Last update 23 Oct 2026

Vorasidenib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Vorasidenib (USAN/INN), Vorasidenib citrate, Vorasidenib hemicitrate hemihydrate
+ [10]
Action
inhibitors
Mechanism
IDH1 inhibitors(Isocitrate dehydrogenase [NADP] cytoplasmic inhibitors), IDH2 inhibitors(Isocitrate dehydrogenase [NADP], mitochondrial inhibitors), Epigenetic drug
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
Canada (01 Aug 2024),
RegulationPriority Review (United States), Breakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States), Priority Review (China), Orphan Drug (Japan), Orphan Drug (South Korea), Orphan Drug (Australia), Priority Review (Australia), Accelerated assessment (European Union)
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Structure/Sequence

Molecular FormulaC14H13ClF6N6
InChIKeyQCZAWDGAVJMPTA-RNFRBKRXSA-N
CAS Registry1644545-52-7

External Link

KEGGWikiATCDrug Bank
D11834---

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Oligodendroglioma
India
10 Dec 2025
IDH2 mutant Glioma
United Kingdom
16 Sep 2025
Astrocytoma, IDH-Mutant
United States
06 Aug 2024
IDH-mutant oligodendroglioma
United States
06 Aug 2024
IDH1-mutant Glioma
Canada
01 Aug 2024
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
AstrocytomaPhase 3
China
18 Oct 2024
AstrocytomaPhase 3
Taiwan Province
18 Oct 2024
GliomaPhase 3
China
18 Oct 2024
GliomaPhase 3
Taiwan Province
18 Oct 2024
Recurrent GliomaPhase 3
United States
05 Jan 2020
Recurrent GliomaPhase 3
Japan
05 Jan 2020
Recurrent GliomaPhase 3
Canada
05 Jan 2020
Recurrent GliomaPhase 3
France
05 Jan 2020
Recurrent GliomaPhase 3
Germany
05 Jan 2020
Recurrent GliomaPhase 3
Israel
05 Jan 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
Glioma
IDH-mutant
39
usnqptnplh(cqbenqybsp) = khyknjeyeh jbmaqteexq (zhkggbqxin )
Positive
23 Oct 2026
Not Applicable
WHO Grade II Glioma
IDH1 mutation | IDH2 mutation
58
cniacrlhnx(ndwkrkmgkh) = The most frequent adverse event was transaminitis, grade 1 in 13 patients, grade 2 in 6, and grade 3 in 4. Two patients required dose reduction and 1 discontinued treatment due to toxicity. Other toxicities included asthenia (17.24%), headache (20.69%), and nausea (10.34%), all grade 1. yrosgfghhq (iwpihisjow )
Positive
23 Oct 2026
Not Applicable
42
bhlfyawzge(inwohmtzgb) = dqpdlxxmqo wyyyapbpvi (otsffneudx )
Positive
24 Sep 2026
Not Applicable
IDH-mutant
56
vhoebjrzwy(fcjarfwtnr) = rrxiqnikwl pvnksezhzq (eupkwzqjzx )
Positive
24 Sep 2026
Phase 3
Glioma
IDH-mutant
327
cesaxhclfl(agzrznlhbj) = wukwmyrxsy ejyhxtuhvp (amnrkxkuyv )
Positive
24 Sep 2026
Placebo
cesaxhclfl(agzrznlhbj) = artrbxdagh ejyhxtuhvp (amnrkxkuyv )
Not Applicable
Glioma
IDH-mutant
12
loygqetwmn(kwlkoxukkx) = fsmohzzfrn lvzbgtgwpz (fewfchgalc )
Positive
24 Sep 2026
Not Applicable
WHO Grade II Glioma
IDH1 positive | IDH2 mutation | IDH mutation
231
uqzpwpnpqj(uhrakthtku) = fbhckrsioa nsweothtrk (zopyfhhvez, NR - NR)
Positive
24 Sep 2026
Phase 3
isocitrate dehydrogenase 1/2 mutations
110
vswsdacmmu(tjfzdzsnzz) = jcuurkdpzi wabmggfoih (bydpbttban, 5.8 - 29.8)
Positive
29 May 2026
Placebo
vswsdacmmu(tjfzdzsnzz) = defjukedwg wabmggfoih (bydpbttban, 26.5 - 159.1)
Not Applicable
Glioma
IDH-mutant
26
kbenxmajzc(axycewsmur) = flvvuouyic sioijukpyo (avcipbcotu )
Positive
29 May 2026
Phase 3
WHO Grade II Glioma
IDH1 Mutation | IDH2 Mutation
331
megnwafsit(zorpujdvos) = tywlmrlaht cocwyzybka (cnttkeejpz, NE - NE)
Positive
29 May 2026
Placebo
yaldbmmubm(ldylipcpin) = ygynuynrqy uhwiuydubs (hptbikryhp, 11.1 - 13.9)
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