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Setmelanotide regulatory status

Current status of Setmelanotide in the United States: FDA approved. In sport: Not WADA prohibited. Details, sources, and the dated timeline follow.

By the PeptideAgent Editorial Team. Draft, pending editorial review.  Last verified

What is the current status of Setmelanotide?

Regulatory: FDA approvedWADA: Not WADA prohibitedVerified: Verified Sep 27, 2026
FDA and compounding
FDA approved product (Imcivree, November 2020 for POMC, PCSK1, and LEPR deficiency obesity; June 2022 for Bardet-Biedl syndrome; December 2024 expansion to ages 2 and older). It is available only by prescription and requires a confirmed genetic diagnosis for coverage. Because an approved product exists and is not in shortage, compounding is not permitted except for a documented patient specific clinical need. Setmelanotide is not on any FDA compounding bulks list. The current label also covers acquired hypothalamic obesity in patients 4 years and older.
WADA
Not WADA prohibited
Access path
  1. Prescription from a specialist after genetic confirmation of an eligible condition, dispensed through a specialty pharmacy as Imcivree.
  2. Not available through compounding pharmacies, telehealth peptide clinics, or for general weight loss.

Full Setmelanotide page: evidence, dosing in the literature, and sources

How has the status of Setmelanotide changed over time?

  1. FDA

    FDA approves Imcivree (setmelanotide) for acquired hypothalamic obesity

    FDA extended Imcivree to acquired hypothalamic obesity in adults and children 4 years and older, based on the phase 3 TRANSCEND trial.

    Regulatory: FDA approvedSource: Manufacturer press release: FDA approval of Imcivree for acquired hypothalamic obesity (March 19, 2026)
  2. FDA

    FDA approves Imcivree (setmelanotide) for rare genetic obesity

    FDA approved setmelanotide injection (Imcivree), an MC4R agonist, for chronic weight management in patients with obesity due to POMC, PCSK1, or LEPR deficiency confirmed by genetic testing.

    Regulatory: FDA approvedSource: Drugs@FDA: Imcivree (setmelanotide) NDA 213793

Sources

Numbered citations in the answers above point here, followed by the regulatory sources on record for Setmelanotide and the source of each dated event.

  1. [1]FDA prescribing information for Imcivree (setmelanotide) injection, via DailyMedFDA, 2026
  2. [2]WADA Prohibited ListWADA, 2026
  3. [3]WADA 2027 Prohibited List (published September 21, 2026, in force January 1, 2027)WADA, 2026
  4. [4]Manufacturer press release: FDA approval of Imcivree for acquired hypothalamic obesity (March 19, 2026)2026
  5. [5]Drugs@FDA: Imcivree (setmelanotide) NDA 213793FDA, 2020