NDAORALCAPSULEPriority Review
Approved
Nov 2019
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
Priority Review
BRUKINSA (zanubrutinib) by BeOne Medicines is bruton's tyrosine kinase inhibitors [moa]. First approved in 2019.
Drug data last refreshed 31m ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BRUKINSA (zanubrutinib) is an oral Bruton's Tyrosine Kinase (BTK) inhibitor approved in November 2019 for B-cell malignancies. It works by selectively inhibiting BTK, a key signaling molecule in B-cell survival and proliferation. The drug is designed to provide improved selectivity and reduced off-target activity compared to earlier-generation BTK inhibitors.
Peak16.6 years to LOE
As a peak-stage product, BRUKINSA teams are focused on market penetration and indication expansion rather than launch activities, with stable headcount and established commercial infrastructure.
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.