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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:
    18h
    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)
    2d
    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)
    9d
    VIOLETA: Vorasidenib in CNS WHO Grade 2 IDH-mutant Diffuse Glioma (clinicaltrials.gov)
    P=N/A, N=150, Recruiting, iOMEDICO AG | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Voranigo (vorasidenib)
    22d
    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
    |
    Voranigo (vorasidenib)
    27d
    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)
    29d
    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 • omeprazole
    29d
    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
    |
    Voranigo (vorasidenib)
    1m
    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
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • IDH wild-type
    |
    metformin • Voranigo (vorasidenib) • Modeyso (dordaviprone)
    1m
    New and Emerging Therapies for Patients with Low-Grade Glioma. (PubMed, CNS Drugs)
    This review will highlight the molecular and genetic underpinnings of these tumors and how targeted therapeutic strategies led to the US Food and Drug Administration's approvals of combination therapy with dabrafenib and trametinib for pediatric patients with BRAF V600E mutant low-grade glioma; tovorafenib, a pan-RAF inhibitor, for pediatric BRAF mutant glioma; and vorasidenib, an inhibitor of mutant IDH1/2 enzymes, for patients with mutant IDH low-grade glioma. Integration of these targeted therapies into currently accepted treatment paradigms remains to be fully understood, along with the long-term impact on patient quality of life and prognosis.
    Review • Journal
    |
    BRAF (B-raf proto-oncogene) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
    |
    BRAF V600E • BRAF V600 • IDH1 mutation • IDH mutation + BRAF V600E
    |
    Mekinist (trametinib) • Tafinlar (dabrafenib) • Ojemda (tovorafenib) • Voranigo (vorasidenib)
    2ms
    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
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
    |
    IDH1 mutation • IDH2 mutation
    |
    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
    |
    temozolomide • Voranigo (vorasidenib)