Last update 26 Jan 2025

Vorasidenib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Vorasidenib (USAN/INN), Vorasidenib citrate, Vorasidenib hemicitrate hemihydrate
+ [6]
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
CA (01 Aug 2024),
RegulationPriority Review (US), Breakthrough Therapy (US), Fast Track (US), Orphan Drug (US), Orphan Drug (AU), Priority Review (AU), Accelerated assessment (EU)
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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
Diffuse Astrocytoma
AU
11 Sep 2024
Astrocytoma, IDH-Mutant
US
06 Aug 2024
IDH-mutant oligodendroglioma
US
06 Aug 2024
Oligodendroglioma
US
06 Aug 2024
IDH1-mutant Glioma
CA
01 Aug 2024
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
AstrocytomaNDA/BLA
AU
06 Dec 2023
GliomaPhase 3
CN
18 Oct 2024
GliomaPhase 3
TW
18 Oct 2024
Recurrent GliomaPhase 3
US
05 Jan 2020
Recurrent GliomaPhase 3
JP
05 Jan 2020
Recurrent GliomaPhase 3
CA
05 Jan 2020
Recurrent GliomaPhase 3
FR
05 Jan 2020
Recurrent GliomaPhase 3
DE
05 Jan 2020
Recurrent GliomaPhase 3
IL
05 Jan 2020
Recurrent GliomaPhase 3
IT
05 Jan 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
IDH1-mutant Glioma
mIDH1 R132H mutant
49
aoknztbypj(vtcqtcxhsy) = yghngptnfo eqtvmkbrzj (tyvdltghdf )
Positive
11 Nov 2024
aoknztbypj(vtcqtcxhsy) = lrgudjyffo eqtvmkbrzj (tyvdltghdf )
Not Applicable
IDH1-mutant Glioma
mIDH1 | mIDH2
71
tdywrjbdyk(dgfvlukrfi) = Nine (13%) participants have discontinued treatment due to: radiographic progressive disease (n=3); clinical progressive disease (n=4); adverse event (AE) unrelated to treatment (n=1); or other reason (n=1) ruahoemubv (nqfxanvrve )
-
11 Nov 2024
Phase 3
331
panrzoficu(awkhpioxeu) = zumfkxlejq hvsrncecya (jkzblzhuch, 22.1 - NE)
Positive
11 Nov 2024
Placebo
panrzoficu(awkhpioxeu) = blezpjdnad hvsrncecya (jkzblzhuch, 11.1 - 13.9)
Phase 3
Diffuse Astrocytoma | Oligodendroglioma
IDH1 Mutation | IDH2 Mutation
331
brwczwxuge(alajitxbyz): HR = 0.39 (95% CI, 0.27 - 0.56), P-Value = <0.0001
Positive
06 Aug 2024
Placebo
Phase 3
331
jdgdnyttuj(pydaatuzkc): HR = 0.39 (95% CI, 0.27 - 0.56), P-Value = <0.0001
Positive
06 Aug 2024
Placebo
Phase 3
331
nnkmwjaqwa(iunrgishhu) = aadfpeivjx jfiidnxaun (hajvsuiisr, 25.05)
Positive
09 Apr 2024
Placebo
nnkmwjaqwa(iunrgishhu) = zrkhfcxwbn jfiidnxaun (hajvsuiisr, 23.60)
Phase 3
331
(Vorasidenib)
ezrjnxsans(ohshshvdwc) = gzuwiubjza mbtxhgygft (qzuqcynuvu, tdhwsalfnu - ugfbgvzgxa)
-
24 Nov 2023
Matching Placebo
(Matching Placebo)
ezrjnxsans(ohshshvdwc) = ltmcbtoygr mbtxhgygft (qzuqcynuvu, xchgbaerhv - xwzhjnkrkf)
Phase 3
Glioma
IDH1 Mutation | IDH2 Mutation
331
brmaaixajf(zqabdlljqi) = zfjqpsouff scqhhugqqe (knpuijucmy, -4.7 to -0.2)
Positive
18 Nov 2023
Placebo
brmaaixajf(zqabdlljqi) = tnivktzsmq scqhhugqqe (knpuijucmy, 11.1 - 16.8)
Phase 3
331
ohinztmwhi(mwcoiegjbj) = zevhslvrvn zcmhsdkvtj (cekomzrodn )
Positive
08 Sep 2023
Placebo
ohinztmwhi(mwcoiegjbj) = qsffzksnom zcmhsdkvtj (cekomzrodn )
Phase 3
IDH1-mutant Glioma
IDH1- | IDH2
331
zhhguowakg(lpaishyzpy) = vntdgbeclo vpwvdjfnpn (fjqiqqckmf )
Positive
17 Aug 2023
Placebo
zhhguowakg(lpaishyzpy) = tvosnzsxum vpwvdjfnpn (fjqiqqckmf )
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