India, Aug. 13 -- Sagimet Biosciences Inc. (SGMT), a clinical-stage biopharmaceutical company, on Thursday said it has received clearance from the U.S. Food and Drug Administration (FDA) for a Phase 3 study of denifanstat in moderate to severe acne.
The study is expected to begin in the second half of 2026 and enroll approximately 800 U.S. patients aged 12 years and older, including about 450 adolescents aged 12 to 17. Patients will be randomized to receive denifanstat 50 mg or placebo once daily for 12 weeks.
The trial will have three co-primary endpoints assessed at week 12, including treatment success based on a global assessment score and changes in inflammatory and non-inflammatory skin lesion counts from baseline.
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