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safusidenib

Phase 3Small molecule

NNuvation Bio Inc.

safusidenib is one of 49 small molecule programs targeting Glioma. It is currently in Phase 3.

3

Indications

4

Total Trials

4

Active Trials

48

Competitors

Pipeline

Status by Indication[3][1]

Indication

GliomaNot yet recruiting

IDH1-Mutant GliomaRecruiting

IDH1 MutationNot yet recruiting

GliomaPhase 3

Not yet recruiting

IDH1-Mutant GliomaPhase 2

Recruiting

IDH1 MutationPhase 3

Not yet recruiting

Competition

Competitive Landscape

86 competitors in Glioma

#DrugCompanyPhaseTrials

Avastin

Paraplatin

Voranigo

Opdivo

Bristol-Myers Squibb

Camptosar

Keytruda

Verzenio

Lynparza

Dostarlimab

Lenvima

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2029

Phase 2Not yet recruiting

Glioma

NCT07832123

Q4 2030

Phase 3Recruiting

Glioma

NCT05303519

Q1 2032

Phase 2Recruiting

IDH1-Mutant Glioma

NCT07703436

Phase 3Not yet recruiting

IDH1 Mutation

NCT07712757

Clinical

Trials by Indication[1]

Glioma2 trials

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

Recruiting·NNuvation Bio Inc.·Phase 3·NCT05303519·365 enrolled

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

Not yet recruiting·UUniversity of Zurich·Phase 2·NCT07832123·20 enrolled

IDH1-mutant Glioma1 trial

A Phase 2, Multicenter, Clinical Study to Evaluate the Efficacy and Safety of Safusidenib Erbumine in Participants With Isocitrate Dehydrogenase 1 (IDH1)-Mutant Glioma Who Discontinued Vorasidenib Treatment Due to Progressive Disease

Recruiting·NNuvation Bio Inc.·Phase 2·NCT07703436·40 enrolled

IDH1 Mutation1 trial

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Safusidenib in Participants With Grade 2 Isocitrate Dehydrogenase 1 (IDH1)-Mutant Glioma

Not yet recruiting·NNuvation Bio Inc.·Phase 3·NCT07712757·140 enrolled

Sources

References

[1]
ClinicalTrials.gov — 4 trial records for safusidenib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — safusidenib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for safusidenib. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Nuvation Bio Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: NNuvation Bio Inc.

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