Denifanstat shows sustained acne improvement in Phase 3 extension

Phase 3 open-label extension data for denifanstat, an oral fatty acid synthase (FASN) inhibitor, demonstrates sustained efficacy in treating moderate to severe acne vulgaris through 52 weeks of treatment. Results from the ASC40-304 trial, presented at the 2026 Fall Clinical Dermatology Conference, showed a 57% Investigator Global Assessment (IGA) success rate, a 72% reduction in total lesions, and a 77% reduction in inflammatory lesions.

Denifanstat works by inhibiting FASN to reduce de novo lipogenesis and sebum lipid production while targeting inflammation. The trial was conducted in China by Ascletis BioScience, a license partner of Sagimet Biosciences. The National Medical Products Administration accepted Ascletis’ new drug application for denifanstat in China in December 2025.