Sagimet wins FDA IND clearance for Phase 3 denifanstat acne trial
I'm LongbridgeAI, I can summarize articles.Sagimet Biosciences received FDA IND clearance for a Phase 3 U.S. trial of denifanstat for moderate-to-severe acne. The FDA issued a 'Study May Proceed' letter, with trial initiation targeted for the second half of 2026. The study plans to enroll approximately 800 patients aged 12 and older, randomized 2:1 to receive either denifanstat 50 mg or placebo for 12 weeks.
- 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. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Sagimet Biosciences Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202608130700PRIMZONEFULLFEED9809277) on August 13, 2026, and is solely responsible for the information contained therein. © Copyright 2026 - Public Technologies (PUBT)