NDAORALCAPSULE
Approved
Jun 2025
Lifecycle
Launch
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
8/8 — Comprehensive
BRUKINSA (zanubrutinib) by BeOne Medicines is bruton's tyrosine kinase inhibitors [moa]. Approved for chronic lymphocytic leukemia, mantle cell lymphoma, marginal zone lymphoma and 1 more indications. First approved in 2025.
Drug data last refreshed 19h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BRUKINSA (zanubrutinib) is an oral Bruton's Tyrosine Kinase (BTK) inhibitor capsule approved in June 2025 for treating refractory marginal zone lymphoma (MZL), small lymphocytic lymphoma (SLL), and refractory follicular lymphoma (FL), including use in combination with obinutuzumab for patients who have received two or more lines of systemic therapy. As a BTK inhibitor, zanubrutinib works by blocking a key enzyme that drives B-cell lymphoma and leukemia proliferation. The drug enters a competitive BTK inhibitor market dominated by CALQUENCE (acalabrutinib), positioning itself as a newer launch option with potentially differentiated selectivity and safety profile.
$0.8BPart D
16.7 years to LOEMechanism of Action
Bruton's Tyrosine Kinase Inhibitors
Pharmacologic Class:
Kinase Inhibitor
Indications (4)
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.