Drugs / Setmelanotide
Drug research

Setmelanotide

Open a linked trial to see its study details and recorded changes, or check the regulatory events below and follow their sources.

Drug identity checked against registry records

Also recorded as IMCIVREE; Imcivree; RM-493; SET

A drug appearing in a clinical trial does not mean it is FDA-approved. Check the original regulatory source for any approval claim.

Included trials

TrialSponsorPhaseStatusPrimary completion
Phase 2 Trial to Evaluate Safety and Efficacy of Setmelanotide (RM-493) in Obese Participants With Prader-Willi SyndromeNCT02311673RYTMPhase 2Completed2016-10-26Actual
EMANATE: A Study of Setmelanotide in Patients With Specific Gene Variants in the MC4R PathwayNCT05093634RYTMPhase 3Completed2025-12-22Actual
Phase 2 Study to Evaluate Safety and Efficacy of RM-493 in Obese ParticipantsNCT01749137RYTMPhase 2Completed2013-09-28Actual
Open-Label Study of Setmelanotide in Hypothalamic ObesityNCT04725240RYTMPhase 2Completed2022-06-28Actual
Long Term Extension Trial of SetmelanotideNCT03651765RYTMPhase 2, Phase 3Completed2025-01-09Actual
A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756)NCT06760546RYTMPhase 3Recruiting2027-03-13Estimated
DAYBREAK: A Study of Setmelanotide in Participants With Specific Gene Variants in the Melanocortin-4 Receptor (MC4R) PathwayNCT04963231RYTMPhase 2Completed2023-08-04Actual
Setmelanotide Phase 2 Treatment Trial in Participants With Rare Genetic Disorders of ObesityNCT03013543RYTMPhase 2Completed2022-03-01Actual
A Study of Setmelanotide in Patients With Prader-Willi SyndromeNCT06772597RYTMPhase 2Active not recruiting2026-10-31Estimated
A Trial of Setmelanotide in Acquired Hypothalamic ObesityNCT05774756RYTMPhase 3Active not recruiting2025-03-18Actual
Setmelanotide (RM-493), Melanocortin-4 Receptor (MC4R) Agonist, in Bardet-Biedl Syndrome (BBS) and Alström Syndrome (AS) Participants With Moderate to Severe ObesityNCT03746522RYTMPhase 3Completed2020-11-16Actual
Setmelanotide in Pediatric Participants With Rare Genetic Diseases of ObesityNCT04966741RYTMPhase 3Completed2023-09-18Actual
Setmelanotide for the Treatment of Early-Onset Pro-Opiomelanocortin (POMC) Deficiency ObesityNCT02896192RYTMPhase 3Completed2020-05-25Actual
Open-Label Extension Study of SetmelanotideNCT06596135RYTMPhase 3Completed2026-06-24Actual

Regulatory dates and decisions

No regulatory events match this view.Try another date range or view. Events appear after automated source checks. This does not mean no FDA events have occurred. Dates that a source does not disclose stay undisclosed.