Douglas Pharmaceuticals Limited launches Winlevi® – a novel topical treatment for acne vulgaris – in New Zealand

Douglas Pharmaceuticals, New Zealand’s largest privately owned pharmaceutical company, announces the launch of Winlevi® (clascoterone cream 1%) following regulatory approval by Medsafe.¹ Winlevi® provides healthcare professionals with a novel topical treatment for patients aged 12 years and older with acne vulgaris.

Winlevi® is a first-in-class topical androgen receptor inhibitor^2,3 in-licensed from Sun Pharmaceutical Industries (Australia) Pty Ltd. It will be available in New Zealand by prescription from 1 May 2025, distributed by Douglas Pharmaceuticals. As Winlevi® is not currently funded in New Zealand, a patient charge will apply.

Douglas Pharmaceuticals is committed to expanding access to effective and innovative dermatological solutions:

“Winlevi® is an exciting addition to the expanding Douglas dermatology portfolio of innovative medicines in New Zealand,” says Philippa Williams, Sales and Marketing Manager, Pharma, at Douglas Pharmaceuticals.

“Winlevi’s novel mechanism of action will be a welcome addition to the physician’s toolkit while treating acne.”

Winlevi® is approved in New Zealand for the topical treatment of acne vulgaris in patients aged 12 years and older, and clinical trial data have demonstrated that it is well tolerated and improves acne severity when compared with placebo treatment.^4,5 It is the first topical androgen receptor inhibitor developed for acne, offering a novel therapeutic approach.^2,3 Although the exact mechanism of action is not fully understood, in vitro studies have indicated that clascoterone works by competing with androgens such as dihydrotestosterone (DHT) for binding to receptors in the skin, particularly within sebaceous glands.³

Androgens play a central role in the development of acne by stimulating excess sebum production and driving inflammation. By locally blocking androgen activity in the skin, Winlevi® is thought to reduce both the production of sebum and inflammatory processes.^2,3 Winlevi® is also rapidly metabolized in the skin, minimizing systemic exposure and thereby reducing the potential for hormone-related side effects.⁶