Setmelanotide — EU research guide.
Setmelanotide (Imcivree) is a melanocortin-4 receptor (MC4R) agonist approved for rare genetic obesity syndromes and, since March 2026, for acquired hypothalamic obesity.
What is Setmelanotide?
Setmelanotide directly activates MC4R, the same appetite-control receptor targeted indirectly by melanotan I/II, restoring satiety signalling in people whose obesity stems from a broken upstream part of the leptin-melanocortin pathway (POMC, PCSK1, LEPR deficiency, or Bardet-Biedl syndrome).
What does the research show?
Rhythm Pharmaceuticals' Phase 3 TRANSCEND trial supported a March 2026 FDA label expansion to acquired hypothalamic obesity, showing an 18.4% placebo-adjusted BMI reduction over 52 weeks; the EU granted marketing authorisation for the same indication shortly after. It is not indicated for common (polygenic) obesity.
EU legal status
EMA-approved prescription medicine (Imcivree) for its specific genetic and acquired-obesity indications only. It is not a generic research peptide for general weight loss.
Molecular information
Pharmacokinetics
Melanocortin-pathway compounds across EU suppliers
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