Setmelanotide
Approved medicineGet notified when the evidence changes.
The FDA has approved a version of this as a medicine, so it has been through large studies in people.
Compiled and reviewed by the PeptideSearch Editorial Team · Status checked 2026-08-04
Also called Imcivree / RM-493
An approved prescription drug for rare genetic forms of obesity.
Official status: Not nominated for 503A compounding · Checked 2026-08-04
Can a doctor prescribe this?
- Small pharmacy (503A)
- Never put forward to FDA
- Large outsourcing facility (503B)
- Never put forward to FDA
Approved as Imcivree for specific genetic conditions. Prescription-only.
503A is a pharmacy making a single prescription for one patient. 503B is a facility making batches. They are governed by separate lists. Where a category is shown, it is a position on the FDA's list of substances that have been put forward and are still being worked through — not the final list, which is set by rulemaking. Category 1 means the FDA does not plan to act against a pharmacy that makes it while the review runs.
Lab suppliers we list: 1
Doses used in research
Taken word for word from the studies and trials listed on this page. This is not a recommendation and not a dose for anyone to take.
- Study in peopleQuality of life improvements with setmelanotide treatment in acquired hypothalamic obesity: TRANSCEND trial interview results from US participants.
Frontiers in behavioral neuroscience · 2026
- Study in peopleSetmelanotide for the Treatment of Acquired Hypothalamic Obesity.
The New England journal of medicine · 2026
- Study in peopleImpact of Setmelanotide on Metabolic Syndrome Risk in Patients With Bardet-Biedl Syndrome.
The Journal of clinical endocrinology and metabolism · 2025
- Study in peopleSetmelanotide in patients aged 2-5 years with rare MC4R pathway-associated obesity (VENTURE): a 1 year, open-label, multicenter, phase 3 trial.
The lancet. Diabetes & endocrinology · 2025
- Study in peopleSetmelanotide for the treatment of acquired hypothalamic obesity: a phase 2, open-label, multicentre trial.
The lancet. Diabetes & endocrinology · 2024
- Study in peopleMonoallelic pathogenic variants in LEPR do not cause obesity.
American journal of human genetics · 2024
- Study in peopleQuality of life improvements following one year of setmelanotide in children and adult patients with Bardet-Biedl syndrome: phase 3 trial results.
Orphanet journal of rare diseases · 2023
- Study in peopleEfficacy and safety of setmelanotide, a melanocortin-4 receptor agonist, in patients with Bardet-Biedl syndrome and Alström syndrome: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial with an open-label period.
The lancet. Diabetes & endocrinology · 2022
- Study in peopleQuality of life outcomes in two phase 3 trials of setmelanotide in patients with obesity due to LEPR or POMC deficiency.
Orphanet journal of rare diseases · 2022
- Study in peopleA Melanocortin-4 Receptor Agonist Induces Skin and Hair Pigmentation in Patients with Monogenic Mutations in the Leptin-Melanocortin Pathway.
Skin pharmacology and physiology · 2021
- Study in peopleEfficacy and safety of setmelanotide, an MC4R agonist, in individuals with severe obesity due to LEPR or POMC deficiency: single-arm, open-label, multicentre, phase 3 trials.
The lancet. Diabetes & endocrinology · 2020
- Study in peopleProopiomelanocortin Deficiency Treated with a Melanocortin-4 Receptor Agonist.
The New England journal of medicine · 2016
- Study in peopleRM-493, a melanocortin-4 receptor (MC4R) agonist, increases resting energy expenditure in obese individuals.
The Journal of clinical endocrinology and metabolism · 2015
- Data from people, not a trialMelanocortin-4 Receptor Regulation of Endocrine Axes and Clinical Effects of Setmelanotide.
The Journal of clinical endocrinology and metabolism · 2026
- Data from people, not a trialClinical Improvements with Setmelanotide in a 2-Year-Old Patient with Hyperphagia and Obesity due to Leptin Receptor Deficiency: A Case Report.
Obesity facts · 2026
- Data from people, not a trialSetmelanotide in Bardet-Biedl Syndrome: A Case Report.
Pediatric dermatology · 2026
- Data from people, not a trialSetmelanotide in Bardet-Biedl Syndrome: A 52-Week Comparison of Phase 3 Trial Participants With a Matched Registry Cohort.
Obesity (Silver Spring, Md.) · 2026
- Data from people, not a trialImpact of the Melanocortin-4 Receptor Agonist Setmelanotide on MASLD and Kidney Function in Bardet-Biedl Syndrome.
The Journal of clinical endocrinology and metabolism · 2026
- Data from people, not a trialSafety and effectiveness of setmelanotide in young patients with severe obesity due to craniopharyngioma: a real world monocentric experience.
Journal of endocrinological investigation · 2026
- Data from people, not a trialCorrection to "Setmelanotide in Bardet-Biedl Syndrome: A 52-Week Comparison of Phase 3 Trial Participants With a Matched Registry Cohort".
Obesity (Silver Spring, Md.) · 2026
- Data from people, not a trialCase Report: Effect of setmelanotide treatment in a young patient with acquired hypothalamic obesity following <i>Escherichia coli</i> sepsis and meningoencephalitis with brain abscess.
Frontiers in endocrinology · 2026
- Data from people, not a trialResolution of chronic idiopathic urticaria with setmelanotide in a patient with Bardet-Biedl Syndrome: A case report.
Obesity pillars · 2025
- Data from people, not a trialCase Report: Improvement in cognitive functioning following setmelanotide initiation in a patient with Bardet-Biedl syndrome.
Frontiers in endocrinology · 2025
- Data from people, not a trialReal-World Efficacy and Safety of Setmelanotide in Adults With Monogenic or Syndromic Obesity: A Prospective Cohort Study.
Obesity (Silver Spring, Md.) · 2025
- Animal study, rats or miceSetmelanotide alleviates diabetes-associated cognitive impairment by interrupting the binding of ICAM-1 and JIP1 in endothelial cells of the blood-brain barrier.
Metabolism: clinical and experimental · 2026
- Animal study, rats or miceModulating food intake by nasal application of peptides targeting melanocortin 4 receptor and ghrelin receptor systems.
Brain communications · 2026
- Animal study, rats or miceMelanocortin receptor 4 agonist setmelanotide treats opioid-induced respiratory depression
2026
- Animal study, rats or miceMice lacking β-arrestin-2 in melanocortin 4 receptor-expressing neurons show marked metabolic deficits.
JCI insight · 2026
- Animal study, rats or miceAttractin-Like Protein 1 (ATRNL1): An Essential Partner of MC4R to Regulate Body Weight
2026
- Animal study, rats or miceDiscovery of TL10: A Soluble and Long-Acting MC4R Agonist with Tunable Lipidation for Sustained Pharmacological Activity.
Journal of medicinal chemistry · 2026
- Animal study, rats or miceSetmelanotide-mediated MC4R activation improves hypothalamic obesity via CaMKK2/AMPK pathways.
Frontiers in pharmacology · 2025
- Animal study, rats or miceThe MC4R agonist, setmelanotide, is associated with an improvement in hypercapnic chemosensitivity and weight loss in male mice.
Respiratory physiology & neurobiology · 2025
- Animal study, rats or miceEvaluation of a melanocortin-4 receptor (MC4R) agonist (Setmelanotide) in MC4R deficiency.
Molecular metabolism · 2017
- Lab dish studyThe role of pH changes during remote loading of setmelanotide in PLGA microspheres.
International journal of pharmaceutics · 2026
- Lab dish studyIncorporation of Three Extracyclic Arginine Residues into a Melanocortin Macrocyclic Agonist (c[Pro-His-DPhe-Arg-Trp-Dap-Lys(Arg-Arg-Arg-Ac)-DPro]) Decreases Food Intake When Administered Intrathecally or Subcutaneously Compared to a Macrocyclic Ligand Lacking Extracyclic Arginine Residues (c[Pro-His-DPhe-Arg-Trp-Dap-Ala-DPro)].
ACS pharmacology & translational science · 2024
- Lab dish studyAqueous remote loading of setmelanotide in poly(lactic-co-glycolic acid) microspheres for long-term obesity treatment.
Journal of controlled release : official journal of the Controlled Release Society · 2023
- Drug information page, not a studyBardet-Biedl Syndrome
2026
- Drug information page, not a studySetmelanotide (Imcivree): CADTH Reimbursement Recommendation: Indication: For weight management in adult and pediatric patients 6 years of age and older with obesity due to Bardet-Biedl syndrome
2023
- Drug information page, not a studySetmelanotide (Imcivree): CADTH Reimbursement Review: Therapeutic area: Bardet-Biedl syndrome
2023
- Drug information page, not a studySetmelanotide
2006
- Effectiveness and Safety of Setmelanotide in a Patient With a Heterozygous PCSK1 Deficiency.
Obesity (Silver Spring, Md.) · 2026
- Melanocortin-4 Receptor Agonist Treatment of Hypothalamic Obesity in ROHHAD Syndrome.
Pediatrics · 2026
- SAR investigation and synergistic optimization of setmelanotide yields a potent, selective, and soluble MC4R agonist.
Bioorganic chemistry · 2026
- Early-Onset Monogenic Obesity due to Leptin Receptor Deficiency: Fatal Outcome in Childhood in the Era of Precision Therapy.
Hormone research in paediatrics · 2026
- Melanocortin 4 receptor signalling in sleep-disordered breathing.
The Journal of physiology · 2026
- Quality of life, morbidity, mortality, and long-term prognosis after craniopharyngioma.
Frontiers in endocrinology · 2026
- Setmelanotide Response Variability in Two Genetically Confirmed Pediatric Kidney Transplant Recipients with Bardet-Biedl Syndrome.
International journal of molecular sciences · 2026
- Rationale of renewed efforts in developing MC4R modulators to treat metabolic disorders.
Acta pharmaceutica Sinica. B · 2026
- MC4R Variants Modulate α-MSH and Setmelanotide Induced Cellular Signaling at Multiple Levels.
The Journal of clinical endocrinology and metabolism · 2024
- Structure elucidation of a human melanocortin-4 receptor specific orthosteric nanobody agonist.
Nature communications · 2024
- MC4R agonism promotes durable weight loss in patients with leptin receptor deficiency.
Nature medicine · 2018
- Review of earlier workA systematic literature review of economic evaluations of setmelanotide.
European journal of clinical pharmacology · 2026
- Review of earlier work<i>In silico</i> characterization of MC4R variants reveals insights into Setmelanotide pharmacogenomics and personalized medicine for obesity.
Personalized medicine · 2026
- Review of earlier workSequential liraglutide and setmelanotide therapy in Bardet-Biedl Syndrome: metabolic and renal outcomes in a real-world case report and literature review.
Nephron · 2026
- Review of earlier workHunger, satiety, and eating behavior after craniopharyngioma - narrative review on current management and future therapeutic perspectives.
Frontiers in endocrinology · 2026
- Review of earlier workRecent Advances in Glucagon-Like Peptide-1 Receptor and Melanocortin-4 Receptor Agonists for the Treatment of Obesity and Type 2 Diabetes.
Hormone and metabolic research = Hormon- und Stoffwechselforschung = Hormones et metabolisme · 2026
- Review of earlier workCurrent and Emerging Parenteral and Peroral Medications for Weight Loss: A Narrative Review.
Diseases (Basel, Switzerland) · 2025
- Review of earlier workSetmelanotide: A Melanocortin-4 Receptor Agonist for the Treatment of Severe Obesity Due to Hypothalamic Dysfunction.
TouchREVIEWS in endocrinology · 2024
- Review of earlier workCould setmelanotide be the game-changer for acquired hypothalamic obesity?
Frontiers in endocrinology · 2023
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