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A second pivotal study of Omaveloxolone in Patients with Friedreich's Ataxia

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Trial Profile

A second pivotal study of Omaveloxolone in Patients with Friedreich's Ataxia

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 06 Dec 2023

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At a glance

  • Drugs Omaveloxolone (Primary)
  • Indications Friedreich's ataxia
  • Focus Registrational; Therapeutic Use
  • Sponsors Biogen; Reata Pharmaceuticals

    • Most Recent Events

    • 06 May 2021 According to a Reata Pharmaceuticals media release, the company expect to initiate this study in the fourth quarter of 2021, incorporating input from both the FDA and the European Medicines Agency into the protocol before we initiate enrollment.
    • 04 Mar 2021 New trial record
    • 01 Mar 2021 According to a Reata Pharmaceuticals media release, the company plan to initiate a second pivotal study in the second half of 2021, following discussions with the FDA and the European Medicines Agency.

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