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Review
.2020 Nov;80(16):1745-1750.
doi: 10.1007/s40265-020-01417-6.

Clascoterone: First Approval

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Review

Clascoterone: First Approval

Sohita Dhillon. Drugs.2020 Nov.

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.

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References

    1. Marks DH, Prasad S, De Souza B, et al. Topical antiandrogen therapies for androgenetic alopecia and acne vulgaris. Am J Clin Dermatol. 2020;21(2):245–54. - PubMed - DOI
    1. Del Rosso JQ, Kircik LH, Stein Gold L, et al. Androgens, androgen receptors, and the skin: from the laboratory to the clinic with emphasis on clinical and therapeutic implications. J Drugs Dermatol. 2020;19(3):30–5. - PubMed
    1. Cassiopea. Winlevi® (clascoterone) cream: US prescribing information. 2020.https://www.cassiopea.com/wp-content/uploads/2020/08/WINLEVI-clascoteron... . Accessed 10 Sept 2020.
    1. Rosette C, Agan FJ, Mazzetti A, et al. Cortexolone 17alpha-propionate (clascoterone) is a novel androgen receptor antagonist that inhibits production of lipids and inflammatory cytokines from sebocytes in vitro. J Drugs Dermatol. 2019;18(5):412–8. - PubMed
    1. Rosette C, Rosette N, Mazzetti A, et al. Cortexolone 17alpha-propionate (clascoterone) is an androgen receptor antagonist in dermal papilla cells in vitro. J Drugs Dermatol. 2019;18(2):197–201. - PubMed

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