^
    6d
    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
    |
    Voranigo (vorasidenib)
    8d
    Long-term (74-month) efficacy and safety of ivosidenib and azacitidine in an elderly patient with mutated IDH1 acute myeloid leukemia: insights from a case report. (PubMed, Postgrad Med)
    The exceptional 74-month long response of this patient demonstrates that a long-term response is possible for a patient unfit for IC with mIDH1 AML treated with ivosidenib and azacitidine. Further insights into the impact of the mutational status of patients and/or the clonal hierarchy are warranted.
    Journal
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • DNMT3A (DNA methyltransferase 1) • RUNX1 (RUNX Family Transcription Factor 1) • ASXL1 (ASXL Transcriptional Regulator 1) • U2AF1 (U2 Small Nuclear RNA Auxiliary Factor 1)
    |
    IDH1 mutation • RUNX1 mutation
    |
    azacitidine • Tibsovo (ivosidenib)
    10d
    DIM-95031-006: An Open-label Phase 3b Study of Ivosidenib in Combination With Azacitidine in Adult Patients Newly Diagnosed With IDH1m Acute Myeloid Leukemia (AML) Ineligible for Intensive Induction Chemotherapy. (clinicaltrials.gov)
    P3, N=245, Recruiting, Servier Affaires Médicales | Trial completion date: Dec 2026 --> Oct 2027 | Trial primary completion date: Jan 2026 --> Oct 2027
    Trial completion date • Trial primary completion date
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 R132
    |
    Tibsovo (ivosidenib)
    19d
    DIM-95031-006: An Open-label Phase 3b Study of Ivosidenib in Combination With Azacitidine in Adult Patients Newly Diagnosed With IDH1m Acute Myeloid Leukemia (AML) Ineligible for Intensive Induction Chemotherapy. (clinicaltrials.gov)
    P3, N=245, Recruiting, Servier Affaires Médicales | N=179 --> 245
    Enrollment change
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 R132
    |
    Tibsovo (ivosidenib)
    19d
    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
    |
    SHH (Sonic Hedgehog Signaling Molecule)
    |
    BRAF V600E • BRAF V600 • IDH mutation + BRAF V600E
    |
    Voranigo (vorasidenib)
    20d
    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
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    Voranigo (vorasidenib)
    25d
    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
    |
    Voranigo (vorasidenib)
    25d
    AG-120 in People With IDH1 Mutant Chondrosarcoma (clinicaltrials.gov)
    P2, N=6, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Mar 2026 --> Mar 2027 | Trial primary completion date: Mar 2026 --> Mar 2027
    Trial completion date • Trial primary completion date
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    Tibsovo (ivosidenib)
    28d
    Real-World Outcomes of Ivosidenib in IDH1-Mutant Biliary Tract Cancer: A Multicenter Retrospective Analysis and Comparison with the TrinetX Database. (PubMed, Target Oncol)
    Real-world data from our cohort and the TriNetX database support the oncological outcomes reported in the ClarIDHy trial and other real-world cohorts.
    Retrospective data • Journal • Real-world evidence
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 mutation • IDH1 R132
    |
    Tibsovo (ivosidenib)
    30d
    Ivosidenib and Vorasidenib decrease intratumoral 2-hydroxyglutarate and total choline levels in patients with lower-grade glioma: an in vivo MR Spectroscopy study. (PubMed, Clin Cancer Res)
    The striking reductions in tumor 2HG and tCho levels early following initiation of targeted therapy using an IDH inhibitor suggest that MRS may provide an important tool for monitoring treatment response of lower-grade gliomas.
    Preclinical • Journal
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
    |
    Tibsovo (ivosidenib) • Voranigo (vorasidenib)
    1m
    A Study of IDH305 in Patients With Advanced Malignancies That Harbor IDH1R132 Mutations (clinicaltrials.gov)
    P1, N=166, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Feb 2027 --> Oct 2030
    Trial completion date
    |
    IDH1 R132
    |
    IDH305
    1m
    A Study of an IDH1m Inhibitor in Participants With IDH1-Mutated Malignancies and Hepatic or Renal Impairment (clinicaltrials.gov)
    P1, N=30, Recruiting, Servier Bio-Innovation LLC
    Trial initiation date
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 R132
    |
    Tibsovo (ivosidenib)