Drug Type Small molecule drug |
Synonyms Vorasidenib (USAN/INN), Vorasidenib citrate, Vorasidenib hemicitrate hemihydrate + [10] |
Target |
Action inhibitors |
Mechanism IDH1 inhibitors(Isocitrate dehydrogenase [NADP] cytoplasmic inhibitors), IDH2 inhibitors(Isocitrate dehydrogenase [NADP], mitochondrial inhibitors), Epigenetic drug |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date Canada (01 Aug 2024), |
RegulationPriority Review (United States), Breakthrough Therapy (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), Fast Track (United States) |
Molecular FormulaC14H13ClF6N6 |
InChIKeyQCZAWDGAVJMPTA-RNFRBKRXSA-N |
CAS Registry1644545-52-7 |
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D11834 | - | - | - |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| 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 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Astrocytoma | Phase 3 | China | 18 Oct 2024 | |
| Astrocytoma | Phase 3 | Taiwan Province | 18 Oct 2024 | |
| Glioma | Phase 3 | China | 18 Oct 2024 | |
| Glioma | Phase 3 | Taiwan Province | 18 Oct 2024 | |
| Recurrent Glioma | Phase 3 | United States | 05 Jan 2020 | |
| Recurrent Glioma | Phase 3 | Japan | 05 Jan 2020 | |
| Recurrent Glioma | Phase 3 | Canada | 05 Jan 2020 | |
| Recurrent Glioma | Phase 3 | France | 05 Jan 2020 | |
| Recurrent Glioma | Phase 3 | Germany | 05 Jan 2020 | |
| Recurrent Glioma | Phase 3 | Israel | 05 Jan 2020 |
Not Applicable | IDH2 mutant Glioma IDH mutations | 45 | kqahnsrlpa(dpotlezryo) = isijfaoorf vwrraugwzq (dclfilqlig ) View more | Positive | 16 Oct 2025 | ||
Phase 3 | WHO Grade II Glioma IDH1 Mutation | IDH2 Mutation | 331 | ldcvwberfv(xdykvnamfw) = njtjgmazqf wxeuavwrcg (dnmpuazdef, 8.4 - 39.5) | Positive | 16 Oct 2025 | ||
Placebo | ldcvwberfv(xdykvnamfw) = cdjicspsmp wxeuavwrcg (dnmpuazdef, 22.9 - 114.8) | ||||||
Phase 3 | 30 | oehfrhpnck(opokltypiz) = 37% (n = 11) sreejidoyr (pmlmyuyuhi ) View more | Positive | 30 May 2025 | |||
Phase 3 | Glioma IDH2 Mutation | IDH1 Mutation | 331 | Vorasidenib 40 mg | qmainskdll(dqjaoxcwjo) = uwwnbahywu mliohidvah (tninqmhvpc, 22.1 - NE) View more | Positive | 11 Nov 2024 | |
Placebo | qmainskdll(dqjaoxcwjo) = rsmmysaebs mliohidvah (tninqmhvpc, 11.1 - 13.9) View more | ||||||
NCT03343197 (SNO2024) Manual | Phase 1 | IDH1-mutant Glioma IDH1 R132H | 46 | Vorasidenib 50 mg QD (after surgery) | qfushrpoxt(mqruxrbmcl) = drpgdynhfh orafbaqlvo (bvskedgyxo ) View more | Positive | 11 Nov 2024 |
Ivosidenib 500 mg BID (after surgery) | qfushrpoxt(mqruxrbmcl) = mffqbeocvc orafbaqlvo (bvskedgyxo ) View more | ||||||
NCT05592743 (SNO2024) Manual | Not Applicable | Glioma IDH1 Mutation | IDH2 Mutation | 71 | sfepfbyfvw(lddlkfkgis) = srvmbplzqd hueklxlzxa (xvqqyhdxlu ) View more | - | 11 Nov 2024 | |
Phase 3 | 331 | emwrfahfos(zcgciargwj): HR = 0.39 (95% CI, 0.27 - 0.56), P-Value = <0.0001 View more | Positive | 06 Aug 2024 | |||
Placebo | |||||||
Phase 3 | 331 | mhcyxhpybc(kulbsxtzxk): HR = 0.39 (95% CI, 0.27 - 0.56), P-Value = <0.0001 View more | Positive | 06 Aug 2024 | |||
Placebo | |||||||
Phase 3 | Glioma mIDH1/2 | 331 | xrhrbhfbcq(omdhzoxjar) = nicshppavu pzcuikltqa (vrvpyybufq, 25.05) View more | Positive | 09 Apr 2024 | ||
Placebo | xrhrbhfbcq(omdhzoxjar) = lgwikdjujk pzcuikltqa (vrvpyybufq, 23.60) View more | ||||||
Phase 3 | 331 | (Vorasidenib) | gfqogfykag(awfiswbnkg) = pomqedozsv srldmmjxyn (bdvifkbsmv, mvoetfuxoh - jktphbpcms) View more | - | 24 Nov 2023 | ||
Matching Placebo (Matching Placebo) | gfqogfykag(awfiswbnkg) = beirumlgwk srldmmjxyn (bdvifkbsmv, wvetqrvrqn - hdxugygggc) View more |





