zanubrutinib
zanubrutinib: developed by 1 company · 44 clinical trials tracked · 2 FDA decisions.
zanubrutinib evidence translation
What we can confirm
2 FDA records · 44 tracked trials
What it means
What to watch
Prepared research question
How could zanubrutinib → ONC affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence8 indications · 5 study sponsors
Related indications
Development Pipeline (1)
| Company | Phase |
|---|---|
| BeOne Medicines Ltd. (ONC) | Approved |
Clinical Trials (44)showing 10 most recent
A Phase 2 Trial Of The Combination Of Zanubrutinib, Sonrotoclax, And Obinutuzumab For Patients With Treatment-Naïve Chronic Lymphocytic Leukemia
Primary endpoint: Safety and Adverse Events (AEs)
ZEN-CLL - A Phase II Trial Evaluating Zanubrutinib in Elderly, Treatment-Naïve, CLL Patients
Primary endpoint: Progression-Free Survival (PFS)
A Phase Two Study of Venetoclax Plus Zanubrutinib in Newly Diagnosed CLL and After Front-Line Time-Limited Venetoclax-Based Therapy
Primary endpoint: Rate of undetectable minimal residual disease (uMRD) (Firstline Cohort)
MOZART MZL: A Randomized Phase II Study Evaluating Mosunetuzumab Alone and in Combination With Either Zanubrutinib or Polatuzumab Vedotin for the Treatment of Patients With Relapsed/Refractory Marginal Zone Lymphoma
Primary endpoint: Complete response rate (arm 1 versus arm 2)
A Phase II Study of Sonrotoclax Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma Planned for Standard of Care CAR-T Cell Therapy
Primary endpoint: Complete response post CAR-T
Phase III Evaluation of Fixed Duration Zanubrutinib Plus Sonrotoclax-Based Therapy Compared to Continuous Zanubrutinib in Previously Untreated Older Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
Primary endpoint: Progression free survival (PFS)
A Phase 2 Study of Emavusertib in Combination With an Approved Bruton Tyrosine Kinase Inhibitor in Patients With Chronic Lymphocytic Leukemia and Other B-cell Malignancies
Primary endpoint: Cohort 1: Undetectable Measurable Residual Disease (uMRD) Rate
A Phase 3, Open-Label, Randomized Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Patients With Previously Untreated Chronic Lymphocytic Leukemia
Primary endpoint: Progression-Free Survival (PFS) as Determined by Independent Review Committee (IRC)
Obinutuzumab, Zanubrutinib, and Lenalidomide as First-Line Therapy for Mantle Cell Lymphoma: A Prospective, Single-Arm, Open-Label, Multicenter Study
Primary endpoint: complete response rate (CR)
A Phase 4, Single-Arm, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Zanubrutinib in Chinese Patients With Treatment-Naive Waldenström Macroglobulinemia
Primary endpoint: Percentage of Participants Achieving a Complete Response (CR) or Very Good Partial Response (VGPR) as Assessed by the Investigator
FDA Decisions2 records
Frequently asked questions
Who is developing zanubrutinib?
zanubrutinib is being developed by BeOne Medicines Ltd..
How many clinical trials involve zanubrutinib?
BioSniper tracks 44 clinical trials involving zanubrutinib.
What is zanubrutinib's latest FDA decision?
The most recent tracked FDA decision for zanubrutinib is Approval for 1 INDICATIONS AND USAGE BRUKINSA is a kinase inhibitor indicated for the treatment of adult patients with: Mantle cell lymphoma (MCL) who have received at least one prior therapy. ( 1.1 ) This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Waldenström's macroglobulinemia (WM). ( 1.2 ) Relapsed or refractory marginal zone lympho, dated June 10, 2025.