What it is
Tesamorelin is a short chain of amino acids (a peptide). It is a man-made copy of a natural brain signal called growth hormone-releasing hormone (GHRH). This signal tells the pituitary gland to release growth hormone. The body breaks down natural GHRH within minutes. Tesamorelin has a small chemical cap on one end. The cap slows that breakdown. So a daily shot keeps boosting the body’s own bursts of growth hormone.
The FDA has approved it under the brand name Egrifta for one narrow use. It reduces deep belly fat that builds up in some people with HIV. These people have taken HIV medicines (antiretroviral therapy) for a long time. It is the only drug of its kind sold in the United States today. An earlier one, sermorelin (Geref), was approved in 1990. It was later taken off the market.
Tesamorelin is human GHRH(1-44) amide with a trans-3-hexenoyl group on the N-terminal tyrosine, which sterically blocks DPP-4 cleavage at the Ala2-Asp3 bond. It binds the GHRH receptor on somatotrophs and augments pulsatile GH secretion while preserving negative feedback through IGF-1 and somatostatin, which distinguishes it from exogenous GH. Downstream effects include increased lipolysis in visceral adipose tissue and a rise in serum IGF-1 of roughly 100 µg/L at the 2 mg dose in the pivotal trials. Current labels give an elimination half-life of about 8–11 minutes in healthy subjects, but the biological effect on GH pulsatility persists across the dosing interval.
Who made it and when
A Montreal company called Theratechnologies developed tesamorelin in the early 2000s. Its code name was TH9507. The FDA approved it in November 2010. A more concentrated version, Egrifta SV, came out in November 2018. Egrifta WR was approved in March 2025. It only needs mixing once a week. Since March 2020, the FDA has treated it as a biologic, not a standard drug. A biologic is a medicine made from larger, more complex molecules.
Theratechnologies advanced TH9507 through two pivotal Phase 3 trials in HIV-associated lipodystrophy (2005–2008). FDA approved Egrifta (application 022505) on 2010-11-10 after an advisory committee voted in favour. Egrifta SV (a more concentrated 2 mg-vial formulation) was approved in November 2018, and Egrifta WR (the F8 formulation, 1.28 mg daily from a vial reconstituted weekly) on 2025-03-25 as a supplemental BLA. Because tesamorelin is a 44-residue peptide, it met the statutory definition of a protein, and its NDA was deemed a biologics license application on 2020-03-23. Composition and use patents are held by Theratechnologies; check current expiry status before relying on them.
What the data say
Two large trials looked at people with HIV. Daily shots cut deep belly fat by about 11–15% over six months. People on a dummy treatment (placebo) had little or no change. The fat came back after people stopped. A smaller study looked at people with HIV and fatty liver disease. Tesamorelin also lowered their liver fat. It has no approved use for weight loss or body shape in people without HIV. No completed trials have tested that use.
A pooled analysis of the two Phase 3 trials (n=806) reported a treatment effect of −15.4% on VAT vs placebo at 26 weeks, with triglyceride reduction and no significant change in abdominal subcutaneous fat; IGF-1 rose by a mean 108 ng/mL. VAT reduction was maintained to 52 weeks with continued treatment and was rapidly lost in those switched to placebo. The NAFLD study (n=61) reported an absolute reduction in hepatic fat fraction of 4.1% vs placebo (a 37% relative reduction) and less fibrosis progression over 12 months, without differences in fasting glucose or HbA1c. Labels report HbA1c of 6.5% or higher by week 26 in 5% of tesamorelin vs 1% of placebo participants. No outcome data exist for cardiovascular events.
Regulatory picture
Egrifta is fully FDA approved for its HIV use. That approval does not cover any other use. Since 2020, tesamorelin has been treated as a biologic. The FDA says biologics cannot be compounded (made to order by pharmacies). So pharmacies have no legal way to make copies of it. Products sold online as “research tesamorelin” are not Egrifta.
Tesamorelin acetate is the active ingredient of Egrifta SV and Egrifta WR, licensed under BLA 022505 since the 2020-03-23 transition of protein products from NDAs to BLAs. FDA’s compounding guidance states that biologics cannot be compounded and that federal law provides no pathway for biologics prepared outside an approved BLA, so the drug-shortage exceptions available to 503A and 503B compounders for conventional drugs do not apply. The approved indication is limited to reduction of excess abdominal fat in HIV-infected adults with lipodystrophy; no supplemental indication has been approved. Off-label prescribing of the approved product is a matter of medical practice, not of this site.
