Sagimet wins FDA IND clearance for Phase 3 denifanstat acne trial - SGMT News | RalliesSagimet wins FDA IND clearance for Phase 3 denifanstat acne trial
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SGMT• FDA clears Phase 3 acne trial of denifanstat
- 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.
- The 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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