Is Setmelanotide (Imcivree) legal?
Setmelanotide (Imcivree) is an FDA approved drug. For drug-tested athletes it is not on the WADA prohibited list. Yes, pediatric endocrinology and metabolic-disease specialists prescribe for the genetic-obesity indications.. Legal status depends on your country and changes over time. This reflects US status at the time of writing and is not legal or medical advice.
Regulatory status
- FDA: Approved as Imcivree (2020) for obesity due to POMC, PCSK1, or LEPR deficiency. 2022 expansion: Bardet-Biedl syndrome.
- WADA: Not listed
- Prescription: Yes, pediatric endocrinology and metabolic-disease specialists prescribe for the genetic-obesity indications.
References
- Setmelanotide for Obesity due to LEPR or POMC deficiency — Clément K et al., Lancet Diabetes Endocrinol, 2020
- Efficacy and safety of setmelanotide in patients with Bardet-Biedl syndrome and Alström syndrome: a phase 3 trial — Haqq AM et al., The Lancet Diabetes & Endocrinology, 2022
- Imcivree (setmelanotide) — Drugs@FDA approval record (ApplNo 213793) — FDA, Drugs@FDA
Pepdex is an editorial reference, not medical advice. Peptides vary in legal and approval status by country, many are research compounds without full human safety data. Talk to a qualified clinician before starting anything.
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Last updated 2026-06-06.