At a glance
FDA approval FDA-approved 1 application
Randomized controlled trials 5 of 228 publications on PubMed
Registered clinical trials 27 5 active
Adverse event reports 270 172 classified as serious
- Setmelanotide is an FDA-approved drug, marketed as Imcivree (first approval: November 25, 2020).
- PubMed lists 228 publications mentioning it, including 5 randomized controlled trials and 13 animal-only studies.
- ClinicalTrials.gov lists 27 registered studies testing it (5 active).
- FDA's adverse event system (FAERS) holds 270 reports mentioning it; 172 classified as serious. Reports do not prove causation.
Research topics
Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).
Regulatory status
Drugs@FDA applications
| Application | Product | Status | First approval | Sponsor |
| NDA213793 | IMCIVREE | Approved, marketed | November 25, 2020 | RHYTHM |
Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query
FDA compounding safety list
Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.
Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026
Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.
Scientific publications
- All publications 228
- Human (MeSH) 137
- Animal only 13
- Clinical trials 17
- Randomized controlled trials 5
- Systematic reviews & meta-analyses 5
- Case reports 25
- Retracted 0
Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 27
- Active
- 5
- With posted results
- 14
| Study | Status | Phase | Start |
| Setmelanotide to Treat Obesity in a Patient With Pseudohypoparathyroidism Type 1a (PHP1a) NCT07496463 Massachusetts General Hospital | Enrolling by invitation | Phase 2 | July 21, 2026 |
| A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756) NCT06760546 Rhythm Pharmaceuticals, Inc. | Recruiting | Phase 3 | September 23, 2025 |
| A Study of Setmelanotide in Patients With Prader-Willi Syndrome NCT06772597 Rhythm Pharmaceuticals, Inc. | Active, not recruiting | Phase 2 | March 4, 2025 |
| A Trial of Setmelanotide in Acquired Hypothalamic Obesity NCT05774756 Rhythm Pharmaceuticals, Inc. Results posted | Active, not recruiting | Phase 3 | April 26, 2023 |
| Real-World Effects of MC4R Agonist Therapy in BBS and Severe Genetic Obesity NCT07674290 Tom Hühne | Recruiting | Phase 4 | January 1, 2023 |
| Open-Label Extension Study of Setmelanotide NCT06596135 Rhythm Pharmaceuticals, Inc. | Completed | Phase 3 | October 21, 2024 |
| Gastric Sleeve-Induced Weight Loss on Shortness of Breath in Obesity NCT05812183 University of California, Los Angeles | Withdrawn | Phase 4 | July 9, 2023 |
| Setmelanotide in Pediatric Participants With Rare Genetic Diseases of Obesity NCT04966741 Rhythm Pharmaceuticals, Inc. Results posted | Completed | Phase 3 | March 8, 2022 |
| Phase 3 Crossover Trial of Two Formulations of Setmelanotide in Participants With Specific Gene Defects in the MC4R Pathway NCT05194124 Rhythm Pharmaceuticals, Inc. Results posted | Completed | Phase 3 | December 21, 2021 |
| EMANATE: A Study of Setmelanotide in Patients With Specific Gene Variants in the MC4R Pathway NCT05093634 Rhythm Pharmaceuticals, Inc. | Completed | Phase 3 | December 10, 2021 |
Show 17 more studies
| Study | Status | Phase | Start |
| DAYBREAK: A Study of Setmelanotide in Participants With Specific Gene Variants in the Melanocortin-4 Receptor (MC4R) Pathway NCT04963231 Rhythm Pharmaceuticals, Inc. Results posted | Completed | Phase 2 | November 30, 2021 |
| Study of Setmelanotide Effects on QTc (Corrected QT) Interval in Healthy Participants NCT05046132 Rhythm Pharmaceuticals, Inc. Results posted | Completed | Phase 4 | August 5, 2021 |
| Open-Label Study of Setmelanotide in Hypothalamic Obesity NCT04725240 Rhythm Pharmaceuticals, Inc. Results posted | Completed | Phase 2 | June 7, 2021 |
| A Phase 1 Study to Evaluate the Pharmacokinetics of Setmelanotide in Subjects With Varying Degrees of Renal Impairment NCT04348175 Rhythm Pharmaceuticals, Inc. | Completed | Phase 1 | July 9, 2020 |
| Setmelanotide (RM-493), Melanocortin-4 Receptor (MC4R) Agonist, in Bardet-Biedl Syndrome (BBS) and Alström Syndrome (AS) Participants With Moderate to Severe Obesity NCT03746522 Rhythm Pharmaceuticals, Inc. Results posted | Completed | Phase 3 | November 23, 2018 |
| Long Term Extension Trial of Setmelanotide NCT03651765 Rhythm Pharmaceuticals, Inc. Results posted | Completed | Phase 2, Phase 3 | July 15, 2018 |
| Setmelanotide for the Treatment of Leptin Receptor (LEPR) Deficiency Obesity NCT03287960 Rhythm Pharmaceuticals, Inc. Results posted | Completed | Phase 3 | January 30, 2018 |
| Setmelanotide in a Single Patient With Partial Lipodystrophy NCT03262610 Rhythm Pharmaceuticals, Inc. | Completed | Phase 2 | August 15, 2017 |
| Setmelanotide for the Treatment of Early-Onset Pro-Opiomelanocortin (POMC) Deficiency Obesity NCT02896192 Rhythm Pharmaceuticals, Inc. Results posted | Completed | Phase 3 | February 14, 2017 |
| Setmelanotide Phase 2 Treatment Trial in Participants With Rare Genetic Disorders of Obesity NCT03013543 Rhythm Pharmaceuticals, Inc. Results posted | Completed | Phase 2 | February 10, 2017 |
| Phase 2 Trial to Evaluate Safety and Efficacy of Setmelanotide (RM-493) in Obese Participants With Prader-Willi Syndrome NCT02311673 Rhythm Pharmaceuticals, Inc. Results posted | Completed | Phase 2 | March 19, 2015 |
| RM-493 Treatment Trial in Proopiomelanocortin (POMC) Deficient Patients NCT02507492 Charite University, Berlin, Germany | Unknown status | Phase 2 | Jan 2015 |
| Phase 1b/2a Study to Evaluate Safety and Efficacy of Setmelanotide in Obese Patients NCT02041195 Rhythm Pharmaceuticals, Inc. Results posted | Completed | Phase 1, Phase 2 | Jan 2014 |
| Effects of RM-493 on Energy Expenditure in Obese Individuals NCT01867437 Rhythm Pharmaceuticals, Inc. | Completed | Phase 1 | May 2013 |
| Phase 2 Study to Evaluate Safety and Efficacy of RM-493 in Obese Participants NCT01749137 Rhythm Pharmaceuticals, Inc. Results posted | Completed | Phase 2 | January 14, 2013 |
| Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RM-493 Administered to Healthy, Obese, Non-diabetic Volunteers NCT02431442 Rhythm Pharmaceuticals, Inc. | Completed | Phase 1 | Jan 2012 |
| An Expanded Access Protocol for Setmelanotide for Treatment of Bardet-Biedl Syndrome (BBS) NCT05183802 Rhythm Pharmaceuticals, Inc. | Approved for marketing | — | — |
All 27 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
- Reports
- 270
- Serious
- 172
- With death outcome
- 4
Most reported reactions
- Nausea 77
- Off label use 74
- Skin hyperpigmentation 61
- Vomiting 42
- Headache 40
- Diarrhoea 38
- Fatigue 35
- Skin discolouration 35
- Decreased appetite 27
- Weight increased 24
- Melanocytic naevus 23
- Injection site pain 22
Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.
Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query
FDA prescribing information
Official US prescribing information. Dosing sections are intentionally not shown.
- Imcivree HUMAN PRESCRIPTION DRUG Rhythm Pharmaceuticals, Inc April 1, 2026
Source: DailyMed / openFDA
Change history
No changes since monitoring began on October 30, 2026.