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Safusidenib · DS-1001b, AB-218

Small molecule · Inhibitor of isocitrate dehydrogenase 1 (IDH1) R132 mutant (IDH1) · developed by Nuvation Bio

Phase 3 Most advanced trial
NUVB Developer
1 Registered trials

What is Safusidenib?

Safusidenib is an orally available inhibitor that binds and inhibits mutant forms of isocitrate dehydrogenase 1 (IDH1), including the R132 substitution mutations, thereby blocking formation of the oncometabolite 2-hydroxyglutarate. It is being studied in glioma, astrocytoma and oligodendroglioma with IDH1 mutations, and it minimally affects wild-type IDH1.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as
DS-1001b, AB-218
Drug type
Small molecule
Targets
isocitrate dehydrogenase 1 (IDH1) R132 mutant (IDH1)
Mechanism
Inhibitor of isocitrate dehydrogenase 1 (IDH1) R132 mutant (IDH1)
Pathways
2-hydroxyglutarate (2HG) production, cellular differentiation, cell proliferation
Therapy area
Oncology
Developer
Nuvation Bio Inc. (NUVB)
FDA status
Investigational, not approved in the US. Most advanced trial: Phase 3
UNII
RCK8KK7SB9

🧪 Clinical trials

TrialPhaseConditionStatusSponsor
NCT05303519 Phase 3 Glioma Recruiting NUVB

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Astrocytoma, Grade IVAstrocytoma, IDH-Mutant, Grade 2Astrocytoma, IDH-Mutant, Grade 3Astrocytoma, IDH-Mutant, Grade 4GliomaIDH1-mutant GliomaOligodendrogliomaOligodendroglioma, IDH-Mutant and 1p/19q-Codeleted

Other drugs acting on IDH1

More from Nuvation Bio

Sources

Updated Oct 11, 2026. Something wrong or missing? Report it on the NUVB page.

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Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z

This data is for informational purposes only, not investment advice. BioRadar does not provide buy/sell recommendations. Past performance does not guarantee future results. Always do your own due diligence.