ASC40 (denifanstat)

Aug. 13, 2026: Sagimet Biosciences (NASDAQ: SGMT) said the FDA cleared the IND and issued a “Study May Proceed” letter for a Phase 3 trial of denifanstat, an oral once-daily FASN inhibitor, in moderate to severe acne. The Phase 3 study is on track to start in 2H 2026, with patient dosing expected this year.

The randomized, double-blind, placebo-controlled U.S. trial is intended to enroll about 800 patients age 12 and older, including about 450 adolescents, randomized 2:1 to denifanstat 50 mg or placebo for 12 weeks. Co-primary endpoints at week 12 are: treatment success on a global assessment score (at least a 2-point reduction to 0 or 1), absolute change in inflammatory lesion counts, and absolute change in non-inflammatory lesion counts. Patients completing the double-blind period may enter a 40-week open-label extension for long-term safety.

The company also cited prior China trials conducted by license partner Ascletis, where denifanstat (ASC40) met all primary and secondary endpoints in a 12-week Phase 3 acne trial, was generally well tolerated, and showed improvement across efficacy endpoints measured at 52 weeks in an open-label Phase 3 long-term safety study.