Ascletis Pharma Inc. (1672) released topline results from a Phase III open-label trial (NCT06248008) evaluating denifanstat (ASC40) in 240 patients with moderate to severe acne vulgaris. The study, conducted across multiple centers in China, assessed the long-term safety of once-daily oral denifanstat (ASC40) over 40 weeks. Most treatment-emergent adverse events were mild or moderate, with no denifanstat-related grade 3 or 4 adverse events or serious adverse events reported.

The announcement follows an earlier 480-patient randomized, double-blind, placebo-controlled Phase III study (NCT06192264), in which denifanstat (ASC40) met all primary, key secondary, and secondary endpoints. Denifanstat (ASC40) is a fatty acid synthase (FASN) inhibitor that directly reduces sebum production and inflammation, addressing a key underlying cause of acne. A new drug application for denifanstat (ASC40) has been accepted by China’s National Medical Products Administration, and the compound is licensed from Sagimet Biosciences Inc. for exclusive rights in Greater China.