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    DRUG CLASS:

    γ-secretase inhibitor

    Related drugs:
    14d
    A Relative Bioavailability and Bioequivalence Study of Varegacestat in Healthy Participants (clinicaltrials.gov)
    P1, N=20, Recruiting, Immunome, Inc.
    New P1 trial
    |
    varegacestat (AL102)
    15d
    Novel NOTCH1-unmutated T-ALL Cell Line With Suppressed Growth by Gamma-secretase Inhibitors. (PubMed, Anticancer Res)
    Alternative mechanisms link GSIs to the regulation of HES1 and MYC. TMD11 provides a unique model for probing NOTCH-independent GSI actions and screening novel targeted therapeutics in NOTCH-unmutated T-ALL.
    Preclinical • Journal
    |
    MYC (V-myc avian myelocytomatosis viral oncogene homolog) • NOTCH1 (Notch 1) • HES1 (Hes Family BHLH Transcription Factor 1)
    29d
    Safety and Efficacy of ALLO-715 BCMA Allogenic CAR T Cells in in Adults With Relapsed or Refractory Multiple Myeloma (UNIVERSAL) (clinicaltrials.gov)
    P1, N=73, Completed, Allogene Therapeutics | Active, not recruiting --> Completed | N=132 --> 73
    Trial completion • Enrollment change • IO biomarker
    |
    cyclophosphamide • fludarabine IV • Ogsiveo (nirogacestat) • ALLO-715 • ALLO-647
    1m
    To Determine the Effect of CYP Induction Following Administration of Nirogacestat in Healthy Adult Male Participants (clinicaltrials.gov)
    P1, N=20, Completed, SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany | Active, not recruiting --> Completed
    Trial completion
    |
    Ogsiveo (nirogacestat) • midazolam hydrochloride • omeprazole
    2ms
    Nirogacestat in Patients With Kaposi Sarcoma (clinicaltrials.gov)
    P2, N=28, Not yet recruiting, AIDS Malignancy Consortium
    New P2 trial
    |
    CD4 (CD4 Molecule)
    |
    Ogsiveo (nirogacestat)
    2ms
    A Study of a New Drug, Nirogacestat, for Treating Desmoid Tumors That Cannot be Removed by Surgery (clinicaltrials.gov)
    P2, N=31, Active, not recruiting, Children's Oncology Group | Trial completion date: Dec 2032 --> Apr 2027
    Trial completion date
    |
    CTNNB1 (Catenin (cadherin-associated protein), beta 1)
    |
    Ogsiveo (nirogacestat)
    2ms
    Nirogacestat in Premenopausal Females With Desmoid Tumor/Aggressive Fibromatosis (DT/AF) (clinicaltrials.gov)
    P4, N=50, Recruiting, SpringWorks Therapeutics, Inc.
    Trial initiation date
    |
    Ogsiveo (nirogacestat)
    2ms
    A Study of Nirogacestat in Japanese Adults With Desmoid Tumors/Aggressive Fibromatosis (DT/AF) (clinicaltrials.gov)
    P2, N=20, Active, not recruiting, SpringWorks Therapeutics, Inc. | Recruiting --> Active, not recruiting | Trial completion date: Dec 2030 --> Oct 2029 | Trial primary completion date: May 2028 --> Mar 2027
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    Ogsiveo (nirogacestat)
    2ms
    Evaluate the Effects of Famotidine or Rabeprazole on the PK of Nirogacestat (clinicaltrials.gov)
    P1, N=24, Completed, SpringWorks Therapeutics, Inc. | Recruiting --> Completed
    Trial completion
    |
    Ogsiveo (nirogacestat)
    2ms
    To Determine the Effect of CYP Induction Following Administration of Nirogacestat in Healthy Adult Male Participants (clinicaltrials.gov)
    P1, N=20, Active, not recruiting, SpringWorks Therapeutics, Inc. | Recruiting --> Active, not recruiting | Trial completion date: Oct 2026 --> Mar 2026
    Enrollment closed • Trial completion date • Trial initiation date
    |
    Ogsiveo (nirogacestat) • midazolam hydrochloride • omeprazole
    3ms
    A Varegacestat Hepatic Impairment Study (clinicaltrials.gov)
    P1, N=35, Completed, Immunome, Inc. | Active, not recruiting --> Completed
    Trial completion
    |
    varegacestat (AL102)
    4ms
    NIR-DT-106: Phase 1 Study to Determine the Effect of CYP Induction Following Administration of Nirogacestat in Healthy Men Participants (2025-521402-18-00)
    P1, N=16, Active, not recruiting, Springworks Therapeutics Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Ogsiveo (nirogacestat)