Cutia Therapeutics has announced positive topline results from a Phase III clinical trial in China for CU-20101, its botulinum toxin type A injection developed for the improvement of moderate to severe glabellar lines. The clinical trial comprised two phases: a randomized, multi-center, double-blind, positive drug control study, and an open-label study to evaluate efficacy and safety. BOTOX® served as the control and reference product. According to the company, the trial met its non-inferiority endpoint for efficacy, as assessed by both on-site investigators and participants, with additional confirmation from an independent assessment committee. All enrolled subjects completed the trial in November 2025, and database lock was completed in early January 2026. The results have already been presented by Cutia Therapeutics. The company noted there is no assurance CU-20101 will ultimately be successfully developed or marketed.
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