Setmelanotide FAQ: common questions answered
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.
- Is Setmelanotide FDA-approved? Yes: Imcivree (specific genetic obesity from age 2; acquired hypothalamic obesity from age 4.). Original approval 2020; BBS added 2022; genetic-obesity age 2 added 2024; acquired hypothalamic obesity added March 2026. General obesity is excluded.
- How do people take it? Under the skin, once daily. Source: drug label.
- What's the difference between Setmelanotide and Liraglutide? Setmelanotide: a daily injection approved for specific genetic obesity and acquired hypothalamic obesity. Liraglutide: a daily GLP-1 injection approved for weight management and type 2 diabetes. Why people pair them: one BBS case used these in sequence for appetite and weight. Liraglutide was stopped first; this was not a concurrent stack.
- Can I take it with Liraglutide followed by setmelanotide? One BBS case used these in sequence for appetite and weight. Liraglutide was stopped first; this was not a concurrent stack. One sequential case cannot establish safety or added benefit from taking both together. Source: clinician-published. Ask a doctor before combining anything.
- Is it banned in sport? It is unclear (WADA 2026). Setmelanotide and MC4R agonists are not named. S0 concerns unapproved drugs; setmelanotide has human approvals. Athlete-specific confirmation remains needed.
- How do I store it once opened? US vial: after first puncture, discard after 30 days or at expiry, whichever comes first. EU/UK vial: discard 28 days after opening. No mixing is needed.
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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