Drugs / Clascoterone
Clascoterone
also known as
Winlevi · CB-03-01 · cortexolone 17α-propionate · Breezula · Clascoterona · Cortexolone 17.alpha.-propionate · Cortodoxone 17.alpha.-propionate
Small molecule targets AR via inhibition
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Winlevi | — | 2025-10-17 | europa.eu ↗ |
| Approved | US (FDA) | WINLEVI | — | 2020-08-26 | fda.gov ↗ |
Trials 23 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT07673094 | Aug 2026 → Feb 2027 expected | acne | Khyber Teaching Hospital | Not yet recruiting | No outcome recorded |
| Phase 12 trials | ||||||
| Phase 1 | NCT06454708 | Aug 2024 | acne | Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03665194 | Jun → Sep 2018 | — | Cassiopea SpA | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05891795 | Jul 2024 → Jan 2026 overdue | acne | Stanford University | Active not recruiting | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT06952517 | Mar → Sep 2025 overdue | rosacea | Narrows Institute for Biomedical Research | Recruiting | No outcome recorded |
| Phase 2 | NCT06286397 | Jan 2025 → Jan 2028 expected | pilonidal sinus | University of Pennsylvania | Recruiting | No outcome recorded |
| Phase 2 | NCT02720627 | Oct 2016 → Mar 2018 | acne | Cassiopea SpA | Completed | No outcome recorded |
| Phase 2 | NCT02279823 | Oct 2014 → Dec 2015 | androgenetic alopecia | Intrepid Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01831960 | Apr → Nov 2013 | acne | Intrepid Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01631474 | Jun 2012 → Feb 2014 | acne | Intrepid Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 37 trials | ||||||
| Phase 3 | NCT07457294 | May 2026 → Aug 2028 expected | acne | Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06403501 | May 2024 → Oct 2026 expected | acne | Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT05914805 | Aug 2023 → Jul 2025 | androgenetic alopecia | Cassiopea SpA | Completed | No outcome recorded |
| Phase 3 | NCT05910450 | Jun 2023 → Jan 2026 | androgenetic alopecia | Cassiopea SpA | Completed | No outcome recorded |
| Phase 3 | NCT02682264 | Mar 2016 → Aug 2018 | acne | Cassiopea SpA | Completed | No outcome recorded |
| Phase 3 | NCT02608450 | Jan 2016 → Apr 2018 | acne | Cassiopea SpA | Completed | No outcome recorded |
| Phase 3 | NCT02608476 | Nov 2015 → Feb 2018 | acne | Cassiopea SpA | Completed | No outcome recorded |
| Phase 46 trials | ||||||
| Phase 4 | NCT06425900 | Jul 2024 → Mar 2026 overdue | acne | Sun Pharmaceutical Industries, Inc. | Active not recruiting | No outcome recorded |
| Phase 4 | NCT06415279 | Feb 2024 → Feb 2025 | acne | Sun Pharmaceutical Industries, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT06415292 | Nov → Dec 2023 | acne | Sun Pharmaceutical Industries, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT06336603 | Nov 2023 → Oct 2024 | acne | Sun Pharmaceutical Industries, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT06336629 | Nov 2023 → Jul 2024 | acne | Sun Pharmaceutical Industries, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT06415305 | Sep 2023 → Apr 2024 | acne | Sun Pharmaceutical Industries, Inc. | Completed | No outcome recorded |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 25 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Clascoterone | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06286397 ↗ |
| Known as | Breezula | ChEMBL registry synonym — accepted as the source's own label CHEMBL3590187 ↗ |
| Known as | CB-03-01 | “CB-03-01 (cortexolone 17α-propionate) Cream, 1%, applied twice daily to whole face (about 1 gram) and affected areas of trunk (if applicable) for up to an additional 9 months.” NCT02682264 ↗ |
| Known as | Clascoterona | ChEMBL registry synonym — accepted as the source's own label CHEMBL3590187 ↗ |
| Known as | Cortexolone 17.alpha.-propionate | ChEMBL registry synonym — accepted as the source's own label CHEMBL3590187 ↗ |
| Known as | cortexolone 17α-propionate | “Cortexolone 17α-propionate (USAN/INN: clascoterone) is a steroidal antiandrogen that is being developed as a 1% cream for the topical treatment of acne vulgaris.” NCT02682264 ↗ |
| Known as | Cortodoxone 17.alpha.-propionate | ChEMBL registry synonym — accepted as the source's own label CHEMBL3590187 ↗ |
| Known as | Winlevi | “Clascoterone Cream 1% (Winlevi) is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.” NCT06454708 ↗6“Winlevi (clascoterone) 1% & Adapalene 0.3% gel” NCT06336603 ↗ “Winlevi (clascoterone) 1% & Duac gel” NCT06336629 ↗ “Winlevi (Clascoterone) cream 1%” NCT06425900 ↗ “Winlevi (clascoterone) 1% cream” NCT06415305 ↗ “Winlevi (clascoterone) 1% cream” NCT06415279 ↗ “Winlevi (clascoterone) 1% cream” NCT06415292 ↗ |
| Action | Inhibit | “topical androgen receptor inhibitor” PMID 36745367 ↗ Feb 20231“Androgen Receptor antagonist” CHEMBL3590187 ↗ |
| Modality | Small molecule | “is a steroidal antiandrogen” NCT02608450 ↗ |
| Route | Topical | “Topical cream, applied once a day” NCT01631474 ↗ |
| Target | AR | “Androgen Receptor antagonist” CHEMBL3590187 ↗ |