Clascoterone
As of the edition of 20 October 2026, Clascoterone is a small molecule: marketed, first approved in 2020 (US); acts on AR; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2025
- Kind
- Small molecule
- Brand name
- Winlevi
- First approved
- 26 August 2020 (US)
- Approvals on record
- 3 in 3 regions
- Holder of the most recent approval
- SUN FARMACĂUTICA DO BRASIL LTDA; 3 holders in all
- Registered trials
- 21, 0 stopped early
- Disease areas
- Skin and connective tissue; Cancer
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
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 Clascoterone.
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 |
|---|---|---|
| AR | Androgen receptor | P10275 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 2 | 1 | 1 | 0 |
| Phase 2 | 6 | 4 | 2 | 0 |
| Phase 3 | 7 | 5 | 2 | 0 |
| Phase 4 | 6 | 5 | 1 | 0 |
| All trials | 21 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Cassiopea | Originator and Lead sponsor of trials | 2015 to now |
| SUN Pharmaceutical Industries | Acquired holder and Lead sponsor of trials | 2021 to now |
| Cassiopea | Applicant | 2025 to now |