52-week clinical results from the Phase 3 ASC40-304 open-label extension of denifanstat in patients with moderate to severe acne vulgaris, conducted by license partner Ascletis BioScience Co. Ltd. (Ascletis) in China, along with mechanistic data, will be presented at the 2026 Fall Clinical Dermatology Conference taking place October 8-11, in Las Vegas, Nevada. Denifanstat is a once-daily oral small molecule fatty acid synthase (FASN) inhibitor being developed by Ascletis as ASC40 in China where it holds an exclusive license to denifanstat, and by Sagimet in the rest of the world.

The Phase 3 OLE clinical trial, ASC40-304, evaluated the long-term safety of denifanstat in patients with moderate to severe acne vulgaris who were previously enrolled in the 12-week randomized, double-blind, placebo-controlled Phase 3 ASC40-303 clinical trial. Both trials were conducted in China by Ascletis. 240 patients rolled over into the OLE trial, for a total trial duration of up to 52 weeks; 116 of those patients had received denifanstat in the original ASC40-303 trial, and 124 patients had received placebo. Primary endpoints of the OLE evaluated safety and secondary endpoints evaluated efficacy, including Investigator’s Global Assessment (IGA) success and reduction in total lesion count and inflammatory lesion count from baseline. Ascletis’ NDA submission for approval in China to the National Medical Products Association (NMPA) was accepted in December 2025.

2026 Fall Clinical Dermatology Conference Poster Presentation Details:

Title:    Denifanstat, a fatty acid synthase inhibitor, achieved significant clinical improvement in moderate-to-severe acne vulgaris: a review of mechanistic and clinical data
Presenting author:    Julie Harper, MD, Founding Director and past President of the American Acne and Rosacea Society, Dermatology and Skin Care Center of Birmingham in Birmingham, Alabama
Date:    October 8 - 11, 2026
Location:    The Wynn Hotel, Las Vegas, Nevada


Key Presentation Highlights:
FASN inhibition reduced sebum lipids in human sebocytes in vitro and in participants of clinical trials in vivo.
Denifanstat, an oral FASN inhibitor, significantly improved IGA scores and reduced lesion counts in patients with moderate-to-severe acne compared to placebo over 12 weeks with significant improvements observed as early as 4 weeks and continued clinical improvements through 52 weeks.
Together, the clinical findings and preclinical mechanistic evidence support FASN inhibition as a novel oral therapeutic approach for acne that targets key aspects of acne pathogenesis by reducing de novo lipogenesis, sebum production, and inflammation.