Sagimet Biosciences Inc. (NASDAQ: SGMT) said on Tuesday it intends to initiate patient enrollment for its Phase 3 AURORA trial of denifanstat in the fourth quarter of 2026, with screening expected to begin in October.
The Foster City, California-based biotech company plans to enroll approximately 800 patients in the U.S., including roughly 450 adolescents aged 12 to 17 years, in the double-blind study. Participants will be randomized 2:1 to receive either 50 mg of denifanstat or a placebo once daily for a 12-week period.
The trial’s co-primary endpoints will be evaluated at week 12, measuring the proportion of patients achieving treatment success in a global assessment score, as well as the absolute change in inflammatory and non-inflammatory skin lesion counts from baseline. Denifanstat is an oral, once-daily fatty acid synthase (FASN) inhibitor.
Sagimet anticipates submitting a New Drug Application (NDA) to U.S. regulators upon completion of the 12-week phase of the study. The company previously reported that denifanstat met all primary and secondary endpoints in a 12-week Phase 3 trial conducted by license partner Ascletis BioScience Co. Ltd. in China.
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