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Drug

Setmelanotide

Approved · EMA
ClassMelanocortin receptor 4 agonistEmerging researchLate-stage development

Also known as Imcivree, Setmelanotida, Setmélanotide, Setmelanotidum.

RxNorm2469247ChEMBLCHEMBL3301624ATCA08AA12UNIIN7T15V1FUY
1
Research papers
7
Active clinical trials
Melanocortin receptor 4
Primary target
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Real-World Effectiveness, Safety and Patient-reported Outcomes of Setmelanotide in Patients With Bardet-Biedl Syndrome: A Prospective Mono Centric Observational Interventional Study

Clinical trial2026-06-29Results expected Q4 2030 · ClinicalTrials.gov

A Phase 3, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Setmelanotide in Patients With Acquired Hypothalamic Obesity

Clinical trial2026-05-29Results posted · ClinicalTrials.gov

Setmelanotide to Treat Obesity in a Patient With Pseudohypoparathyroidism Type 1a (PHP1a)

Clinical trial2026-04-01Results expected Q4 2026 · ClinicalTrials.gov

A Phase 2 Open-label Study of Setmelanotide in Patients With Prader-Willi Syndrome

Clinical trial2026-02-12Results expected Q4 2026 · ClinicalTrials.gov

A Phase 3, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Setmelanotide in Patients With Acquired Hypothalamic Obesity

Clinical trial2026-02-12Results expected Q1 2027 · ClinicalTrials.gov

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial: Multiple Independent Sub-studies of Setmelanotide in Patients With POMC/PCSK1, LEPR, NCOA1(SRC1), or SH2B1 Gene Variants in the Melanocortin-4 Receptor Pathway

Clinical trial2025-12-22Primary completion · ClinicalTrials.gov

Open-Label Extension Study of Setmelanotide in Patients With a Rare Genetic, Syndromic or Acquired Disease of the MC4R Pathway

Clinical trial2025-09-04Results expected Q4 2027 · ClinicalTrials.gov

A 2-Stage (Open-Label Followed by Randomized Double-Blind, Placebo-Controlled Stage), Phase 2 Trial of Setmelanotide in Patients With Specific Gene Variants in the Melanocortin-4 Receptor Pathway

Clinical trial2025-07-02Results posted · ClinicalTrials.gov

Long Term Extension Trial of Setmelanotide (RM-493) for Patients Who Have Completed a Trial of Setmelanotide for the Treatment of Obesity Associated With Genetic Defects Upstream of the MC4 Receptor in the Leptin-melanocortin Pathway

Clinical trial2025-05-31Results posted · ClinicalTrials.gov

A Phase 2, Open-Label 20-Week Study to Evaluate the Safety and Efficacy of Setmelanotide in Subjects With Hypothalamic Obesity

Clinical trial2025-02-07Results posted · ClinicalTrials.gov

Lead-in calorie restriction enhances the weight-lowering efficacy of incretin hormone-based pharmacotherapies in mice.

Research2024-09-13Molecular metabolism

Approval: Imcivree (EMA)

Regulatory2021-07-16EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Setmelanotide
Aliases & brands
ImcivreeSetmelanotidaSetmélanotideSetmelanotidum
RxNorm CUI
2469247
ChEMBL ID
CHEMBL3301624
ATC codes
A08AA12
UNII
N7T15V1FUY
Primary mechanism
Melanocortin receptor 4 agonist
Regulatory jurisdictions
ema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Melanocortin receptor 4
MC4R · P32245
AGONISTMelanocortin receptor 4 agonist

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2021-07-16
Latest approval
2021-07-16
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2021-07-16Approval
Approval: Imcivree (EMA)
Indication: Imcivree is indicated for the treatment of obesity and the control of hunger in adults and children 4 years of age and above with acquired hypothalamic obesity (aHO) due to… Show full indication

Imcivree is indicated for the treatment of obesity and the control of hunger in adults and children 4 years of age and above with acquired hypothalamic obesity (aHO) due to hypothalamic injury or impairment.  Imcivree is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed Bardet Biedl syndrome (BBS) in adults and children 2 years of age and above.  Imcivree is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed loss-of-function biallelic pro-opiomelanocortin (POMC), including PCSK1, deficiency or biallelic leptin receptor (LEPR) deficiency in adults and children 2 years of age and above. 

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

22 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
22
registered trials across all phases
LATEST COMPLETION 2025
7
Active studies
4
Recruiting
12
Late-stage (III+)
15
Completed
PHASE DISTRIBUTIONn = 22
Phase 11Phase 1 / 21Phase 28Phase 2 / 31Phase 39Phase 42

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Real-World Effectiveness, Safety and Patient-reported Outcomes of Setmelanotide in Patients With Bardet-Biedl Syndrome: A Prospective Mono Centric Observational Interventional Study

RecruitingPH IVTom Hühnen=2002030

A Randomized, Double-Blind, 3-arm, Parallel Group, Placebo- and Positive-controlled Study to Investigate the Effects of Setmelanotide on QTc Interval in Healthy Subjects

CompletedPH IVRhythm Pharmaceuticals, Inc.n=772022

A Phase 3, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Setmelanotide in Patients With Acquired Hypothalamic Obesity

RecruitingPH IIIRhythm Pharmaceuticals, Inc.n=392028

Open-Label Extension Study of Setmelanotide in Patients With a Rare Genetic, Syndromic or Acquired Disease of the MC4R Pathway

Enrolling by invitationPH IIIRhythm Pharmaceuticals, Inc.n=302027

A Phase 3, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Setmelanotide in Patients With Acquired Hypothalamic Obesity

Active, not recruitingPH IIIRhythm Pharmaceuticals, Inc.n=1432027

Recent completions

Trials that read out recently, adding to the completed evidence base.

Long Term Extension Trial of Setmelanotide (RM-493) for Patients Who Have Completed a Trial of Setmelanotide for the Treatment of Obesity Associated With Genetic Defects Upstream of the MC4 Receptor in the Leptin-melanocortin Pathway

CompletedPH II/IIIRhythm Pharmaceuticals, Inc.n=2052025

A Phase 3 Multi-Center, 1-Year, Open-Label Study of Setmelanotide in Pediatric Patients Aged 2 to <6 Years of Age With Rare Genetic Causes of Obesity

CompletedPH IIIRhythm Pharmaceuticals, Inc.n=122024

A 2-Stage (Open-Label Followed by Randomized Double-Blind, Placebo-Controlled Stage), Phase 2 Trial of Setmelanotide in Patients With Specific Gene Variants in the Melanocortin-4 Receptor Pathway

CompletedPH IIRhythm Pharmaceuticals, Inc.n=1642024

A Phase 3, Randomized, Double-Blind Trial of Two Formulations of Setmelanotide (Daily and Weekly) With a Crossover to Open-Label Once Weekly Setmelanotide in Patients With Specific Gene Defects in the Melanocortin-4 Receptor Pathway Who Are Currently on a Stable Dose of the Once Daily Formulation

CompletedPH IIIRhythm Pharmaceuticals, Inc.n=192023

A Phase 2, Open-Label 20-Week Study to Evaluate the Safety and Efficacy of Setmelanotide in Subjects With Hypothalamic Obesity

CompletedPH IIRhythm Pharmaceuticals, Inc.n=182022

A Randomized, Double-Blind, 3-arm, Parallel Group, Placebo- and Positive-controlled Study to Investigate the Effects of Setmelanotide on QTc Interval in Healthy Subjects

CompletedPH IVRhythm Pharmaceuticals, Inc.n=772022

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Major research themes7
Caloric Restriction1Glucagon-Like Peptide-1 Receptor1Glucagon-Like Peptide-1 Receptor Agonists1Glucagon-Like Peptides1Incretins1Obesity1Weight Loss1
Journals, researchers & institutions
Top journals
  • Molecular metabolism1
Leading researchers
  • Clemmensen C1
  • Holm S1
  • Lund J1
  • Merrild C1
  • Petersen J1
Leading institutions
free-text, unnormalised
  • Novo Nordisk Foundation Center for Basic Metabolic Research1

Related drugs

2 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Semaglutide

Studied across 2 of the same disease areas as Setmelanotide in the shared literature.

2 shared diseases1 shared paper
Tirzepatide

Studied across 2 of the same disease areas as Setmelanotide in the shared literature.

2 shared diseases1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.