U.S. Food and Drug Administration (FDA)
Is Setmelanotide legal in United States?
Approved, restrictedFDA-approved as Imcivree (2020) for specific rare genetic or hypothalamic forms of obesity, not for general obesity
Approved, but with limits on who can get it or how.
Setmelanotide is FDA-approved as Imcivree (first approved 25 November 2020) to reduce excess body weight and maintain weight reduction in specific patient groups. The current label covers acquired hypothalamic obesity in people aged 4 and over, and obesity due to Bardet-Biedl syndrome or to confirmed POMC, PCSK1 or LEPR gene variants in people aged 2 and over. It is not approved for common obesity or other uses.
Last verified 2026-09-29 · how we verify
Setmelanotide elsewhere
Sources (1)
- 01IMCIVREE (setmelanotide) injection prescribing informationU.S. Food and Drug Administration · 2026-03 · accessed 2026-09-29