U.S. Food and Drug Administration (FDA)
Is Tesamorelin legal in United States?
Approved, restrictedFDA-approved since 2010 as Egrifta only for extra belly fat in adults with HIV and lipodystrophy; not for weight loss
Approved, but with limits on who can get it or how.
Tesamorelin is FDA-approved (Egrifta SV and Egrifta WR, first approved 10 November 2010) to reduce excess abdominal fat in HIV-infected adults with lipodystrophy. The label states it is not indicated for weight loss and that long-term cardiovascular safety has not been established. It is regulated as a biologic under a Biologics License Application, and FDA says biologics are not eligible for compounding exemptions. In August 2026 FDA warned an online seller that tesamorelin sold with 'research use only' labels is an unapproved new drug.
Last verified 2026-09-29 · how we verify
Tesamorelin elsewhere
Sources (3)
- 01EGRIFTA (tesamorelin) prescribing informationU.S. Food and Drug Administration · 2025-03 · accessed 2026-09-29
- 02Compounding and the FDA: Questions and AnswersU.S. Food and Drug Administration · 2025-09-16 · accessed 2026-09-29
- 03FDA warning letter 735127 to an online seller of retatrutide, semaglutide, SS-31, PT-141 and tesamorelin labelled 'research use only'U.S. Food and Drug Administration · 2026-08-24 · accessed 2026-09-29