Setmelanotide
Also known as: RM-493, BIM-22493, Setmelanotide acetate, Imcivree
Classification
Peptide
Regulatory Status
FDA-approved prescription product (Imcivree)
Overview
Setmelanotide is a cyclic peptide MC4R agonist acting downstream in the leptin-melanocortin pathway to reduce hunger and body weight in patients with specific genetic or acquired hypothalamic pathway defects.
Evidence and limitations
Human/preclinical evidence breakdown is not available in this record.
Pathways
Benefits
FDA-approved IMCIVREE (setmelanotide) reduces excess body weight in patients with obesity due to certain POMC/PCSK1/LEPR pathway variants, Bardet-Biedl syndrome, and acquired hypothalamic injury as specified in labeling. Explicitly not approved for common polygenic obesity. Educational reference only.
Interactions & cautions
Drug interactions
other prescription or research weight-loss agents including GLP-1 agonists — Additive GI or other effects possible; not a substitute for genotype-restricted labeled use. (review)
These are observational flags for review, not individualized instructions.
Sources
- https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=70c3ccf7-4df0-4c75-ba07-fede9970c8d9 (opens in a new tab)
- https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-treatment-weight-management-people-certain-rare-genetic-conditions (opens in a new tab)
- https://pubmed.ncbi.nlm.nih.gov/33137293/ (opens in a new tab)
Educational reference only — not medical advice.