What is Setmelanotide?

The short answer

Setmelanotide is a peptide, a short chain of amino acids. In the US, you need a prescription to get Setmelanotide.

  • What it is

    Setmelanotide: MC4 receptor agonist (peptide).

  • What people look into

    Weight

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What it is

Also known as
imcivree

Regulatory status

FDA-approved (Rx) How we label status

As of October 4, 2026, Setmelanotide is an FDA-approved prescription drug for acquired hypothalamic obesity in adults and children aged 4 and older; obesity due to Bardet-Biedl syndrome or genetically confirmed POMC, PCSK1 or LEPR deficiency in adults and children aged 2 and older.

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Federal (FDA)
Approved Rx (Imcivree NDA213793, 2020)
503A compounding
Approved-drug component (not in any 503A category) (as of May 14, 2026)

References

Sources as of October 4, 2026

  1. DailyMed: dailymed.nlm.nih.gov/dailymed/drugInfo.cfm