Ascletis Reports Positive Phase III Long-Term Safety Data for Denifanstat in Acne

Ascletis Pharma announced positive top-line results from its Phase III open-label study evaluating the long-term safety of denifanstat (ASC40) in moderate to severe acne vulgaris. The trial enrolled 240 patients in China, all of whom had previously received denifanstat or placebo for 12 weeks, then took denifanstat once daily for 40 weeks.

Primary endpoints focused on safety: incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and discontinuations due to AEs. Denifanstat was well tolerated, with most TEAEs being mild or moderate, and no grade 3–4 AEs, related SAEs, or deaths reported.

Denifanstat works via dual mechanisms: inhibiting de novo lipogenesis in sebocytes to reduce sebum and decreasing inflammatory cytokine secretion and Th17 differentiation.

Ascletis holds exclusive rights in Greater China under a license from Sagimet Biosciences, and the China NMPA has accepted its NDA. Previous Phase III studies also showed strong efficacy in reducing acne lesions.

31-01-2026