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Expanded Access to ONC201 for Patients With H3 K27M-mutant and/or Midline High Grade Gliomas

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Trial Profile

Expanded Access to ONC201 for Patients With H3 K27M-mutant and/or Midline High Grade Gliomas

Status: Completed
Phase of Trial: Clinical Phase Unknown

Latest Information Update: 30 Oct 2025

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At a glance

  • Drugs Dordaviprone (Primary)
  • Indications Diffuse intrinsic pontine glioma; Glioma
  • Focus Expanded access; Registrational; Therapeutic Use
  • 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.
  • 06 Aug 2025 According to Jazz Pharmaceuticals media release, the company will host a webcast on August 27, 2025, at 4:30 p.m. ET / 9:30 p.m. IST to provide investors an overview of clinical data, patient need and commercialization strategy for Modeyso.
  • 06 Aug 2025 According to Jazz Pharmaceuticals media release, The FDA's accelerated approval decision was based on an integrated efficacy analysis of 50 patients with recurrent H3 K27M-mutant diffuse midline glioma, selected from five open-label clinical studies (ONC006, ONC013, ONC014, ONC016, and ONC018).

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