Also known as: Imcivree, IMCIVREE
Setmelanotide is marketed as IMCIVREE, an MC4 receptor agonist for chronic weight management in acquired hypothalamic obesity, Bardet-Biedl syndrome, and specific monogenic obesity conditions related to POMC, PCSK1, or LEPR deficiency. The labeling describes restoration of MC4 receptor pathway activity to reduce food intake and promote weight loss. U.S. initial approval was in 2020, with major indications update in March 2026.
Rhythm reported Q1 2026 IMCIVREE revenue of $60.1 million and said more than 150 patient start forms were received after U.S. approval in acquired hypothalamic obesity. The company also cited European authorization and a Japanese application under review.
Rhythm Pharmaceuticals announced expanded Phase 3 TRANSCEND trial data showing an 18.8% placebo-adjusted BMI reduction at 52 weeks for setmelanotide in acquired hypothalamic obesity, with FDA PDUFA goal date set for March 20, 2026.
Three GLP-1 weight-loss drugs—semaglutide, tirzepatide and retatrutide—reduced weight and improved metabolic health in mice lacking the MC4R gene, offering potential treatment for rare genetic obesity.
The FDA is set to announce decisions in March 2026 on several drug applications, including label expansions for approved therapies and new drug candidates, with some making repeat approval attempts.
The FDA is set to make approval decisions on five drug applications in March 2026, including treatments for psoriatic arthritis, dry eye disease, hypothalamic obesity, cholestatic pruritus, and a rare genetic disorder.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07496463 |
Setmelanotide to Treat Obesity in a Patient With Pseudohypoparathyroidism Type 1a (PHP1a) |
NOT_YET_RECRUITING | PHASE2 |
| NCT06772597 |
A Study of Setmelanotide in Patients With Prader-Willi Syndrome |
ACTIVE_NOT_RECRUITING | PHASE2 |
| NCT06760546 |
A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756) |
RECRUITING | PHASE3 |
| NCT06596135 |
Open-Label Extension Study of Setmelanotide |
ENROLLING_BY_INVITATION | PHASE3 |
| NCT05774756 |
A Trial of Setmelanotide in Acquired Hypothalamic Obesity |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT05093634 |
EMANATE: A Study of Setmelanotide in Patients With Specific Gene Variants in the MC4R Pathway |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT05046132 |
Study of Setmelanotide Effects on QTc (Corrected QT) Interval in Healthy Participants |
COMPLETED | PHASE4 |
| NCT04966741 |
Setmelanotide in Pediatric Participants With Rare Genetic Diseases of Obesity |
COMPLETED | PHASE3 |
| NCT04963231 |
DAYBREAK: A Study of Setmelanotide in Participants With Specific Gene Variants in the Melanocortin-4 Receptor (MC4R) Pathway |
COMPLETED | PHASE2 |
| NCT04725240 |
Open-Label Study of Setmelanotide in Hypothalamic Obesity |
COMPLETED | PHASE2 |
