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Zanubrutinib · Brukinsa, BGB-3111

Small molecule · Inhibitor of Bruton's tyrosine kinase (BTK) · developed by Beone Medicines Usa

Approved FDA, Nov 2019
1 Registered trials

What is Zanubrutinib?

Zanubrutinib is a small-molecule inhibitor of Bruton's tyrosine kinase (BTK) that forms a covalent bond with a cysteine residue in the BTK active site. It inhibits BTK signaling in the B-cell antigen receptor and cytokine receptor pathways, preventing B-cell proliferation, trafficking, and adhesion.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as
Brukinsa, BGB-3111, BRUKINSA
Drug type
Small molecule
Targets
Bruton's tyrosine kinase (BTK)
Mechanism
Inhibitor of Bruton's tyrosine kinase (BTK)
Pathways
B-cell antigen receptor signaling, cytokine receptor signaling, B-cell proliferation, B-cell trafficking
Therapy area
Oncology
Developer
Beone Medicines Usa
In trials of
CRIS
FDA status
Approved as Brukinsa (November 14, 2019), NDA213217 · FDA label
UNII
AG9MHG098Z

✅ FDA-approved uses

From the indications section of the FDA label (version of Jul 21, 2026). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

TrialPhaseConditionStatusSponsor
NCT07271667 Phase 2 Chronic Lymphocytic Leukemia Recruiting CRIS

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

B-cell MalignanciesChronic Lymphocytic Leukemia

Other drugs acting on BTK

Acalabrutinib FDA approved Pirtobrutinib FDA approved APG-3288 Phase 1

Sources

Updated Oct 3, 2026.

Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z

This data is for informational purposes only, not investment advice. BioRadar does not provide buy/sell recommendations. Past performance does not guarantee future results. Always do your own due diligence.