For research and educational purposes only. Not medical advice.
Setmelanotide Reference
Educational, not medical advice reference for Setmelanotide: Fat Loss, Hormonal, Metabolic; regulatory status, evidence posture, source review, and schedule…
Reference summary
Setmelanotide is a label-verified MC4-receptor agonist with FDA Phase 3 evidence in BBS, POMC/PCSK1/LEPR deficiency, and acquired hypothalamic obesity. pepSmart surfaces label-reference content only.
- Categories
- Fat Loss, Hormonal, Metabolic
- Aliases
- Imcivree, RM-493, MC4R agonist
- Evidence posture
- human - Approved only for narrow syndromic / monogenic obesity indications. Not approved for general weight loss. Skin hyperpigmentation, depression / suicidal ideation signal, and spontaneous penile erection are label-level warnings.
- Regulatory status
- FDA-approved prescription medication (Imcivree). Initial US approval 2020. Indicated only for chronic weight management in (a) adults and pediatric patients age 2 years and older with obesity due to Bardet-Biedl syndrome (BBS); (b) adults and pediatric patients age 2 years and older with monogenic obesity due to confirmed POMC, PCSK1, or LEPR deficiency; (c) adults and pediatric patients age 4 years and older with acquired hypothalamic obesity. Not indicated for general or polygenic obesity. Prescription-only; clinician-managed.
- Content review status
- label verified