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Brukinsa (ZANUBRUTINIB)
Brukinsa (generic name: ZANUBRUTINIB) is a Kinase Inhibitor [EPC] Small molecule drug developed by BeiGene. It is currently FDA-approved (first approved 2019) for Mantle cell lymphoma (MCL), Waldenström's macroglobulinemia (WM), Marginal zone lymphoma (MZL).
Brukinsa is a small molecule inhibitor that targets the tyrosine-protein kinase BTK. It is used to treat various blood cancers, including Waldenstrom Macroglobulinaemia, Multiple Myeloma, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Mantle Cell Lymphoma, and Marginal Zone Lymphoma.
At a glance
| Generic name | ZANUBRUTINIB |
|---|---|
| Sponsor | BeiGene |
| Drug class | Kinase Inhibitor [EPC] |
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 2019 |
Approved indications
- Mantle cell lymphoma (MCL)
- Waldenström's macroglobulinemia (WM)
- Marginal zone lymphoma (MZL)
- Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
- Follicular lymphoma (FL)
Common side effects
- Neutrophil count decreased
- Platelet count decreased
- Upper respiratory tract infection
- Hemorrhage
- Musculoskeletal pain
Serious adverse events
- Pneumonia
- Hemorrhage
- Major hemorrhage
- Cerebral hemorrhage
- Hepatitis B
Key clinical trials
- Testing the Combination of Venetoclax and Rituximab, in Comparison to the Usual Treatment (Ibrutinib Plus Rituximab or Zanubrutinib Alone) for Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma (PHASE2)
- Study of Zanubrutinib, Obinutuzumab, and Venetoclax in Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL) (PHASE2)
- Study of Bcl-2 Inhibitor Sonrotoclax (BGB-11417) in Participants With Mature B-Cell Malignancies (PHASE1)
- Treatment of CD79B Mutant Relapsed/Refractory Diffuse Large B-Cell Lymphoma With Bruton Tyrosine Kinase Inhibitor Zanubrutinib (PHASE2)
- Sonrotoclax Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma Planned for Standard of Care CAR-T Cell Therapy (PHASE2)
- A Study to Investigate the Relative Bioavailability and Food Effect of a Fixed-Dose Combination Tablet Containing Zanubrutinib and Sonrotoclax (BG-71332) in Healthy Adults (PHASE1)
- A Study to Investigate Sonrotoclax Combined With Zanubrutinib Versus Zanubrutinib Alone in Participants With Previously Untreated Chronic Lymphocytic Leukemia (PHASE2)
- Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Participants With Chronic Lymphocytic Leukemia (CLL) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Brukinsa CI brief — competitive landscape report
- Brukinsa updates RSS · CI watch RSS
- BeiGene portfolio CI
Frequently asked questions about Brukinsa
What is Brukinsa?
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Who makes Brukinsa?
What is the generic name of Brukinsa?
What drug class is Brukinsa in?
When was Brukinsa approved?
What development phase is Brukinsa in?
What are the side effects of Brukinsa?
Related
- Drug class: All Kinase Inhibitor [EPC] drugs
- Manufacturer: BeiGene — full pipeline
- Indication: Drugs for Mantle cell lymphoma (MCL)
- Indication: Drugs for Waldenström's macroglobulinemia (WM)
- Indication: Drugs for Marginal zone lymphoma (MZL)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing