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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: 30 Apr 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

  • 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.
  • 21 Apr 2025 According to Jazz Pharmaceuticals plc media release, Dordaviprone may be eligible for a Rare Pediatric Disease Priority Review Voucher (PRV), if it is approved by the USFDA.

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