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A confirmatory study of masitinib in the treatment of Amyotrophic Lateral Sclerosis

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Trial Profile

A confirmatory study of masitinib in the treatment of Amyotrophic Lateral Sclerosis

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 18 May 2025

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At a glance

  • Drugs Masitinib (Primary)
  • Indications Amyotrophic lateral sclerosis
  • Focus Registrational; Therapeutic Use
  • Sponsors AB Science

Most Recent Events

  • 12 May 2025 According to an AB science media release, new confirmatory study AB23005, which simplifies patient recruitment and targets the best responders to masitinib, will be launched in accordance with FDA and EMA recommendations. The study design has been approved by the FDA and the EMA. The confirmatory study has been approved by the FDA.
  • 17 Oct 2024 According to an AB science media release, company announces that European Medicines Agency (EMA) confirmed a negative opinion for conditional marketing authorization of masitinib in treatment of amyotrophic lateral sclerosis (ALS), this opinion supports design of this confirmatory study of masitinib in ALS, as the same dichotomization and the same cut-off have been pre-specified for the confirmatory study.
  • 30 Sep 2019 According to an AB science media release, the company expects to initiate this study in Q1 2020.

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