Italian speciality pharmaceutical firm Cassiopea has received approval from the US Food and Drug Administration (FDA) for Winlevi (clascoterone cream 1%) as a topical treatment for acne vulgaris.

Indicated for patients aged 12 years and above, the drug is the first FDA-approved therapy with a new mechanism of action (MOA) against acne for almost 40 years.

Winlevi is an androgen receptor inhibitor. The exact mechanism of action is not known, but laboratory studies indicate that the active ingredient, clascoterone, competes with androgens for binding to the androgen receptors in the sebaceous gland and hair follicles.

Acne is a multifactorial skin condition characterised by excess sebum generation, clogged pores (hyperkeratinization), bacteria growth and inflammation.

Topical treatments targeting androgens, known to drive sebum production and inflammation, are currently limited in the market.

Winlevi acts on the androgen hormone component of acne in both males and females. It mitigates the effects of these hormones on rising sebum production and inflammation.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Gold Skin Care Center and Tennessee Clinical Research Center investigator and medical director Michael Gold said: “This game-changing topical drug offers a non-antibiotic approach to people with acne, by targeting the androgen receptors directly in the skin. It fills a longstanding gap in acne therapy.”

In pivotal human trials, the drug was able to reduce acne lesions and was well-tolerated when used two times per day. The most frequent local skin reaction was mild erythema.

The drug should commercially launch in the US early next year.

Cassiopea is now planning to expand its Dermatology franchise and advance its next experimental drug candidate for androgenetic alopecia.