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A Phase IIb/III, Randomized, Double-blind, Placebo-controlled Trial of BHV-4157 Troriluzole in Adult Subjects With Spinocerebellar Ataxia

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Trial Profile

A Phase IIb/III, Randomized, Double-blind, Placebo-controlled Trial of BHV-4157 Troriluzole in Adult Subjects With Spinocerebellar Ataxia

Status: Active, no longer recruiting
Phase of Trial: Phase II/III

Latest Information Update: 03 Aug 2023

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At a glance

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

    • Most Recent Events

    • 27 Jul 2023 According to a Biohaven Pharmaceuticals media release, Troriluzole was submitted under a 505(b)(2) application.
    • 27 Jul 2023 According to a Biohaven Pharmaceuticals media release, the FDA informed Biohaven that it would not review the recently submitted NDA application given that the study's primary endpoint was not met and would not permit a substantive review. The company may request a Type A meeting within 30 days. Any updates regarding the Type A meeting will be provided subsequent to the upcoming regulatory interaction.
    • 31 May 2023 According to a Biohaven media release, based on the data of this study (BHV4157-206) and open-label (OLE) extension phase of the study BHV4157-201, the company has submitted New Drug Application (NDA) to the USA FDA for troriluzole for the treatment of spinocerebellar ataxia type 3 (SCA3).
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