IMCIVREE

PeakPeptide

setmelanotide

NDASUBCUTANEOUSSOLUTIONPriority Review
Approved
Nov 2020
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20

Mechanism of Action

Melanocortin 4 Receptor Agonists

Pharmacologic Class:

Melanocortin 4 Receptor Agonist

Clinical Trials (5)

NCT06760546Phase 3Recruiting

A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756)

Started Sep 2025
39 enrolled
Hypothalamic ObesityMultiple Pituitary Hormone Deficiency Genetic FormSepto-Optic Dysplasia+3 more
NCT06772597Phase 2Active Not Recruiting

A Study of Setmelanotide in Patients With Prader-Willi Syndrome

Started Mar 2025
18 enrolled
Prader-Willi SyndromeObesityHyperphagia
NCT06596135Phase 3Enrolling By Invitation

Open-Label Extension Study of Setmelanotide

Started Oct 2024
30 enrolled
Obesity Associated With Defects in Leptin-melanocortin Pathway
NCT05774756Phase 3Active Not Recruiting

A Trial of Setmelanotide in Acquired Hypothalamic Obesity

Started Apr 2023
120 enrolled
Hypothalamic Obesity
NCT04966741Phase 3Completed

Setmelanotide in Pediatric Participants With Rare Genetic Diseases of Obesity

Started Mar 2022
12 enrolled
Bardet-Biedl SyndromePOMC Deficiency ObesityPCSK1 Deficiency Obesity+1 more

Loss of Exclusivity

LOE Date
Jul 4, 2034
101 months away
Patent Expiry
Jul 4, 2034
Exclusivity Expiry
Dec 20, 2031

Patent Records (3)

Patent #ExpiryTypeUse Code
9458195
Oct 13, 2027
SubstanceProduct
8039435
Aug 21, 2032
SubstanceProduct
11129869
Jul 4, 2034
Product