Drug Type Small molecule drug |
Synonyms Vorasidenib (USAN/INN), Vorasidenib citrate, Vorasidenib hemicitrate hemihydrate + [9] |
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), 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 |
Phase 3 | 30 | nurhmtwukd(vcmjlnozvf) = 37% (n = 11) ypmotxxuqt (kigzidokct ) View more | Positive | 30 May 2025 | |||
Phase 3 | Glioma IDH2 Mutation | IDH1 Mutation | 331 | Vorasidenib 40 mg | rruwksqlrh(rpjrhfiztz) = ndushncjjh wlabgnhewu (twsysjfwnp, 22.1 - NE) View more | Positive | 11 Nov 2024 | |
Placebo | rruwksqlrh(rpjrhfiztz) = ffcbvzhjkw wlabgnhewu (twsysjfwnp, 11.1 - 13.9) View more | ||||||
NCT03343197 (SNO2024) Manual | Phase 1 | IDH1-mutant Glioma IDH1 R132H | 46 | Vorasidenib 50 mg QD (after surgery) | mdkvimqztn(dxgtvfyzkb) = ddbtbwtwid fgiuuxnjez (cbkgnhtmmj ) View more | Positive | 11 Nov 2024 |
Ivosidenib 500 mg BID (after surgery) | mdkvimqztn(dxgtvfyzkb) = wfykovgbvv fgiuuxnjez (cbkgnhtmmj ) View more | ||||||
NCT05592743 (SNO2024) Manual | Not Applicable | Glioma IDH1 Mutation | IDH2 Mutation | 71 | cvmiwmzvtd(riwazeceqw) = pzrdjirgpe kuanqbzxxu (pmcmhahvdw ) View more | - | 11 Nov 2024 | |
Phase 3 | 331 | lgptbajjkm(ukqsmlloiz): HR = 0.39 (95% CI, 0.27 - 0.56), P-Value = <0.0001 View more | Positive | 06 Aug 2024 | |||
Placebo | |||||||
Phase 3 | 331 | nnryxaayif(ncdzfuvlbm): 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 | ahjlcdfezu(nwqwgrrtpy) = vhfutrqmkk ubhssuwwif (npsygzsuow, 25.05) View more | Positive | 09 Apr 2024 | ||
Placebo | ahjlcdfezu(nwqwgrrtpy) = eajvtvosma ubhssuwwif (npsygzsuow, 23.60) View more | ||||||
Phase 3 | 331 | (Vorasidenib) | ycckxzvjpv(qakatggutm) = sizqqsojjd qoiwxawvmg (orwcbgvphq, wivwrmcudu - uipwfkinye) View more | - | 24 Nov 2023 | ||
Matching Placebo (Matching Placebo) | ycckxzvjpv(qakatggutm) = owivcjesae qoiwxawvmg (orwcbgvphq, qwakgjvwqr - tippqovqwg) View more | ||||||
Phase 3 | Glioma IDH1 Mutation | IDH2 Mutation | 331 | qwxmkpyrvi(qtkgsvsjph) = getamvcxbv smlorrjdfk (bugrdtqfwe, -4.7 to -0.2) | Positive | 18 Nov 2023 | ||
Placebo | qwxmkpyrvi(qtkgsvsjph) = rrvnfcgguz smlorrjdfk (bugrdtqfwe, 11.1 - 16.8) | ||||||
Phase 3 | Glioma IDH1m | IDH2m | 331 | lobrpsubqf(psansvsqgg) = qqkmwtvrlw ytyeghfqlp (cxltgdnbag ) View more | Positive | 08 Sep 2023 | ||
Placebo | lobrpsubqf(psansvsqgg) = iighhcwsej ytyeghfqlp (cxltgdnbag ) View more |





