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 12h ago · AI intelligence enriched 1mo 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 hematologic malignancies. It works by selectively inhibiting BTK signaling, a critical pathway in B-cell lymphomas and leukemias. The drug is currently in peak commercial lifecycle stage with strong patent protection extending to 2043.
Peak16.3 years to LOE
Product is in peak commercial phase with established market presence, indicating stable team sizing and mature commercial infrastructure supporting steady-state operations.
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)
A Phase 2 Trial Of The Combination Of Zanubrutinib, Sonrotoclax, And Obinutuzumab For Patients With Treatment-Naïve Chronic Lymphocytic Leukemia
Started Dec 2026
40 enrolled
Chronic Lymphocytic Leukemia
Study of Zanubrutinib in Older Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL)
Started Dec 2026
95 enrolled
Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma
Venetoclax Plus Zanubrutinib for the Treatment of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
Started Oct 2026
155 enrolled
Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma
A Study of Zanubrutinib, Obinutuzumab, and Sonrotoclax in People With Mantle Cell Lymphoma
Started Sep 2026
45 enrolled
Mantle Cell Lymphoma
Sonrotoclax Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma Planned for Standard of Care CAR-T Cell Therapy
Started Aug 2026
40 enrolled
Mantle Cell Lymphoma
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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.