Safusidenib

DRUG3 trials

Sponsors

Nuvation Bio Inc.

Conditions

Astrocytoma IDH Mutant Grade 2Astrocytoma IDH Mutant Grade 3Astrocytoma, Grade IVAstrocytoma, IDH-Mutant, Grade 2Astrocytoma, IDH-Mutant, Grade 3Astrocytoma, IDH-Mutant, Grade 4GliomaGrade 2 Glioma (Astrocytoma or Oligodendroglioma) With an IDH1 Mutation

Phase 2

Safety and Efficacy Study of Safusidenib in Participants With IDH1-Mutant Glioma Who Discontinued Vorasidenib Treatment Due to Progressive Disease

Not yet recruitingNCT07703436

Nuvation Bio Inc.Astrocytoma IDH Mutant Grade 2, Astrocytoma IDH Mutant Grade 3, Glioma +5

Start: 2027-03-01End: 2032-03-01Target: 40Updated: 2026-08-28

Phase 3

SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance)

RecruitingNCT05303519

Nuvation Bio Inc.Astrocytoma, Grade IV, Astrocytoma, IDH-Mutant, Grade 2, Astrocytoma, IDH-Mutant, Grade 3 +5

Start: 2023-06-05End: 2030-12-01Target: 365Updated: 2026-08-28

Safety and Efficacy Study of Safusidenib in Participants With Grade 2 IDH1-Mutant Glioma

Not yet recruitingNCT07712757

Nuvation Bio Inc.Astrocytoma IDH Mutant Grade 2, Grade 2 Glioma (Astrocytoma or Oligodendroglioma) With an IDH1 Mutation, IDH-mutant Gliomas +2

Start: 2027-03-01End: 2032-03-01Target: 140Updated: 2026-07-17

Related Papers

CTNI-19. PHASE 2, MULTICENTER, RANDOMIZED CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SAFUSIDENIB IN PATIENTS WITH HIGH-GRADE ISOCITRATE DEHYDROGENASE 1 (IDH1)-MUTANT GLIOMA

Neuro-Oncology2025-11-01

The first-in-human phase I study of a brain-penetrant mutant IDH1 inhibitor DS-1001 in patients with recurrent or progressive IDH1-mutant gliomas

Neuro-Oncology2022-06-2076 citations