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    DRUG:

    Voranigo (vorasidenib)

    i
    Other names: S 095032, S-095032, S 95032, S-95032, S95032, S095032, AGI-0023088, AGI-23088, AG-881, AG881, AG 881, AGI0023088, AGI 0023088, AGI23088, AGI 23088
    Company:
    Royalty, Servier
    Drug class:
    IDH1 inhibitor, IDH2 inhibitor
    Related drugs:
    2d
    A network-driven computational framework for identifying FDA-approved drug repurposing across heterogeneous brain cancers. (PubMed, Front Mol Biosci)
    As a result, three repurposed drugs were identified as priorities: (i) mefloquine (reference drug: vorasidenib citrate), (ii) clofibric acid (reference drug: carmustine), and armillarisin A (reference drug: lomustine). These results also suggest repurposing candidates for synergistic combinations across different brain tumors. The two applications developed in this work are freely accessible and in the public domain at https://assay.smallmoles.com/escorwin.
    FDA event • Journal
    |
    EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • TP53 (Tumor protein P53) • PDGFRA (Platelet Derived Growth Factor Receptor Alpha) • TERT (Telomerase Reverse Transcriptase) • KDR (Kinase insert domain receptor) • CDK1 (Cyclin-dependent kinase 1)
    |
    lomustine • carmustine • Voranigo (vorasidenib)
    17d
    EORTC-2427-BTG: ??Vorasidenib for the treatment of IDH-mutant astrocytoma after standard chemoradiotherapy (2024-519404-27-00)
    P2/3, N=247, Recruiting, Europese Organisatie Voor Onderzoek En Behandeling Van Kanker Organisation Europeenne Pour La Recherche Et Le Traitement Du Cancer European Organi
    New P2/3 trial
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
    |
    IDH2 mutation
    |
    Voranigo (vorasidenib)
    23d
    IDH-mutant inhibitors enhance the sensitivity of IDH1-mutant gliomas to cysteine-methionine deprivation and ferroptosis. (PubMed, bioRxiv)
    In addition, treatments with the IDH-mutant inhibitors vorasidenib and ivosidenib further sensitize the cells to ferroptosis. Furthermore, dietary cysteine-methionine deprivation alone or in combination with convection-enhanced delivery of RSL3 or ivosidenib in vivo significantly prolongs survival of IDH1-mutant tumor-bearing mice. Our findings suggest that targeting cysteine and methionine metabolism in combination with IDH-mutant inhibition provides promising therapeutic strategies for IDH1-mutant gliomas.
    Journal
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 mutation • IDH wild-type
    |
    Tibsovo (ivosidenib) • Voranigo (vorasidenib) • RSL3
    26d
    Isocitrate Dehydrogenase Inhibitors in Acute Myeloid Leukemia. (PubMed, Chem Biodivers)
    Inhibitors of mutated IDH1 and IDH2, vorasidenib, ivosidenib, olutasidenib, and enasidenib, respectively, were recently approved by the FDA for relapsed/refractory AML. In this review, we mainly focus on IDH inhibitors in leukemia therapy, including the discovery, structure optimization, activity of IDH inhibitors, and applications, which provided the reference for the discovery of new anticancer agents.
    Review • Journal
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
    |
    IDH1 mutation • IDH2 mutation
    |
    Tibsovo (ivosidenib) • Idhifa (enasidenib) • Rezlidhia (olutasidenib) • Voranigo (vorasidenib)
    1m
    VIGOR: Vorasidenib Maintenance for IDH Mutant Astrocytoma (clinicaltrials.gov)
    P3, N=468, Recruiting, European Organisation for Research and Treatment of Cancer - EORTC | Not yet recruiting --> Recruiting
    Enrollment open
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
    |
    IDH2 mutation
    |
    Voranigo (vorasidenib)
    1m
    18F-DOPA-PET and advanced MRI improve treatment response assessment in IDH1/2-mutant gliomas treated with IDH inhibitors. (PubMed, Clin Cancer Res)
    These results highlight the potential of ¹⁸F-DOPA-PET and advanced MRI sequences as valuable complements to standard RANO 2.0 MRI evaluations for assessing treatment response in glioma patients undergoing IDHi therapy.
    Journal
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
    |
    Tibsovo (ivosidenib) • Voranigo (vorasidenib)
    2ms
    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 | Recruiting --> Active, not recruiting | Trial completion date: Jun 2031 --> Oct 2030 | Trial primary completion date: Jun 2026 --> Oct 2025
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
    |
    IDH2 mutation • IDH1 R132 • IDH2 R172
    |
    Voranigo (vorasidenib)
    2ms
    Drug-drug Interaction Study of Vorasidenib With Bupropion, Repaglinide, Flurbiprofen, Omeprazole, Midazolam, and Rosuvastatin in Healthy Adult Participants (clinicaltrials.gov)
    P1, N=28, Completed, Institut de Recherches Internationales Servier (I.R.I.S.) | Recruiting --> Completed
    Trial completion
    |
    Voranigo (vorasidenib) • midazolam hydrochloride • omeprazole
    2ms
    Vorasidenib in Combination With Temozolomide (TMZ) in IDH-mutant Glioma (clinicaltrials.gov)
    P1/2, N=51, Active, not recruiting, Institut de Recherches Internationales Servier | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • CDKN2B (Cyclin Dependent Kinase Inhibitor 2B) • ATRX (ATRX Chromatin Remodeler)
    |
    IDH2 mutation • CDKN2A deletion
    |
    temozolomide • Voranigo (vorasidenib)
    3ms
    Vorasidenib in Combination With Temozolomide (TMZ) in IDH-mutant Glioma (clinicaltrials.gov)
    P1/2, N=55, Recruiting, Institut de Recherches Internationales Servier | N=42 --> 55
    Enrollment change
    |
    temozolomide • Voranigo (vorasidenib)
    3ms
    Vorasidenib Study in Pediatric Participants With Grade 2 Astrocytoma or Oligodendroglioma With an IDH1 or IDH2 Mutation (clinicaltrials.gov)
    P2, N=10, Not yet recruiting, Institut de Recherches Internationales Servier (I.R.I.S.)
    New P2 trial
    |
    IGF1 (Insulin-like growth factor 1)
    |
    Voranigo (vorasidenib)