Sagimet wins FDA IND clearance for Phase 3 denifanstat acne trial
Reuters2026/08/13 11:05- Sagimet won FDA IND clearance for a Phase 3 U.S. trial of denifanstat in moderate-to-severe acne.
- FDA issued a “Study May Proceed” letter; trial initiation remains targeted for 2H 2026.
- Study aims to enroll about 800 patients ages 12+, randomized 2:1 to denifanstat 50 mg or placebo for 12 weeks.
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