TheraRadar
Data updated: May 26, 2026

BRUKINSA (zanubrutinib)

Bruton's Tyrosine Kinase Inhibitors Genetically Validated Trial Activity: Growth 74 active trials
Orphan Drug Breakthrough Therapy Priority Review Accelerated Approval
Oncology Approved 2019-11-14

BRUKINSA is a kinase inhibitor indicated for the treatment of adult patients with: Mantle cell lymphoma (MCL) who have received at least one prior therapy. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Waldenström's macroglobulinemia (WM).

Source: FDA Label • BEONE MEDICINES USA
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

BeiGene conducting 31 trials (29%)
156 indications explored (Broad Platform)
→ chronic lymphocytic leukemia (15 trials)
→ mantle cell lymphoma (13 trials)
→ marginal zone lymphoma (8 trials)
7
Indications
--
Phase 3 Trials
2
Priority Reviews
6
Years on Market

Details

Status
Prescription
First Approved
2019-11-14
Patent Cliff
2043

Pro Metrics

Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
CAPSULE, TABLET

Companies

BEONE MEDICINES USA
Active Ingredient: ZANUBRUTINIB

BRUKINSA Approval History

2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
13 FDA actions from 2019 to 2025 · 5 indication expansions
Jun 2025 ORIGINAL
New Form · Type 3 - New Dosage Form
FDA Letter Label
Jan 2025 SUPPL
Label · Labeling
FDA Letter Label
Jun 2024 SUPPL
Label · Labeling
FDA Letter Label

What BRUKINSA Treats

7 FDA approvals

Originally approved for its first indication in 2019 . Covers 7 distinct patient populations.

  • Other (7)

BRUKINSA Target & Pathway

Pro

Target

BTK (Bruton's Tyrosine Kinase) Intracellular Kinase

A kinase essential for B-cell development and signaling. BTK inhibitors block B-cell receptor signaling, making them highly effective in B-cell malignancies like chronic lymphocytic leukemia and mantle cell lymphoma.

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Clinical Trial Registry

107 trials
Trial Sponsor ID Phase Status Title
NCT04840602 NCI-2021-02851 NCI-2021-02851, S2005 Ph 2 recruiting Testing the Combination of Venetoclax and Rituximab, in Comparison to the Usual Treatment (Ibrutinib Plus Rituximab or Zanubrutinib Alone) for Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma
NCT06504199 ZGR IIT2024010 Ph 2 active not recruiting Obinutuzumab, Zanubrutinib, and Lenalidomide Followed Short-Cycle of Obinutuzumab and Cytarabine in Newly Diagnosed Mantle Cell Lymphoma
NCT07261163 IIT2025103 Ph 2 recruiting Obinutuzumab, Zanubrutinib, and Lenalidomide in First-line Treatment of Mantle Cell Lymphoma
NCT05100862 MAHOGANY BGB-3111-308 CTR20232545, 2022-502548-12-00 Ph 3 recruiting A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphoma
NCT07277231 BGB-11417-304 2025-524366-21-00 Ph 3 recruiting A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia
NCT06634589 BGB-16673-104 2024-516234-35-00, CTR20244676 Ph 1, Ph 2 recruiting A Study to Investigate Safety and Effectiveness of BGB-16673 in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies
NCT06073821 BGB-11417-301 CTR20241195 Ph 3 active not recruiting Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Participants With Chronic Lymphocytic Leukemia (CLL)
NCT06742996 BGB-11417-302 2024-515593-27-00, CTR20250207 Ph 3 recruiting A Study to Investigate the Efficacy and Safety of Sonrotoclax Plus Zanubrutinib Compared With Placebo Plus Zanubrutinib in Adults With Relapsed/Refractory Mantle Cell Lymphoma (CELESTIAL-RRMCL)
NCT05718869 22183 NCI-2022-10205, 22183 Ph 2 active not recruiting Tafasitamab and Zanubrutinib for the Treatment of Patients With Newly Diagnosed Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, TaZA CLL Study
NCT05976763 A052101 NCI-2023-03577 Ph 3 recruiting Testing Continuous Versus Intermittent Treatment With the Study Drug Zanubrutinib for Older Patients With Previously Untreated Mantle Cell Lymphoma
NCT03824483 18-427 Ph 2 recruiting Study of Zanubrutinib, Obinutuzumab, and Venetoclax in Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL)
NCT05356858 BGB-3111-2005-IIT Ph 2 terminated An Open Label Study of the Effects and Safety of Zanubrutinib in NMOSDs Adult Patients
NCT06839053 RG1124587 NCI-2025-00319, 20623 Ph 2 recruiting Sonrotoclax, Rituximab, and Zanubrutinib in Treating Participants With Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, and Mantle Cell Lymphoma
NCT07141511 BG-71332-101 Ph 1 completed 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
NCT06637501 BGB-11417-204 2024-513970-23-00 Ph 2 active not recruiting A Study to Investigate Sonrotoclax Combined With Zanubrutinib Versus Zanubrutinib Alone in Participants With Previously Untreated Chronic Lymphocytic Leukemia
NCT06859008 24273 NCI-2025-01388, 24273 Ph 1 recruiting Zanubrutinib in Combination With Sonrotoclax for the Treatment of Underrepresented Ethnic and Racial Minorities With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
NCT06824701 TARZAN HCI183680 Ph 1 suspended Tazemetostat in Combination With Zanubrutinib and Anti-CD20 Monoclonal Antibody in Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
NCT05735834 RITZ IELSG48 2023-503755-10-00 Ph 3 active not recruiting Comparison Between Rituximab Plus Zanubrutinib Versus Rituximab Monotherapy in Untreated SMZL Patients
NCT06561347 ZEBRA 24-294 Ph 2 recruiting Zanubrutinib, Bendamustine, Rituximab Prev. Untreated WM
NCT07271667 CA-4948-203 2025-523600-68-00 Ph 2 recruiting A Study of Emavusertib + An Approved Bruton Tyrosine Kinase Inhibitor (BTKi) in Participants With Chronic Lymphocytic Leukemia (CLL) and Other B-cell Malignancies
NCT04277637 BGB-11417-101 2024-515592-35-00, 2020-004641-37 Ph 1 active not recruiting Study of Bcl-2 Inhibitor Sonrotoclax (BGB-11417) in Participants With Mature B-Cell Malignancies
NCT05068440 results posted BGB-3111-218 CTR20210786 Ph 2 completed Treatment of CD79B Mutant Relapsed/Refractory Diffuse Large B-Cell Lymphoma With Bruton Tyrosine Kinase Inhibitor Zanubrutinib
NCT07341191 I245 Ph 2 recruiting Sonrotoclax Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma Planned for Standard of Care CAR-T Cell Therapy
NCT04458610 2019-0012 NCI-2020-05053, 2019-0012 Ph 2 active not recruiting Zanubrutinib and Rituximab for the Treatment of Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
NCT03336333 SEQUOIA results posted BGB-3111-304 2017-001551-31, CTR20190416 Ph 3 active not recruiting A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL
NCT05707377 ALMOND BGB-3111-309 2022-501147-32-00, CTR20230546 Ph 2, Ph 3 active not recruiting A Study to Examine the Efficacy and Safety of Zanubrutinib Given to Adults With Primary Membranous Nephropathy
NCT05681195 2021-LIN-001 Ph 2 recruiting Zanubrutinib With Pemetrexed to Treat Relapsed/Refractory Primary and Secondary Central Nervous System (CNS) Lymphomas
NCT05873712 OSU-22157 NCI-2023-03669 Ph 2 recruiting Zanubrutinib and Lisocabtagene Maraleucel for the Treatment of Richter's Syndrome
NCT04282018 results posted BGB-A317-3111-10188-101 CTR20220463 Ph 1, Ph 2 completed Study of BGB-10188 as Monotherapy, and in Combination With Zanubrutinib, and Tislelizumab
NCT06854003 BRAZAN 24-654 Ph 2 recruiting 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
NCT06563596 24-393 Ph 2 recruiting Epco, Zanu, Ritux for R/R FL or MZL
NCT03332017 ROSEWOOD results posted BGB-3111-212 2017-001552-54, CTR20220712 Ph 2 completed A Study Comparing Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R/R Follicular Lymphoma
NCT07377578 LP-168-CN302 Ph 3 recruiting A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cell Lymphoma
NCT04850495 OSU-20189 NCI-2021-01332 Ph 1 suspended Zanubrutinib in Combination With R-PolaCHP (ZaR-PolaCHP) for Newly Diagnosed Diffuse Large B-Cell Lymphoma
NCT06350318 MCC-22005 Ph 2 recruiting Rituximab and Zanubrutinib in Patients With Indolent B-cell Lymphomas
NCT04116437 BGB-3111-215 Ph 2 completed Zanubrutinib (BGB-3111) in Participants With Previously Treated B-Cell Lymphoma Intolerant of Prior Bruton Tyrosine Kinase Inhibitor (BTKi) Treatment
NCT05665530 PRT2527-02 Ph 1 completed A Study of PRT2527 as Monotherapy and in Combination With Zanubrutinib or Venetoclax in Participants With R/R Hematologic Malignancies
NCT06846463 MCC-24-21151 HM20031622 Ph 2 recruiting Zanubrutinib in Patients With DLBCL and MYD88 or NOTCH1 Mutation or CD5+
NCT06563505 2024-0243 NCI-2024-06965 Ph 2 recruiting A Phase 2 Trial of Mosunetuzumab and Zanubrutinib for Patients With Relapsed/Refractory Marginal Zone Lymphoma
NCT06647732 B2024-594-01 Ph 2 recruiting Zanubrutinib Plus Rituximab as Front-line Treatment for Mucosa-associated Lymphoid Tissue Lymphoma (MALT)
NCT07321652 A042302 Ph 3 not yet recruiting Testing the Addition of Anti-Cancer Drug Sonrotoclax, to the Standard Treatment Zanubrutinib, for Previously Untreated CLL/SLL
NCT05952037 BGB-11417-203 U1111-1291-4524, CTR20232718 Ph 2 active not recruiting A Study to Investigate Efficacy and Safety of BCL2 Inhibitor Sonrotoclax as Monotherapy and in Combination With Zanubrutinib in Adults With Waldenström Macroglobulinemia
NCT05389293 22-100 Ph 2 recruiting A Study of Mosunetuzumab Alone or With Zanubrutinib in People With Follicular Lymphoma
NCT07169331 BGB-3111-404 Ph 4 recruiting A Study to Evaluate the Efficacy and Safety of Zanubrutinib in Chinese Adults With Treatment-Naive Waldenström Macroglobulinemia
NCT06697184 BGB-11417-108 Ph 1, Ph 2 active not recruiting A Study to Investigate the Safety of Novel Dose Ramp-up Schedule(s) When Initiating Sonrotoclax in Participants Treated for Blood Cancers.
NCT07052695 25-277 Ph 1, Ph 2 recruiting Mosunetuzumab for CLL MRD Clearance
NCT06803693 GUIDANCE05 Ph 2 recruiting Efficacy and Safety of Pola-RCHP-X vs Pola-RCHP in Untreated DLBCL
NCT07270835 HLH-003 Ph 4 recruiting Zanubrutinib Combined With Rituximab in the Treatment of Secondary HLH in B-cell Lymphoma
NCT05168930 21-279 Ph 2 recruiting Zanubrutinib and Venetoclax in CLL (ZANU-VEN)
NCT04172246 BGB-3111-111 JapicCTI-195047 Ph 1, Ph 2 completed Study of Zanubrutinib in Japanese Participants With B-Cell Malignancies

Showing 50 of 107 trials

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

BRUKINSA FDA Label Details

Indications & Usage

FDA Label (PDF)

BRUKINSA is a kinase inhibitor indicated for the treatment of adult patients with: Mantle cell lymphoma (MCL) who have received at least one prior therapy. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Waldenström's macroglobulinemia (WM). Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti–CD20-based regimen. This indication is approved under accelerated approval based on overall res...

View full patent landscape →
13 OB patents · 5 families · 178 international docs across 33 countries

BRUKINSA Patents & Exclusivity

Latest Patent: Jan 2043
Exclusivity: Mar 2031

Patents (13 active)

US11896596 Expires Jan 19, 2043
US11786531 Expires Jan 19, 2043
US11911386 Expires Jan 19, 2043
US12233069 Expires Jun 10, 2040
US11701357 Expires Jun 24, 2039
US11884674 Expires Aug 15, 2037
US11591340 Expires Aug 15, 2037
US11970500 Expires Aug 15, 2037
US10927117 Expires Aug 15, 2037
US11851437 Expires Aug 15, 2037
US11142528 Expires Apr 22, 2034
US10570139 Expires Apr 22, 2034
US9447106 Expires Apr 22, 2034

Exclusivity

I-817 Until Jan 2026
I-936 Until Mar 2027
ODE* Until Mar 2031
ODE* Until Sep 2028
ODE* Until Jan 2030
ODE* Until Aug 2028
ODE* Until Nov 2026
I-817 Until Jan 2026
I-936 Until Mar 2027
ODE* Until Mar 2031
ODE* Until Sep 2028
ODE* Until Jan 2030
ODE* Until Aug 2028
ODE* Until Nov 2026
I-817 Until Jan 2026
I-936 Until Mar 2027
ODE-274 Until Jan 2030
ODE-276 Until Nov 2026
ODE-370 Until Sep 2028
ODE-371 Until Aug 2028
ODE-467 Until Mar 2031
Source: FDA Orange Book

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Revenue Insights

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  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2043
  • • 206 active patents

Trial Analysis

  • • 108 total trials
  • • Stage: Growth

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA218785 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment