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    DRUG CLASS:

    IDH2 inhibitor

    Related drugs:
    8d
    Pharmacokinetic Study of Vorasidenib in Severe Hepatically Impaired and Matched-Control Participants (clinicaltrials.gov)
    P1, N=20, Not yet recruiting, Institut de Recherches Internationales Servier (I.R.I.S.)
    New P1 trial
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    Voranigo (vorasidenib)
    14d
    VIOLETA: Vorasidenib in CNS WHO Grade 2 IDH-mutant Diffuse Glioma (clinicaltrials.gov)
    P=N/A, N=150, Not yet recruiting, iOMEDICO AG
    New trial
    |
    Voranigo (vorasidenib)
    15d
    Drug-drug Interaction Study of Vorasidenib With Bupropion, Repaglinide, Flurbiprofen, Omeprazole, Midazolam, and Rosuvastatin in Healthy Adult Participants (clinicaltrials.gov)
    P1, N=28, Recruiting, Institut de Recherches Internationales Servier (I.R.I.S.)
    New P1 trial
    |
    Voranigo (vorasidenib) • midazolam hydrochloride
    16d
    A Drug-drug Interaction Study of Vorasidenib and a Combined Oral Contraceptive in Healthy Female Participants (clinicaltrials.gov)
    P1, N=28, Recruiting, Institut de Recherches Internationales Servier (I.R.I.S.)
    New P1 trial
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    Voranigo (vorasidenib)
    17d
    Integration and Intersection of Cancer Metabolism with Epigenetic Pathways in Gliomas. (PubMed, Annu Rev Pathol)
    Inhibiting IDH mutations with vorasidenib lowers D-2HG and is beneficial to patients. Other drugs like ONC201 and metformin can metabolically suppress oncogenic chromatin states in pediatric gliomas. This dynamic cross talk between metabolism and epigenetics not only underpins tumor biology but also presents opportunities for innovative therapeutic strategies.
    Review • Journal
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    EGFR (Epidermal growth factor receptor)
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    EGFR mutation • IDH wild-type
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    metformin • Voranigo (vorasidenib) • Modeyso (dordaviprone)
    24d
    NCI-2021-00893: Decitabine/Cedazuridine and Venetoclax in Combination With Ivosidenib or Enasidenib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov)
    P1/2, N=84, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Nov 2025 --> Nov 2027 | Trial primary completion date: Nov 2025 --> Nov 2027
    Trial completion date • Trial primary completion date
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    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
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    IDH2 mutation
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    Venclexta (venetoclax) • Tibsovo (ivosidenib) • Idhifa (enasidenib) • Inqovi (decitabine/cedazuridine)
    29d
    A Study of Enasidenib in People With Clonal Cytopenia of Undetermined Significance (clinicaltrials.gov)
    P1, N=4, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Oct 2025 --> Oct 2026 | Trial primary completion date: Oct 2025 --> Oct 2026
    Trial completion date • Trial primary completion date
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    IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
    |
    IDH2 mutation • IDH2 R172
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    Idhifa (enasidenib)
    1m
    Vorasidenib in IDH1-mutant or IDH2-mutant low-grade glioma (INDIGO): secondary and exploratory endpoints from a randomised, double-blind, placebo-controlled, phase 3 trial. (PubMed, Lancet Oncol)
    Vorasidenib reduced tumour growth rate and improved seizure control compared with placebo, with no observed negative effects on HRQOL or neurocognition. Additional follow-up supported the robustness of progression-free survival and time to next intervention in patients with grade 2 IDH1/2-mutant diffuse glioma. These findings support the use of vorasidenib in patients with grade 2 IDH1/2-mutant gliomas who only had surgical intervention and are not in immediate need of radiotherapy or chemotherapy.
    P3 data • Journal
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    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
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    IDH1 mutation • IDH2 mutation
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    Voranigo (vorasidenib)
    2ms
    Testing Addition of an Anti-cancer Drug, Vorasidenib to Temozolomide, After Radiation for Advanced Brain Cancer (clinicaltrials.gov)
    P3, N=408, Not yet recruiting, Alliance for Clinical Trials in Oncology
    New P3 trial
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    temozolomide • Voranigo (vorasidenib)
    2ms
    Enasidenib plus venetoclax in patients with IDH2-mutated relapsed or refractory acute myeloid leukaemia or myelodysplastic syndrome (ENAVEN-AML): a multicentre, single-arm, phase 1b/2 trial. (PubMed, Lancet Haematol)
    Enasidenib plus venetoclax is safe, with no unexpected TEAEs or treatment-related deaths, and shows preliminary activity in patients with relapsed or refractory IDH2-mutated AML and MDS.
    P1/2 data • Journal • IO biomarker
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    IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • ARG1 (Arginase 1)
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    IDH2 mutation
    |
    Venclexta (venetoclax) • Idhifa (enasidenib)
    2ms
    Enasidenib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia Patients With an IDH2 Mutation (clinicaltrials.gov)
    P2, N=1, Active, not recruiting, Children's Oncology Group | N=10 --> 1 | Trial completion date: Sep 2025 --> Oct 2026
    Enrollment change • Trial completion date
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    IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
    |
    IDH2 mutation
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    Idhifa (enasidenib)
    2ms
    Final Results from a First-in-Human Phase 1 Study of the Dual Isocitrate Dehydrogenase (IDH) 1/2 Inhibitor, LY3410738, in Advanced Solid Tumors Harboring IDH1 or IDH2 Mutations. (PubMed, Clin Cancer Res)
    LY3410738 demonstrated largely cytostatic antitumor activity in IDH1- or IDH2-mutated cholangiocarcinoma and IDH1-mutated gliomas. LY3410738 plus cisplatin-gemcitabine exhibited favorable antitumor activity in patients with treatment-naïve IDH-mutated cholangiocarcinoma, warranting further exploration as a treatment strategy.
    P1 data • Journal • PD(L)-1 Biomarker • First-in-human
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    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
    |
    IDH1 mutation • IDH2 mutation
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    cisplatin • Imfinzi (durvalumab) • gemcitabine • LY3410738