IMCIVREE (setmelanotide acetate)
IMCIVREE is a melanocortin 4 (MC4) receptor agonist indicated for chronic weight management (to reduce excess body weight and maintain weight reduction long term) in adults and pediatric patients aged 2 years and older with obesity due to: * Bardet-Biedl syndrome (BBS). * Pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency. For POMC, PCSK1, or LEPR deficiency, variants must be confirmed by an FDA-approved test and interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS). IMCIVREE is not indicated for patients with variants classified as benign or likely benign, or for general polygenic obesity.
How IMCIVREE Works
Setmelanotide is an MC4 receptor agonist. MC4 receptors in the brain are key regulators of hunger, satiety, and energy expenditure. In patients with BBS or deficiencies in POMC, PCSK1, or LEPR, the MC4 pathway is insufficiently activated. Setmelanotide re-establishes MC4 receptor pathway activity to reduce food intake (promoting satiety) and increase energy expenditure. The drug also activates MC1 receptors expressed on melanocytes, which can lead to increased skin pigmentation independent of ultraviolet light exposure. It also exhibits minor activity at MC3 receptors.
Details
- Status
- Prescription
- First Approved
- 2020-11-25
- Patent Cliff
- 2034
- Routes
- SUBCUTANEOUS
- Dosage Forms
- SOLUTION
IMCIVREE Approval History
What IMCIVREE Treats
5 indicationsIMCIVREE is approved for 5 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Obesity
- Bardet-Biedl Syndrome
- Pro-opiomelanocortin Deficiency
- Proprotein Convertase Subtilisin/Kexin Type 1 Deficiency
- Leptin Receptor Deficiency
IMCIVREE Competitive Set
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Indication competitors
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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3 of 14FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Active Pipeline
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Trial Timeline
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
IMCIVREE FDA Label Details
Indications & Usage
FDA Label (PDF)IMCIVREE is indicated for the treatment of Obesity; Bardet-Biedl Syndrome; Pro-opiomelanocortin Deficiency; Proprotein Convertase Subtilisin/Kexin Type 1 Deficiency; Leptin Receptor Deficiency.
IMCIVREE Patents & Exclusivity
Patents (3 active)
Exclusivity
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Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2034
- • 3 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 14 similar drugs
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.