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Weight Loss FDA Approved

Setmelanotide

An FDA-approved MC4R agonist marketed as Imcivree for specific rare genetic forms of obesity.

MC4RFDA ApprovedRare DiseaseObesityImcivree

Also referenced as: Imcivree, RM-493

Also appears in: Hormone

Status
FDA Approved

This peptide maps to at least one regulated medical product or label context in the United States.

Category
Weight Loss

Primary lane: Weight Loss. Also surfaces under Hormone for browsing and discovery.

Aliases
2

Imcivree, RM-493

Signal depth
High

FDA label signal · 29 trials · 197 PubMed results


What setmelanotide is

Setmelanotide is an MC4R agonist sold as Imcivree, and it is already an FDA-approved treatment for specific rare genetic and syndromic forms of obesity.

Why it matters

It gives the library a much-needed example of an obesity peptide that is both approved and highly specialized. Unlike semaglutide or tirzepatide, setmelanotide is not meant for general obesity.

Regulatory context

Setmelanotide is FDA approved in the United States for specific labeled indications tied to rare genetic obesity syndromes.

Practical reading note

Setmelanotide is a good reminder that “obesity peptide” does not always mean broad consumer use. Some of the most important drugs in the category are highly indication-specific.