NDAORALCAPSULE
Approved
Jun 2025
Lifecycle
Launch
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
7/8 — Comprehensive
BRUKINSA (zanubrutinib) by BeOne Medicines is bruton's tyrosine kinase inhibitors [moa]. First approved in 2025.
Drug data last refreshed Yesterday · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BRUKINSA (zanubrutinib) is an oral Bruton's Tyrosine Kinase (BTK) inhibitor developed by BeOne Medicines that selectively targets BTK to treat B-cell malignancies and immune disorders. The drug works by blocking BTK signaling, which is critical for B-cell survival and proliferation. It represents a next-generation approach within the BTK inhibitor class with improved selectivity and tolerability profiles.
$0.8BPart D
Launch16.6 years to LOERecently launched product with established market presence ($801M Medicare Part D spending in 2023) signals an active commercial infrastructure and expanding team needs across sales, marketing, and market access functions.
Mechanism of Action
Bruton's Tyrosine Kinase Inhibitors
Pharmacologic Class:
Kinase Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Sonrotoclax Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma Planned for Standard of Care CAR-T Cell Therapy
Started Jun 2026
40 enrolled
Mantle Cell Lymphoma
Zanubrutinib in Combination With Sonrotoclax for the Treatment of Underrepresented Ethnic and Racial Minorities With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
Started Feb 2026
A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia
Started Jan 2026
500 enrolled
Chronic Lymphocytic Leukemia
Testing the Addition of Anti-Cancer Drug Sonrotoclax, to the Standard Treatment Zanubrutinib, for Previously Untreated CLL/SLL
Started Jan 2026
466 enrolled
Chronic Lymphocytic LeukemiaSmall Lymphocytic Leukemia
Study Evaluating the Efficacy and Tolerance of a Zanubrutinib and BGB-11417 Combination in Patients Previously Treated for Waldenström Macroglobulinemia
Started Dec 2025
102 enrolled
Waldenstrom Macroglobulinemia
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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.