Clascoterone: First Approval.

Abstract:

:Clascoterone (Winlevi®) is an androgen receptor inhibitor being developed as a topical cream and solution by Cassiopea (a spin-out company of Cosmo Pharmaceuticals) for the treatment of androgen-dependent skin disorders, including androgenetic alopecia and acne vulgaris. Although the exact mechanism of action of clascoterone for the topical treatment of acne vulgaris is unknown, the drug is believed to compete with the androgen dihydrotestosterone for binding to androgen receptors in the sebaceous gland and hair follicles to attenuate signalling necessary for acne pathogenesis. In August 2020, clascoterone cream 1% received its first approval in the USA for the topical treatment of acne vulgaris in patients 12 years of age or older. Clinical studies of a different formulation of clascoterone (a solution containing a higher concentration of the drug) for the treatment of androgenetic alopecia are underway in Germany and the USA. This article summarizes the milestones in the development of clascoterone leading to this first approval for the topical treatment of acne vulgaris.

journal_name

Drugs

journal_title

Drugs

authors

Dhillon S

doi

10.1007/s40265-020-01417-6

subject

Has Abstract

pub_date

2020-11-01 00:00:00

pages

1745-1750

issue

16

eissn

0012-6667

issn

1179-1950

pii

10.1007/s40265-020-01417-6

journal_volume

80

pub_type

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