Ascletis Pharma Announces Successful Phase III Trial of Denifanstat, a Groundbreaking Oral FASN Inhibitor for Acne Treatment

Reuters
04 Jun
Ascletis Pharma Announces Successful Phase III Trial of Denifanstat, a Groundbreaking Oral FASN Inhibitor for Acne Treatment

Ascletis Pharma Inc. has announced that its Phase III clinical trial for denifanstat (ASC40), a first-in-class, once-daily oral fatty acid synthase (FASN) inhibitor, has met all primary, key secondary, and secondary endpoints for the treatment of moderate to severe acne vulgaris. The randomized, double-blind, placebo-controlled, multicenter trial conducted in China involved 480 patients. Denifanstat demonstrated a statistically significant improvement in treatment outcomes, with a 33.2% treatment success rate and reductions in total, inflammatory, and non-inflammatory lesion counts by 57.4%, 63.5%, and 51.9% respectively, compared to baseline. The trial results indicate that denifanstat was more effective than several FDA-approved acne treatments in placebo-adjusted percent treatment success. The drug maintained a favorable safety and tolerability profile throughout the study. Ascletis plans to submit the treatment for approval by the China National Medical Products Administration (NMPA).

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Ascletis Pharma Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: CN02091) on June 03, 2025, and is solely responsible for the information contained therein.

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