Tesamorelin — Wolverine Health

How it works

The only FDA-approved GHRH analog. Approved in 2010 for HIV-associated lipodystrophy under the brand name Egrifta — specifically for the excess visceral fat accumulation that antiretroviral therapy causes. Two Phase III trials showed a 15–18% reduction in visceral adipose tissue over 26 weeks. Off-label interest in body composition is driven by those numbers. The compounding restriction is firm: you cannot compound a copy of an approved drug.

FDA status: FDA-approved (NDA 022505) for HIV-associated lipodystrophy. Brand: Egrifta / Egrifta SV. Compounding prohibited under FD&C Act (essentially a copy of an approved drug with an active NDA).
WADA status: Permitted in sport
Route: subcutaneous injection

Key studies

Tesamorelin (Egrifta) FDA Drug Approval — NDA 022505

Tesamorelin acetate (Egrifta) was approved by the FDA in November 2010 for treatment of excess abdominal fat in HIV-infected patients with lipodystrophy, based on two Phase III placebo-controlled trials.

Effects of tesamorelin on visceral adipose tissue in HIV-infected patients — NEJM

In two Phase III trials, tesamorelin 2 mg/day produced a mean 15.2% reduction in visceral adipose tissue area at 26 weeks compared with 1.1% reduction with placebo.

Safety

Common adverse effects include injection-site reactions, peripheral edema, and joint pain. IGF-1 monitoring recommended. Contraindicated in active malignancy and during pregnancy.

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Research on Tesamorelin

Growth hormone secretagogues: what they are and why four peptides keep showing up together

WADA

CJC-1295, ipamorelin, sermorelin, and tesamorelin all sit in the growth-hormone-secretagogue class. They are routinely confused for each other. Here is the mechanism, the human evidence on each, and the four separate regulatory files behind the shared label.

Sermorelin vs tesamorelin: two routes to the same receptor, two very different approval histories

WADA

Sermorelin and tesamorelin hit the same pituitary receptor and pull the same upstream lever on growth hormone. One had two FDA approvals and lost them for business reasons. The other still has one, for a population almost no buyer belongs to. Same mechanism, different paperwork.

Tesamorelin: Drug-Approved GH Analog, Off-Label Use, and Compounding Restrictions

WADA

Science-journalism analysis of tesamorelin — the GHRH analog with a specific FDA drug approval for HIV-associated lipodystrophy, what off-label interest means, and why compounding restrictions apply.