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Clascoterone

Generic Name
Clascoterone
Brand Names
Winlevi
Drug Type
Small Molecule
Chemical Formula
C24H34O5
CAS Number
19608-29-8
Unique Ingredient Identifier
XN7MM8XG2M

Overview

Clascoterone (cortexolone 17α-propionate, CB-03-01) is a novel antagonist of androgen receptors. It binds to androgen receptors with high affinity. By competing with androgens for binding to androgen receptors, clascoterone works by blocking the androgen receptor signalling cascades that promote acne pathogenesis, such as sebaceous gland proliferation, excess sebum production, and inflammatory pathways. In August 2020, FDA approved clascoterone for the first-in-class topical treatment of acne (acne vulgaris) in male and female patients 12 years and older. Clascoterone is also being investigated as a novel treatment for androgenetic alopecia.

Background

Clascoterone (cortexolone 17α-propionate, CB-03-01) is a novel antagonist of androgen receptors. It binds to androgen receptors with high affinity. By competing with androgens for binding to androgen receptors, clascoterone works by blocking the androgen receptor signalling cascades that promote acne pathogenesis, such as sebaceous gland proliferation, excess sebum production, and inflammatory pathways. In August 2020, FDA approved clascoterone for the first-in-class topical treatment of acne (acne vulgaris) in male and female patients 12 years and older. Clascoterone is also being investigated as a novel treatment for androgenetic alopecia.

Indication

Clascoterone is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

Associated Conditions

  • Acne Vulgaris

FDA Approved Products

Winlevi
Manufacturer:Sun Pharmaceutical Industries, Inc.
Route:TOPICAL
Strength:1 g in 100 g
Approved: 2023/02/20
NDC:47335-994

Singapore Approved Products

Winlevi Cream 1% w/w
Manufacturer:Cosmo S.p.A.
Form:CREAM
Strength:1% w/w
Online:Yes
Approved: 2024/08/28
Approval:SIN17072P

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