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: the peptides that turn your own growth hormone back up

WADA

CJC-1295, ipamorelin, sermorelin, and tesamorelin share one job — getting your own pituitary to release more growth hormone, the repair-and-recovery signal that fades after your twenties. Here is the appeal, the two peptide families inside the class, and how far the human proof actually goes.

Sermorelin vs tesamorelin: which growth-hormone peptide is the right tool for you

WADA

Sermorelin and tesamorelin both nudge your pituitary to make more growth hormone. One targets deep visceral fat with a real Phase 3 behind it; the other is the gentler GH-axis nudge with an FDA past. Here's which one fits which goal — and why one is still an approved drug and the other isn't.

Tesamorelin: the GHRH peptide with a real FDA approval behind it

WADA

Tesamorelin is the rare peptide that went through a Phase 3 trial and came out an approved drug — and what it targets is the deep, dangerous belly fat. Here is what it could do for you, and exactly where the approved evidence stops and off-label hope begins.