Setmelanotide results: what to expect and when
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.
At least 28 interventional study records, including ongoing studies; rare-obesity trials support approval. Case reports and secondary analyses overlap.
Key studies
- Energy use: 72-hour infusion: A short infusion raised resting energy use; it did not establish a general weight-loss regimen. (source)
- MC4R variants: early dose finding: Some MC4R variants responded, but this does not support all MC4R variants or general obesity. (source)
- First POMC patients: Two adults with POMC deficiency had large reductions in hunger and weight. (source)
- First LEPR patients: Three LEPR-deficient patients responded during roughly one year of follow-up. (source)
- POMC/PCSK1: pivotal trial: Weight loss varied by genetic defect; selected responders regained weight during placebo withdrawal. (source)
- LEPR: pivotal trial: Weight loss varied by genetic defect; selected responders regained weight during placebo withdrawal. (source)
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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