Is Setmelanotide FDA approved?
This profile records Setmelanotide as FDA approved.
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Approval can be specific to a formulation, indication, and prescribing context, so review the regulatory and source details on this page.
Metabolic CATEGORY
Setmelanotide
THE GENETIC HUNGER CONTROLLER
RM-493; Imcivree
Setmelanotide (Imcivree) is a highly selective MC4R agonist FDA-approved for rare genetic obesity disorders like POMC, PCSK1, and LEPR deficiency. It works by activating the melanocortin-4 receptor to restore satiety signaling that's broken in these genetic conditions. It produces dramatic weight loss in patients who previously had no treatment options.
Setmelanotide
Setmelanotide
Setmelanotide
Setmelanotide Evidence Snapshot
How these guides are reviewed
REGULATORY STATUS
FDA-approved uses exist
DOSING GUIDANCE
Reviewed by our clinical team
LINKED EVIDENCE
2 research sources
CONTENT UPDATED
Jul 13, 2026
Dose and schedule recommendations shown below come from The Peptide App Clinical Team. Research links are provided so readers can inspect the supporting evidence directly. Review the sources.
Quick Answers About Setmelanotide
What dose does The Peptide App Clinical Team recommend for Setmelanotide?
Dose: 3 mg daily subcutaneously.
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Schedule: daily. Cycle: Ongoing as prescribed. This is clinical-team guidance for reference and does not replace individualized instructions from a licensed clinician.
What research supports this Setmelanotide guide?
This guide links to 2 curated or current research sources.
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Open the research section to inspect the source titles, publication details, study types, and available abstracts directly.
Studied Effects & Mechanisms
MC4R Activation
Selectively activates melanocortin-4 receptors
Satiety Restoration
Bypasses genetic defects to restore fullness signals
Thermogenesis
Increases sympathetic tone and energy expenditure
Genetic Bypass
Works downstream of POMC/LEPR genetic defects
Patients with POMC deficiency obesity
Those with PCSK1 deficiency obesity
Patients with LEPR deficiency obesity
Anyone with diagnosed genetic obesity syndrome
Those who failed other obesity treatments due to genetics
Setmelanotide Research
Live research temporarily unavailableThe live research feed did not return papers for this page. The curated references below remain available for crawlable source context.
RESEARCH REFERENCES