Ascletis announces phase iii trial of denifanstat (asc40), a first-in-class, once-daily oral fasn inhibitor for acne, meets all endpoints

Denifanstat (asc40), a once-daily oral fatty acid synthase (fasn) inhibitor, demonstrated statistically significant and clinically meaningful improvement compared to placebo in all primary, key secondary, and secondary endpoints denifanstat demonstrated a favorable safety and tolerability profile denifanstat was 98% and 178% more effective than u.s. food and drug administration (fda)-approved sarecycline and doxycycline with regard to placebo-adjusted percent treatment success, respectively, 18.6% for denifanstat versus 9.4% for sarecycline, 18.6% versus 6.7% for doxycycline denifanstat was 60% more effective than fda-approved clascoterone cream with regard to placebo-adjusted percent treatment success, 18.6% for denifanstat versus 11.6% for clascoterone cream, respectively the exceptional efficacy of denifanstat coupled with its favorable safety profile in the phase iii trial provides a potential major break-through for the treatment of acne hong kong , june 3, 2025 /prnewswire/ -- ascletis pharma inc. (hkex: 1672, "ascletis") announces today that denifanstat (asc40), a first-in-class, once-daily oral small molecule fatty acid synthase (fasn) inhibitor, meets all primary, key secondary, and secondary endpoints in the phase iii clinical trial for the treatment of moderate to severe acne vulgaris (nct06192264). the phase iii clinical trial was a randomized, double-blind, placebo-controlled, multicenter clinical trial in china to evaluate the safety and efficacy of denifanstat once-daily oral tablet in 480 patients with moderate to severe acne vulgaris.
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