Wednesday, July 8, 2026

Drug profile · INN

clascoterone

clascoterone (WINLEVI) is a androgen receptor antagonist. Route of administration: topical. Current US regulatory status: approved.

FDA: approved EMA: approved Dermatologicals (D10) D10AX06
US status approved
Patents linked 5
Pipeline programs 4
News articles 0
Drug details — clascoterone
US status
approved
Class
Dermatologicals (D10)
Route
TOPICAL
Patents
5
Programs
4
Data quality
0.84

Quick answer

clascoterone (WINLEVI) is a androgen receptor antagonist. Route of administration: topical. Current US regulatory status: approved.

Key facts

INN clascoterone
Brand WINLEVI
Mechanism Androgen Receptor antagonist
Target Androgen receptor
Therapeutic class Dermatologicals (D10)
Route TOPICAL
Formulation CREAM
ATC code D10AX06

Mechanism of action

Androgen Receptor antagonist

Primary target: Androgen receptor

Approval history

Authority Status Date
FDA approved
EMA approved

Pipeline programs

  1. 1% Clascoterone Cream Phase 3 · Sunshine Guojian Pharmaceutical · Acne Vulgaris
  2. Clascoterone Phase 3 · Sunshine Guojian Pharmaceutical · Acne Vulgaris
  3. CB-03-01/39 Phase 1 · Cassopeia Pharmaceuticals Pvt · Test of vasocontriction properties for classification of top
  4. Clascoterone Cream 1% Phase 1 · Sunshine Guojian Pharmaceutical · Acne Vulgaris

Related & competitor drugs

  1. beremagene geperpavec Dermatologicals (D03)
  2. bicalutamide Androgen Receptor antagonist
  3. danazol Progesterone receptor agonist
  4. dupilumab Dermatologicals (D11)
  5. imiquimod Dermatologicals (D06)
  6. lebrikizumab Dermatologicals (D11)

Related patents

  1. WO 2025125508

    COMBINAISONS DE CORTEXOLONE-17ΑLPHA-PROPIONATE POUR LE TRAITEMENT DE L'ACNÉ

    Expires Wed Jun 14 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. WO 2025068281

    CORTÉXOLONE-17α-PROPIONATE POUR LE TRAITEMENT D'ÉRUPTIONS ACNÉIFORMES

    Expires Wed Mar 29 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. EP 4529925

    CORTEXOLON-17-ALPHA-PROPIONAT ZUR BEHANDLUNG VON AKNEIFORMEN ERUPTEN

    Expires Tue Mar 28 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. CA 2934118

    PROPIONATE DE CORTEXOLONE-17' DESTINE A ETRE UTILISE DANS LE TRAITEMENT DE LESIONS CUTANEES ET/OU DE TROUBLES DE LA PEAU ATROPHIQUE

    Expires Wed Jun 20 2035 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. AU 2005207635

    Therapeutic methods and pharmaceutical compositions for treating warts with tellurium compounds

    Expires Wed Jul 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time)

    expired

Frequently asked questions

What is clascoterone?

clascoterone (WINLEVI) is a androgen receptor antagonist. Route of administration: topical. Current US regulatory status: approved.

What is the brand name for clascoterone?

WINLEVI is a marketed brand name for clascoterone. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of clascoterone?

clascoterone has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.