Is Tesamorelin FDA-Approved? Yes, as Egrifta, for One Narrow Use

Yes. Tesamorelin is FDA-approved as Egrifta, a growth-hormone-releasing-hormone analogue held by Theratechnologies. FDA approved it on November 10, 2010 (application 022505), and Drugs@FDA lists it as a current prescription product. Among the growth-hormone-releasing peptides people ask about, it is the only one with an FDA approval in force.

That approval is specific. It covers one product, made by one company, for one indication: reducing excess abdominal fat in HIV-infected adults with lipodystrophy. It does not make tesamorelin approved for anything else, and it does not make a compounded tesamorelin preparation an approved drug.

The Egrifta SV prescribing information lists a single indication: reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy. The same label adds limitations. It states that Egrifta SV is not indicated for weight-loss management, that its long-term cardiovascular safety has not been established, and that continuing treatment should be weighed in patients whose visceral fat has not fallen.

That is why "tesamorelin is FDA-approved" is true but easy to over-read. The approval rests on two pivotal Phase 3 trials in one population. It does not cover general fat loss, body composition or anti-aging.

FDA approval attaches to a specific finished product, its manufacturing and its label, not to a molecule in the abstract. FDA’s own guidance on compounding is blunt: compounded drugs are not FDA-approved, so FDA does not verify their safety, effectiveness or quality before they are marketed.

Tesamorelin also does not appear on FDA’s 503A category list. A compounded tesamorelin preparation is therefore not the approved drug, even though it shares Egrifta’s active ingredient. If a seller or clinic calls its tesamorelin "FDA-approved", ask whether it means Egrifta itself.

Tesamorelin shows that drug approval and sport eligibility are separate systems. It is approved, and it is still prohibited at all times under the WADA Prohibited List 2026, named under S2.2.4 as a GHRH analogue.

Confirm current rules through Global DRO or your anti-doping organisation before use.