NDATOPICALCREAM
Approved
Aug 2020
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
5
Data completeness
5/8 — Partial
WINLEVI (clascoterone) by Fosun Pharma is androgen receptor antagonists [moa]. First approved in 2020.
Drug data last refreshed 5h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
WINLEVI (clascoterone) is a topical androgen receptor antagonist cream approved in 2020 for acne vulgaris. It works by blocking androgen receptor signaling in sebaceous glands and hair follicles, reducing sebum production and acne lesion formation. This is the first topical anti-androgen with a novel mechanism targeting hormone-driven acne at the local level.
$0.88MPart D
Peak4.1 years to LOEProduct is in peak commercial phase with modest Part D penetration; team size likely stable with focus on market expansion and market share defense against high competitive pressure.
Mechanism of Action
Androgen Receptor Antagonists
Pharmacologic Class:
Androgen Receptor Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (5)
1% Clascoterone Cream for the Treatment Acne Vulgaris
Started May 2026
692 enrolled
Acne Vulgaris
Pharmacokinetics, Safety and Tolerability of Clascoterone Cream 1% in Healthy Chinese Adult Subjects
Started Aug 2024
12 enrolled
Acne Vulgaris
Efficacy and Safety of Clascoterone Cream 1% in Facial Acne Vulgaris
Started May 2024
692 enrolled
Acne Vulgaris
A Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss (SCALP2)
Started Aug 2023
762 enrolled
Alopecia, Androgenetic
A Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss
Started Jun 2023
703 enrolled
Alopecia, Androgenetic
Worked on WINLEVI at Fosun Pharma? Share your interview experience or compensation data (+7 days Pro)
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.