Ascletis Pharma Announces Positive Phase III Results for Denifanstat (ASC40) in Moderate-to-Severe Acne and Completes Pre-NDA Consultation with China NMPA

Reuters

2025/10/14

Ascletis Pharma Announces Positive Phase III Results for Denifanstat (ASC40) in Moderate-to-Severe Acne and Completes Pre-NDA Consultation with China NMPA

Ascletis Pharma Inc. has announced the completion of a pre-New Drug Application (NDA) consultation with the China National Medical Products Administration (NMPA) for denifanstat (ASC40) for the treatment of moderate-to-severe acne vulgaris. The company plans to submit an NDA for the drug soon. Denifanstat (ASC40) met all primary, key secondary, and secondary efficacy endpoints in a Phase III randomized, double-blind, placebo-controlled, multicenter clinical trial, demonstrating significant improvement in moderate-to-severe acne vulgaris compared with placebo. There were no denifanstat-related serious adverse events, permanent treatment discontinuations, or withdrawals observed. The results of the Phase III study were presented as an oral presentation at the European Academy of Dermatology and Venereology (EADV) Congress 2025 in Paris, France, on September 17, 2025.

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. Ascletis Pharma Inc. published the original content used to generate this news brief on October 14, 2025, and is solely responsible for the information contained therein.

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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. 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Ascletis Pharma Inc. has announced the completion of a pre-New Drug Application  consultation with the China National Medical Products Administration  for denifanstat  for the treatment of moderate-to-severe acne vulgaris. The company plans to submit an NDA for the drug soon. Denifanstat  met all primary, key secondary, and secondary efficacy endpoints in a Phase III randomized, double-blind, placebo-controlled, multicenter clinical trial, demonstrating significant improvement in moderate-to-severe acne vulgaris compared with placebo. There were no denifanstat-related serious adverse events, permanent treatment discontinuations, or withdrawals observed. 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The company plans to submit an NDA for the drug soon. Denifanstat (ASC40) met all primary, key secondary, and secondary efficacy endpoints in a Phase III randomized, double-blind, placebo-controlled, multicenter clinical trial, demonstrating significant improvement in moderate-to-severe acne vulgaris compared with placebo. There were no denifanstat-related serious adverse events, permanent treatment discontinuations, or withdrawals observed. The results of the Phase III study were presented as an oral presentation at the European Academy of Dermatology and Venereology (EADV) Congress 2025 in Paris, France, on September 17, 2025.\n      \n\nDisclaimer: 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. 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