Tesamorelin is the one growth-hormone-releasing peptide most people have heard of that has full FDA approval for an ongoing treatment. That makes it a useful reference point when you see other "GH peptides" marketed online. Here is what it is, what it is approved for, and what its label says about safety.
Key takeaways
- Tesamorelin is a lab-made version of GHRH, the brain's natural "release growth hormone" signal.
- It is sold as Egrifta WR and is FDA-approved to reduce excess abdominal fat in adults with HIV and lipodystrophy.
- The label says it is not indicated for weight loss, and long-term heart safety has not been established.
- In trials, deep belly fat came back after people stopped treatment.
- The label requires monitoring of IGF-1 and blood sugar, and lists active cancer and pregnancy as reasons not to use it.
What tesamorelin is
Your hypothalamus releases GHRH in pulses. GHRH tells the pituitary gland to make and release growth hormone (GH). GH then raises IGF-1, which carries out many of GH's effects.
Tesamorelin is a GHRH analog. The label describes it as acting on pituitary cells "to stimulate the synthesis and pulsatile release of endogenous growth hormone." In plain terms, it nudges your own pituitary to release more of your own GH, in pulses, instead of giving GH directly.
What it is approved for
HIV-associated lipodystrophy is a change in how the body stores fat that some people living with HIV develop. One common feature is extra visceral fat, the deep fat packed around the organs in the belly. This type of fat is linked to heart and metabolic risks.
The Egrifta WR label says tesamorelin is "indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy." It also lists limits of use:
- Long-term cardiovascular safety has not been established.
- It is not indicated for weight loss.
- There are no data showing it improves adherence to HIV medication.
Any other use, such as general fat loss or anti-aging, would be off-label. That is a decision only a licensed prescriber can make, and it comes with less evidence.
What the trials showed
The label describes two randomized, double-blind, placebo-controlled trials with 816 adults with HIV and excess abdominal fat. The main phase lasted 26 weeks, followed by a 26-week extension.
| Trial | Change in visceral fat at week 26, tesamorelin | Change, placebo |
|---|---|---|
| Study 1 (412 people) | about -18% | about +2% |
| Study 2 (404 people) | about -14% | about -2% |
Visceral fat was measured with a CT scan. In the extension, people who were switched from tesamorelin to placebo saw their visceral fat rise again by week 52. People who stayed on tesamorelin did not see a meaningful further drop, but kept their earlier results.
These results apply to the people studied. They do not tell us how tesamorelin works in people without HIV.
Label warnings and side effects
The prescribing information lists these warnings and precautions:
- Increased risk of neoplasms (growths): GH can stimulate tissue growth, so active cancer is a reason not to use it.
- Elevated IGF-1: In trials, 47% of people had IGF-1 above 2 standard deviations of normal at week 26. The label says to monitor IGF-1 and consider stopping when it stays high, especially if the response is weak.
- Fluid retention: swelling, joint pain or tingling (carpal tunnel-like symptoms).
- Glucose intolerance or diabetes: The label says to check blood sugar before starting and periodically after. A1c of 6.5% or higher occurred in 5% of people on tesamorelin versus 1% on placebo.
- Hypersensitivity reactions, including rash and hives.
- Injection site reactions.
- Increased mortality in people with acute critical illness, a warning shared with GH treatments.
The most common side effects in the label were joint pain, injection site redness and itching, pain in the arms or legs, swelling in the limbs and muscle pain.
Contraindications (reasons not to use it) include disruption of the hypothalamic-pituitary axis, active cancer, known allergy to tesamorelin, and pregnancy.
How it is supplied
Egrifta WR comes as a powder in a vial that is mixed with the bacteriostatic water supplied in the kit. The label says to use only the supplied diluent, to swirl gently rather than shake, and that one vial covers seven daily doses before the remainder is discarded. It is stored at room temperature and should not be frozen or refrigerated once mixed.
Your prescriber and pharmacist set the dose and teach the technique. If you want to understand the general idea of mixing a vial, see our reconstitution guide, and you can track daily injections in the PepSteady app. Follow the Instructions for Use that came with your kit first.
How it compares to other GHRH peptides
Tesamorelin is one of several GHRH analogs. Sermorelin was approved in the past but the brand was discontinued. CJC-1295 was studied but never approved. Of the three, tesamorelin is the only one with a current FDA label, large controlled trials and a defined monitoring plan.
The 2026 WADA Prohibited List names tesamorelin as a banned GHRH analog, so tested athletes should not use it without a valid therapeutic use exemption.
Questions to ask your prescriber
- Am I a candidate based on the approved use?
- What do my baseline IGF-1, blood sugar and A1c look like?
- How often will we recheck labs?
- What happens if I stop, and how would we decide when to stop?
- What should I do about swelling, joint pain or injection site reactions?
The bottom line
Tesamorelin is a well-studied GHRH analog with one clear FDA-approved use: reducing excess belly fat in adults with HIV-associated lipodystrophy. It works while you take it, needs lab monitoring and has real warnings. Use outside that label is a prescriber's call, not a self-experiment.
Sources
- EGRIFTA WR (tesamorelin) prescribing information, DailyMed
- EGRIFTA WR full prescribing information (PDF), FDA
- World Anti-Doping Agency: The Prohibited List (2026)
Frequently asked questions
What is tesamorelin approved for?
The FDA label for Egrifta WR says it is indicated to reduce excess abdominal fat in adults with HIV who have lipodystrophy. The label also says it is not indicated for weight loss.
Does tesamorelin's effect last after stopping?
In the label's 52-week trial data, people switched from tesamorelin to placebo saw their deep belly fat return toward baseline by week 52. That suggests the effect depends on continued use, which is something to discuss with your prescriber.
Why do doctors check IGF-1 and blood sugar on tesamorelin?
Tesamorelin raises growth hormone, which raises IGF-1 and can affect blood sugar. The label tells prescribers to monitor IGF-1 and glucose and to consider stopping in some people with persistent high IGF-1 or new glucose problems.