", "publisher": "Cell Mol Neurobiol (PubMed)", "url": "https://pubmed.ncbi.nlm.nih.gov/19633950/", "identifier": "PMID 19633950", "published": "2010 Jan", "sourceType": "preclinical", "supports": "Neurotrophin transcription effects after cerebral ischemia in rats, the basis of the mechanism section." }, { "title": "Functional Connectomic Approach to Studying Selank and Semax Effects", "publisher": "Dokl Biol Sci (PubMed)", "url": "https://pubmed.ncbi.nlm.nih.gov/32342318/", "identifier": "PMID 32342318", "published": "2020 Jan", "sourceType": "preclinical", "supports": "Functional connectomic study of Semax and Selank effects." }, { "title": "Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act", "publisher": "U.S. Food and Drug Administration", "url": "https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act", "identifier": "", "published": "", "sourceType": "fda-regulatory", "supports": "Current status of the substance for compounding under section 503A." }, { "title": "Compounding and the FDA: Questions and Answers", "publisher": "U.S. Food and Drug Administration", "url": "https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers", "identifier": "", "published": "", "sourceType": "fda-regulatory", "supports": "The statement that compounded preparations are not FDA-approved, and that a drug registered only outside the United States is not FDA-approved." } ], "relatedUrls": [ "https://goal.md/peptides/dsip", "https://goal.md/peptides/selank" ] }, { "slug": "tb-500", "canonicalName": "TB-500", "aliases": [ "TB4 Fragment", "Thymosin Beta-4 fragment" ], "aliasPaths": [ "/peptides/tb500", "/peptides/thymosin-beta-4" ], "category": "repair", "categoryLabel": "Tissue and gut signalling", "regulatoryStatus": "investigational", "regulatoryLabel": "Investigational", "regulatoryMeaning": "This substance is studied in research settings. It is not an FDA-approved drug product, and its use outside research is not an established standard of care.", "approvedIndication": "", "evidenceTier": "none-published", "evidenceTierMeaning": "No published controlled human trials were identified for the uses discussed here.", "summary": "TB-500 is the name used in the research-chemical marketplace for a synthetic peptide related to a short active region of thymosin beta-4, a naturally occurring protein involved in cell movement and structural signalling within cells. It is not an FDA-approved drug product, and \"TB-500\" itself is not a scientifically standardized name, which means products sold under it are not independently verified to contain what their labels claim. Most available evidence comes from animal studies of tissue and vascular signalling rather than controlled human trials. Patients researching it should distinguish between the biology of thymosin beta-4 as studied in labs and the unregulated commercial products marketed as TB-500.", "canonicalUrl": "https://goal.md/peptides/tb-500", "lastReviewed": "2026-08-13", "reviewers": [ { "name": "Michael Fitch, MD", "credential": "MD", "role": "medical", "reviewedAt": "2026-08-13" }, { "name": "Michael Mimlitz, MD", "credential": "MD", "role": "compliance", "reviewedAt": "2026-08-13" } ], "citations": [ { "title": "Study of Thymosin Beta 4 in Patients With Venous Stasis Ulcers (Phase 2, Completed)", "publisher": "U.S. National Library of Medicine, ClinicalTrials.gov", "url": "https://clinicaltrials.gov/study/NCT00832091", "identifier": "NCT00832091", "published": "2006-07", "sourceType": "trial-registry", "supports": "Phase 2 venous stasis ulcer trial, cited for wound-healing human data on thymosin beta-4 rather than on TB-500 itself." }, { "title": "Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome : ARISE-2 (Phase 3, Completed)", "publisher": "U.S. National Library of Medicine, ClinicalTrials.gov", "url": "https://clinicaltrials.gov/study/NCT02974907", "identifier": "NCT02974907", "published": "2016-11", "sourceType": "trial-registry", "supports": "Completed phase 3 ophthalmic thymosin beta-4 program, the most developed human data for the parent peptide." }, { "title": "beta-Thymosins", "publisher": "Ann N Y Acad Sci (PubMed)", "url": "https://pubmed.ncbi.nlm.nih.gov/17468232/", "identifier": "PMID 17468232", "published": "2007 Sep", "sourceType": "narrative-review", "supports": "Characterization of beta-thymosins and the relationship between TB-500 and thymosin beta-4." }, { "title": "Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks", "publisher": "U.S. Food and Drug Administration", "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks", "identifier": "", "published": "", "sourceType": "fda-regulatory", "supports": "FDA's bulk-substance safety risk listing relevant to thymosin beta-4 related substances in compounding." }, { "title": "Compounding and the FDA: Questions and Answers", "publisher": "U.S. Food and Drug Administration", "url": "https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers", "identifier": "", "published": "", "sourceType": "fda-regulatory", "supports": "The statement that compounded preparations are not FDA-approved." } ], "relatedUrls": [ "https://goal.md/peptides/bpc-157", "https://goal.md/peptides/ghk-cu", "https://goal.md/peptides/kpv" ] }, { "slug": "tesamorelin", "canonicalName": "Tesamorelin", "aliases": [ "Tesamorelin acetate" ], "aliasPaths": [ "/peptides/tesamorelin-acetate" ], "category": "growth-hormone", "categoryLabel": "Growth hormone axis", "regulatoryStatus": "fda-approved-specific-indication", "regulatoryLabel": "FDA-approved for a specific indication", "regulatoryMeaning": "This substance has FDA approval for one or more named indications. Approval applies only to those indications and to the specific approved product, not to every use discussed on this page.", "approvedIndication": "Reduction of excess abdominal fat in adult patients with HIV-associated lipodystrophy. This is the only approved use; the approval does not cover general weight loss, general body composition improvement, athletic performance, or longevity goals.", "evidenceTier": "established-for-approved-indication", "evidenceTierMeaning": "Human evidence is well developed for a specific approved indication and does not extend to other uses.", "summary": "Tesamorelin is a growth hormone-releasing hormone (GHRH) analogue with one specific FDA approval: reduction of excess abdominal fat in adults with HIV-associated lipodystrophy. That approval is narrow and does not extend to general weight loss, general body composition change, athletic performance, or longevity goals in people without this diagnosis. Any other use is off-label. This page separates what the approval actually covers from what patients often hope it means.", "canonicalUrl": "https://goal.md/peptides/tesamorelin", "lastReviewed": "2026-08-13", "reviewers": [ { "name": "Michael Fitch, MD", "credential": "MD", "role": "medical", "reviewedAt": "2026-08-13" }, { "name": "Michael Mimlitz, MD", "credential": "MD", "role": "compliance", "reviewedAt": "2026-08-13" } ], "citations": [ { "title": "Phase II Trial of Tesamorelin for Cognition in Aging HIV-Infected Persons (Phase 2, Completed)", "publisher": "U.S. National Library of Medicine, ClinicalTrials.gov", "url": "https://clinicaltrials.gov/study/NCT02572323", "identifier": "NCT02572323", "published": "2017-02-15", "sourceType": "trial-registry", "supports": "Example of a registered human trial in a non-approved use (cognition in aging with HIV), cited to distinguish investigation from approval." }, { "title": "EGRIFTA WR (tesamorelin) for injection, prescribing information", "publisher": "U.S. National Library of Medicine, DailyMed", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=839334d3-8c1d-4c26-9036-2ab524a6ea75", "identifier": "DailyMed setid 839334d3-8c1d-4c26-9036-2ab524a6ea75", "published": "", "sourceType": "fda-label", "supports": "The only FDA-approved indication: reduction of excess abdominal fat in HIV-associated lipodystrophy, plus the boxed warnings, contraindications, and IGF-1 monitoring language quoted on this page." }, { "title": "Efficacy and safety of tesamorelin in people with HIV on integrase inhibitors", "publisher": "AIDS (PubMed)", "url": "https://pubmed.ncbi.nlm.nih.gov/38905488/", "identifier": "PMID 38905488", "published": "2024 Oct 1", "sourceType": "human-trial", "supports": "Randomized human trial data on efficacy and safety in people with HIV taking integrase inhibitors." }, { "title": "Body composition, hepatic fat, metabolic, and safety outcomes of Tesamorelin, a GHRH analogue, in HIV-associated lipodystrophy: A meta-analysis of randomized controlled trials", "publisher": "Obes Res Clin Pract (PubMed)", "url": "https://pubmed.ncbi.nlm.nih.gov/41545261/", "identifier": "PMID 41545261", "published": "2026 Jan-Feb", "sourceType": "systematic-review", "supports": "Pooled body-composition, hepatic-fat, metabolic, and safety outcomes across tesamorelin trials." }, { "title": "Compounding and the FDA: Questions and Answers", "publisher": "U.S. Food and Drug Administration", "url": "https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers", "identifier": "", "published": "", "sourceType": "fda-regulatory", "supports": "The statement that compounded preparations are not FDA-approved." } ], "relatedUrls": [ "https://goal.md/peptides/aod-9604", "https://goal.md/peptides/cjc-1295", "https://goal.md/peptides/ipamorelin" ] }, { "slug": "thymosin-alpha-1", "canonicalName": "Thymosin Alpha-1", "aliases": [ "Ta1", "Zadaxin" ], "aliasPaths": [ "/peptides/ta1-peptide", "/peptides/thymosin-alpha1" ], "category": "immune", "categoryLabel": "Immune signalling", "regulatoryStatus": "investigational", "regulatoryLabel": "Investigational", "regulatoryMeaning": "This substance is studied in research settings. It is not an FDA-approved drug product, and its use outside research is not an established standard of care.", "approvedIndication": "", "evidenceTier": "early-limited", "evidenceTierMeaning": "Human research exists but is early, small, or narrow in scope, so conclusions about general use are premature.", "summary": "Thymosin alpha-1 is a naturally occurring thymic peptide studied for its role in modulating immune cell activity, and it carries a genuinely split regulatory story. In the United States it remains investigational and is not an FDA-approved drug product, while in some other countries it is registered or approved under brand names such as Zadaxin for specific indications. That foreign status does not transfer to the United States, and separately, the FDA's review of thymosin alpha-1 under the list of bulk substances eligible for 503A compounding has directly affected whether US compounding pharmacies can prepare it, a status that changes over time and needs to be verified before any discussion proceeds.", "canonicalUrl": "https://goal.md/peptides/thymosin-alpha-1", "lastReviewed": "2026-08-13", "reviewers": [ { "name": "Michael Fitch, MD", "credential": "MD", "role": "medical", "reviewedAt": "2026-08-13" }, { "name": "Michael Mimlitz, MD", "credential": "MD", "role": "compliance", "reviewedAt": "2026-08-13" } ], "citations": [ { "title": "The Efficacy and Safety of Thymosin-α1 in Patients With HBV-related ACLF (NA, Completed)", "publisher": "U.S. National Library of Medicine, ClinicalTrials.gov", "url": "https://clinicaltrials.gov/study/NCT03082885", "identifier": "NCT03082885", "published": "2017-04-10", "sourceType": "trial-registry", "supports": "Registered human trial in HBV-related acute-on-chronic liver failure." }, { "title": "The efficacy of thymosin alpha-1 therapy in moderate to critical COVID-19 patients: a systematic review, meta-analysis, and meta-regression", "publisher": "Inflammopharmacology (PubMed)", "url": "https://pubmed.ncbi.nlm.nih.gov/37845598/", "identifier": "PMID 37845598", "published": "2023 Dec", "sourceType": "systematic-review", "supports": "Meta-analysis in moderate to critical COVID-19, cited with its limitations rather than as proof of benefit." }, { "title": "Comprehensive Review of the Safety and Efficacy of Thymosin Alpha 1 in Human Clinical Trials", "publisher": "Altern Ther Health Med (PubMed)", "url": "https://pubmed.ncbi.nlm.nih.gov/38308608/", "identifier": "PMID 38308608", "published": "2024 Jan", "sourceType": "systematic-review", "supports": "Systematic review of safety and efficacy across human clinical trials, the basis for describing where human data exist." }, { "title": "Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks", "publisher": "U.S. Food and Drug Administration", "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks", "identifier": "", "published": "", "sourceType": "fda-regulatory", "supports": "FDA's bulk-substance safety risk listing relevant to thymosin alpha-1 in compounding." }, { "title": "Compounding and the FDA: Questions and Answers", "publisher": "U.S. Food and Drug Administration", "url": "https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers", "identifier": "", "published": "", "sourceType": "fda-regulatory", "supports": "The statement that compounded preparations are not FDA-approved, and that approval elsewhere is not FDA approval." } ], "relatedUrls": [ "https://goal.md/peptides/kpv", "https://goal.md/peptides/ll-37" ] } ] }