Ascletis acne drug NDA accepted by China NMPA

Ascletis Pharma Inc. announced its New Drug Application (NDA) for denifanstat (ASC40) has been accepted by the China National Medical Products Administration (NMPA). Denifanstat is a first-in-class, once-daily oral small molecule fatty acid synthase (FASN) inhibitor for moderate-to-severe acne vulgaris. This follows positive feedback from a pre-NDA consultation with the NMPA.

The acceptance is based on the successful completion of Phase II and Phase III studies. The Phase III trial demonstrated that denifanstat met all primary, key secondary, and secondary efficacy endpoints, significantly improving acne compared to placebo. It also exhibited a favorable safety profile, with all denifanstat-related treatment-emergent adverse events being mild (Grade 1) or moderate (Grade 2), and no Grade 3 or 4 events, serious adverse events, or permanent treatment discontinuations.

Ascletis holds exclusive rights to denifanstat (ASC40) in Greater China, licensed from Sagimet Biosciences Inc. The Phase III study results were presented at the European Academy of Dermatology and Venereology (EADV) Congress 2025 in Paris, France.