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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
    26d
    Phase II study of safusidenib erbumine in patients with chemotherapy- and radiotherapy-naïve isocitrate dehydrogenase 1-mutated WHO grade 2 gliomas. (PubMed, Neuro Oncol)
    Safusidenib erbumine is a potential treatment option for patients with chemotherapy- and radiotherapy-naïve IDH1-mutated WHO grade 2 gliomas.
    P2 data • Journal
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 mutation
    |
    safusidenib (DS-1001)
    5ms
    Safusidenib Phase 2 Study in IDH1 Mutant Glioma (clinicaltrials.gov)
    P2, N=125, Recruiting, Nuvation Bio Inc. | Active, not recruiting --> Recruiting
    Enrollment open
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 R132
    |
    temozolomide • safusidenib (DS-1001)
    6ms
    Establishment and characterization of TK-DDCS1: a novel IDH1 mutated dedifferentiated chondrosarcoma cell line. (PubMed, Hum Cell)
    The mutant IDH1 inhibitor, DS-1001b, inhibited the proliferation of TK-DDCS1 in a dose-dependent manner in both two-dimensional and spheroid cultures. The tumorigenicity of TK-DDCS1 was demonstrated through xenografting into EGFP-transgenic BALB/c Rag2-/-/Jak3-/- (EGFP-BRJ) mice, where the tumors exhibited undifferentiated phenotypes of DDCS in both morphological and immunohistochemical features. Thus, TK-DDCS1 serves as a valuable model for investigating the characteristics of DDCS and exploring molecular targeted therapies.
    Preclinical • Journal
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • JAK3 (Janus Kinase 3)
    |
    IDH1 mutation • IDH1 R132
    |
    safusidenib (DS-1001)
    6ms
    Safusidenib Phase 2 Study in IDH1 Mutant Glioma (clinicaltrials.gov)
    P2, N=125, Active, not recruiting, Nuvation Bio Inc. | N=95 --> 125 | Trial completion date: Jul 2027 --> Mar 2028 | Trial primary completion date: Mar 2027 --> Dec 2027
    Enrollment change • Trial completion date • Trial primary completion date
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 R132
    |
    temozolomide • safusidenib (DS-1001)
    9ms
    Study of DS-1001b in Patients With Gene IDH1-Mutated Gliomas (clinicaltrials.gov)
    P=N/A, N=47, Active, not recruiting, Daiichi Sankyo | Trial completion date: Mar 2026 --> Aug 2026
    Trial completion date
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 R132
    |
    safusidenib (DS-1001)
    1year
    Safusidenib Phase 2 Study in IDH1 Mutant Glioma (clinicaltrials.gov)
    P2, N=95, Active, not recruiting, Nuvation Bio Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 R132H • IDH1 R132C • IDH1 R132
    |
    safusidenib (DS-1001)
    1year
    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
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    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 mutation
    |
    safusidenib (DS-1001)
    over1year
    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)
    over1year
    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)
    over1year
    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)
    almost2years
    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)
    almost2years
    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)