Pharmaceutical company Cassiopea SpA (SIX:SKIN) said on Tuesday that it has filed a New Drug Application (NDA) with the US Food and Drug Administration (FDA) seeking marketing approval for clascoterone cream 1% for the treatment of the dermatological condition acne.

Under investigation as a first-in-class topical androgen receptor inhibitor for treating acne, the clascoterone cream 1% is a topically delivered small molecule that penetrates the skin to reach the androgen receptors of the sebaceous gland. The clascoterone inhibits lipid production from oil producing cells and reduces proinflammatory cytokines, mediators influenced by androgens, added the company.

Unlike oral hormonal therapies for acne, the clascoterone cream 1% may be used in both male and female patients and is also the first new mechanism of action for acne in nearly 40 years, according to the company.

Based on the topline results from two pivotal phase III clinical trials for clascoterone cream 1%, the candidate demonstrated highly statistically significant improvements for all primary clinical endpoints. The safety results were confirmed in an open-label safety study for a treatment period of up to one year, with an expanded drug application surface area that included both the face and trunk.

In addition, clascoterone is on track to becoming the first effective and safe topical anti-androgen without systemic side effects, concluded the company.