NDASUBCUTANEOUSSOLUTIONPriority Review
Approved
Nov 2020
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
Priority Review
IMCIVREE (setmelanotide) by Rhythm Pharmaceuticals is melanocortin 4 receptor agonists [moa]. First approved in 2020.
Drug data last refreshed 4h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
IMCIVREE (setmelanotide) is a subcutaneous melanocortin 4 receptor (MC4R) agonist approved in November 2020 for rare genetic obesity disorders. It works by activating the MC4R pathway in the brain to regulate appetite and energy expenditure in patients with specific genetic mutations affecting this pathway.
Peak8.0 years to LOE
Product is at peak commercial maturity with growing market presence; commercial teams are actively expanding market access and patient identification programs.
Mechanism of Action
Melanocortin 4 Receptor Agonists
Pharmacologic Class:
Melanocortin 4 Receptor Agonist
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
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
A Study of Setmelanotide in Patients With Prader-Willi Syndrome
Started Mar 2025
18 enrolled
Prader-Willi SyndromeObesityHyperphagia
Open-Label Extension Study of Setmelanotide
Started Oct 2024
30 enrolled
Obesity Associated With Defects in Leptin-melanocortin Pathway
A Trial of Setmelanotide in Acquired Hypothalamic Obesity
Started Apr 2023
143 enrolled
Hypothalamic Obesity
Setmelanotide in Pediatric Participants With Rare Genetic Diseases of Obesity
Started Mar 2022
12 enrolled
Bardet-Biedl SyndromePOMC Deficiency ObesityPCSK1 Deficiency Obesity+1 more
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.