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Drug

Clascoterone

Approved · EMA
ClassAndrogen Receptor antagonistEmerging researchLate-stage development

Also known as Cortexolone 17alpha-propionate, Winlevi.

RxNorm2474340ChEMBLCHEMBL3590187ATCD10AX06UNIIXN7MM8XG2M
1
Research papers
1
Active clinical trials
Androgen receptor
Primary target
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Approval: Winlevi (EMA)

Regulatory2025-10-17EMA

A Multicenter, Randomized, Double-Blind, Vehicle-Controlled Clinical Study to Evaluate the Efficacy and Safety of Clascoterone Cream 1% in Treatment of Subjects With Facial Acne Vulgaris

Clinical trial2025-07-09Results expected Q4 2026 · ClinicalTrials.gov

Guidelines of care for the management of acne vulgaris.

Research2024-01-30Journal of the American Academy of Dermatology

An Open Label Evaluation of the Adrenal Suppression Potential and Pharmacokinetic Properties of Cortexolone 17α-Propionate (CB-03-01) Cream Applied Every Twelve Hours for Two Weeks in Subjects With Acne Vulgaris

Clinical trial2020-12-02Results posted · ClinicalTrials.gov

An Open Label Evaluation of the Adrenal Suppression Potential and Trough Plasma Concentrations of Cortexolone 17α-Propionate (CB-03-01) Cream Applied Every 12 Hours for Two Weeks in Subjects 9 to <12 Years of Age With Acne Vulgaris

Clinical trial2020-11-20Results posted · ClinicalTrials.gov

A Randomised, Double Blind, Placebo Controlled Phase I Study to Investigate the Effects of Systemically Absorbed Cortexolone 17α-propionate (and Its Metabolites) on QT Interval Following Repeat Topical Administration in Healthy Volunteers

Clinical trial2018-09-12Completed · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Clascoterone
Aliases & brands
Cortexolone 17alpha-propionateWinlevi
RxNorm CUI
2474340
ChEMBL ID
CHEMBL3590187
ATC codes
D10AX06
UNII
XN7MM8XG2M
Primary mechanism
Androgen Receptor antagonist
Regulatory jurisdictions
ema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Androgen receptor
AR · P10275
ANTAGONISTAndrogen Receptor antagonist

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2025-10-17
Latest approval
2025-10-17
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2025-10-17Approval
Approval: Winlevi (EMA)
Indication: Adults&nbsp;Winlevi is indicated for the treatment of acne vulgaris. Adolescents (from 12 to &lt;&nbsp;18&nbsp;years of age)&nbsp;Winlevi is indicated for the treatment of facial… Show full indication

Adults&nbsp;Winlevi is indicated for the treatment of acne vulgaris. Adolescents (from 12 to &lt;&nbsp;18&nbsp;years of age)&nbsp;Winlevi is indicated for the treatment of facial acne vulgaris.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

4 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
4
registered trials across all phases
LATEST COMPLETION 2018
1
Active studies
1
Recruiting
1
Late-stage (III+)
3
Completed
PHASE DISTRIBUTIONn = 4
Phase 11Phase 22Phase 31

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Multicenter, Randomized, Double-Blind, Vehicle-Controlled Clinical Study to Evaluate the Efficacy and Safety of Clascoterone Cream 1% in Treatment of Subjects With Facial Acne Vulgaris

RecruitingPH IIIZhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.n=6922026

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Randomised, Double Blind, Placebo Controlled Phase I Study to Investigate the Effects of Systemically Absorbed Cortexolone 17α-propionate (and Its Metabolites) on QT Interval Following Repeat Topical Administration in Healthy Volunteers

CompletedPH ICassiopea SpAn=322018

An Open Label Evaluation of the Adrenal Suppression Potential and Trough Plasma Concentrations of Cortexolone 17α-Propionate (CB-03-01) Cream Applied Every 12 Hours for Two Weeks in Subjects 9 to <12 Years of Age With Acne Vulgaris

CompletedPH IICassiopea SpAn=272018

An Open Label Evaluation of the Adrenal Suppression Potential and Pharmacokinetic Properties of Cortexolone 17α-Propionate (CB-03-01) Cream Applied Every Twelve Hours for Two Weeks in Subjects With Acne Vulgaris

CompletedPH IIIntrepid Therapeutics, Inc.n=422013

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Most influential

Guidelines of care for the management of acne vulgaris.

Journal of the American Academy of Dermatology · 2024 · 236 cites
Recent papers

Guidelines of care for the management of acne vulgaris.

Journal of the American Academy of Dermatology · 2024 · 236 cites
Major research themes8
Acne Vulgaris1Anti-Bacterial Agents1Benzoyl Peroxide1Dermatologic Agents1Dicarboxylic Acids1Doxycycline1Isotretinoin1Salicylic Acid1
Journals, researchers & institutions
Top journals
  • Journal of the American Academy of Dermatology1
Leading researchers
  • Barbieri JS1
  • Cheng CE1
  • Cook-Bolden F1
  • Desai SR1
  • Druby KM1
  • Freeman EE1
  • Han JM1
  • Keri JE1
Leading institutions
free-text, unnormalised
  • American Academy of Dermatology1
  • Beth Israel Deaconess Medical Center1
  • Brigham and Women's Hospital1
  • Emory University School of Medicine1
  • Massachusetts General Hospital1
  • Mayo Clinic1

Related drugs

8 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Azelaic acid

Studied across the same disease area as Clascoterone in the shared literature.

1 shared disease1 shared paper
Benzoyl Peroxide

Studied across the same disease area as Clascoterone in the shared literature.

1 shared disease1 shared paper
Doxycycline

Studied across the same disease area as Clascoterone in the shared literature.

1 shared disease1 shared paper
Isotretinoin

Studied across the same disease area as Clascoterone in the shared literature.

1 shared disease1 shared paper
Minocycline

Studied across the same disease area as Clascoterone in the shared literature.

1 shared disease1 shared paper
Salicylic Acid

Studied across the same disease area as Clascoterone in the shared literature.

1 shared disease1 shared paper
Sarecycline

Studied across the same disease area as Clascoterone in the shared literature.

1 shared disease1 shared paper
Spironolactone

Studied across the same disease area as Clascoterone in the shared literature.

1 shared disease1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.