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    DRUG:

    safusidenib (DS-1001)

    i
    Other names: DS-1001, AB-218, DS 1001, DS-1001b, AB218, AB 218, DS1001, DS1001b, DS 1001b
    Associations

    News

    Trials
    Company:
    Daiichi Sankyo, Nuvation Bio
    Drug class:
    IDH1 inhibitor
    Related drugs:
    Associations

    News

    Trials
    28d
    IDH1 Inhibitor AB-218 in Patients With Advanced IDH1 Mutant Cholangiocarcinoma and Other Solid Tumor (clinicaltrials.gov)
    P1, N=9, Terminated, AnHeart Therapeutics Inc. | N=63 --> 9 | Trial completion date: May 2026 --> Aug 2024 | Recruiting --> Terminated | Trial primary completion date: Aug 2025 --> Aug 2024; Sponsor adjusted the study strategy
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date • Metastases
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 mutation
    |
    safusidenib (DS-1001)
    3ms
    A perioperative study of Safusidenib in patients with IDH1-mutated glioma. (PubMed, Future Oncol)
    This research will enable objective measurement of biological activity of safusidenib in patients with IDH1 mutated glioma. Anti-tumor activity will be assessed by progression free survival and time to next intervention.Clinical Trial Registration: NCT05577416 (ClinicalTrials.gov).
    Journal
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    safusidenib (DS-1001)
    5ms
    AB-218-IIT-201: A Study of AB-218 in Patients With IDH1 Mutated Low Grade Glioma (clinicaltrials.gov)
    P1, N=15, Recruiting, Melbourne Health | Active, not recruiting --> Recruiting | N=10 --> 15
    Enrollment open • Enrollment change
    |
    safusidenib (DS-1001)
    8ms
    AB-218-IIT-201: A Study of AB-218 in Patients With IDH1 Mutated Low Grade Glioma (clinicaltrials.gov)
    P1, N=10, Active, not recruiting, Melbourne Health | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    LY3295668 • safusidenib (DS-1001)
    11ms
    A Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-Naive IDH1 Mutated WHO Grade II Glioma (clinicaltrials.gov)
    P2, N=25, Active, not recruiting, Daiichi Sankyo Co., Ltd. | Trial primary completion date: Sep 2023 --> Mar 2023
    Trial primary completion date
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 mutation • IDH1 R132
    |
    safusidenib (DS-1001)
    11ms
    IDH1 Inhibitor AB-218 in Patients With Advanced IDH1 Mutant Cholangiocarcinoma and Other Solid Tumor (clinicaltrials.gov)
    P1, N=63, Recruiting, AnHeart Therapeutics Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 mutation
    |
    safusidenib (DS-1001)
    over1year
    A Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-Naive IDH1 Mutated WHO Grade II Glioma (clinicaltrials.gov)
    P2, N=25, Active, not recruiting, Daiichi Sankyo Co., Ltd. | Trial primary completion date: Jun 2023 --> Sep 2023
    Trial primary completion date
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 mutation • IDH1 R132
    |
    safusidenib (DS-1001)
    over1year
    Safusidenib Phase 2 Study in IDH1 Mutant Glioma (clinicaltrials.gov)
    P2, N=95, Recruiting, AnHeart Therapeutics Inc. | Not yet recruiting --> Recruiting | Trial completion date: Feb 2027 --> Jul 2027 | Trial primary completion date: Jan 2026 --> Mar 2027
    Enrollment open • Trial completion date • Trial primary completion date
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 R132H • IDH1 R132C • IDH1 R132
    |
    LY3295668 • safusidenib (DS-1001)
    over1year
    IDH1 Inhibitor AB-218 in Patients With Advanced IDH1 Mutant Cholangiocarcinoma and Other Solid Tumor (clinicaltrials.gov)
    P1, N=63, Not yet recruiting, AnHeart Therapeutics Inc.
    New P1 trial • Metastases
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 mutation
    |
    safusidenib (DS-1001)
    over2years
    AB-218 Safety and Efficacy Study in Patients With IDH1 Mutant Glioma (clinicaltrials.gov)
    P2, N=114, Not yet recruiting, AnHeart Therapeutics Inc.
    New P2 trial
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • CDKN2B (Cyclin Dependent Kinase Inhibitor 2B)
    |
    IDH1 mutation • CDKN2A deletion
    |
    safusidenib (DS-1001)
    over3years
    Study of DS-1001b in Patients With Gene IDH1-Mutated Gliomas (clinicaltrials.gov)
    P=N/A, N=47, Active, not recruiting, Daiichi Sankyo Co., Ltd. | Trial completion date: Mar 2022 --> Mar 2026 | Trial primary completion date: Jan 2022 --> Jan 2021
    Clinical • Trial completion date • Trial primary completion date
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    safusidenib (DS-1001)
    almost4years
    A Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-Naive IDH1 Mutated WHO Grade II Glioma (clinicaltrials.gov)
    P2, N=25, Active, not recruiting, Daiichi Sankyo Co., Ltd. | Recruiting --> Active, not recruiting
    Clinical • Enrollment closed
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 mutation
    |
    safusidenib (DS-1001)
    over4years
    A Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-Naive IDH1 Mutated WHO Grade II Glioma (clinicaltrials.gov)
    P2, N=25, Recruiting, Daiichi Sankyo Co., Ltd. | Not yet recruiting --> Recruiting
    Clinical • Enrollment open
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 mutation
    |
    safusidenib (DS-1001)
    over4years
    A Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-Naive IDH1 Mutated WHO Grade II Glioma (clinicaltrials.gov)
    P2, N=25, Not yet recruiting, Daiichi Sankyo Co., Ltd.
    Clinical • New P2 trial
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 mutation
    |
    safusidenib (DS-1001)
    over4years
    Selective inhibition of mutant IDH1 by DS-1001b ameliorates aberrant histone modifications and impairs tumor activity in chondrosarcoma. (PubMed, Oncogene)
    DS-1001b treatment reversed the epigenetic changes caused by aberrant histone modifications. The present data strongly suggest that inhibition of mutant IDH1 is a promising therapeutic approach in chondrosarcoma, particularly for the treatment of relapsed or dedifferentiated chondrosarcoma.
    Journal
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    safusidenib (DS-1001)
    over4years
    Study of DS-1001b in Patients With Gene IDH1-Mutated Gliomas (clinicaltrials.gov)
    P=N/A, N=60, Active, not recruiting, Daiichi Sankyo Co., Ltd. | Trial completion date: Mar 2020 --> Mar 2022 | Trial primary completion date: Jan 2020 --> Jan 2022
    Clinical • Trial completion date • Trial primary completion date
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    safusidenib (DS-1001)