Afamelanotide
As of the edition of 20 October 2026, Afamelanotide is a protein: marketed, first approved in 2014 (EU); acts on MC1R; US protection ended in 2026.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2019
- Kind
- Protein
- Brand name
- Scenesse
- First approved
- 22 December 2014 (EU)
- Approvals on record
- 2 in 2 regions
- Holder of the most recent approval
- Clinuvel; 2 holders in all
- Registered trials
- 22, 0 stopped early
- Disease areas
- Skin and connective tissue; Inherited and neonatal; Nutrition and metabolism; Digestive system; Cancer; Heart and blood vessels
US protection
US protection ended in 2026.
The last listed US exclusivity ended in 2026. The application that gives this date is held by Clinuvel.
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 product1 listing counts 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 Afamelanotide.
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 |
|---|---|---|
| MC1R | Melanocyte-stimulating hormone receptor | Q01726 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 1 | 0 | 0 |
| Phase 1 | 3 | 3 | 0 | 0 |
| Phase 2 | 13 | 9 | 0 | 0 |
| Phase 3 | 5 | 5 | 0 | 0 |
| All trials | 22 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Clinuvel | Applicant and Lead sponsor of trials | 2007 to now |