How Setmelanotide works
A daily injection approved for specific genetic obesity and acquired hypothalamic obesity.
Also called: Imcivree, RM-493, BIM-22493, setmelanotide acetate, CAM4072.
Melanocortin agonists · Melanocortin-4 receptor agonist · Evidence: Approved drug.
It activates MC4 receptors in the brain, which help signal fullness and control energy use. This can bypass some broken hunger signals caused by rare genetic defects or hypothalamic injury. It also activates skin pigment pathways, so skin and moles can darken.
- MC4 receptor: Reduces hunger and food intake; may increase energy use.
- MC1 receptor: Off-target activity increases skin pigment and can darken moles.
Half-life: Effective elimination half-life about 11 hours.
Related to Setmelanotide
- Bremelanotide: An as-needed injection for low libido before menopause; nausea is common.
- Melanotan II: An unapproved tanning peptide with small human trials and reports of serious harm.
- Melanotan I / Afamelanotide: The molecule in an approved EPP implant; online tanning powder is a different formulation.
- Semaglutide: A GLP-1 medicine with strong weight, glucose, heart and kidney evidence; dose and formulation matter.
- Liraglutide: A daily GLP-1 injection approved for weight management and type 2 diabetes.
Sources
- 503B Bulk Drug Substances List, FDA · FDA · 2026
- Assessment report: IMCIVREE, European Medicines Agency · 2026
- Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act, FDA · FDA · 2026
- Clinical Review: Imcivree (Setmelanotide), Ginger Winston, FDA · 2026
- Compounding and the FDA: Questions and Answers, FDA · FDA · 2026
- FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize, FDA · 2026
- IMCIVREE_10mg-ml_solution_PIL_UK_M120256AF_ver07b.indd, 2026
- IMCIVREE- setmelanotide solution, DailyMed · DailyMed · 2026
- IMCIVREE, INN-setmelanotide, European Medicines Agency · 2026
- Product Monograph Including Patient Medication Information IMCIVREE, Health Canada · 2026
- Pyrogen and Endotoxins Testing: Questions and Answers, FDA · 2026
- The 2026 Prohibited List, World Anti-Doping Agency · WADA · 2026
- Therapeutic Goods (Poisons Standard—October 2026) Instrument 2026, Australian Government · Australian Government · 2026
- IMCIVREE, INN-setmelanotide, European Medicines Agency · 2021
- Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances, FDA · FDA · 2000
Sources checked: 2026-10-18.
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