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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:
    10d
    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)
    10d
    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
    11d
    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)
    1m
    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)
    1m
    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)
    1m
    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)
    2ms
    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)
    2ms
    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)
    2ms
    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
    2ms
    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)
    2ms
    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)