Setmelanotide (Imcivree)
Setmelanotide acetate (RM-493; trade name IMCIVREE)
Approved status applies to specific products, routes, and indications, not every use context discussed online.
An FDA-approved daily injection (IMCIVREE) for rare forms of severe obesity caused by specific genetic conditions that disrupt the brain's appetite-control system, including Bardet-Biedl syndrome and certain gene deficiencies. It is not intended for typical obesity -- it specifically helps people whose weight is driven by an identified genetic cause.
Setmelanotide (Imcivree) is FDA-approved.
Use according to current labeled indication and prescribing guidance.
Safety Summary
Side effects are generally mild to moderate and often transient, with nausea/vomiting tending to resolve within the first month of treatment. Skin hyperpigmentation is the most characteristic effect (mediated by residual MC1R agonism) and is reversible upon discontinuation, occurring in up to 83% of patients. The psychiatric warnings (depression 26%, suicidal ideation 11% in POMC/PCSK1/LEPR population) are labeled as Warnings and Precautions, requiring active monitoring especially in patients with psychiatric history. Spontaneous penile erection (~25% of males, similar to PT-141/bremelanotide) is a known pharmacologic effect requiring patient counseling. Post-marketing pharmacovigilance (FAERS, 93 cases 2020-2024) showed mostly mild adverse events with no reported deaths. Anti-drug antibodies have been detected including antibodies to endogenous α-MSH, but clinical significance is unclear. No evidence of abuse potential or dependence. No significant drug-drug interactions identified (no CYP metabolism).
Clinical check-in
If real-world use or exposure is being considered, review potential interactions, contraindications, and monitoring needs with a licensed clinician rather than relying on summary copy alone.
Cited sources
Every claim on this page links to one of the 14 sources below. Identifiers are PubMed (PMID), ClinicalTrials.gov (NCT), or DOI; click through to the source of record before acting on a claim.
- 1PMID 33137293PubMed
- 2PMID 36356613PubMed
- 3NCT04966741ClinicalTrials.gov
- 4NCT04725240ClinicalTrials.gov
- 5NCT05774756ClinicalTrials.gov
- 6NCT03651765ClinicalTrials.gov
- 7NCT04963231ClinicalTrials.gov
- 8NCT06772597ClinicalTrials.gov
- 9NCT06759546ClinicalTrials.gov
- 10NCT05093634ClinicalTrials.gov
- 11PMID 37888071PubMed
- 12PMID 39924461PubMed
- 13doi:10.1038/s41422-021-00569-8DOI
- 14Insights into the Allosteric Mechanism of Setmelanotide (RM-493) as a Potent and First-in-Class Melanocortin-4 Receptor (MC4R) Agonist To Treat Rare Genetic Disorders of Obesity through an in Silico ApproachReference