^
    6d
    A Study to Investigate the Pharmacokinetics of Tirabrutinib in Participants With Mild, Moderate, and Severe Hepatic Impairment Compared to Healthy Participants (clinicaltrials.gov)
    P1, N=40, Active, not recruiting, Ono Pharmaceutical Co., Ltd. | Recruiting --> Active, not recruiting | Trial primary completion date: Nov 2026 --> Apr 2026
    Enrollment closed • Trial primary completion date
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    Velexbru (tirabrutinib)
    23d
    Study of Tirabrutinib (ONO-4059) in Patients With Primary Central Nervous System Lymphoma (PROSPECT Study) (clinicaltrials.gov)
    P2, N=119, Active, not recruiting, Ono Pharmaceutical Co. Ltd | Trial primary completion date: Mar 2027 --> Jan 2026
    Trial primary completion date
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    temozolomide • Velexbru (tirabrutinib)
    3ms
    Study of Tirabrutinib vs Rituximab/Temozolomide for Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) (clinicaltrials.gov)
    P3, N=132, Recruiting, Ono Pharmaceutical Co. Ltd | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Rituxan (rituximab) • temozolomide • Velexbru (tirabrutinib)
    3ms
    Study of Tirabrutinib vs Rituximab/Temozolomide for Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) (clinicaltrials.gov)
    P3, N=132, Not yet recruiting, Ono Pharmaceutical Co. Ltd | Initiation date: Nov 2025 --> Feb 2026
    Trial initiation date
    |
    Rituxan (rituximab) • temozolomide • Velexbru (tirabrutinib)
    5ms
    Tirabrutinib-anthracycline interactions in the brain tumor microenvironment: a focus on metabolic inactivation and resistance. (PubMed, Expert Opin Drug Metab Toxicol)
    Our in vitro data demonstrate that tirabrutinib influences daunorubicin pharmacodynamics by targeting both metabolic and transport pathways. However, Chou - Talalay analysis highlights the importance of appropriate dosing to achieve therapeutic synergy in combination regimens.
    Journal
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    AKR1C3 (Aldo-Keto Reductase Family 1 Member C3)
    |
    daunorubicin • Velexbru (tirabrutinib)
    6ms
    Bing-Neel Syndrome in Waldenström Macroglobulinemia: Updates on Clinical Management and BTK Inhibitor Efficacy. (PubMed, Cancers (Basel))
    Historically, high-dose methotrexate- or cytarabine-based chemotherapy, intrathecal therapy, and radiotherapy have been used; however, responses varied, and toxicity was considerable...Retrospective data support durable responses with ibrutinib, tirabrutinib, and zanubrutinib, while early findings suggest that non-covalent BTK inhibitors expand options for relapsed or refractory cases. Herein, we synthesize current evidence on epidemiology, pathophysiology, and diagnostic work-up. We also outline therapeutic recommendations integrating the genotype, disease pattern, and patient fitness and conclude with unmet needs and future directions.
    Review • Journal
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    MYD88 (MYD88 Innate Immune Signal Transduction Adaptor)
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    Imbruvica (ibrutinib) • cytarabine • Brukinsa (zanubrutinib) • methotrexate • Jaypirca (pirtobrutinib) • Velexbru (tirabrutinib) • methotrexate IV
    6ms
    Study of Tirabrutinib (ONO-4059) in Patients With Primary Central Nervous System Lymphoma (PROSPECT Study) (clinicaltrials.gov)
    P2, N=119, Active, not recruiting, Ono Pharmaceutical Co. Ltd | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    temozolomide • Velexbru (tirabrutinib)
    6ms
    A Study to Investigate the Pharmacokinetics of Tirabrutinib in Participants With Mild, Moderate, and Severe Hepatic Impairment Compared to Healthy Participants (clinicaltrials.gov)
    P1, N=32, Recruiting, Ono Pharmaceutical Co. Ltd | Not yet recruiting --> Recruiting | N=24 --> 32 | Initiation date: Jan 2026 --> Oct 2025
    Enrollment open • Enrollment change • Trial initiation date
    |
    Velexbru (tirabrutinib)
    7ms
    A Study to Investigate the Pharmacokinetics of Tirabrutinib in Participants With Mild, Moderate, and Severe Hepatic Impairment Compared to Healthy Participants (clinicaltrials.gov)
    P1, N=24, Not yet recruiting, Ono Pharmaceutical Co. Ltd
    New P1 trial
    |
    Velexbru (tirabrutinib)
    7ms
    Membranous nephropathy preceding Bing-Neel syndrome: successful treatment with tirabrutinib. (PubMed, J Nephrol)
    Despite initial partial remission with corticosteroids and cyclosporine, neurological symptoms emerged alongside nephrotic syndrome relapse two years after onset...After bendamustine-rituximab therapy showed partial effectiveness, tirabrutinib, a Bruton tyrosine kinase inhibitor, achieved complete remission of both renal and neurological manifestations with sustained response over three years. Immunofluorescence staining revealed increased nuclear factor (NF)-κB and STAT3 expression in infiltrating immune cells and elevated NF-κB in surrounding tubular epithelial cells, suggesting activation of these pathways downstream of the MYD88 mutation in kidney pathology. Our findings suggest a potential contribution of Bruton's tyrosine kinase signaling to both kidney and neurological pathology in Bing-Neel syndrome, with tirabrutinib achieving clinical improvement in both organ manifestations.
    Journal
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    MYD88 (MYD88 Innate Immune Signal Transduction Adaptor) • STAT3 (Signal Transducer And Activator Of Transcription 3)
    |
    Rituxan (rituximab) • bendamustine • cyclosporine • Velexbru (tirabrutinib)
    9ms
    Study of Tirabrutinib vs Rituximab/Temozolomide for Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) (clinicaltrials.gov)
    P3, N=132, Not yet recruiting, Ono Pharmaceutical Co. Ltd
    New P3 trial
    |
    Rituxan (rituximab) • temozolomide • Velexbru (tirabrutinib)
    11ms
    Phase I Study Evaluating Tolerability, Safety, Pharmacokinetics, and Efficacy of Combined ONO-4059 and R-MPV Therapy for PCNSL (clinicaltrials.gov)
    P1, N=20, Active, not recruiting, Ono Pharmaceutical Co. Ltd | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Rituxan (rituximab) • vincristine • Matulane (procarbazine hydrochloride) • Velexbru (tirabrutinib)