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Drug

Zanubrutinib

Approved · EMA
Emerging researchLate-stage development

Also known as Brukinsa.

RxNorm2262435ChEMBLCHEMBL3936761UNIIAG9MHG098Z
3
Research papers
81
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Prospective, Open-label, Multicenter Phase-II Trial to Evaluate the Efficacy and Safety of Zanubrutinib (BGB-3111), a BTK Inhibitor, Plus Tislelizumab (BGB-A317), a PD1 Inhibitor, for Treatment of Patients with Richter Transformation with or Without Sonrotoclax（BGB-11417), a Bcl-2 Inhibitor (CLL-RT1-trial of the GCLLSG).

Clinical trial2026-08-01Primary completion · ClinicalTrials.gov

Efficacy and Safety of Glofitamab, Polatuzumab Vedotin and Zanubrutinib in the First-line Treatment of Elderly Patients With Diffuse Large B-cell Lymphoma (DLBCL): A Single-center, Single-arm, Prospective, Phase II Trial

Clinical trial2026-07-31Primary completion · ClinicalTrials.gov

A Phase II Randomized Study Comparing BTK Inhibitors (Ibrutinib Plus Rituximab or Zanubrutinib Alone) vs. BCL-2 Inhibitor (Venetoclax) and Rituximab in Previously Untreated Waldenström's Macroglobulinemia (WM) / Lymphoplasmacytic Lymphoma (LPL)

Clinical trial2026-07-29Results expected Q1 2028 · ClinicalTrials.gov

A Phase 3, Open-Label, Randomized Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Patients With Previously Untreated Chronic Lymphocytic Leukemia

Clinical trial2026-07-22Results expected Q1 2032 · ClinicalTrials.gov

A Phase 2 Trial of Mosunetuzumab and Zanubrutinib for Patients With Relapsed/Refractory Marginal Zone Lymphoma

Clinical trial2026-07-15Results expected Q4 2026 · ClinicalTrials.gov

A Phase 1b/2, Open-Label, Master Protocol Study of BTK-Degrader BGB-16673 in Combination With Other Agents in Patients With Relapsed or Refractory B-Cell Malignancies

Clinical trial2026-07-10Results expected Q4 2028 · ClinicalTrials.gov

A Phase 3, Open-Label, Randomized Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Patients With Previously Untreated Chronic Lymphocytic Leukemia

Clinical trial2026-07-10Results expected Q1 2031 · ClinicalTrials.gov

A Phase II, Multicenter, Open-label Study Evaluating Glofitamab in Combination With Venetoclax Plus Zanubrutinib or Venetoclax Alone in Subjects With Untreated or Relapsed/Refractory High-risk Mantle-cell Lymphoma

Clinical trial2026-07-10Results expected Q2 2028 · ClinicalTrials.gov

Approval: Brukinsa (EMA)

Regulatory2021-11-22EMA

Zanubrutinib for the treatment of relapsed or refractory mantle cell lymphoma.

Research2021-06-01Blood advances

Treatment of Patients with Relapsed or Refractory Mantle-Cell Lymphoma with Zanubrutinib, a Selective Inhibitor of Bruton's Tyrosine Kinase.

Research2020-05-27Clinical cancer research : an official journal of the American Association for Cancer Research

Treatment of relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma with the BTK inhibitor zanubrutinib: phase 2, single-arm, multicenter study.

Research2020-05-11Journal of hematology & oncology

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Zanubrutinib
Aliases & brands
Brukinsa
RxNorm CUI
2262435
ChEMBL ID
CHEMBL3936761
UNII
AG9MHG098Z
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2021-11-22
Latest approval
2021-11-22
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2021-11-22Approval
Approval: Brukinsa (EMA)
Indication: Brukinsa as monotherapy is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first… Show full indication

Brukinsa as monotherapy is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy. Brukinsa as monotherapy is indicated for the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy. Brukinsa as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL). Brukinsa in combination with obinutuzumab is indicated for the treatment of adult patients with refractory or relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

130 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
130
registered trials across all phases
LATEST COMPLETION 2026
81
Active studies
62
Recruiting
20
Late-stage (III+)
30
Completed
19
Discontinued
PHASE DISTRIBUTIONn = 130
Phase 120Phase 1 / 28Phase 282Phase 2 / 31Phase 314Phase 42Phase N / A3

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Phase 4, Single-Arm, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Zanubrutinib in Chinese Patients With Treatment-Naive Waldenström Macroglobulinemia

RecruitingPH IVBeiGenen=182028

The Study of Zanubrutinib Combined With Rituximab in the Treatment of Secondary Hemophagocytic Lymphohistiocytosis in B-cell Lymphoma

RecruitingPH IVThe First Affiliated Hospital of Soochow Universityn=402027

Phase III Evaluation of Fixed Duration Zanubrutinib Plus Sonrotoclax-Based Therapy Compared to Continuous Zanubrutinib in Previously Untreated Older Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

RecruitingPH IIIAlliance for Clinical Trials in Oncologyn=4662038

A Randomized Phase 3 Trial of Continuous vs. Intermittent Maintenance Therapy With Zanubrutinib as Upfront Treatment in Older Patients With Mantle Cell Lymphoma

RecruitingPH IIIAlliance for Clinical Trials in Oncologyn=4212038

A Randomized, Open-label, Multicenter, Phase III Clinical Study Comparing Rocbrutinib Monotherapy Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL) (PRIME Study)

RecruitingPH IIIGuangzhou Lupeng Pharmaceutical Company LTD.n=3942033

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase 1, Single-dose, Open-label, Randomized, Crossover Study in Healthy Adult Participants to Evaluate Relative Bioavailability and Food Effect of a Fixed-Dose Combination Tablet Containing Zanubrutinib and Sonrotoclax (BG-71332)

CompletedPH IBeOne Medicinesn=242026

A Phase 1 Open-Label, Multi-Center, Safety and Efficacy Study of PRT2527 as Monotherapy and in Combination With Zanubrutinib or Venetoclax in Participants With Relapsed/Refractory Hematologic Malignancies

CompletedPH IPrelude Therapeuticsn=862026

A Phase 2, Multicenter, Single-arm Study of Zanubrutinib (BGB-3111) in Patients With Previously Treated B-Cell Lymphoma Intolerant of Prior Treatment With Ibrutinib and/or Acalabrutinib

CompletedPH IIBeiGenen=962026

A Phase 1/2 Study of Zanubrutinib in Japanese Patients With Mature B-Cell Malignancies

CompletedPH I/IIBeiGenen=552025

A Phase II, Single-Site, Open-Label Study of Zanubrutinib in Patients With IgG4-Related Disease

CompletedPH IIMatthew C. Bakern=102025

A Phase 2, Single-Arm, Open-Label, Multicenter Study of the Bruton Tyrosine Kinase Inhibitor Zanubrutinib in Patients With CD79B Mutant Relapsed/Refractory Diffuse Large B-Cell Lymphoma

CompletedPH IIBeiGenen=652025

Research activity

3 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20202021
Major research themes1
Lymphoma, Mantle-Cell1
Journals, researchers & institutions
Top journals
  • Blood advances1
  • Clinical cancer research : an official journal of the American Association for Cancer Research1
  • Journal of hematology & oncology1
Leading researchers
  • Huang J3
  • Novotny W3
  • Feng R2
  • Gao S2
  • Guo H2
  • Hu J2
  • Wei R2
  • Xu W2
Leading institutions
free-text, unnormalised
  • Fujian Institute of Hematology2
  • Nanfang Hospital of Southern Medical University2
  • Tongji Hospital2
  • West China Hospital of Sichuan University2
  • Affiliated Cancer Hospital of Zhengzhou University1
  • Banner MD Anderson Cancer Center1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.