Peptide reference
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.
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.
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.
Common adverse effects include injection-site reactions, peripheral edema, and joint pain. IGF-1 monitoring recommended. Contraindicated in active malignancy and during pregnancy.
Tesamorelin is the full 44-amino-acid sequence of human growth-hormone-releasing hormone, with a chemical modification added to the front end that extends its half-life and resists rapid breakdown. Like sermorelin, it signals the pituitary to release growth hormone, but the stabilizing modification is what makes once-daily dosing workable and is what separates it structurally from sermorelin's shorter, unmodified fragment.
The pivotal trial behind tesamorelin's approval enrolled 412 HIV-infected adults with lipodystrophy and found it reduced visceral fat significantly more than placebo over 26 weeks. A separate, smaller trial in non-HIV adults with reduced growth hormone found a similar effect, though with only 60 people. A third trial found a modest cognitive benefit in older adults; that one is frequently misattributed to sermorelin in marketing copy, but the peptide tested was tesamorelin. Two later trials found no significant cognitive benefit.
Yes, but narrowly. Tesamorelin is FDA-approved, currently marketed as Egrifta WR, for one specific population and use: reducing excess abdominal fat in HIV-infected adults with lipodystrophy. It isn't approved for weight loss, longevity, or performance in anyone else; those are off-label uses. Because it's an approved drug, it also isn't on the FDA's PCAC compounding review list; that list is for substances without their own approval, and tesamorelin already has one.
Yes. Tesamorelin is banned for athletes despite its FDA approval. It falls under WADA's S2 category for growth-hormone-releasing factors, prohibited at all times for athletes subject to testing. An approved medical use for HIV-associated lipodystrophy doesn't create an exception for someone using it for another purpose in sport.
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