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Imcivree (SETMELANOTIDE)

Rhythm · FDA-approved approved Recombinant protein Quality 51/100

Imcivree works by activating the melanocortin 4 receptor, a protein that helps regulate appetite and metabolism.

At a glance

Generic nameSETMELANOTIDE
SponsorRhythm
Drug classMelanocortin 4 Receptor Agonist [EPC]
TargetMelanocortin receptor 4
ModalityRecombinant protein
Therapeutic areaMetabolic
PhaseFDA-approved
First approval2020

Mechanism of action

Setmelanotide is an MC4 receptor agonist with 20-fold less activity at the melanocortin (MC3) and melanocortin (MC1) receptors. MC4 receptors in the brain are involved in regulation of hunger, satiety, and energy expenditure. In patients with obesity due to POMC, PCSK1, and LEPR deficiency associated with insufficient activation of the MC4 receptor, setmelanotide may re-establish MC4 receptor pathway activity to reduce hunger and promote weight loss through decreased caloric intake and increased energy expenditure. Nonclinical evidence shows that MC4 receptors are important for setmelanotide-regulated appetite and weight loss. The MC1 receptor is expressed on melanocytes, and activation of this receptor leads to accumulation of melanin and increased skin pigmentation independently of ultraviolet light [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)].

Approved indications

Common side effects

Key clinical trials

Patents

PatentExpiryType

Primary sources

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SourceUsed for
FDA labelMechanism, indications, dosing, boxed warnings, drug interactions
ClinicalTrials.govTrial enrolment, design, endpoints, results
FDA Orange BookPatents + exclusivity

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