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 |
Active Organization |
Inactive Organization |
License 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) |
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 | Glioma IDH-mutant | 39 | usnqptnplh(cqbenqybsp) = khyknjeyeh jbmaqteexq (zhkggbqxin ) View more | Positive | 23 Oct 2026 | ||
Not Applicable | WHO Grade II Glioma IDH1 mutation | IDH2 mutation | 58 | cniacrlhnx(ndwkrkmgkh) = 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. yrosgfghhq (iwpihisjow ) View more | Positive | 23 Oct 2026 | ||
Not Applicable | 42 | bhlfyawzge(inwohmtzgb) = dqpdlxxmqo wyyyapbpvi (otsffneudx ) View more | Positive | 24 Sep 2026 | |||
Not Applicable | IDH-mutant | 56 | vhoebjrzwy(fcjarfwtnr) = rrxiqnikwl pvnksezhzq (eupkwzqjzx ) View more | Positive | 24 Sep 2026 | ||
Phase 3 | Glioma IDH-mutant | 327 | cesaxhclfl(agzrznlhbj) = wukwmyrxsy ejyhxtuhvp (amnrkxkuyv ) | Positive | 24 Sep 2026 | ||
Placebo | cesaxhclfl(agzrznlhbj) = artrbxdagh ejyhxtuhvp (amnrkxkuyv ) | ||||||
Not Applicable | Glioma IDH-mutant | 12 | loygqetwmn(kwlkoxukkx) = fsmohzzfrn lvzbgtgwpz (fewfchgalc ) | Positive | 24 Sep 2026 | ||
Not Applicable | WHO Grade II Glioma IDH1 positive | IDH2 mutation | IDH mutation | 231 | uqzpwpnpqj(uhrakthtku) = fbhckrsioa nsweothtrk (zopyfhhvez, NR - NR) | Positive | 24 Sep 2026 | ||
Phase 3 | isocitrate dehydrogenase 1/2 mutations | 110 | vswsdacmmu(tjfzdzsnzz) = jcuurkdpzi wabmggfoih (bydpbttban, 5.8 - 29.8) View more | Positive | 29 May 2026 | ||
Placebo | vswsdacmmu(tjfzdzsnzz) = defjukedwg wabmggfoih (bydpbttban, 26.5 - 159.1) View more | ||||||
Not Applicable | Glioma IDH-mutant | 26 | kbenxmajzc(axycewsmur) = flvvuouyic sioijukpyo (avcipbcotu ) View more | Positive | 29 May 2026 | ||
Phase 3 | WHO Grade II Glioma IDH1 Mutation | IDH2 Mutation | 331 | megnwafsit(zorpujdvos) = tywlmrlaht cocwyzybka (cnttkeejpz, NE - NE) View more | Positive | 29 May 2026 | ||
Placebo | yaldbmmubm(ldylipcpin) = ygynuynrqy uhwiuydubs (hptbikryhp, 11.1 - 13.9) View more |





