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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: 25 Sep 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

  • 09 Sep 2025 According to Jazz Pharmaceuticals plc media release, Modeyso received accelerated approval based on a pre-specified integrated efficacy analysis of 50 adult and pediatric patients with recurrent H3 K27M-mutant diffuse midline glioma enrolled across five open-label clinical studies (ONC006, ONC013, ONC014, ONC016 and ONC018). Continued approval may be contingent upon verification and description of clinical benefit in the ongoing Phase 3 ACTION trial.
  • 23 Apr 2025 According to Jazz Pharmaceuticals plc media release, an oral abstract of this study will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting from May 30-June 3, 2025, in Chicago and online.
  • 21 Apr 2025 According to Jazz Pharmaceuticals plc media release, Chimerix is now a wholly owned subsidiary of Jazz Pharmaceuticals plc. This acquisition will leverage the development and commercial capabilities to deliver Dordaviprone to patients as soon as in the 2H 2025.

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