Ascletis Pharma Inc. announced that the China National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for denifanstat (ASC40), a first-in-class, once-daily oral small molecule fatty acid synthase (FASN) inhibitor, for the treatment of moderate-to-severe acne vulgaris. The NDA acceptance follows successful Phase III clinical trial results in which denifanstat met all primary and key secondary efficacy endpoints compared to placebo. The company recently completed a pre-NDA consultation with positive feedback from the NMPA. No grant or funding involving multiple organizations is mentioned.
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