Benefits
Specific hypothalamic, syndromic or genetic obesity indications; eligible ages and diagnostic requirements vary.
Named U.S. presentation only; selected label sections.
Peptide library
Setmelanotide
Your guide to this compound.
Mechanism illustrationEnlarge
Evidence in perspective
The named U.S. product label is the appropriate source for its approved use, contraindications and handling. IMCIVREE subcutaneous setmelanotide: effective elimination half-life is approximately 11 hours; median time to peak is about eight hours. Renal impairment and pediatric age/weight affect exposure, so the adult estimate must not define every patient’s regimen. A label extraction is not an independent appraisal of every supporting trial or approval of other products with the same ingredient.
About this assessment
Named U.S. product label sections assessed.
Product-specific editorial extraction. Complete clinical review and clinician sign-off remain pending; other jurisdictions are not inferred.
Editorial assessment · 2026-09-07
Who was studied
The population specified by this product label; other indications and jurisdictions remain outside this check.
What the sources found
Specific hypothalamic, syndromic or genetic obesity indications; eligible ages and diagnostic requirements vary.
Regulatory scope
U.S. label record for NDA213793. This does not confer authorization on other products using the ingredient name.
What remains unknown
Named-product label sections were expanded for pharmacokinetics, contraindications and selected handling or interaction details on September 7, 2026. This is not a complete trial-program appraisal or clinician sign-off. Other formulations, patient-specific decisions and other jurisdictions require separate assessment.
How it works
IMCIVREE setmelanotide 10 mg/mL multidose vial
Consult the product label for pharmacology. A mechanism does not extend its approved indications.
Approved product exists
Approval applies to a particular product and indication. It does not extend to every use, route, compounded preparation or research vial sold under the same compound name. Check the current prescribing information.
Reported adverse effects
- Depression/suicidal ideation, sexual-arousal disturbances and hypersensitivity are important warnings.
Named U.S. presentation only; selected label sections.
Contraindications
- IMCIVREE: previous serious hypersensitivity to setmelanotide or excipients. Depression, suicidal thoughts and sexual-arousal disturbances are separate warnings requiring assessment.
Approved product exists
Approval applies to a particular product and indication. It does not extend to every use, route, compounded preparation or research vial sold under the same compound name. Check the current prescribing information.
Sources used for this snapshot
Claim-by-claim evidence
Adverseeffects
Depression/suicidal ideation, sexual-arousal disturbances and hypersensitivity are important warnings.
Named U.S. presentation only; selected label sections.
Storage
IMCIVREE: unopened refrigerated until expiry. After removal, ≤25°C for up to 30 days with brief excursions to 30°C; after puncture discard after 30 days. Earliest applicable limit or expiry governs.
Named U.S. presentation only; selected label sections.
Pharmacokinetics
IMCIVREE subcutaneous setmelanotide: effective elimination half-life is approximately 11 hours; median time to peak is about eight hours. Renal impairment and pediatric age/weight affect exposure, so the adult estimate must not define every patient’s regimen.
Named U.S. product only; label revision 20260401. Educational extraction, not complete clinical review.
Contraindications
IMCIVREE: previous serious hypersensitivity to setmelanotide or excipients. Depression, suicidal thoughts and sexual-arousal disturbances are separate warnings requiring assessment.
Named U.S. product only; label revision 20260401. Educational extraction, not complete clinical review.
References
IMCIVREE setmelanotide 10 mg/mL multidose vial. U.S. structured product label, effective 20260401. Selected sections only.
Catalog review date: Sep 7, 2026. This date alone does not establish independent clinical review.