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A Phase 3, Multicenter, Clinical Study to Evaluate the Efficacy and Safety of Safusidenib Erbumine in Participants With Isocitrate Dehydrogenase 1 (IDH1)-Mutant Glioma

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Trial Profile

A Phase 3, Multicenter, Clinical Study to Evaluate the Efficacy and Safety of Safusidenib Erbumine in Participants With Isocitrate Dehydrogenase 1 (IDH1)-Mutant Glioma

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 14 Apr 2026

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At a glance

  • Drugs Safusidenib (Primary)
  • Indications Astrocytoma; Glioma; Oligodendroglioma
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms G203; SIGMA
  • Sponsors AnHeart Therapeutics; Nuvation Bio

Most Recent Events

  • 01 Apr 2026 According to Nuvation Bio media release,The pivotal portion of the study will enroll approximately 300 patients and Data is anticipated to be available in 2029. A non-pivotal cohort will This cohort is expected to enroll approximately 40 patients and Data is anticipated to be available in 2027.
  • 02 Mar 2026 According to Nuvation Bio media release, In October 2025, the Company enrolled the first patient in the global SIGMA study (G203).
  • 09 Feb 2026 According to Nuvation Bio media release, company expects initial data for the separate oligodendroglioma cohort in 2027.

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