Setmelanotide
As of the edition of 20 October 2026, Setmelanotide is a protein: marketed, first approved in 2020 (US); acts on MC4R; US protection ends in 2032.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2021
- Kind
- Protein
- Brand name
- Imcivree
- First approved
- 25 November 2020 (US)
- Approvals on record
- 2 in 2 regions
- Holder of the most recent approval
- Rhythm Pharmaceuticals; 2 holders in all
- Registered trials
- 23, 0 stopped early
- Disease areas
- Nutrition and metabolism; Inherited and neonatal; Nervous system; Eye; Pregnancy and women's health; Urinary and reproductive
US protection
US protection ends in 2032.
The last listed US drug-substance patent ends in 2032. The application that gives this date is held by Rhythm Pharmaceuticals.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product8 listings count towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Setmelanotide.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| MC4R | Melanocortin receptor 4 | P32245 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 0 | 0 | 0 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 9 | 6 | 2 | 0 |
| Phase 3 | 10 | 8 | 2 | 0 |
| Phase 4 | 2 | 1 | 1 | 0 |
| All trials | 23 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Rhythm Pharmaceuticals | Originator, Applicant and Lead sponsor of trials | 2020 to now |