MetabolicFDA Approved

Setmelanotide (Imcivree)

Subcutaneous injection (daily)

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.

Mechanism of Action

It represents one of the first precision medicines for genetically defined obesity..

Research Summary & Key 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.

Clinical Status

FDA Approved

Setmelanotide (Imcivree) has received FDA approval and is available for clinical use under appropriate medical supervision. Consult a qualified healthcare provider for prescribing information.

Administration Routes

Subcutaneous injection (daily)

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Disclaimer: This information is provided for educational and research purposes only. It is not intended as medical advice, diagnosis, or treatment. Always consult a qualified healthcare provider before starting any peptide therapy. The Peptide Association does not endorse or recommend any specific treatment protocol.