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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: 22 Sep 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

  • 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).
  • 06 Aug 2025 According to Jazz Pharmaceuticals media release, company announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Modeyso (dordaviprone) for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.

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