Peptide
Setmelanotide (Imcivree)
Setmelanotide (brand name Imcivree) is an 8-amino-acid cyclic peptide that acts as a selective melanocortin-4 receptor (MC4R) agonist. It was FDA-approved in November 2020 as the first therapy for chronic weight management in patients with obesity due to POMC, PCSK1, or LEPR deficiency, and in 2022 for Bardet-Biedl syndrome (BBS). It works by restoring MC4R pathway signaling to reduce hyperphagia and promote weight loss.
- Updated
- How we grade
- 37 studies cited
Research notice. This page is for education and research. Peptides may not be FDA-approved for human use and may only be legally available for research. Talk to a qualified clinician before considering any peptide.
- Best evidence
- Grade A
- Conditions studied
- 2
- Outcomes
- 11
- Graded outcomes
- 5402
Evidence by condition
- Strong
- Moderate
- Limited
- Very limited
General
Key findings
- Weight Loss (Bardet-Biedl Syndrome)Improves (the measure goes down)
- Weight Loss (POMC/PCSK1 Deficiency)Improves (the measure goes down)
- Weight Loss (LEPR Deficiency)Improves (the measure goes down)
Studies cited
37 studies from PubMed
- Polymorphism of Melanocortin Receptor Genes-Association with Inflammatory Traits and Diseases.
- Real-life experience on efficacy and safety of setmelanotide treatment in prepubertal children.
- Adverse event profile of setmelanotide in obesity: an integrated assessment and systematic review using disproportionality analysis, case reports and meta-analysis.
- Real-World Efficacy and Safety of Setmelanotide in Adults With Monogenic or Syndromic Obesity: A Prospective Cohort Study.
- Risk of Glaucoma in Patients without Diabetes Using a Glucagon-Like Peptide 1 Receptor Agonist.
- Setmelanotide in patients aged 2-5 years with rare MC4R pathway-associated obesity (VENTURE): a 1 year, open-label, multicenter, phase 3 trial.
- Current and Emerging Parenteral and Peroral Medications for Weight Loss: A Narrative Review.
- Management of Acquired Hypothalamic Obesity After Childhood-Onset Craniopharyngioma-A Narrative Review.
- Approach to Obesity Treatment in Primary Care: A Review.
- Setmelanotide for the treatment of acquired hypothalamic obesity: a phase 2, open-label, multicentre trial.
- Quality of life improvements following one year of setmelanotide in children and adult patients with Bardet-Biedl syndrome: phase 3 trial results
- Interview-Based Patient- and Caregiver-Reported Experiences of Hunger and Improved Quality of Life with Setmelanotide Treatment in Bardet-Biedl Syndrome
- An evaluation of setmelanotide injection for chronic weight management in adult and pediatric patients with obesity due to Bardet-Biedl syndrome
- Setmelanotide: a promising advancement for pediatric patients with rare forms of genetic obesity
- Efficacy and Safety of Setmelanotide, a Melanocortin-4 Receptor Agonist, for Obese Patients: A Systematic Review and Meta-Analysis
- Efficacy and Safety of Setmelanotide, a Melanocortin-4 Receptor Agonist, for Obese Patients: A Systematic Review and Meta-Analysis.
- An update on peptide-based therapies for type 2 diabetes and obesity.
- Clinical Trials in Prader-Willi Syndrome: A Review.
- Setmelanotide for controlling weight and hunger in Bardet-Biedl syndrome
- Setmelanotide: A Novel Targeted Treatment for Monogenic Obesity
- Drugs for Treating Obesity.
- Quality of life outcomes in two phase 3 trials of setmelanotide in patients with obesity due to LEPR or POMC deficiency.
- Natural History of Obesity Due to POMC, PCSK1, and LEPR Deficiency and the Impact of Setmelanotide.
- A systematic review of licensed weight-loss medications in treating antipsychotic-induced weight gain and obesity in schizophrenia and psychosis.
- Efficacy 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 efficacy and safety of setmelanotide in individuals with Bardet-Biedl syndrome or Alström syndrome: Phase 3 trial design
- The melanocortin pathway and energy homeostasis: From discovery to obesity therapy.
- Pharmacotherapy of obesity: An update.
- Next Generation Antiobesity Medications: Setmelanotide, Semaglutide, Tirzepatide and Bimagrumab: What do They Mean for Clinical Practice?
- Setmelanotide (Imcivree) for rare genetic forms of obesity.
- Efficacy 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
- Effect of setmelanotide, a melanocortin-4 receptor agonist, on obesity in Bardet-Biedl syndrome
- Setmelanotide: what does it mean for clinical care of patients with obesity?
- Setmelanotide treatment in a 2-year-old patient with POMC deficiency
- Insights into the Allosteric Mechanism of Setmelanotide (RM-493) as a Potent and First-in-Class Melanocortin-4 Receptor (MC4R) Agonist To Treat Rare Genetic Disorders of Obesity through an in Silico Approach.
- Setmelanotide, a Novel, Selective Melanocortin Receptor-4 Agonist Exerts Anti-inflammatory Actions in Astrocytes and Promotes an Anti-inflammatory Macrophage Phenotype.
- Proof of Concept for POMC Deficiency: First Experience with Setmelanotide Treatment