Brukinsa

(Zanubrutinib)

ApprovedSmall molecule

Zanubrutinib is used to treat certain types of blood cancers, particularly chronic lymphocytic leukemia and lymphomas. It works by blocking a protein that helps cancer cells grow and survive.[2] Brukinsa is currently approved and in use across 58 indications[4].[1]

Brukinsa is one of 595 small molecule programs targeting Follicular Lymphoma. It is currently in Approved.

Indications

175

Total Trials

120

Active Trials

594

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Follicular LymphomaNot yet recruiting

Mantle Cell LymphomaActive, not recruiting

Chronic Lymphocytic LeukemiaCompleted

Diffuse Large B-Cell LymphomaActive, not recruiting

MacroglobulinemiaCompleted

Efficacy and SafetyRecruiting

Marginal Zone B-Cell LymphomaApproved

Castleman DiseaseApproved

Immunoglobulin G4-Related Sclerosing DiseaseApproved

Central Nervous System LymphomaApproved

Follicular LymphomaPhase 2

Not yet recruiting

Mantle Cell LymphomaPhase 3

Active, not recruiting

Chronic Lymphocytic LeukemiaPhase 3

Completed

Diffuse Large B-Cell LymphomaPhase 3

Active, not recruiting

MacroglobulinemiaPhase 2

Completed

Efficacy and SafetyPhase 2

Recruiting

Marginal Zone B-Cell LymphomaApproved

Approved

Castleman DiseaseApproved

Approved

Immunoglobulin G4-Related Sclerosing DiseaseApproved

Approved

Central Nervous System LymphomaApproved

Approved

Showing 10 of 58 indications

Competition

Competitive Landscape

449 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Brukinsa

BBeOne Medicines

Approved

1 2

Tabrecta

Novartis

Phase 3

8 3

Krazati

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Phase 3

6 4

Tepmetko

EMD Serono

Phase 3

5 5

Remeron

OOrganon and Co

Preclinical

1 6

Valemetostat Tosylate

Daiichi Sankyo

Preclinical

1 7

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Preclinical

—8

Ftorafur

TThe First Affiliated Hospital with Nanjing Medical University

Preclinical

—9

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Treatment

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

AIN

NCT04624958

Phase 2Recruiting

Newly Diagnosed

NCT06005870

Phase 1Active, not recruiting

Chronic Lymphocytic Leukemia/small Lymphocytic Lymphoma

NCT06547944

Active, not recruiting

Waldenström Macroglobulinemia (WM)

NCT06441214

Phase 1Active, not recruiting

Diffuse Large B-Cell Lymphoma

NCT04850495

Phase 2Recruiting

Richter's Syndrome

NCT05873712

Clinical

Trials by Indication[1]

Lymphoma23 trials

Zillion: Zanubrutinib Combined With Chemotherapy for Newly Diagnosed CNS Lymphoma

Not yet recruiting·RRuijin Hospital·Phase 2·NCT07405255·19 enrolled

R-MTX-zanbrutinib in Secondary CNS Lymphoma

Unknown status·PPeking University·Phase 2·NCT05398224·45 enrolled

A Study to Evaluate Zanubrutinib and Tislelizumab in Progressive Lymphoma Post CAR-T

Recruiting·UUniversity Health Network, Toronto·Phase 2·NCT06167785·76 enrolled

Show 20 more trials

Zanubrutinib Combined With R-CHOP in Newly-diagnosed Intravascular Large B-cell Lymphoma

Unknown status·PPeking Union Medical College Hospital·Phase 2·NCT04899570·20 enrolled

A Study of ME-401 in Subjects With CLL/SLL, FL, and B-cell Non Hodgkin's Lymphoma

Terminated·MMEI Pharma, Inc.·Phase 1·NCT02914938·97 enrolled

Study of Zanubrutinib (BGB-3111) in Participants With Marginal Zone Lymphoma

Completed· BeiGene logo

BeiGene·Phase 2·NCT03846427·68 enrolled

Zanubrutinib With Pemetrexed to Treat Relapsed/Refractory Primary and Secondary Central Nervous System (CNS) Lymphomas

Recruiting·BBaptist Health South Florida·Phase 2·NCT05681195·15 enrolled

Zanubrutinib Combined With Rituximab in the Treatment of Secondary HLH in B-cell Lymphoma

Recruiting·TThe First Affiliated Hospital of Soochow University·Phase 4·NCT07270835·40 enrolled

Zanubrutinib Combined With Standard Chemotherapy in the Treatment for Patients With Diffuse Large B Cell Lymphoma

Suspended·HHenan Cancer Hospital·Phase 2·NCT04668365·59 enrolled

Study of BTK Inhibitor Zanubrutinib in Participants With Relapsed/Refractory Non-GCB Type Diffuse Large B Cell Lymphoma

Completed· BeiGene logo

BeiGene·Phase 2·NCT03145064·41 enrolled

Rituximab and Zanubrutinib in Patients With Indolent B-cell Lymphomas

Recruiting·HH. Lee Moffitt Cancer Center and Research Institute·Phase 2·NCT06350318·43 enrolled

Zanubrutinib in Combination With Pola-R-CHP and High-dose Methotrexate in Patients With Secondary CNS Lymphoma

Recruiting·—·Phase 1·NCT06730542·20 enrolled

The Efficacy and Safety of ZR2 Versus R-CHOP-like Regimen for Elderly Patients With Newly Diagnosed Diffuse Large B Cell Lymphoma.

Unknown status·FFirst Affiliated Hospital of Wenzhou Medical University·Phase 2·NCT05428670·150 enrolled

Study of Zanubrutinib, Rituximab and Combination Chemotherapy in Newly-diagnosed Aggressive B-cell Non-Hodgkin Lymphoma

Unknown status·SShandong Provincial Hospital·Phase 3·NCT05164770·160 enrolled

A Single-arm, Single-center, Open-label Phase II Study of Zanubrutinib Combined With R-CHOP/R-DHAP in Newly Diagnosed Mantle CellLymphoma Patients

Not yet recruiting·SShanxi Province Cancer Hospital·Phase 2·NCT06255704·23 enrolled

Zanubrutinib Combined With Rituximab in the Treatment for Patients With Marginal Zone Lymphoma

Recruiting·HHenan Cancer Hospital··NCT07233720·30 enrolled

Study Adding Drugs to Usual Treatment for Large B-Cell Lymphoma That Returned or Did Not Respond to Treatment

Recruiting·SSWOG Cancer Research Network·Phase 2·NCT05890352·227 enrolled

A Study to Investigate Zanubrutinib in Chinese Participants With B-cell Lymphoma

Completed· BeiGene logo

BeiGene·Phase 1·NCT03189524·44 enrolled

Zanubrutinib in Combination With Sonrotoclax for the Treatment of Underrepresented Ethnic and Racial Minorities With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

Recruiting·—·Phase 1·NCT06859008·37 enrolled

Zanubrutinib and CAR T-cell Therapy for the Treatment of Recurrent or Refractory Aggressive B-cell Non-Hodgkin's Lymphoma or Transformed Indolent B-cell Lymphoma

Active, not recruiting·NNorthwestern University·Phase 2·NCT05202782·24 enrolled

A Phase II Study of Zanubrutinib, Lenalidomide Plus R-CHOP as the First-line Treatment for Diffused Large B-cell Lymphoma

Unknown status·TThe First Affiliated Hospital with Nanjing Medical University·Phase 2·NCT05200312·36 enrolled

GZL Sequential CD19/CD22 CAR-T in Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

Unknown status·TThe First Affiliated Hospital of Soochow University·N/A·NCT05797948·20 enrolled

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

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT06563505·36 enrolled

Chronic Lymphocytic Leukemia17 trials

Sonrotoclax, Rituximab, and Zanubrutinib in Treating Participants With Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, and Mantle Cell Lymphoma

Recruiting·FFred Hutchinson Cancer Center·Phase 2·NCT06839053·20 enrolled

The Real World Study of Zanubrutinib in the Treatment of Chronic Lymphocytic Leukemia in China

Not yet recruiting·PPeking University People's Hospital··NCT06489184·490 enrolled

Tafasitamab and Zanubrutinib for the Treatment of Patients With Newly Diagnosed Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, TaZA CLL Study

Active, not recruiting·—·Phase 2·NCT05718869·26 enrolled

Show 14 more trials

A Study of Emavusertib + An Approved Bruton Tyrosine Kinase Inhibitor (BTKi) in Participants With Chronic Lymphocytic Leukemia (CLL) and Other B-cell Malignancies

Recruiting·CCuris, Inc.·Phase 2·NCT07271667·108 enrolled

Zanubrutinib and Rituximab for the Treatment of Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT04458610·60 enrolled

Zanubrutinib and Venetoclax as Initial Therapy for Chronic Lymphocytic Leukemia (CLL) With Response-based Obinutuzumab

Active, not recruiting·WWeill Medical College of Cornell University·Phase 2·NCT05650723·50 enrolled

Phase II Trial of Zanubrutinib, Obinutuzumab, Bendamustine (ZGB) as First-Line Therapy for Chronic Lymphocytic Leukemia: A Single-Center Study

Not yet recruiting·TThe First Hospital of Jilin University·Phase 2·NCT07003464·30 enrolled

A Study of Zanubrutinib (BGB-3111) Versus Ibrutinib in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia

Completed· BeiGene logo

BeiGene·Phase 3·NCT03734016·652 enrolled

ZEN-CLL - A Phase II Trial Evaluating Zanubrutinib in Elderly, Treatment-Naïve, CLL Patients

Not yet recruiting·TThe Lymphoma Academic Research Organisation·Phase 2·NCT07739459·95 enrolled

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

Recruiting·BBeOne Medicines·Phase 3·NCT07277231·500 enrolled

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)

Recruiting·AAlliance for Clinical Trials in Oncology·Phase 3·NCT07321652·466 enrolled

A Phase Two Study of Venetoclax Plus Zanubrutinib in Newly Diagnosed CLL and After Front-Line Time-Limited Venetoclax-Based Therapy

Recruiting·KKerry Rogers·Phase 2·NCT07734038·155 enrolled

A Multicenter Phase 2 Study of Zanubrutinib, Obinutuzumab, and Sonrotoclax (BOSon) or Tacabrutideg (BGB-16673), Obinutuzumab, and Sonrotoclax (DOSon) in Treatment-Naïve Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Recruiting·MMassachusetts General Hospital·Phase 2·NCT06849713·80 enrolled

A Phase 1/2 Open-label Study to Investigate the Safety of Sonrotoclax Ramp-up Schedule(s) in Adult Patients With Hematological Malignancies.

Recruiting· BeiGene logo

BeiGene·Preclinical·NCT06697184·258 enrolled

A Multicenter, Open-Label, Phase 2 Study to Investigate the Efficacy and Safety of Sonrotoclax Combined With Zanubrutinib Compared With Zanubrutinib Monotherapy in Adult Patients With Previously Untreated Chronic Lymphocytic Leukemia

Active, not recruiting·BBeOne Medicines·Phase 2·NCT06637501·94 enrolled

A Phase 2 Trial Of The Combination Of Zanubrutinib, Sonrotoclax, And Obinutuzumab For Patients With Treatment-Naïve Chronic Lymphocytic Leukemia

Not yet recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT07674810·40 enrolled

A Multicenter, Phase 2 Randomized, Open Label Study to Evaluate Zanubrutinib in Combination With Obinutuzumab in Previously Untreated Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) (GELLC-10-ZANUBIO)

Recruiting·PPETHEMA Foundation·Phase 2·NCT06544785·106 enrolled

Mantle Cell Lymphoma17 trials

Zanubrutinib-rituximab(ZR) in Patients With Newly Diagnosed Untreated Mantle Cell Lymphoma

Unknown status·TThe First Affiliated Hospital of Soochow University·Phase 2·NCT05504603·20 enrolled

This is a Phase II, Open-label, Multicentre Study of Zanubrutinib-containing Regimens in Patients With Newly Diagnosed Mantle Cell Lymphoma

Not yet recruiting·HHenan Cancer Hospital·Phase 2·NCT06427213·41 enrolled

Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL)

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT04662255·500 enrolled

Show 14 more trials

Study to Evaluate Efficacy and Safety of BGB-3111 in Participants With Relapsed or Refractory Mantle Cell Lymphoma (MCL)

Completed· BeiGene logo

BeiGene·Phase 2·NCT03206970·86 enrolled

A Study of the Zanubrutinib Given in Combination With Bendamustine and Rituximab in (Elderly or TP53 Alterations or Chemotherapy Intolerance) Patients With Newly Diagnosed Mantle Cell Lymphoma

Recruiting·RRuijin Hospital·Phase 2·NCT06136351·23 enrolled

Zanubrutinib and Tafasitamab in Mantle Cell Lymphoma

Recruiting·—·Phase 1/2·NCT06029309·27 enrolled

BRAZAN: A Randomized Phase 2 Study of Bendamustine, Rituximab, Cytarabine (AraC) Induction With Zanubrutinib (BRAZAN) Followed by Zanubrutinib/Rituximab +/- Sonrotoclax Maintenance in Treatment-Naïve Mantle Cell Lymphoma

Recruiting·CChristine Ryan·Phase 2·NCT06854003·60 enrolled

A Multicenter, Prospective, Phase II Study of Zanubrutinib for Maintenance in Patients With Mantle Cell Lymphoma

Recruiting·FFudan University·Phase 2·NCT06341556·52 enrolled

A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cell Lymphoma

Recruiting·GGuangzhou Lupeng Pharmaceutical Company LTD.·Phase 3·NCT07377578·394 enrolled

Zanubrutinib Plus Rituximab for Patients With Indolent Mantle Cell Lymphoma

Recruiting·UUniversity College, London·Phase 2·NCT05635162·50 enrolled

Obinutuzumab, Zanubrutinib, and Lenalidomide in First-line Treatment of Mantle Cell Lymphoma

Not yet recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT07261163·37 enrolled

Obinutuzumab, Zanubrutinib, and Lenalidomide Followed Short-Cycle of Obinutuzumab and Cytarabine in Newly Diagnosed Mantle Cell Lymphoma

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT06504199·39 enrolled

A Study to Investigate the Efficacy of Zanubrutinib Plus Rituximab Compared With Bendamustine Plus Rituximab in Adults With Previously Untreated Mantle Cell Lymphoma Who Are Ineligible for Stem Cell Transplantation

Active, not recruiting· BeiGene logo

BeiGene·Phase 3·NCT04002297·510 enrolled

A Phase II Study of Sonrotoclax Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma Planned for Standard of Care CAR-T Cell Therapy

Recruiting·CCanadian Cancer Trials Group·Phase 2·NCT07341191·40 enrolled

A Phase 3 Randomized Double-Blind Multicenter Study of Sonrotoclax Plus Zanubrutinib Versus Placebo Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma

Recruiting·BBeOne Medicines·Phase 3·NCT06742996·300 enrolled

A Phase II Study of MRD-guided Zanubrutinib, Obinutuzumab, and Sonrotoclax (BOSon) for Previously Untreated Transplant-ineligible Patients With Mantle Cell Lymphoma

Not yet recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT07799220·45 enrolled

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

Recruiting·AAlliance for Clinical Trials in Oncology·Phase 3·NCT05976763·421 enrolled

Diffuse Large B-Cell Lymphoma11 trials

Prospective Clinical Study of ZPR Regimen in Elderly Treatment-naive Diffuse Large B-cell Lymphoma

Unknown status·PPeng Liu·Phase 2·NCT05940064·30 enrolled

Application of Zanubrutinib-based Combination Regimens in the Treatment of Newly-diagnosed Diffuse Large B-cell Lymphoma

Recruiting·—·Phase 2·NCT07371923·50 enrolled

A Study of Zanubrutinib in Combination With Polatuzumab Vedotin, Bendamustine and Rituximab in the Treatment of Relapsed/Refractory Diffuse Large B-cell Lymphoma

Recruiting·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 2·NCT06554600·36 enrolled

Show 8 more trials

The Efficacy and Safety of Pola-ZR2 Versus ZR2 in the Treatment of Old Patients With de Novo Diffuse Large B-cell Lymphoma

Recruiting·RRuijin Hospital·Phase 3·NCT06522555·100 enrolled

Zanubrutinib, Lenalidomide and Rituximab (ZR2) in Elderly Treatment-naive Patients With Diffuse Large B-cell Lymphoma (DLBCL)

Active, not recruiting·RRuijin Hospital·Phase 2·NCT04460248·40 enrolled

Prospective Clinical Study of ZPR Regimen in Relapsed/Refractory Diffuse Large B-cell Lymphoma

Unknown status·PPeng Liu·Phase 2·NCT05940051·35 enrolled

Novel Targeted Drugs Combined With R-ICE Regimen in Relapsed and Refractory Diffuse Large B-cell Lymphoma

Recruiting·RRuijin Hospital·Phase 2·NCT05348213·76 enrolled

Treatment of CD79B Mutant Relapsed/Refractory Diffuse Large B-Cell Lymphoma With Bruton Tyrosine Kinase Inhibitor Zanubrutinib

Completed· BeiGene logo

BeiGene·Phase 2·NCT05068440·65 enrolled

BTK Inhibitor BGB-3111 in Chinese Participants With Diffuse Large B-Cell Lymphoma (Non-GCB) and Indolent Lymphoma (FL and MZL)

Completed· BeiGene logo

BeiGene·Phase 2·NCT03520920·41 enrolled

Zanubrutinib, in Combination With Lenalidomide, With or Without Rituximab in Participants With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Completed· BeiGene logo

BeiGene·Phase 1·NCT04436107·66 enrolled

A Phase Ib Trial of Zanubrutinib in Combination With R-PolaCHP (ZaR-PolaCHP) for Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma

Active, not recruiting·YYazeed Sawalha·Phase 1·NCT04850495·38 enrolled

Newly Diagnosed9 trials

High-dose Methotrexate Combined with Thiotepa and Zanubrutinib in the Treatment of Newly Diagnosed PCNSL (MTZ)

Not yet recruiting·SSun Yat-sen University·Phase 2·NCT06646211·30 enrolled

Zanubrutinib Plus BR in Newly Diagnosed Symptomatic WM

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT05914662·42 enrolled

Zanubrutinib Combined With R-CHOP in the Treatment of Newly Diagnosed DLBCL With p53 Protein Expression

Recruiting·HHuazhong University of Science and Technology·Phase 2·NCT06005870·41 enrolled

Show 6 more trials

Zanubrutinib Followed Zanubrutinib Plus FCR / BR in Newly Diagnosed Symptomatic CLL/SLL

Unknown status·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT05287984·63 enrolled

Zanubrutinib Plus R-CHOP for Patients With Newly Diagnosed Untreated Non-GCB DLBCL

Unknown status·TThe First Affiliated Hospital of Soochow University·Phase 2·NCT04835870·78 enrolled

Zanubrutinib Combined With R-CHOP Regimen in the Treatment of Newly Diagnosed DLBCL With High-risk Factors

Unknown status·LLiaoning Cancer Hospital & Institute·Phase 2·NCT05887726·30 enrolled

Polatuzumab Vedotin and Zanubrutinib Plus R-CHP for Patients With Newly Diagnosed Untreated Non-GCB DLBCL

Enrolling by invitation·TThe First Affiliated Hospital of Soochow University·Phase 2·NCT06468943·20 enrolled

MRD Guided Sonrotoclax and Zanubrutinib in Newly Diagnosed CLL/SLL

Not yet recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT06367374·66 enrolled

Intravitreal MTX and ZR Regimen in Newly Diagnosed PVRL

Unknown status·PPeking Union Medical College Hospital·Phase 2·NCT04899453·42 enrolled

63 more indications

Macroglobulinemia7 trials

Study Evaluating the Efficacy and Tolerance of a Zanubrutinib and BGB-11417 Combination in Patients Previously Treated for Waldenström Macroglobulinemia

Not yet recruiting·FFrench Innovative Leukemia Organisation·Phase 2·NCT06547866·102 enrolled

A Phase II Clinical Study of Zanubrutinib Combined With Four Cycles of CD20 Monoclonal Antibody and Reduced-Dose Bendamustine in the Treatment of Untreated Waldenström Macroglobulinemia

Not yet recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT07259122·43 enrolled

Zanubrutinib Combined With BR in the First-line Treatment of Waldenström's Macroglobulinemia

Not yet recruiting·PPeking Union Medical College Hospital·N/A·NCT06942507·104 enrolled

Show 4 more trials

A Phase 2 Clinical Trial to Evaluate Zanubrutinib Combined With BR (Bendamustine/Rituximab) Regimen in Subjects With Newly-diagnosed Waldenström's Macroglobulinemia

Unknown status·SShanghai Changzheng Hospital·Phase 2·NCT05979948·60 enrolled

A Study to Investigate Efficacy and Safety of BCL2 Inhibitor Sonrotoclax as Monotherapy and in Combination With Zanubrutinib in Adults With Waldenström Macroglobulinemia

Active, not recruiting·BBeOne Medicines·Phase 2·NCT05952037·114 enrolled

Zanubrutinib, Ixazomib and Dexamethasone in Patients With Treatment Naive Waldenstrom's Macroglobulinemia

Completed·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT04463953·25 enrolled

Study of BTK Inhibitor BGB-3111 in Chinese Subjects With Relapsed/Refractory Waldenström's Macroglobulinemia (WM)

Completed· BeiGene logo

BeiGene·Phase 2·NCT03332173·44 enrolled

Follicular Lymphoma6 trials

Zanubrutinib in Combination With Obinutuzumab (ZO) for Newly Diagnosed Follicular Lymphoma

Recruiting·TThe First Affiliated Hospital of Xiamen University·Phase 2·NCT06553352·39 enrolled

Fixed-Duration Zanubrutinib, Bendamustine, and Obinutuzumab (ZBG) in Treatment-Naïve Advanced Stage Follicular Lymphoma

Recruiting·TThe First Affiliated Hospital with Nanjing Medical University·N/A·NCT07126678·15 enrolled

Zanubrutinib and G-CHOP in Untreated Intermediate-high Risk Follicular Lymphoma

Not yet recruiting·TTianjin Medical University Cancer Institute and Hospital·Phase 2·NCT06474481·30 enrolled

Show 3 more trials

Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR) in High-risk Treatment-naive Patients with Follicular Lymphoma (FL)

Not yet recruiting·RRuijin Hospital·Phase 2·NCT06549335·66 enrolled

A Study Comparing Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R/R Follicular Lymphoma

Completed· BeiGene logo

BeiGene·Phase 2·NCT03332017·217 enrolled

An Open-Label, Multicenter, Single-Arm, Sequential Phase-2 Study of Mosunetuzumab Alone or With Zanubrutinib for the Treatment of Patients With Newly Diagnosed Follicular Lymphoma in Need of Systemic Therapy

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT05389293·152 enrolled

B-cell Malignancies5 trials

Zanubrutinib (BGB-3111) in Combination With Tislelizumab (BGB-A317) in Participants With B-cell Malignancies

Completed· BeiGene logo

BeiGene·Phase 1·NCT02795182·75 enrolled

Interaction Study of Zanubrutinib With Moderate and Strong CYP3A Inhibitors in Participants With B-Cell Malignancies

Completed· BeiGene logo

BeiGene·Phase 1·NCT04551963·26 enrolled

A Single-Arm, Expanded Access Study of Zanubrutinib in Participants With B-cell Malignancies

No longer available· BeiGene logo

BeiGene··NCT04052854

Show 2 more trials

Study of Zanubrutinib in Japanese Participants With B-Cell Malignancies

Completed· BeiGene logo

BeiGene·Phase 1/2·NCT04172246·55 enrolled

An Open-label, Multi-center, Long-term Extension Study of Zanubrutinib (BGB-3111) Regimens in Patients With B-cell Malignancies

Active, not recruiting· BeiGene logo

BeiGene·Phase 3·NCT04170283·955 enrolled

Maintenance Therapy5 trials

Zanubrutinib and Lenalidomide as Maintenance Therapy in DLBCL

Recruiting·NNavy General Hospital, Beijing·Phase 2·NCT06503263·240 enrolled

Immunobridging/Maintenance Therapy Versus Non-bridging Therapy in CAR-T Therapy for Low-risk R/R B-NHL

Recruiting·RRuijin Hospital·Phase 2·NCT06695013·144 enrolled

Zanubrutinib in Maintenance Therapy of DLBCL Patients With Initial Remission

Not yet recruiting·LLanZhou University·Phase 2·NCT05596097·15 enrolled

Show 2 more trials

Zanubrutinib-based Maintenance Therapy of Newly Diagnosed DLBCL With Initial Remission

Not yet recruiting·RRuijin Hospital·Phase 2·NCT06669143·19 enrolled

ARTA-based Chemo-free Bridging/Maintenance Therapy in CAR-T Treatment for High-Risk R/R B-NHL Ineligible for HDCT and ASCT

Not yet recruiting·RRuijin Hospital·Phase 2·NCT06646666·35 enrolled

Immune Thrombocytopenia4 trials

Optimal Dose of Zanubrutinib to Treat Adult Immune Thrombocytopenia

Not yet recruiting·PPeking University People's Hospital·Phase 1·NCT07315373·60 enrolled

Zanubrutinib and Eltrombopag as Second-line Treatment in Adults With Primary Immune Thrombocytopenia

Unknown status·PPeking University People's Hospital·Phase 2·NCT05369377·150 enrolled

A Prospective, One-arm and Open Clinical Study of Zanubrutinib in the Treatment of Immune Thrombocytopenia

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT05214391·30 enrolled

Show 1 more trial

The Combination of Zanubrutinib and High-dose Dexamethasone as First-line Treatment in Adult Immune Thrombocytopenia

Not yet recruiting·PPeking University People's Hospital·Phase 2·NCT05369364·150 enrolled

Adult4 trials

An Open Label Study of the Effects and Safety of Zanubrutinib in NMOSDs Adult Patients

Unknown status·XXuanwu Hospital, Beijing·Phase 2·NCT05356858·20 enrolled

Bioequivalence of a Zanubrutinib Tablet Compared to Capsules in Healthy Adult Participants

Completed· BeiGene logo

BeiGene·Phase 1·NCT05767398·58 enrolled

Relative Bioavailability of Zanubrutinib Tablets Compared to Capsules and Effects of Food on the Pharmacokinetics of the Tablet in Healthy Adults

Completed· BeiGene logo

BeiGene·Phase 1·NCT05547399·43 enrolled

Show 1 more trial

A Study to Investigate the Relative Bioavailability and Food Effect of a Fixed-Dose Combination Tablet Containing Zanubrutinib and Sonrotoclax (BG-71332) in Healthy Adults

Completed·BBeOne Medicines·Phase 1·NCT07141511·24 enrolled

Chronic Lymphocytic Leukemia/small Lymphocytic Lymphoma3 trials

Zanubrutinib, Obinutuzumab and Lenalidomide in Newly Diagnosed Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

Active, not recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 1·NCT06547944·30 enrolled

Efficacy and Safety of Zanubrutinib in Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Completed· BeiGene logo

BeiGene·Phase 2·NCT03206918·91 enrolled

Phase 2 Study of Fixed-Duration Zanubrutinib and Sonrotoclax (Z+S) All-Oral Combination Therapy in CLL/SLL Patients in 1st Relapse After Initial Fixed-Duration Novel Therapy (ZeuS-2 Trial)

Not yet recruiting·CCity of Hope Medical Center·Phase 2·NCT07812246·44 enrolled

Efficacy and Safety2 trials

A Study to Evaluate Efficacy and Safety of Zanubrutinib With R-CHOP in Newly Diagnosed Non-GCB DLBCL Patients With Double Expression

Active, not recruiting·FFudan University·Phase 2·NCT05189197·41 enrolled

Efficacy and Safety of Pola-RCHP-X vs Pola-RCHP in Untreated DLBCL

Recruiting·RRuijin Hospital·Phase 2·NCT06803693·152 enrolled

B-cell Lymphoid Malignancies2 trials

Study of the Safety and Pharmacokinetics of BGB-3111 in Subjects With B-Cell Lymphoid Malignancies

Completed· BeiGene logo

BeiGene·Phase 1/2·NCT02343120·385 enrolled

BGB 3111 in Combination With Obinutuzumab in Participants With B-Cell Lymphoid Malignancies

Completed· BeiGene logo

BeiGene·Phase 1·NCT02569476·119 enrolled

Tics2 trials

The Effect of Moderate CYP3A Inducer Rifabutin on the Pharmacokinetics of Zanubrutinib in Healthy Males

Completed· BeiGene logo

BeiGene·Phase 1·NCT04470908·13 enrolled

Study to Evaluate the Effect of Food on the Pharmacokinetics of a BGB-3111 in Healthy Subjects

Completed· BeiGene logo

BeiGene·Phase 1·NCT04163523·18 enrolled

CLL2 trials

Zanubrutinib and Venetoclax in CLL (ZANU-VEN)

Recruiting·—·Phase 2·NCT05168930·45 enrolled

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

Active, not recruiting·BBeOne Medicines·Phase 3·NCT06073821·652 enrolled

DLBCL2 trials

ZR-CHOP in DLBCL With Specific Gene Abnormality

Unknown status·FFudan University·Phase 2·NCT05290337·62 enrolled

Zanubrutinib in Patients With DLBCL and MYD88 or NOTCH1 Mutation or CD5+

Recruiting·VVirginia Commonwealth University·Phase 2·NCT06846463·21 enrolled

Tislelizumab2 trials

Study of BGB-10188 as Monotherapy, and in Combination With Zanubrutinib, and Tislelizumab

Completed· BeiGene logo

BeiGene·Phase 1/2·NCT04282018·97 enrolled

Zanubrutinib Combined With Tislelizumab in the Treatment of r/r PMBCL and EBV+ DLBCL

Unknown status·RRuijin Hospital·Phase 2·NCT04705129·40 enrolled

Waldenström's Macroglobulinemia2 trials

Zanubrutinib (Brukinsa®) in Patients With Waldenström's Macroglobulinemia (WM), Chronic Lymphocytic Leukemia (CLL), Marginal Zone Lymphoma (MZL) and Follicular Lymphoma (FL) - a Prospective Multicenter Observational Cohort Study

Recruiting·IiOMEDICO AG··NCT05326308·845 enrolled

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

Active, not recruiting· BeiGene logo

BeiGene·Approved·NCT07169331·16 enrolled

Waldenstrom macroglobulinemia2 trials

A Phase 2 Multicenter Study of the Combination Zanubrutinib, Bendamustine, and Rituximab in Previously Untreated Waldenström Macroglobulinemia (ZEBRA Trial)

Recruiting·MMassachusetts General Hospital·Phase 2·NCT06561347·65 enrolled

A Phase 4, Observational Study Evaluating the Efficacy and Safety of the Bruton Tyrosine Kinase (BTK) Inhibitor Zanubrutinib in Patients With Waldenström Macroglobulinemia

Recruiting· BeiGene logo

BeiGene··NCT05640102·111 enrolled

Safety and Efficacy1 trial

A Clinical Study Evaluating the Safety and Efficacy of ZRMT Regimen in the Treatment of PCNSL

Recruiting·HHuai'an First People's Hospital·N/A·NCT06445257·30 enrolled

HLH1 trial

Zanubrutinib for HLH

Completed·—·Phase 3·NCT05320575·16 enrolled

COVID-191 trial

Covid-19 Infection and Pulmonary Distress Treatment With Zanubrutinib in Hospitalized Participants

Completed· BeiGene logo

BeiGene·Phase 2·NCT04382586·63 enrolled

Hematologic Malignancies1 trial

A Study of PRT2527 as Monotherapy and in Combination With Zanubrutinib or Venetoclax in Participants With R/R Hematologic Malignancies

Completed·PPrelude Therapeutics·Phase 1·NCT05665530·86 enrolled

Richter's Syndrome1 trial

Zanubrutinib and Lisocabtagene Maraleucel for the Treatment of Richter's Syndrome

Recruiting·AAseel Alsouqi·Phase 2·NCT05873712·24 enrolled

PCO1 trial

Epco, Zanu, Ritux for R/R FL or MZL

Recruiting·—·Phase 2·NCT06563596·45 enrolled

Hemolytic Anemia1 trial

The Safety and Efficacy of Zanubrutinib in Refractory/Relapsed Autoimmune Hemolytic Anemia

Unknown status·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT06021977·33 enrolled

IgG4 Related Disease1 trial

Zanubrutinib in Patients With IgG4-Related Disease

Completed·MMatthew C. Baker·Phase 2·NCT04602598·10 enrolled

MRD1 trial

Mosunetuzumab for CLL MRD Clearance

Recruiting·IInhye Ahn·Phase 1/2·NCT07052695·40 enrolled

Relapsed or Refractory1 trial

A Study of GFH009 in Combination With Zanubrutinib in Subjects With Relapsed or Refractory DLBCL

Recruiting·GGenfleet Therapeutics (Shanghai) Inc.·Phase 1/2·NCT06375733·51 enrolled

Antiphospholipid Syndrome1 trial

Safety and Efficacy of Zanubrutinib in the Treatment of Antiphospholipid Syndrome With Secondary Thrombocytopenia

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT05199909·10 enrolled

Refractory1 trial

Zanubrutinib Combined With BEAM for ASCT in Relapsed and Refractory DLBCL

Not yet recruiting·RRuijin Hospital·Phase 2·NCT06652165·66 enrolled

AIN1 trial

Zanubrutinib and Rituximab Followed by R-DHAOx Then Maintenance with Zanubrutinib for Newly-Diagnosed MCL

Active, not recruiting·SSun Yat-sen University·Phase 2·NCT04624958·42 enrolled

TED1 trial

Zanubrutinib Combined With G-CVP in Previously Untreated FL

Recruiting·—·Phase 2·NCT06959732·40 enrolled

Relapsed/Refractory1 trial

Zanubrutinib in the Treatment of Relapsed/Refractory wAIHA

Recruiting·CChen Miao·Phase 2·NCT05922839·22 enrolled

ART1 trial

A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL

Active, not recruiting· BeiGene logo

BeiGene·Phase 3·NCT03336333·590 enrolled

Chemotherapy1 trial

Zanubrutinib Combined With Rituximab and Chemotherapy for Newly-Diagnosed PCNSLBCL Patients Intolerant to HSCT

Unknown status·RRuijin Hospital·Phase 2·NCT05896007·29 enrolled

Central Nervous System Lymphoma1 trial

Zanubrutinib Monotherapy in Relapsed/Refractory Central Nervous System Lymphoma

Unknown status·PPeking University People's Hospital·N/A·NCT05117814·20 enrolled

Function1 trial

Safety and Pharmacokinetics of Zanubrutinib (BGB-3111) in Healthy Subjects and Those With Impaired Liver Function

Completed· BeiGene logo

BeiGene·Phase 1·NCT03465059·29 enrolled

First-line1 trial

Glofitamab, Polatuzumab Vedotin and Zanubrutinib in First-line Elderly DLBCL

Not yet recruiting·SShanghai Zhongshan Hospital·Phase 2·NCT07012980·38 enrolled

ITP1 trial

A Study of Zanubrutinib in Patients With ITP

Completed·PPeking University People's Hospital·Phase 2·NCT05279872·20 enrolled

Atrial Fibrillation1 trial

Zanubrutinib and Acalabrutinib Use and Risk of Atrial Fibrillation in Patients With Chronic B-cell Malignancies

Not yet recruiting·UUniversity Hospital, Caen··NCT07283965·15,000 enrolled

Cold Agglutinin Disease1 trial

Zanubrutinib in Primary Cold Agglutinin Disease

Active, not recruiting·SStichting Hemato-Oncologie voor Volwassenen Nederland·Phase 2·NCT06067048·25 enrolled

Monoclonal Gammopathy1 trial

Zanubrutinib Treatment in Patients With IgM Monoclonal Gammopathy and Antri-MAG Related Polyneuropathy

Recruiting·UUMC Utrecht·Phase 2·NCT05939037·35 enrolled

Lupus Nephritis1 trial

Zanubrutinib in Participants With Active Proliferative Lupus Nephritis

Completed· BeiGene logo

BeiGene·Phase 2·NCT04643470·177 enrolled

Prospective1 trial

Zanuburutinib in Relapsed and Refractory iMCD: a Prospective, Single-center, Single-arm Trial

Unknown status·PPeking Union Medical College Hospital·Phase 2·NCT04743687·30 enrolled

Lymphoplasmacytic Lymphoma1 trial

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)

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT04840602·92 enrolled

Recurrent Transformed Chronic Lymphocytic Leukemia1 trial

A Phase I Study of Covalent BTK Inhibitor Zanubrutinib in Combination With a CD3-CD20 Bispecific Antibody Odronextamab in Patients With Richter's Transformation

Recruiting·CCity of Hope Medical Center·Phase 1·NCT06735664·23 enrolled

Lymphoid1 trial

Zanubrutinib Plus Rituximab as Front-line Treatment for Mucosa-associated Lymphoid Tissue Lymphoma (MALT): a Single-arm, Open-label, Multicenter, Phase II Study（ZAMA）

Active, not recruiting·SSun Yat-sen University·Phase 2·NCT06647732·42 enrolled

B-cell Malignancy1 trial

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

Recruiting·BBeOne Medicines·Preclinical·NCT06634589·80 enrolled

Primary Membranous Nephropathy1 trial

A Phase 2/3, Multicenter, Randomized, Active-Controlled, Open-label Study to Evaluate the Efficacy and Safety of Zanubrutinib in Patients With Primary Membranous Nephropathy

Active, not recruiting·BBeOne Medicines·Preclinical·NCT05707377·178 enrolled

Relapsed/Refractory Follicular Lymphoma1 trial

A Phase 3 Randomized, Open-Label Multicenter Study of Zanubrutinib (BGB-3111) Plus Anti-CD20 Antibodies Versus Lenalidomide Plus Rituximab in Patients With Relapsed/Refractory Follicular or Marginal Zone Lymphoma

Active, not recruiting· BeiGene logo

BeiGene·Phase 3·NCT05100862·799 enrolled

Intraocular Lymphoma1 trial

A Prospective, Phase II Clinical Trial Using the Combination of Zanubrutinib, Rituximab and High-dose Intravenous Methotrexate With Intravitreal Methotrexate Injection Therapy for the Treatment of Primary Intraocular Lymphoma

Recruiting·PPeking Union Medical College Hospital·Phase 2·NCT06973811·47 enrolled

Chronic Lymphocytic Leukemia (CLL)1 trial

Phase 2 Study of Zanubrutinib, Obinutuzumab, and Venetoclax in Previously Untreated Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) and Mantle Cell Lymphoma (MCL)

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT03824483·230 enrolled

Polyneuropathy1 trial

Zanubrutinib, a Second Generation BTK Inhibitor, in Anti-MAG Antibody Neuropathy: a Phase II Italian Multicenter Clinical Trial (MAZINGA)

Recruiting·AAzienda Ospedaliera di Padova·Phase 2·NCT07392229·50 enrolled

Waldenström Macroglobulinemia (WM)1 trial

Retrospective-prospective Study to Evaluate Treatment Management and Outcomes of Patients With Waldenström's Macroglobulinemia (WM) Treated in Italy According to the Zanubrutinib (Brukinsa®) Compassionate Use Program (CUP) and in Common Practice Following Commercial Approval

Active, not recruiting·FFondazione Italiana Linfomi - ETS··NCT06441214·212 enrolled

Chronic Lymphoid Leukemia1 trial

A Prospective, Open-label, Multicenter Phase-II Trial to Evaluate the Efficacy and Safety of a Sequential Regimen of Bendamustine Followed by Obinutuzumab (GA101), Zanubrutinib (BGB-3111) and Venetoclax (ABT-199) in Patients With Relapsed/Refractory CLL (CLL2-BZAG Protocol)

Active, not recruiting·GGerman CLL Study Group·Phase 2·NCT04515238·42 enrolled

Richter Transformation1 trial

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).

Recruiting·GGerman CLL Study Group·Phase 2·NCT04271956·83 enrolled

Splenic Marginal Zone Lymphoma1 trial

Phase 3, Interventional, Multicentre, Open-label, Randomized Study Comparing Rituximab Plus Zanubrutinib to Rituximab Monotherapy in Previously Untreated, Symptomatic Splenic Marginal Zone Lymphoma (RITZ)

Active, not recruiting·IInternational Extranodal Lymphoma Study Group (IELSG)·Phase 3·NCT05735834·122 enrolled

Large B-Cell Lymphoma (LBCL)1 trial

A Study to Evaluate the Efficacy and Safety of an AI-Driven Treatment Strategy Versus ZR2 in Older Treatment-naive Patients With Large B-cell Lymphoma (LBCL)

Not yet recruiting·RRuijin Hospital·Phase 2·NCT07717177·112 enrolled

Ann Arbor Stage II Follicular Lymphoma1 trial

Safety and Efficacy of Zanubrutinib in Combination With Rituximab and Venetoclax in Previously Untreated Follicular Lymphoma: An Open Label, Phase 2 Study

Recruiting·CChinese PLA General Hospital·Phase 2·NCT06471738·30 enrolled

Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue1 trial

MOZART MZL: A Randomized Phase II Study Evaluating Mosunetuzumab Alone and in Combination With Either Zanubrutinib or Polatuzumab Vedotin for the Treatment of Patients With Relapsed/Refractory Marginal Zone Lymphoma

Not yet recruiting·SSWOG Cancer Research Network·Phase 2·NCT07638722·138 enrolled

Lymphoma, Mantle-Cell1 trial

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

Recruiting·TThe Lymphoma Academic Research Organisation·Phase 2·NCT06558604·100 enrolled

Hairy Cell Leukemia1 trial

A Multicenter Phase 2 Study of Rituximab+ Zanubrutinib for Patients With Hairy Cell Leukemia and Hairy Cell Variant (RiZan Regimen)

Enrolling by invitation·BBnai Zion Medical Center·Phase 2·NCT07690761·12 enrolled

Refractory B-Cell Non-Hodgkin Lymphoma1 trial

A Phase 1b Study of Tazemetostat in Combination With Zanubrutinib and Anti-CD20 Monoclonal Antibody in Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphomas (TARZAN Trial)

Active, not recruiting·UUniversity of Utah·Phase 1·NCT06824701·24 enrolled

CLL (Chronic Lymphocytic Leukemia)1 trial

A Prospective Study of MRD-Guided, Time-Limited Therapy With Zanubrutinib Plus Sonrotoclax in Treatment-Naïve, High-Risk Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) Patients

Recruiting·TThe First Affiliated Hospital with Nanjing Medical University·Phase 2·NCT07671378·24 enrolled

Mature B-cell Malignancies1 trial

A Phase 1a/1b Open-Label Dose Escalation and Expansion Study of Bcl-2 Inhibitor BGB-11417 in Patients With Mature B-Cell Malignancies

Active, not recruiting· BeiGene logo

BeiGene·Phase 1·NCT04277637·437 enrolled

Non-Small Cell Lung Cancer1 trial

GALAXY: Zanubrutinib in BTK-Resistant CLL

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT04116437·150 enrolled

Regulatory

FDA Approval Timeline[5]

Nov 14, 2019

BRUKINSA

NDA NDA213217

Jun 10, 2025

BRUKINSA

NDA NDA218785

Sources

References

[1]
ClinicalTrials.gov — 175 trial records for Zanubrutinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Brukinsa drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Zanubrutinib compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Zanubrutinib. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA218785). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Brukinsa. U.S. Food & Drug Administration.
[7]
PubMed — 10 publications indexed for Zanubrutinib. U.S. National Library of Medicine.
[8]
SEC EDGAR — BeOne Medicines company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: BTK Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: BBeOne Medicines

Patent Landscape[6]

Patent Cliff

Apr 22, 2034

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9447106Apr 22, 2034

10570139Apr 22, 2034

11142528Apr 22, 2034

11591340Aug 15, 2037

10927117Aug 15, 2037

8 more patents

11970500Aug 15, 2037

11851437Aug 15, 2037

11884674Aug 15, 2037

11701357Jun 24, 2039

12233069Jun 10, 2040

11786531Jan 19, 2043

11911386Jan 19, 2043

11896596Jan 19, 2043

Key Publications[7]

Three-dimensional simulations for planning fenestrated/branched endografts in endovascular aneurysm repair for complex abdominal aortic aneurysm: a retrospective cohort study.

Ther Adv Cardiovasc DisDec 1, 2026DOI: 10.1177/17539447261457539

[Guidelines for off-label use of anti-tuberculosis drugs].

Zhonghua Jie He He Hu Xi Za ZhiSep 12, 2026DOI: 10.3760/cma.j.cn112147-20251230-00836

[Clinical practice guideline for digital smoking cessation technologies (2026 edition)].

Zhonghua Jie He He Hu Xi Za ZhiSep 12, 2026DOI: 10.3760/cma.j.cn112147-20260507-00260

[Chinese expert consensus on a standardized echocardiography procedure and right heart evaluation for pulmonary thromboembolism (2026 edition)].

Zhonghua Jie He He Hu Xi Za ZhiSep 12, 2026DOI: 10.3760/cma.j.cn112147-20260507-00257

[Expert consensus on standardized ultrasound screening for lower extremity deep vein thrombosis in prevention and management of venous thromboembolism].

Zhonghua Jie He He Hu Xi Za ZhiSep 12, 2026DOI: 10.3760/cma.j.cn112147-20260519-00285

[Chinese expert recommendations on the standardized establishment of hemoptysis centers].

Zhonghua Jie He He Hu Xi Za ZhiSep 12, 2026DOI: 10.3760/cma.j.cn112147-20260410-00193

[Efficacy and safety of direct oral anticoagulants for the treatment of non-triple-positive antiphospholipid syndrome-associated pulmonary thromboembolism].

Zhonghua Jie He He Hu Xi Za ZhiSep 12, 2026DOI: 10.3760/cma.j.cn112147-20251214-00789

[Extracorporeal catheter fenestration assisted bronchial artery embolization for hemoptysis].

Zhonghua Jie He He Hu Xi Za ZhiSep 12, 2026DOI: 10.3760/cma.j.cn112147-20260520-00290

[Systemic air embolism caused by CT-guided percutaneous lung puncture localization: a case report].

Zhonghua Jie He He Hu Xi Za ZhiSep 12, 2026DOI: 10.3760/cma.j.cn112147-20260215-00094

Sirtuin 1 modulation unlocks the therapeutic potential of sodium-glucose co-transporter 2 inhibitors (SGLT2i) in calcific aortic valve stenosis.

Cardiovasc ResSep 8, 2026DOI: 10.1093/cvr/cvag199