Last reviewed 2026-04-20 · How we verify

Brukinsa (BGB-3111)

Brukinsa blocks the BTK protein, which is involved in the activation of B cells.

Brukinsa (BGB-3111) is a small molecule kinase inhibitor developed by BEIGENE USA INC, targeting the tyrosine-protein kinase BTK. It is FDA-approved for the treatment of various types of non-Hodgkin lymphoma, including chronic lymphocytic leukemia, mantle cell lymphoma, marginal zone lymphoma, and Waldenström macroglobulinemia. Brukinsa works by inhibiting the activity of BTK, a protein involved in the activation of B cells, thereby reducing tumor growth and proliferation. As a patented product, Brukinsa is not yet available as a generic medication. Key safety considerations include potential risks of infections, bleeding, and liver damage.

At a glance

Mechanism of action

Zanubrutinib is small-molecule inhibitor of Brutons tyrosine kinase (BTK). Zanubrutinib forms covalent bond with cysteine residue in the BTK active site, leading to inhibition of BTK activity. BTK is signaling molecule of the B-cell antigen receptor (BCR) and cytokine receptor pathways. In B-cells, BTK signaling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis and adhesion. In nonclinical studies, zanubrutinib inhibited malignant B-cell proliferation and reduced tumor growth.

Approved indications

• Chronic lymphoid leukemia, disease
• Mantle cell lymphoma
• Marginal zone lymphoma
• Waldenström macroglobulinemia

Common side effects

• Neutrophil count decreased
• Upper respiratory tract infection
• Platelet count decreased
• Hemorrhage
• Lymphocyte count decreased
• Rash
• Musculoskeletal pain
• Neutropenia
• Thrombocytopenia
• Leukopenia
• Anemia
• Pneumonia

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 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)
• 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)
• Zanubrutinib and Rituximab for the Treatment of Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (PHASE2)
• A Study to Investigate the Efficacy and Safety of Sonrotoclax Plus Zanubrutinib Compared With Placebo Plus Zanubrutinib in Adults With Relapsed/Refractory Mantle Cell Lymphoma (CELESTIAL-RRMCL) (PHASE3)

Patents

Primary sources

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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 Usa Inc portfolio CI