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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
    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)
    24d
    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)
    25d
    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
    25d
    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)
    2ms
    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)
    2ms
    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)
    2ms
    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)
    3ms
    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
    3ms
    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)