Winlevi: Cassiopea’s Breakthrough Acne Treatment

Winlevi (clascoterone cream 1%) will definitely come to the US market in early 2021! Official website here. I forgot that I wrote this post on Winlevi and acne before, so am updating it now. Also see my related posts on clascoterone based hair loss treatment Breezula.

Many people will inevitably try to use Winlevi on their scalps for hair growth (via off-label prescription). This is not recommended by the manufacturer.

Update: August 27, 2020

Winlevi Approved by the FDA to Treat Acne

Cassiopea’s Winlevi topical androgen receptor inhibitor has just been approved as an acne treatment by the US FDA. It is the first acne treatment with a new mechanism of action to be approved in 40 years.

More information from Cosmo Pharma (Ireland — COPN:SWX), which owns 45 percent of Cassiopea (Italy — SKIN:SW). Winlevi will be on sale in early 2021.

CEO Diana Harbort quote:

Dermatologists have said targeting androgen hormonal activity in the skin is ‘the holy grail’ of acne treatment for both males and females.

Update: November 8, 2019 — Cassiopea announces US FDA reviewing new drug application (NDA) for clascoterone cream 1% to treat acne.

August 23, 2019

I have covered Italian company Cassiopea numerous times on this blog. Primarily due to its Breezula topical product for male pattern hair loss. Earlier this year, Cassiopea announced very good 12-month Phase 2 clinical trial results for Breezula.

Clascoterone, Winlevi and Acne

Cassiopea is also working on an acne product called Winlevi. Both Breezula and Winlevi are based on the same key ingredient: Clascoterone. However, the dosage in Winlevi is significantly lower at 1%. Winlevi is almost ready to come to market per Cassiopea’s product pipeline.

 

Earlier this week, Cassiopea made a major announcement. The company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking marketing approval for clascoterone cream 1% for the treatment of acne.

My Thoughts

Some interesting points in the press release and my thoughts:

• Clascoterone cream 1% targets androgen receptors at the site of application. This inhibits the local (skin) effects of dihydrotestosterone (DHT). Apparently, DHT is a key driver of acne lesion development. Most people wrongly assume it is solely testosterone.
•  This acne treatment product will be safe to use in both males and females.
• If approved, clascoterone cream 1% will represent the first new mechanism of action in the treatment of acne in almost 40 years. Interestingly, if Breezula is approved for hair loss in 2021, it will be the first new topical or oral treatment for hair loss in almost 25 years.

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