clascoterone
Trade name: Winlevi
Approved
Aug 26, 2020
Clascoterone, sold under the brand name Winlevi, is an antiandrogen medication which is used topically in the treatment of acne. The medication is used as a cream by application to the skin, for instance the face and scalp. Clascoterone is an antiandrogen, or antagonist of the androgen receptor (AR), the biological target of androgens such as testosterone and dihydrotestosterone. It shows minimal systemic absorption when applied to skin. — Wikipedia
Clinical trial activity
19 trials · 15 clinical orgs · 2 marketing orgs
Earliest trial started Jun 1, 2012 (NCT01631474)
Timeline
2010s
- Jan 1, 2012
Earliest Phase 2 Sponsor(trial)
- Jan 1, 2015
Cassiopea SpA — Earliest Phase 3 Sponsor(trial)
- Jan 1, 2018
Cassiopea SpA — Earliest Phase 1 Sponsor(trial)
2020s
- Aug 26, 2020
Sun Pharmaceuticals — Earliest FDA Approval
- Aug 26, 2020
Cassiopea SpA — Marketing Organization
- Aug 26, 2020
Sun Pharmaceuticals — Marketing Organization
- Aug 26, 2020
Sun Pharmaceuticals — NDA Secondary Org
- Aug 26, 2020
Sun Pharmaceuticals — NDA Organization
Indications
Approved for
Mechanism of action
- Androgen ReceptorANTAGONIST
AR antagonist
Approval history
- approvedAug 26, 2020
Chemistry & pharmacology
SMILES
CCC(=O)O[C@@]1(CCC2C3CCC4=CC(=O)CC[C@]4(C)C3CC[C@]12C)C(=O)CO- Mol. weight
- 402.53 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Racemic Mixture
- Inorganic
- No
- Polymer
- No
- Availability
- Prescription Only
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaClascoterone ↗
- ChEMBLCHEMBL3590187 ↗
- ChEMBLCHEMBL3545016 ↗
Also known as
- cb-03-01
- cb-03-01
- cb-03-01
- cb-03-01
- cortexolone 17alpha-propionate
- cortexolone 17alpha-propionate
- cortexolone 17alpha-propionate
- cortexolone 17alpha-propionate
- cortexolone 17α-propionate
- cortexolone 17α-propionate
- cortexolone 17α-propionate
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06952517 | Phase 2 | Mar 14, 2025 | Narrows Institute for Biomedical Research, State University of New York, Brooklyn, Sun Pharmaceuticals |
| NCT06286397 | Phase 2 | Nov 1, 2024 | University of Pennsylvania |
| NCT06454708 | Phase 1 | Jul 31, 2024 | Sunshine Lake Pharma Co., Ltd. |
| NCT06425900 | Phase 4 | Jul 1, 2024 | Sun Pharmaceuticals |
| NCT06415279 | Phase 4 | Feb 29, 2024 | Sun Pharmaceuticals |
| NCT06415292 | Phase 4 | Nov 27, 2023 | Sun Pharmaceuticals |
| NCT06415305 | Phase 4 | Sep 1, 2023 | Sun Pharmaceuticals |
| NCT05914805 | Phase 3 | Jun 30, 2023 | Canfield Scientific Inc., Cassiopea SpA, Ergomed, ICON, Pharmapace |
| NCT05910450 | Phase 3 | Jun 30, 2023 | Canfield Scientific Inc., Cassiopea SpA, Ergomed, ICON, Pharmapace |
| NCT05891795 | Phase 1/Phase 2 (Phase 2) | Jun 1, 2023 | Stanford University |
| NCT03863145 | Early Phase 1 (Phase 1) | Jul 31, 2019 | Cosmo Technologies Ltd |
| NCT03665194 | Phase 1 | Jun 6, 2018 | Cassiopea SpA, Richmond Pharmacology |
| NCT02720627 | Phase 2 | Oct 1, 2016 | Cassiopea SpA |
| NCT02682264 | Phase 3 | Mar 1, 2016 | Cassiopea SpA |
| NCT02608476 | Phase 3 | Nov 1, 2015 | Cassiopea SpA |
| NCT02608450 | Phase 3 | Nov 1, 2015 | Cassiopea SpA |
| NCT02279823 | Phase 2 | Oct 1, 2014 | Intrepid Therapeutics, Inc., Therapeutics, Inc. |
| NCT01831960 | Phase 2 | Apr 1, 2013 | Intrepid Therapeutics, Inc., Therapeutics, Inc. |
| NCT01631474 | Phase 2 | Jun 1, 2012 | Intrepid Therapeutics, Inc., Therapeutics, Inc. |
Organizations
Research & Development (15)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Cassiopea SpA | For profit | 7 | 7 | 3 | 2015 |
| Sun Pharmaceuticals | For profit | 5 | 4 | 2 | 2023 |
| Intrepid Therapeutics, Inc. | For profit | 3 | 3 | 1 | 2012 |
| Therapeutics, Inc. | For profit | 3 | 0 | 1 | 2012 |
| Canfield Scientific Inc. | For profit | 2 | 0 | 1 | 2023 |
| Ergomed | For profit | 2 | 0 | 1 | 2023 |
| ICON | For profit | 2 | 0 | 1 | 2023 |
| Pharmapace | For profit | 2 | 0 | 1 | 2023 |
| Cosmo Technologies Ltd | For profit | 1 | 1 | 1 | 2019 |
| Narrows Institute for Biomedical Research | Academic/Hospital | 1 | 1 | 1 | 2025 |
| Richmond Pharmacology | For profit | 1 | 0 | 1 | 2018 |
| Stanford University | Academic/Hospital | 1 | 1 | 1 | 2023 |
| State University of New York, Brooklyn | Academic/Hospital | 1 | 0 | 1 | 2025 |
| Sunshine Lake Pharma Co., Ltd. | For profit | 1 | 1 | 1 | 2024 |
| University of Pennsylvania | Academic/Hospital | 1 | 1 | 1 | 2024 |
Marketing (4)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Cassiopea SpA | For profit | MKTG | Aug 26, 2020 |
| Sun Pharmaceuticals | For profit | MKTG | Aug 26, 2020 |
| Sun Pharmaceuticals | For profit | NDA2 | Aug 26, 2020 |
| Sun Pharmaceuticals | For profit | NDA | Aug 26, 2020 |