Drugs / Clascoterone
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 19
| 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 11 trial | ||||||
| Phase 1 | NCT06454708 | Aug 2024 | acne | Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd. | 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 24 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 | NCT02279823 | Oct 2014 → Dec 2015 | androgenetic alopecia | Intrepid Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01631474 | Jun 2012 → Feb 2014 | acne | Intrepid Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 36 trials · 2 met primary | ||||||
| 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 | NCT02608450 | Jan 2016 → Apr 2018 | acne | Cassiopea SpA | Completed | Met primary |
| Phase 3 | NCT02608476 | Nov 2015 → Feb 2018 | acne | Cassiopea SpA | Completed | Met primary |
| Phase 46 trials · 1 met primary · 1 missed | ||||||
| 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 | Met primary |
| Phase 4 | NCT06415292 | Nov → Dec 2023 | acne | Sun Pharmaceutical Industries, Inc. | Completed | Missed primary |
| Phase 4 | NCT06336629 | Nov 2023 → Jul 2024 | 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 | NCT06415305 | Sep 2023 → Apr 2024 | acne | Sun Pharmaceutical Industries, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2026-03-27 | Sun Pharmaceutical Industries, Inc. | Results Sun Pharma Highlights Advances in Alopecia Areata, Psoriasis, and Acne Research at 2026 AAD Annual Meeting sunpharma.com ↗
An open- label, 52- week study evaluating WINLEVI ® (clascoterone cream 1%) demonstrated significant and progressive reduction in casual facial sebum production and acne severity, further reinforcing its ability to directly target the androgen -sebum pathway. |
| 2025-11-18 | Glenmark Pharmaceuticals Ltd. India | Regulatory Cosmo and Glenmark Announce Market Authorization of Winlevi® (clascoterone) 10 mg/g cream for Treatment of Acne in 15 countries in Europe glenmarkpharma.com ↗
Winlevi® is authorized in EU for the treatment of acne vulgaris in both adults and adolescents aged 12 to <18 years, with usage in adolescents limited to facial application. |
| 2024-10-25 | Sun Pharmaceutical Industries, Inc. | Results WINLEVI poster presentations at 2024 Fall Clinical Dermatology Conference sunpharma.com ↗ |
| 2024-03-19 | Sun Pharmaceutical Industries, Inc. | Regulatory Sun Pharmaceuticals announces approval of Winlevi® in Australia sunpharma.com ↗
Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715) (“Sun Pharma ”) announced that the Australian Therapeutic Goods Administration (TGA) has granted regulatory approval for Winlevi® (clascoterone cream 1% ). |
| 2023-06-19 | Sun Pharmaceutical Industries, Inc. | Regulatory Sun Pharma Announces Health Canada Approval of PRWINLEVI® (clascoterone cream 1%) for Topical Treatment of Acne sunpharma.com ↗
Sun Pharma Canada Inc., a wholly owned subsidiary of Sun Pharmaceutical Industries Limited (Reuters: SUN.BO) (Bloomberg: SUNP IN) (NSE: SUNPHARMA) (BSE: 524715), "Sun Pharma" is pleased to announce Health Canada’s approval of PrWINLEVI (clascoterone cream 1%). |
| 2022-03-25 | Sun Pharmaceutical Industries, Inc. | Results Sun Pharma Presents Phase 3 Data for WINLEVI® (clascoterone) cream 1% for the Topical Treatment of Acne Vulgaris at the AAD Annual Meeting sunpharma.com ↗
The results, which showed favorable safety and efficacy data in patients 12 years of age and older with acne, were reported today in a poster podium presentation at the American Academy of Dermatology (AAD) 2022 Annual Meeting in Boston, Massachusetts. |
All press releases naming this drug 15 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 20 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Clascoterone | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06425900 ↗ |
| Known as | CB-03-01 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02608476 ↗ |
| 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” NCT06415279 ↗ “Winlevi (clascoterone) 1% cream” NCT06415292 ↗ “Winlevi (clascoterone) 1% cream” NCT06415305 ↗ |
| Action | Inhibit | “topical androgen receptor inhibitor” PMID 36745367 ↗ Feb 2023 |
| Modality | Small molecule | “is a steroidal antiandrogen” NCT02608450 ↗ |
| Route | Topical | “Topical cream, applied once a day” NCT01631474 ↗ |