Setmelanotide is mC4R agonist peptide for rare genetic obesity. Setmelanotide, sold as Imcivree by Rhythm Pharmaceuticals, is a peptide medicine for people whose severe obesity is caused by rare genetic defects in the brain's hunger-control pathway. It is not a general weight-loss drug.
Education only. Not medical advice. No dosing information.
Status (verified Oct 29, 2026): FDA approved Nov 25, 2020 (Imcivree, NDA 213793) for specific rare genetic obesities. Source: VENTURE trial in ages 2-5 published
Evidence tier: FDA approved; Phase 3 trials
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What it is
Setmelanotide, sold as Imcivree by Rhythm Pharmaceuticals, is a peptide medicine for people whose severe obesity is caused by rare genetic defects in the brain's hunger-control pathway. It is not a general weight-loss drug.
How it works
It activates the melanocortin-4 receptor (MC4R) in the brain, restoring a 'stop eating' signal that is broken in conditions like POMC, PCSK1 or LEPR deficiency and Bardet-Biedl syndrome.
What it's researched for
Obesity from POMC, PCSK1 or LEPR deficiency, Bardet-Biedl syndrome, and other rare MC4R-pathway disorders, including in young children.
Where it shows up on Peptide Horizon
Regulatory and research timeline
- 2020-11-25: FDA approves Imcivree (NDA 213793) (source)
- 2020-12: Phase 3 POMC/LEPR results published (source)
- 2025-01: VENTURE trial in ages 2-5 published (source)
Key trials and studies
- Phase 3 in LEPR and POMC deficiency (Lancet Diabetes Endocrinol 2020)
- VENTURE, ages 2-5 (Lancet Diabetes Endocrinol 2025)
- Drugs@FDA: Imcivree NDA 213793
FAQ
Is setmelanotide FDA approved?
Yes, since Nov 25, 2020, but only for specific rare genetic causes of obesity confirmed by testing or diagnosis.
Is setmelanotide a general weight-loss drug?
No. Its approval covers rare genetic obesities, not common obesity.
How does it relate to PT-141?
Both act on melanocortin receptors. Setmelanotide targets MC4R for appetite; bremelanotide (PT-141) is approved for low sexual desire.
Related peptides
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Sources
- https://pubmed.ncbi.nlm.nih.gov/33137293
- https://pubmed.ncbi.nlm.nih.gov/39549719
- https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213793
Editorial review - Last reviewed Oct 29, 2026