Metabolic · FDA Approved
Setmelanotide (Imcivree)
FDA-approved
01 · Overview
A cyclic peptide melanocortin-4 receptor (MC4R) agonist designed to restore MC4R signaling in patients with obesity caused by genetic defects in the leptin-melanocortin pathway. Setmelanotide acts downstream of defects in POMC, PCSK1, or LEPR genes by directly activating MC4R, and in phase 3 trials it reduced weight and hunger scores in people with POMC or LEPR deficiency (PMID 33137293).
It is a targeted therapy for specific genetic and hypothalamic forms of obesity rather than common obesity.
02 · Research summary & key findings
FDA-approved in 2020 for obesity due to POMC, PCSK1, or LEPR deficiency; in phase 3 trials 80% of POMC and 45% of LEPR participants lost at least 10% of body weight at about 1 year (PMID 33137293). Approval later expanded to Bardet-Biedl syndrome (PMID 36356613) and, per the current label, acquired hypothalamic obesity, where BMI fell 16.5% (PMID 42418774). Common side effects include injection site reactions and skin hyperpigmentation (PMID 36356613).
03 · Regulatory status
Setmelanotide (Imcivree) has received FDA approval and is available for clinical use under appropriate medical supervision. Consult a qualified healthcare provider for prescribing information.
Setmelanotide (Imcivree) is an FDA-approved medicine prescribed for the conditions on its label. It is not part of our intake, so we do not propose protocols for it. If you think it may be relevant to you, talk to your own doctor. How to ask your doctor.
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04 · Administration routes
- Subcutaneous injection (daily)
References
- [1]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 Lancet Diabetes Endocrinol, 2020. PMID 33137293
- [2]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 Lancet Diabetes Endocrinol, 2022. PMID 36356613
- [3]Setmelanotide for the Treatment of Acquired Hypothalamic Obesity N Engl J Med, 2026. PMID 42418774
Primary literature
- PubMed: "Setmelanotide"
Peer-reviewed literature indexed by the National Library of Medicine.
- ClinicalTrials.gov: "Setmelanotide"
Registered interventional and observational studies, including status and phase.
- PubChem: "Setmelanotide"
Chemical structure, molecular properties, and bioactivity data.
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