Core Insights - Denifanstat has successfully met all primary and secondary endpoints in a Phase 3 clinical trial for moderate to severe acne in China, demonstrating its efficacy and safety [1][2][4] Company Developments - Ascletis has completed the pre-New Drug Application (NDA) consultation with China's NMPA and plans to submit an NDA for denifanstat soon [3] - Sagimet Biosciences is developing denifanstat as a once-daily oral small molecule fatty acid synthase (FASN) inhibitor for acne treatment in China and for metabolic dysfunction associated steatohepatitis (MASH) in other regions [1][7] Clinical Trial Details - The Phase 3 trial was a randomized, double-blind, placebo-controlled study involving 480 patients, with treatment arms receiving either denifanstat 50mg or placebo for 12 weeks [2] - Key primary endpoints included treatment success rates, total lesion count, and inflammatory lesion count, all of which were significantly improved with denifanstat compared to placebo [2][4] Market Context - Acne affects over 50 million people annually in the U.S., highlighting a significant market opportunity for innovative treatments like denifanstat [5][8] - The U.S. acne market includes approximately 5.1 million patients treated by dermatologists each year, indicating a strong demand for effective therapies [8]