marked.bio

IDH1 inhibitor · small molecule

safusidenib

5 active trials, targeting IDH1. Not approved for any biomarker on marked.bio yet.

Also known as DS-1001b, DS-1001.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
IDH1/2 mutation 5 7 Phase 3

Sponsors

Industry sponsors leading active biomarker-selected trials of safusidenib.

  1. Nuvation Bio 3
  2. Daiichi Sankyo 1

Trials

5 of 7 trials shown

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

    Not yet recruiting Phase 3 Nuvation Bio Starts 2027Primary completion 2029-05 NCT07712757

    safusidenib

    Histologically confirmed Grade 2, IDH1-mutant oligodendroglioma or astrocytoma according to World Health Organization Central Nervous S…

    IDH1/2 mutationGrade 2 Glioma (Astrocytoma or Oligodendroglioma) With an IDH1 Mutation, Astrocytoma IDH Mutant Grade 2, Oligodendroglioma, Oligodendroglioma IDH-mutant and 1p/19q-codeleted

  2. SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance)

    Recruiting Phase 3 Nuvation Bio Started 2023Primary completion 2028-12 NCT05303519

    safusidenib

    …stologically confirmed recurrent or progressive WHO Grade 2 glioma or Grade 3 glioma with IDH1 R132H or R132C mutation confirmed by immunohistochemistry or molecular genetic testing.

    IDH1/2 mutationGlioma, Astrocytoma, Grade IV, IDH1-mutant Glioma, Astrocytoma, IDH-Mutant, Grade 3

  3. Safusidenib for Patients With Newly Diagnosed IDH1-mutant CNS WHO Grade 3 Oligodendroglioma and Astrocytoma - a Single Arm Phase II Study

    Not yet recruiting Phase 2 University of Zurich Starts 2027Primary completion 2029-03 NCT07832123

    safusidenib

    Newly diagnosed and histologically confirmed IDH1-mutant WHO grade 3 glioma, without or with residual disease: astrocytoma IDH1-mutant, or oligode…

    IDH1/2 mutationGlioma : Oligodendroglioma or Astrocytoma

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

    Recruiting Phase 2 Nuvation Bio Starts 2027Primary completion 2030-09 NCT07703436

    safusidenib

    Histologically confirmed Grade 2 or 3 IDH-mutant astrocytoma or IDH-mutant and 1p19q co-deleted oligodendroglioma, according to WHO CNS 20…

    IDH1/2 mutationGrade 2 IDH1-mutant Glioma, Grade 3 IDH1-mutant Glioma, Glioma, IDH1-mutant Glioma

  5. A Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-Naive IDH1 Mutated WHO Grade II Glioma

    Active, not recruiting Phase 2 Daiichi Sankyo Started 2020Primary completion 2023-03 NCT04458272

    safusidenib

    Has a histopathologically documented IDH1 mutated WHO grade II glioma according to the 2016 WHO classification.

    IDH1/2 mutationWHO Grade II Glioma