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ONC201 for the Treatment of Newly Diagnosed H3 K27M-mutant Diffuse Glioma Following Completion of Radiotherapy: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study

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Trial Profile

ONC201 for the Treatment of Newly Diagnosed H3 K27M-mutant Diffuse Glioma Following Completion of Radiotherapy: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 05 Mar 2025

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At a glance

  • Drugs Dordaviprone (Primary)
  • Indications Glioma
  • Focus Registrational; Therapeutic Use
  • Acronyms ACTION; the ACTION Study
  • Sponsors Chimerix

    • Most Recent Events

    • 18 Feb 2025 According to a Chimerix media release, the company announced that U.S. FDA has accepted its New Drug Application (NDA) seeking accelerated approval for dordaviprone as a treatment for patients with recurrent H3 K27M-mutant diffuse glioma. The application has been granted Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 18, 2025. The FDA does not currently plan to hold an advisory committee meeting to discuss the application.
    • 07 Nov 2024 According to a Chimerix media release,Phase 3 ACTION trial is currently enrolling at over 145 sites in 15 countries.
    • 13 Aug 2024 According to a Chimerix media release, Phase 3 ACTION trial is currently enrolling H3 K27M-mutant diffuse glioma patients at over 140 sites in 13 countries. Company expects interim OS data in the third quarter of 2025.

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