Which peptides did the FDA panel recommend in 2026?
BPC-157, KPV, TB-500, MOTS-c, Epitalon, and Semax were recommended for the Section 503A Bulk Drug Substances List. Emideltide, also called DSIP, was not recommended. All of the votes were advisory, and the FDA has not made a final decision.
The results at a glance
BPC-157 (reviewed for ulcerative colitis): 8 yes, 6 no, 1 abstention — recommended. KPV (wound healing and inflammatory conditions): 8 yes, 6 no, 1 abstention — recommended. TB-500 (wound healing): 8 yes, 6 no, 1 abstention — recommended.
MOTS-c (obesity and osteoporosis): 7 yes, 5 no, 2 abstentions — recommended. Epitalon (insomnia): 7 yes, 4 no, 1 abstention — recommended. Semax (cerebral ischemia, migraine, trigeminal neuralgia): 8 yes, 5 no, 1 abstention — recommended. Emideltide / DSIP (opioid withdrawal, chronic insomnia, narcolepsy): 6 yes, 7 no, 1 abstention — not recommended.
The committee voted separately on the free-base and acetate forms of each peptide, with the same outcome for both forms. The conditions listed are the uses FDA evaluated for the meeting — they are not FDA-approved indications.
What a recommendation means
Advisory committee recommendations are expert advice and are not binding on the FDA. Before the meeting, FDA staff recommended against adding all seven substances. The committee went the other way on six, which the agency must now consider.
This was not a decision about "peptides" as a category. Only seven specific substances were reviewed. Retatrutide, for example, was not part of this meeting and remains an investigational drug in clinical trials.
Medically reviewed by Dr. Michael Mimlitz, MD (NPI 1508891870), Chief Physician of GOAL.MD. Physician-supervised telehealth. More at goal.md/answers.