Tesamorelin
Also referred to as Egrifta, TH9507.
Status: FDA-approved for a specific indication. Tesamorelin has FDA approval for one narrow indication in adults with HIV-associated lipodystrophy. That approval does not extend to general body composition, longevity, or performance use, and it does not apply to compounded preparations, which are not FDA-approved.
Tesamorelin is a synthetic analogue of growth hormone-releasing hormone. It holds FDA approval for a single specific indication, the reduction of excess abdominal fat in adults with HIV-associated lipodystrophy. Use outside that indication is off-label, is not covered by the approval, and is a clinical judgement a physician makes case by case after evaluation.
How it is described in the literature
Tesamorelin acts on the pathway that prompts the pituitary to release growth hormone, which in turn raises IGF-1. The registration trials measured change in visceral adipose tissue in a specific patient population. Effects observed in that population are not automatically transferable to people without that condition.
What researchers and clinicians are studying
- Visceral adipose tissue change in adults with HIV-associated lipodystrophy
- IGF-1 response and glucose measures during therapy
- Durability of measured changes after therapy stops
- Exploratory work in other metabolic populations, at a much earlier evidence stage
What is not established
- Benefit for general weight loss or for cosmetic body composition goals has not been established
- Benefit for athletic performance or for longevity outcomes has not been established
- Measured reductions in the approved population reversed after therapy stopped in trial follow-up
- Compounded preparations are not FDA-approved and are not covered by the approved product's data
Safety and eligibility
- Glucose tolerance can worsen for some patients, so glucose and metabolic markers are monitored
- Injection-site reactions, joint aches, and swelling were reported in trials
- Because it raises IGF-1, physicians screen for conditions where that is undesirable
How eligibility is evaluated
- A physician confirms the clinical picture, reviews labs, and discusses whether any use would be on-label or off-label
- Active malignancy and pituitary disease are specific screening points
- Where the evidence does not support your goal, the physician will say so rather than prescribe around it
Generally not appropriate for
- Anyone who is pregnant, planning pregnancy, or breastfeeding
- Anyone with active malignancy or disruption of the hypothalamic-pituitary axis, absent specialist management
- Anyone seeking it purely for cosmetic or performance goals, where the evidence does not support use
Frequently asked questions
What exactly is tesamorelin approved for?
Reduction of excess abdominal fat in adults with HIV-associated lipodystrophy. That is the whole scope of the approval. Any other use is off-label.
Does an FDA approval for one indication make other uses safe?
No. An approval reflects evidence reviewed for a specific population, dose, and product. Outside that, the safety and benefit questions are open and are decided clinically.
Is compounded tesamorelin FDA-approved?
No. Compounded preparations are not FDA-approved, regardless of whether an approved product containing the same active substance exists.
Will effects persist after stopping?
In the registration trials, the measured reduction in visceral fat regressed after therapy was discontinued. Durability after stopping was not demonstrated.
This page is educational. Nothing here can be ordered from this page and nothing here is a prescription or medical advice. Compounded preparations are not FDA-approved. Talk with a GOAL.MD physician at goal.md/intake or call or text 314-907-3103.
Medically reviewed by Dr. Michael Mimlitz, MD (NPI 1508891870), Chief Physician of GOAL.MD. Last reviewed 2026-08-12.