Setmelanotide (Imcivree)
Overview
A cyclic peptide melanocortin-4 receptor (MC4R) agonist designed to restore MC4R signaling in patients with obesity caused by genetic deficiencies in the leptin-melanocortin pathway. Setmelanotide bypasses upstream defects in POMC, PCSK1, or LEPR genes by directly activating MC4R, reducing hunger and increasing energy expenditure. It represents one of the first precision medicines for genetically defined obesity.
Key Research Findings
FDA-approved in 2020 for chronic weight management in patients 6 years and older with POMC, PCSK1, or LEPR deficiency obesity. Clinical trials showed 25-51% body weight reduction in responders. Expanded approval in 2022 to include Bardet-Biedl syndrome. Most common side effects include injection site reactions and skin hyperpigmentation.
Subcutaneous injection (daily)
FDA Approved
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