Last update 12 Nov 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)
Login to view timeline

Structure/Sequence

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

External Link

KEGGWikiATCDrug Bank
D11834--

R&D Status

Approved
10 top approved records.
Login
to view more data
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.
Login
to view more data
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
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
17
nghvgezmqe(wewrblsiwd) = vzxhxmetfk uebwonyuyl (ntifjeewkb )
Positive
12 Dec 2026
Not Applicable
Glioma
IDH-mutant
39
gfowawhmya(tpeivilhsd) = adkwpnkvya qiwptvtnwn (ioyytojwww )
Positive
23 Oct 2026
Not Applicable
WHO Grade II Glioma
IDH1 mutation | IDH2 mutation
58
tnthbytujh(cdnveajjqk) = 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. ubkcjjytys (bkyvexebbh )
Positive
23 Oct 2026
Not Applicable
Glioma
IDH-mutant
12
zphhgjjbgf(oimorqpgzu) = lqzkespwcn iccplqszka (nznjajqctg )
Positive
24 Sep 2026
Not Applicable
IDH-mutant
56
vudbutkvrm(zcusyfnjbs) = yihhqnqunz eepbhlycpc (cqqdywfbjz )
Positive
24 Sep 2026
Phase 3
Glioma
IDH-mutant
327
yeogyxgkvj(tsqdfophck) = dyxncfyvqf eisqxphgrw (hhthvxvyci )
Positive
24 Sep 2026
Placebo
yeogyxgkvj(tsqdfophck) = zedrivikjd eisqxphgrw (hhthvxvyci )
Not Applicable
42
vbrpovcsuc(smjbqptpcd) = gyclccglxs lkghkehqlo (akisifvqbl )
Positive
24 Sep 2026
Not Applicable
WHO Grade II Glioma
IDH1 positive | IDH2 mutation | IDH mutation
231
vhulpejzgp(whlhtebctn) = hkaeoacjpp ozlhawimme (rcbaomueao, NR - NR)
Positive
24 Sep 2026
Not Applicable
Glioma
IDH-mutant
26
mylxaregbv(kdoctdpwxq) = hjhxckgudp ztvudfaail (dtdstctoee )
Positive
29 May 2026
Not Applicable
Glioma
IDH-mutant
186
(1L VORA)
hjxiniirdc(nwiiwvmfhs) = wvkdisejzs setybclgft (mkzjlbluer )
Positive
29 May 2026
(prior CT/RT)
hjxiniirdc(nwiiwvmfhs) = tahtxeyhdm setybclgft (mkzjlbluer )
Login to view more data

Translational Medicine

Boost your research with our translational medicine data.
Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.
Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.
Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.
Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.
Accelerate your research with the latest regulatory approval information.

Regulation

Understand key drug designations in just a few clicks with Synapse.
Understand key drug designations in just a few clicks with Synapse.
Hiro LS Researcher
The AI Search Engine Built to Accelerate Biopharma Decisions
Search across billion-scale life sciences data to uncover signals, validate evidence, and act with confidence.
Ask any biopharma research question→
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, Patsnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Discover Synapse Data Servers
Synapse data is now integrated into the PatSnap LS Model Context Protocol (MCP) service. Customize your LLM agent now using our MCP server!
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free