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    DRUG CLASS:

    IDH2 inhibitor

    Related drugs:
    2d
    A072301: Testing Addition of an Anti-cancer Drug, Vorasidenib to Temozolomide, After Radiation for Advanced Brain Cancer (clinicaltrials.gov)
    P3, N=408, Recruiting, Alliance for Clinical Trials in Oncology | Not yet recruiting --> Recruiting | Initiation date: Oct 2025 --> Jul 2026
    Enrollment open • Trial initiation date
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    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • CDKN2B (Cyclin Dependent Kinase Inhibitor 2B) • CYP1A2 (Cytochrome P450, family 1, subfamily A, polypeptide 2)
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    CDKN2A deletion • IDH1 R132
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    temozolomide • Voranigo (vorasidenib)
    6d
    Clinical and Molecular Response to Vorasidenib in Post-Transplant Patient with IDH2-mutant Intrahepatic Cholangiocarcinoma. (PubMed, Oncologist)
    This case highlights the potential clinical relevance of IDH-directed therapy in IDH2-mutant cholangiocarcinoma and demonstrates feasibility in an immunosuppressed post-transplant setting. These findings are hypothesis-generating and support further evaluation of IDH inhibition in this population.
    Journal • IO biomarker
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    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
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    IDH2 mutation • IDH2 R172
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    Voranigo (vorasidenib)
    13d
    VALIENT: VorAsidenib With Lomustine In Patients With rEcurrent IDH-mutaNT Glioma Harboring IDH1 and/or IDH2 Mutations (clinicaltrials.gov)
    P1, N=24, Not yet recruiting, Megan Mantica
    New P1 trial
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    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
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    IDH2 mutation • IDH1 R132 • IDH2 R172
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    lomustine • Voranigo (vorasidenib)
    13d
    Pharmacokinetic Study of Vorasidenib in Severe Hepatically Impaired and Matched-Control Participants (clinicaltrials.gov)
    P1, N=20, Recruiting, Institut de Recherches Internationales Servier (I.R.I.S.) | Not yet recruiting --> Recruiting | Trial completion date: Jul 2026 --> Nov 2026 | Trial primary completion date: Jul 2026 --> Nov 2026
    Enrollment open • Trial completion date • Trial primary completion date
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    Voranigo (vorasidenib)
    14d
    Phase 3 Study of Vorasidenib (S095032/AG-881) in Asian Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 orIDH2 Mutation (clinicaltrials.gov)
    P3, N=57, Active, not recruiting, Servier | Trial primary completion date: Oct 2025 --> May 2026
    Trial primary completion date
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    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
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    IDH2 mutation • IDH1 R132 • IDH2 R172
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    Voranigo (vorasidenib)
    29d
    Imaging diagnosis of adult-type diffuse gliomas in the era of WHO CNS5 and cIMPACT-NOW updates 8-11: a narrative review. (PubMed, Jpn J Radiol)
    The recent INDIGO trial, which demonstrated efficacy of the IDH1/2 inhibitor vorasidenib in residual grade 2 IDH-mutant glioma, has further increased the importance of preoperative imaging assessment of IDH mutation status...Third, we discuss the implications of cIMPACT-NOW Updates 8-11 for neuroradiologic diagnosis. In the WHO CNS5 era, imaging plays a central role in supporting integrated diagnosis and prioritizing appropriate molecular testing.
    Review • Journal
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    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
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    IDH wild-type
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    Voranigo (vorasidenib)
    1m
    A Drug-drug Interaction Study of Vorasidenib and a Combined Oral Contraceptive in Healthy Female Participants (clinicaltrials.gov)
    P1, N=28, Completed, Institut de Recherches Internationales Servier (I.R.I.S.) | Recruiting --> Completed
    Trial completion
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    Voranigo (vorasidenib)
    1m
    Enasidenib in Combination With Cobimetinib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov)
    P1, N=3, Completed, City of Hope Medical Center | Active, not recruiting --> Completed | Trial completion date: May 2027 --> Mar 2026 | Trial primary completion date: May 2027 --> Mar 2026
    Trial completion • Trial completion date • Trial primary completion date
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    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • HRAS (Harvey rat sarcoma viral oncogene homolog) • NF1 (Neurofibromin 1) • PTPN11 (Protein Tyrosine Phosphatase Non-Receptor Type 11) • RIT1 (Ras Like Without CAAX 1)
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    KRAS mutation • IDH2 mutation • RAS mutation
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    Cotellic (cobimetinib) • Idhifa (enasidenib)
    2ms
    Targeted therapies in adolescent and young adult patients with central nervous system tumors. (PubMed, Neurooncol Adv)
    The IDH-mutant inhibitor vorasidenib has been demonstrated to prolong progression-free survival in grade 2 IDH-mutant glioma; however, there is a lack of evidence in patients younger than 18...Craniopharyngioma is a rare CNS tumor in the AYA population, and BRAFV600E mutations in papillary craniopharyngioma represent a targetable alteration. Solutions to improving the care of AYA should include appropriate representation in clinical trials and specialized care by experienced clinicians.
    Review • Journal
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    SHH (Sonic Hedgehog Signaling Molecule)
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    BRAF V600E • BRAF V600 • IDH mutation + BRAF V600E
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    Voranigo (vorasidenib)
    2ms
    A Phase 1, Open-Label, Single Ascending (Two Levels) Dose Study to Evaluate the Pharmacokinetics of Vorasidenib in Healthy Japanese and Non-Asian Participants. (PubMed, J Clin Pharmacol)
    In conclusion, vorasidenib was generally safe and well tolerated, and plasma exposures were generally similar between Japanese and non-Asian participants following single oral 10- and 50-mg vorasidenib doses. These results enabled vorasidenib clinical development in Japan and supported inclusion of Japanese sites in subsequent vorasidenib clinical trials without dose adjustments.
    P1 data • PK/PD data • Journal
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    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
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    Voranigo (vorasidenib)
    2ms
    Multi-Omics and Machine Learning Analyses Reveal PIK3CG, PRKCD, and TRIM22 as Potential Markers of Poor Prognosis and Immune Activation in Glioblastoma. (PubMed, J Korean Med Sci)
    This study identifies PIK3CG, PRKCD, and TRIM22 as potential biomarkers and therapeutic targets in IDH-wildtype GBM. Their paradoxical association with poor survival and immune activation may inform personalized treatment strategies that combine conventional chemotherapy with immune-based therapies. While our findings are robust across both mixed and IDH-wildtype-focused cohorts, further mechanistic validation is warranted.
    Journal • PD(L)-1 Biomarker • IO biomarker
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    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • PIK3CG (Phosphatidylinositol-4,5-Bisphosphate 3-Kinase Catalytic Subunit Gamma) • CD4 (CD4 Molecule)
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    PD-L1 expression • IDH wild-type
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    linsitinib (ASP7487) • AGI-6780
    2ms
    LGG PRO's: Patient Voice in the Treatment of Low-grade Gliomas: Use of Patient-reported Outcomes, Vorasidenib and Radiotherapy Compared (clinicaltrials.gov)
    P=N/A, N=90, Recruiting, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
    New trial
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    Voranigo (vorasidenib)