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Real-World Data Study Assessing the Efficacy of Troriluzole-Treated Subjects With Spinocerebellar Ataxia (SCA) Compared to a Matched External SCA Control Using Natural History Cohort Data

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Trial Profile

Real-World Data Study Assessing the Efficacy of Troriluzole-Treated Subjects With Spinocerebellar Ataxia (SCA) Compared to a Matched External SCA Control Using Natural History Cohort Data

Status: Active, no longer recruiting
Phase of Trial: Phase IV

Latest Information Update: 20 May 2025

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At a glance

  • Drugs Troriluzole (Primary)
  • Indications Spinocerebellar ataxias
  • Focus Registrational; Therapeutic Use
  • Sponsors Biohaven Pharmaceuticals

Most Recent Events

  • 14 May 2025 According to a Biohaven Pharmaceuticals media release, company announced that the Division of Neurology 1 within FDA's Office of Neuroscience informed the extending the PDUFA date for the troriluzole NDA for the treatment of SCA by 3 months to provide time for a full review of company recent submissions requests from the FDA. The Division also currently planning to hold an advisory committee meeting to discuss the application. The FDA's decision regarding the NDA is now expected in 4Q 2025.
  • 12 May 2025 According to a Biohaven Pharmaceuticals media release, the Company completed a mid-cycle review meeting with the FDA of the NDA for troriluzole for the treatment of SCA. The FDA has not conveyed any intention of holding an Advisory Committee Meeting
  • 28 Apr 2025 According to a Biohaven Pharmaceuticals media release, company announced that it has entered into an agreement with Oberland Capital Management LLC (Oberland Capital) for an investment of up to $600 million in the Company. The additional capital provides significant financial resources for ongoing clinical trials and supports commercialization efforts in anticipation of a potential U.S. Food and Drug Administration (FDA) approval of troriluzole for the treatment of patients with SCA

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