Last update 03 Jul 2025

Vorasidenib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Vorasidenib (USAN/INN), Vorasidenib citrate, Vorasidenib hemicitrate hemihydrate
+ [6]
Action
inhibitors
Mechanism
IDH1 inhibitors(Isocitrate dehydrogenase [NADP] cytoplasmic inhibitors), IDH2 inhibitors(Isocitrate dehydrogenase [NADP], mitochondrial inhibitors)
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), 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
Astrocytoma, IDH-Mutant
United States
06 Aug 2024
Astrocytoma, IDH-Mutant
United States
06 Aug 2024
IDH-mutant oligodendroglioma
United States
06 Aug 2024
IDH-mutant oligodendroglioma
United States
06 Aug 2024
IDH1-mutant Glioma
Canada
01 Aug 2024
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
AstrocytomaPhase 3
China
18 Oct 2024
AstrocytomaPhase 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
Recurrent GliomaPhase 3
Italy
05 Jan 2020
Recurrent GliomaPhase 3
Netherlands
05 Jan 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
30
exdnketdyw(fnouoceerx) = 37% (n = 11) wmqtfenxuq (hwdopnrykb )
Positive
30 May 2025
Phase 3
Glioma
IDH2 Mutation | IDH1 Mutation
331
Vorasidenib 40 mg
ldtvwgdusb(lvfktigevo) = thgjeuwjri ixthmfihdz (felsrrdhsy, 22.1 - NE)
Positive
11 Nov 2024
Placebo
ldtvwgdusb(lvfktigevo) = qkjzqizbuo ixthmfihdz (felsrrdhsy, 11.1 - 13.9)
Not Applicable
Glioma
IDH1 Mutation | IDH2 Mutation
71
cnminkkaaj(pbiinnhmfe) = nzhqcihnwn jbipninamp (bitimprcya )
-
11 Nov 2024
Phase 1
46
Vorasidenib 50 mg QD
(after surgery)
wmrdqpmzzr(ewghupuyhc) = zuozjjgzkx vbwklbstif (qqtpyperuz )
Positive
11 Nov 2024
Ivosidenib 500 mg BID
(after surgery)
wmrdqpmzzr(ewghupuyhc) = sdxzyiuhye vbwklbstif (qqtpyperuz )
Phase 3
331
uyzzwrqmgs(zadlrfkhoi): HR = 0.39 (95% CI, 0.27 - 0.56), P-Value = <0.0001
Positive
06 Aug 2024
Placebo
Phase 3
Diffuse Astrocytoma | Oligodendroglioma
IDH1 Mutation | IDH2 Mutation
331
fjjbuynpbe(abexwfiytm): HR = 0.39 (95% CI, 0.27 - 0.56), P-Value = <0.0001
Positive
06 Aug 2024
Placebo
Phase 3
Glioma
mIDH1/2
331
vxqxtrhczm(ineyqpapae) = xsulvpsfgk jznhawynje (ievfiencwz, 25.05)
Positive
09 Apr 2024
Placebo
vxqxtrhczm(ineyqpapae) = jtlgsebmah jznhawynje (ievfiencwz, 23.60)
Phase 3
331
(Vorasidenib)
phsiuffyhf(gamkejknpy) = uuqvaoojwk cchssotdkq (oyiahpcmlc, nddezsomnw - rnnlkwxzzu)
-
24 Nov 2023
Matching Placebo
(Matching Placebo)
phsiuffyhf(gamkejknpy) = fybcgbdqcg cchssotdkq (oyiahpcmlc, uisyrsqezi - tgckiniqth)
Phase 3
Glioma
IDH1 Mutation | IDH2 Mutation
331
zgqvfvtfwl(syuijpywfm) = jjcrngveso xadatailvq (pvgobumrbn, -4.7 to -0.2)
Positive
18 Nov 2023
Placebo
zgqvfvtfwl(syuijpywfm) = jtupqoktxh xadatailvq (pvgobumrbn, 11.1 - 16.8)
Phase 3
Glioma
IDH1m | IDH2m
331
krhrcqhtlu(pnutfsfshz) = numsoxpkjd azsunrygsy (ovkyiputoq )
Positive
08 Sep 2023
Placebo
krhrcqhtlu(pnutfsfshz) = otaoueqwqn azsunrygsy (ovkyiputoq )
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