Setmelanotide comment watch save

  • FDA APPROVAL DATE: 11/25/2020
  • CLINICALLY IMPORTANT, POTENTIALLY HAZARDOUS INTERACTIONS WITH:
    None known
  • PREGNANCY: Setmelanotide should be discontinued when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus.

Setmelanotide is not approved for use in neonates or infants due to the presence of an excipient (benzyl alcohol) in the formulated product.

Setmelanotide is indicated for chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency confirmed by genetic testing demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance.
Setmelanotide is not indicated for the treatment of patients with the following conditions as it would not be expected to be effective:
• obesity due to suspected POMC, PCSK1, or LEPR deficiency with POMC, PCSK1, or
LEPR variants classified as benign or likely benign.
• other types of obesity not related to POMC, PCSK1 or LEPR deficiency, including
obesity associated with other genetic syndromes and general (polygenic) obesity.

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Page last updated 06/30/2025

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Incidence

<1% 1‑5% 5‑10% 10‑15% 15‑20% 20‑30% >30%

Seriousness

Hospitalization possible
Life threatening
Fatal

Warnings in other populations

BreastfeedingBreast feeding

GeriatricGeriatric

PediatricPediatric

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