Ascletis Pharma concludes pre-NDA consultation for acne treatment Denifanstat

Ascletis Pharma Inc. has announced the completion of its pre-New Drug Application (NDA) consultation with China's National Medical Products Administration (NMPA) for denifanstat (ASC40), a treatment for moderate-to-severe acne vulgaris. The company plans to submit an NDA soon, following consultations that concluded in October 2025.

Denifanstat (ASC40) has completed both Phase II and Phase III studies. The Phase III trial demonstrated that denifanstat significantly outperformed placebo in improving moderate-to-severe acne vulgaris, meeting all primary, key secondary, and secondary efficacy endpoints. The drug also exhibited a favorable safety and tolerability profile, with all denifanstat-related treatment-emergent adverse events being mild or moderate. No Grade 3 or 4 events, serious adverse events, or permanent treatment discontinuations were reported.

The positive Phase III study results were presented at the European Academy of Dermatology and Venereology (EADV) Congress 2025 in Paris, France, on September 17, 2025. Ascletis licensed denifanstat (ASC40) from Sagimet Biosciences Inc. for exclusive rights in Greater China.