^
    5d
    Multifunctional Nanoplatform for Synergistic Cancer Therapy via Enhanced Immunogenic Cell Death and Immune Modulation. (PubMed, ACS Appl Mater Interfaces)
    Additionally, the drug Tirabrutinib (Tir) could suppress activity of Bruton's tyrosine kinase (BTK) and alleviate the immunosuppressive tumor microenvironment...The in vitro and in vivo investigation verified that the ZPMTH could restrain the proliferation of primary and contralateral rechallenge tumor model with satisfactory effectiveness. Therefore, ZPMTH provided a promising approach for introducing ICD nanoinducer into antitumor immunotherapy for synergistic cancer therapy.
    Journal
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    BTK (Bruton Tyrosine Kinase)
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    Velexbru (tirabrutinib)
    21d
    REVEAL: Real-World Evidence of Effectiveness and Safety of Tirabrutinib in Patients With Relapsed or Refractory Primary Central Nervous System Lymphoma in Taiwan: A Nationwide Study (clinicaltrials.gov)
    P=N/A, N=24, Completed, Ono Pharmaceutical Co., Ltd. | Not yet recruiting --> Completed | N=35 --> 24 | Trial completion date: Dec 2026 --> Mar 2026 | Trial primary completion date: Dec 2026 --> Mar 2026
    Trial completion • Enrollment change • Trial completion date • Trial primary completion date • HEOR • Real-world evidence
    |
    Velexbru (tirabrutinib)
    24d
    ONO-4059-17: Study of Tirabrutinib vs Rituximab/Temozolomide for Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) (2025-523389-26-00)
    P2/3, N=6, Not yet recruiting, Deciphera Pharmaceuticals Inc.
    New P2/3 trial
    |
    Rituxan (rituximab) • temozolomide • Truxima (rituximab-abbs) • Velexbru (tirabrutinib)
    2ms
    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
    |
    Velexbru (tirabrutinib)
    2ms
    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
    |
    temozolomide • Velexbru (tirabrutinib)
    4ms
    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)
    5ms
    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)
    7ms
    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)
    7ms
    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)
    |
    Imbruvica (ibrutinib) • cytarabine • Brukinsa (zanubrutinib) • methotrexate • Jaypirca (pirtobrutinib) • Velexbru (tirabrutinib) • methotrexate IV
    8ms
    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)
    8ms
    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)
    8ms
    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)