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Sagimet Biosciences Gets FDA Clearance for Phase 3 Denifanstat Acne Trial

Sagimet Biosciences logoSagimet Biosciences
Sig2.85Sen+6.40Env0.00Soc+1.85Gov+1.10

FDA cleared Sagimet Biosciences’ IND and issued a Study May Proceed letter for a Phase 3 denifanstat trial in moderate to severe acne. The multi-center randomized double-blind study will start in 2H 2026 and enroll about 800 U.S. patients, including about 450 adolescents, with a 12-week blinded period followed by a 40-week open-label extension to assess long-term safety.

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