Wednesday, July 8, 2026

Drug profile · INN

zanubrutinib

zanubrutinib (BRUKINSA) is a tyrosine-protein kinase btk inhibitor. Associated with BEONE MEDICINES AUS PTY LTD. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved NMPA: clinical trials Antineoplastic and immunomodulating agents (L01) L01EL03
US status approved
Patents linked 0
Pipeline programs 44
News articles 0
Drug details — zanubrutinib
US status
approved
Class
Antineoplastic and immunomodulating agents (L01)
Route
ORAL
Patents
0
Programs
44
Data quality
0.89

Quick answer

zanubrutinib (BRUKINSA) is a tyrosine-protein kinase btk inhibitor. Associated with BEONE MEDICINES AUS PTY LTD. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN zanubrutinib
Brand BRUKINSA
Mechanism Tyrosine-protein kinase BTK inhibitor
Target Tyrosine-protein kinase BTK
Therapeutic class Antineoplastic and immunomodulating agents (L01)
Route ORAL
Formulation CAPSULE
ATC code L01EL03

Mechanism of action

Tyrosine-protein kinase BTK inhibitor

Primary target: Tyrosine-protein kinase BTK

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved
NMPA clinical trials

Pipeline programs

  1. APG2575CG301 Phase 3 · Anaxis Pharma · Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
  2. BGB-11417 for Previously Untreated Chronic Lymphocytic Leukemia Phase 3 · BEONE MEDICINES AUS · Previously Untreated Chronic Lymphocytic Leukemia
  3. BGB-11417-302 Phase 3 · BEONE MEDICINES AUS · relapsed or refractory mantle cell lymphoma (R/R MCL)
  4. BGB-11417-304 Phase 3 · BEONE MEDICINES AUS · treatment-naive Chronic Lymphocytic Leukemia
  5. BGB-3111-304 Phase 3 · BEONE MEDICINES AUS · Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic
  6. BGB-3111-306 Phase 3 · BEONE MEDICINES AUS · Mantle Cell Lymphoma
  7. NHL-014 Phase 3 · Chinese Academy of · Diffuse Large B-Cell Lymphoma
  8. Zanubrutinib Phase 3 · BeiGene · B-cell Malignancies

Related & competitor drugs

  1. abiraterone acetate Antineoplastic and immunomodulating agents (L02)
  2. anagrelide Antineoplastic and immunomodulating agents (L01)
  3. apremilast Antineoplastic and immunomodulating agents (L04)
  4. arsenic trioxide Antineoplastic and immunomodulating agents (L01)
  5. axitinib Antineoplastic and immunomodulating agents (L01)
  6. azacitidine Antineoplastic and immunomodulating agents (L01)

Frequently asked questions

What is zanubrutinib?

zanubrutinib (BRUKINSA) is a tyrosine-protein kinase btk inhibitor. Associated with BEONE MEDICINES AUS PTY LTD. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for zanubrutinib?

BRUKINSA is a marketed brand name for zanubrutinib. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of zanubrutinib?

zanubrutinib has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.