Setmelanotide
FDA-approved drugAlso known as: 920014-72-8, RM-493, BIM-22493, Setmelanotida, N7T15V1FUY, (4R,7S,10S,13R,16S,19R,22R)-22-[[(2S)-2-acetamido-5-(diaminomethylideneamino)pentanoyl]amino]-13-benzyl-10-[3-(diaminomethylideneamino)propyl]-16-(1H-imidazol-5-ylmethyl)-7-(1H-indol-3-ylmethyl)-19-methyl-6,9,12,15,18,21-hexaoxo-1,2-dithia-5,8,11,14,17,20-hexazacyclotricosane-4-carboxamide, Setmelanotidum, DTXSID501032320
Setmelanotide (920014-72-8, RM-493, BIM-22493) is classified under melanocortin agonists, an FDA-approved drug.
Read the full guide: what the research shows on Setmelanotide →What the research says
Aggregated from the cited literature below. We summarize sources — we don't author claims.
Setmelanotide is described in the provided sources as a melanocortin-4 receptor (MC4R) agonist investigated for obesity/hyperphagia associated with genetic or hypothalamic etiologies, including Bardet-Biedl syndrome, Alström syndrome, MC4R pathway deficiencies, and acquired hypothalamic obesity. (PMIDs: 36356613, 38697184, 29031731, 33137293, 33638809)
Mechanism (as reported)
Research described setmelanotide as an MC4R agonist that acts on neurons in the leptin-melanocortin pathway involved in bodyweight regulation and may affect melanocortin signalling after hypothalamic injury. (PMIDs: 36356613, 38697184, 33137293, 29031731)
Key findings (each cites a source)
- A multicentre, randomized, double-blind, placebo-controlled phase 3 trial reported that after 52 weeks, a proportion of patients aged 12 years or older with Bardet-Biedl syndrome achieved at least a 10% reduction in bodyweight when treated with setmelanotide, while results for Alström syndrome were described as inconclusive. [PMID 36356613]
- In the Bardet-Biedl syndrome/Alström syndrome phase 3 trial, the most commonly reported treatment-emergent adverse events included skin hyperpigmentation and injection site erythema, and the report stated that serious adverse events occurred but none were considered related to setmelanotide. [PMID 36356613]
- A phase 2, open-label, multicentre trial in acquired hypothalamic obesity reported that the primary endpoint was met, with most enrolled patients achieving at least a 5% reduction in BMI after 16 weeks compared with a historic control rate. [PMID 38697184]
- In the acquired hypothalamic obesity phase 2 trial, frequent adverse events included nausea, vomiting, skin hyperpigmentation, and diarrhoea; the report also described longer-term extension follow-up with mean BMI change over time among participants continuing into an extension study. [PMID 38697184]
- Two single-arm, open-label, multicentre phase 3 trials reported that in severe obesity due to POMC or LEPR deficiency, a proportion of participants achieved at least 10% weight loss at approximately 1 year, and hunger scores decreased in the reported analyses. [PMID 33137293]
- In the POMC and LEPR deficiency phase 3 trials, common adverse events included injection site reaction and hyperpigmentation, and the report stated that no serious treatment-related adverse events occurred. [PMID 33137293]
Independent test grades
No independent third-party test data is available for Setmelanotide yet. Our test grades are aggregated from Finnrick, which independently tests a subset of research peptides — many approved drugs and newer or niche compounds aren't covered.
Research literature (13)
Consolidated from PubMed — each links to the original record.
- Setmelanotide for the Treatment of Acquired Hypothalamic Obesity.
Miller JL, van Santen HM, Phillips SA, Hamilton J, Aberle J, Sathyapalan T · The New England journal of medicine · 2026 · PMID 42418774
- Craniopharyngioma - What's next.
Müller HL · Pituitary · 2025 · PMID 41205018
- Pharmacotherapy for Obesity: Recent Updates.
Fredrick TW, Camilleri M, Acosta A · Clinical pharmacology : advances and applications · 2025 · PMID 40995421
- Setmelanotide in patients aged 2-5 years with rare MC4R pathway-associated obesity (VENTURE): a 1 year, open-label, multicenter, phase 3 trial.
Argente J, Verge CF, Okorie U, Fennoy I, Kelsey MM, Cokkinias C · The lancet. Diabetes & endocrinology · 2025 · PMID 39549719
- Setmelanotide for the treatment of acquired hypothalamic obesity: a phase 2, open-label, multicentre trial.
Roth CL, Scimia C, Shoemaker AH, Gottschalk M, Miller J, Yuan G · The lancet. Diabetes & endocrinology · 2024 · PMID 38697184
- Clinical Trials in Prader-Willi Syndrome: A Review.
Mahmoud R, Kimonis V, Butler MG · International journal of molecular sciences · 2023 · PMID 36768472
- Current Treatments for Patients with Genetic Obesity.
Faccioli N, Poitou C, Clément K, Dubern B · Journal of clinical research in pediatric endocrinology · 2023 · PMID 37191347
FAQ
- What is Setmelanotide?
- Setmelanotide (920014-72-8, RM-493, BIM-22493) is classified under melanocortin agonists, an FDA-approved drug. Research goals associated with it include metabolic & weight.
- Is Setmelanotide FDA-approved?
- Yes — Setmelanotide is approved by the FDA (marketed as 920014-72-8, RM-493).
- What does the research on Setmelanotide say?
- peptideone aggregates 13 references from PubMed for Setmelanotide. The summary on this page digests them with citations; we summarize sources and make no efficacy claims.