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A Phase III, Long-Term, Randomized, Double-blind, Placebo-controlled Trial of Troriluzole in Adult Participants With Spinocerebellar Ataxia.

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A Phase III, Long-Term, Randomized, Double-blind, Placebo-controlled Trial of Troriluzole in Adult Participants With Spinocerebellar Ataxia.

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

Latest Information Update: 17 Mar 2025

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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

    • 03 Mar 2025 According to a Biohaven Pharmaceuticals media release, company is preparing for commercial launch in all-genotype SCA in 2025, following FDA filing acceptance and 3Q 2025 PDUFA date.
    • 11 Feb 2025 According to a Biohaven Pharmaceuticals media release, based on data from BHV4157-201, BHV4157-206 and Study BHV4157-206-RWE , US Food and Drug Administration (FDA) has accepted for review the Company's New Drug Application (NDA) for troriluzole for the treatment of adult patients with spinocerebellar ataxia (SCA) and has granted Priority Review. Based on FDA Priority Review timelines and if ultimately approved, company is prepared to commercialize troriluzole for SCA in the US in 2025.
    • 16 Dec 2024 According to a Biohaven Pharmaceuticals media release, A new drug application (NDA) was submitted to the US FDA for troriluzole in the treatment of all genotypes of spinocerebellar ataxia (SCA), following the completion of a pre-NDA meeting in 4Q 2024.

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