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Last update 28 Jan 2026

Zanubrutinib

Last update 28 Jan 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

BRUKINSAPP, Zanubrutinib (USAN/INN), 赞布替尼

+ [5]

Target

BTK

Action

inhibitors

Mechanism

BTK inhibitors(Tyrosine-protein kinase BTK inhibitors)

Therapeutic Areas

NeoplasmsImmune System DiseasesCardiovascular Diseases+ [6]

Active Indication

Plasmablastic LymphomaFollicular LymphomaWaldenstrom's macroglobulinaemia refractory+ [53]

Inactive Indication

Burkitt LymphomaCOVID-19Indolent Non-Hodgkin Lymphoma+ [2]

Originator Organization

BeOne Medicines Ltd.

Active Organization

Prelude Therapeutics, Inc.

BeOne Medicines Ltd.

BeiGene (Suzhou) Co. Ltd.

+ [12]

Inactive Organization

Lite Strategy, Inc.

License Organization

NANOLEK LLC

Genfleet Therapeutics (Shanghai), Inc.

Glenmark Specialty SA

+ [7]

Drug Highest PhaseApproved

First Approval Date

United States (14 Nov 2019),

Mantle-Cell Lymphoma

RegulationFast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Breakthrough Therapy (China), Conditional marketing approval (China), Priority Review (China), Special Review Project (China), Breakthrough Therapy (United States)

Structure/Sequence

Molecular FormulaC27H29N5O3

InChIKeyRNOAOAWBMHREKO-QFIPXVFZSA-N

CAS Registry1691249-45-2

235

Clinical Trials associated with Zanubrutinib

NCT07341191

/ Not yet recruitingPhase 2IIT

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

The purpose of this study is to evaluate the effects of adding two oral medications (sonrotoclax plus zanubrutinib) to standard of care chimeric antigen receptor (CAR-T) cell therapy in participants with mantle cell lymphoma.

Start Date31 Mar 2026

Sponsor / Collaborator

Canadian Cancer Trials Group

[+1]

NCT06859008

/ RecruitingPhase 1IIT

Feasibility of Treating Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma With Zanubrutinib in Combination With the BCL2 Inhibitor, Sonrotoclax, Focusing on Access for Underrepresented Ethnic/Racial Minorities

This phase I trial tests zanubrutinib in combination with sonrotoclax for treating underrepresented ethnic and racial minorities with B-cell non-Hodgkin lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Many racial and ethnic minorities face additional treatment challenges which may lead to poorer outcomes, however, there are fewer racial and ethnic minorities participating in clinical trials. Zanubrutinib, a type of tyrosine kinase inhibitor, blocks a protein called Bruton tyrosine kinase (BTK), which may help keep cancer cells from growing. Sonrotoclax works by blocking a protein called B-cell lymphoma-2 (Bcl-2). This protein helps certain types of blood cancer cells to survive and grow. When sonrotoclax blocks Bcl-2, it slows down or stops the growth of cancer cells and causes them to die. Zanubrutinib and sonrotoclax have been shown to be an effective treatment for B-cell cancers. Giving zanubrutinib in combination with sonrotoclax may be effective in treating ethnic and racial minorities with relapsed or refractory B-cell non-Hodgkin lymphoma.

Start Date07 Feb 2026

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

NCT07277231

/ Not yet recruitingPhase 3

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

The purpose of this study is to investigate the efficacy and safety of fixed-duration sonrotoclax (also known as BGB-11417) plus zanubrutinib (also known as BGB-3111) (SZ) compared with fixed-duration of venetoclax plus acalabrutinib (AV) in participants with previously untreated chronic lymphocytic leukemia (CLL).

Start Date31 Jan 2026

Sponsor / Collaborator

BeOne Medicines Ltd.

100 Clinical Results associated with Zanubrutinib

100 Translational Medicine associated with Zanubrutinib

100 Patents (Medical) associated with Zanubrutinib

571

Literatures (Medical) associated with Zanubrutinib

31 Dec 2026·JOURNAL OF MEDICAL ECONOMICS

Prolonged progression-free survival with zanubrutinib in relapsed/refractory CLL: an indirect treatment comparison versus other BTK inhibitors using multilevel network meta-regression

Article

Author: Xu, Sheng ; Yang, Keri ; Bouwmeester, Walter ; Mohseninejad, Leyla ; Shadman, Mazyar ; Jevdjevic, Milica ; Jansen, Jeroen P. ; Williams, Rhys

BACKGROUND:

Bruton tyrosine kinase inhibitors (BTKis) are therapeutic agents for relapsed/refractory chronic lymphocytic leukemia (R/R CLL). Previous indirect treatment comparisons are limited in simultaneously comparing multiple interventions and adjusting for population differences. This study aimed to use a more rigorous approach called multilevel network meta-regression (ML-NMR) to estimate the relative treatment effects of zanubrutinib compared to acalabrutinib and ibrutinib in two target populations: a general R/R CLL population similar to the phase 3 ALPINE trial's intention-to-treat (ITT) population, and a high-risk population with del(17p) and/or del(11q), similar to the ITT population of the phase 3 ELEVATE-RR trial.

METHODS:

The ML-NMR was conducted using data from three phase 3 randomized controlled trials: ALPINE (N = 652), ELEVATE-RR (N = 533), and ASCEND (N = 310). Progression-free survival (PFS) and overall survival (OS) were the outcomes of interest. The ML-NMR integrated individual patient data from ALPINE with aggregate data from the other trials, incorporating important effect modifiers to estimate relative treatment effects for the target populations.

RESULTS:

In the general R/R CLL population, zanubrutinib showed an improved PFS compared to ibrutinib (HR = 0.67, 95% Credible Interval [CrI] = 0.52-0.87) and acalabrutinib (HR = 0.57, 95% CrI = 0.34-0.95). In the high-risk population, zanubrutinib maintained its PFS advantage over ibrutinib and acalabrutinib. OS was similar across BTKis in both populations, with wide CrIs that included an estimate of no difference between treatments.

CONCLUSION:

This ML-NMR suggests that zanubrutinib offers improved PFS compared to ibrutinib and acalabrutinib in both general and high-risk R/R CLL populations. OS results were uncertain due to limited follow-up.

01 Apr 2026·DIAGNOSTIC MICROBIOLOGY AND INFECTIOUS DISEASE

Aspergillus fumigatus brain abscess in an immunocompromised patient receiving a second-generation Bruton Tyrosine Kinase inhibitor (BTKi)

Article

Author: Alexiou, George A ; Voulgaris, Spyridon ; Kafritsas, Georgios ; Romeo, Eleni ; Kittas, Christos ; Lampros, Marios

Chronic lymphocytic leukemia (CLL) is a frequent type of adult leukemia. Bruton Tyrosine Kinase inhibitors (BTKi) are first-line treatments for CLL. Despite being efficient, BTKi have also been associated with significant side effects, including arrhythmias, hemorrhagic complications, and opportunistic infections. Zanubrutinib is a second-generation BTKi that recently received FDA approval for CLL and is associated with improved outcomes and a better safety profile compared to first-generation BTKi. In the present study, we report a case of a patient with CLL, with an in-range absolute neutrophil count and an isolated Aspergillus fumigatus brain abscess mimicking a brain tumor. The lesion was excised "en bloc", and lesion cultures revealed Aspergillus fumigatus sensitive to amphotericin and voriconazole. The patient received postoperative treatment with voriconazole. While invasive fungal infections with brain involvement have been previously reported, to our knowledge, this is the first documented case of an isolated Aspergillus fumigatus brain abscess in a patient receiving zanubrutinib.

01 Feb 2026·EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY

Zanubrutinib in B-cell lymphomas: from clinical pharmacology to therapeutic application

Review

Author: Chen, Tian-Bo ; Yan, Yu-Ting ; Guo, Yu-Jiao ; Wang, Yong-Qing ; Sun, Lu-Ning

255

News (Medical) associated with Zanubrutinib

13 Jan 2026

·www.biospace.com

BeOne Medicines Highlights Global Oncology Leadership at 44th Annual J.P. Morgan Healthcare Conference

Company outlines foundational hematology leadership, multiple 2026 data catalysts, a unique global clinical development superhighway, and continued financial excellence SAN CARLOS, Calif.--(BUSINESS WIRE)-- $ONC #BeOne -- BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, will outline the pillars of its growing global oncology leadership during its presentation today at the 44 th Annual J.P. Morgan Healthcare Conference in San Francisco. John V. Oyler, Co-Founder, Chairman, and CEO at BeOne, will highlight the Company’s transformative leadership in treating B-cell malignancies. The presentation will feature BRUKINSA ® , the global leader among Bruton’s tyrosine kinase (BTK) inhibitors, as well as foundational hematology assets: sonrotoclax, a next-generation and potentially best-in-class B-cell lymphoma 2 (BCL2) inhibitor that received its first global regulatory approvals on December 30, and BGB-16673, a potentially first-in-class and best-in-class BTK chimeric degradation activation compound (CDAC). In addition, Mr. Oyler will share further information on BeOne’s global development superhighway, which encompasses global, wholly internal, and competitively advantaged clinical capabilities that can greatly reduce the cost and time to develop a new medicine, thereby increasing the speed of access to innovation for patients around the world. “BeOne is emerging as the world’s leading oncology company with established leadership in the treatment of B-cell malignancies, an industry-leading pipeline and a unique set of internal capabilities to address tremendous unmet patient need around the world,” Mr. Oyler said. “BRUKINSA has entrenched itself as the best-in-class, foundational BTK inhibitor and global revenue leader with an unparallelled long-term efficacy and safety pro all approved indications. The investigational combination of BRUKINSA and BCL2 inhibitor sonrotoclax has the potential to change the fixed-duration treatment landscape for CLL with best-in-class rates and kinetics of minimal residual disease. BGB-16673 is the most advanced BTK degrader in the clinic and continues to emerge as a potential first-in-class and best-in-class treatment. Combining one of the industry’s most innovative research teams with our vertically integrated clinical development capabilities puts us in a strong position for our next phase of growth with a solid financial pro a growing global footprint.” Key themes from BeOne’s presentation (7:30 a.m. PT, Tuesday, Jan. 13, 2026) at the J.P. Morgan Healthcare Conference include: BeOne is the only company with potentially best-in-class, foundational medicines in three key MOAs in CLL BeOne is the leading company in the treatment of chronic lymphocytic leukemia (CLL) with three approved or clinical-stage foundational medicines addressing all patient subtypes. BRUKINSA is now the global revenue leader in the BTKi class and the only BTKi to demonstrate superior progression-free survival (PFS) and cardiac safety pro ibrutinib in a Phase 3 head-to-head trial. At the American Society of Hematology (ASH) Annual Meeting in December, the Company presented landmark six-year results from the global, Phase 3 SEQUOIA trial of BRUKINSA versus bendustamine plus rituximab (BR) in treatment-naïve CLL or small lymphocytic lymphoma with an estimated 74% PFS compared with 32% PFS for BR. The overall survival (OS) at 72 months was 84% for BRUKINSA and 80% with BR. After adjusting for COVID-19, the OS rates were 88% and 82%, respectively. BeOne is rapidly advancing the investigational combination of BRUKINSA and sonrotoclax as a potential best-in-class fixed-duration regimen for the treatment of first-line CLL with clinical results showing potential best-in-class rates of undetectable minimal residual disease (uMRD) at the earliest time as exploratory endpoints. The Company anticipates uMRD results from the Phase 3 CELESTIAL trial of zanubrutinib plus sonrotoclax (ZS) versus venetoclax plus obinutuzumab (VO) in 2026. In addition, the Company continues to advance BGB-16673 as a potentially first-in-class and best-in-class targeted degrader of BTK with Phase 1 trial results in heavily pretreated CLL patients at a median follow-up of 18 months demonstrating an overall response rate of 86% and 12-month progression-free survival of 79%. The Company anticipates potentially pivotal Phase 2 trial results for BGB-16673 in R/R CLL in 2026. BeOne’s peerless global development superhighway combined with an industry-leading oncology R&D team drives faster development, accelerated regulatory registrations, and broader global patient access BeOne is leveraging one of the largest oncology research teams in the industry alongside nearly 6,000 clinical development and manufacturing colleagues supporting the Company’s wholly internal, strategically advantaged global development superhighway to rapidly bring our medicines to cancer patients around the world. The Company’s dedicated team of research scientists holds deep expertise in designing innovative small-molecule inhibitors, biologics, targeted protein degraders, multispecific antibodies and antibody drug conjugates. In the past 18 months, the Company has advanced 15 New Molecular Entities (NME) into the clinic across a broad range of modalities and expects to deliver an additional eight to 10 NMEs per year into the clinic starting in 2026. BeOne plans to share updates for the following programs, each of which has achieved clinical proof of concept and presents a significant market opportunity: CDK4 inhibitor, B7-H4 ADC, PRMT5 inhibitor, GPC3x41BB bispecific antibody, and CEA ADC. A strong financial pro investment for BeOne’s future growth BeOne’s strong financial position enables the Company to achieve greater global scale while maintaining profitability in 2026 and beyond. The Company generated more than $350 million in free cash flow in the third quarter of 2025 with more than $4 billion in cash on hand. BeOne will continue to invest in driving innovation across its hematology and solid tumor pipelines to maximize long-term value for patients and shareholders while pursuing value-creating business development, including opportunities to leverage the Company’s global development superhighway. Live webcast of BeOne’s presentation can be accessed from the investors section of the Company’s website at . Archived replays will be available on the Company’s website. About BeOne Medicines BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. The Company has a growing global team of nearly 12,000 colleagues spanning six continents who are driven by scientific excellence and exceptional speed to reach more patients than ever before. To learn more about BeOne, please visit and follow us on LinkedIn , X , Facebook and Instagram . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding BeOne’s anticipated presentation at the 44 th Annual J.P. Morgan Healthcare Conference; the potential of sonrotoclax to be a best-in-class BCL2 inhibitor and BGB-16673 to be a first-in-class BTK CDAC; BeOne’s internal capabilities to drive innovation to address unmet patient need around the world; the potential of the combination of BRUKINSA and sonrotoclax to treat CLL; BeOne’s positioning for growth; anticipated timing of results from BeOne’s clinical trials of ZS versus VO and BGB-16673; BeOne’s expectations with respect to advancing NMEs into the clinic; BeOne’s ability to achieve greater global scale while maintaining profitability; BeOne’s plans to continue to invest in commercial assets and geographies that drive profitable growth; and BeOne’s plans, commitments, aspirations and goals under the caption “About BeOne.” Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeOne’s ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeOne’s ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeOne’s ability to obtain and maintain protection of intellectual property for its medicines and technology; BeOne’s reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeOne’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products; BeOne’s ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and those risks more fully discussed in the section entitled “Risk Factors” in BeOne’s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeOne’s subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeOne undertakes no duty to update such information unless required by law. BeOne’s financial guidance is based on estimates and assumptions that are subject to significant uncertainties. Contacts Investor Contact Liza Heapes +1 857-302-5663 ir@beonemed.com Media Contact Kyle Blankenship +1 667-351-5176 media@beonemed.com

Clinical ResultPhase 1Phase 3Phase 2Drug Approval

15 Dec 2025

·www.biopharmadive.com

Sanofi MS drug hits two setbacks

Sanofi is scrapping plans to get one of its more advanced experimental medicines approved for a certain kind of multiple sclerosis, following negative results from a clinical trial disclosed Monday.The French pharmaceutical giant didnt release any specific data, only that its drug, tolebrutinib, failed to meet the main goal of a late-stage trial titled PERSEUS. The study enrolled 767 participants with a rarer form of MS known as primary progressive, and looked at whether tolebrutinib was any better at delaying the disabilities that typically worsen over the course of the disease.Based on these results, Sanofi will not attempt to get the drug approved in this setting. The company is also evaluating if it needs to take an impairment charge related to tolebrutinibs intangible value, given that the drug was the centerpiece of a $3.7 billion buyout. Sanofi intends to provide an update on this evaluation in January though it noted that, either way, the outcome wont impact net income or earnings per share. Its 2025 financial guidance remains unchanged.We are disappointed by todays results; however, we do believe [they] will improve our understanding of the underlying disease biology of multiple sclerosis, said Houman Ashrafian, head of Sanofis research and development, in a statement.Separately, Sanofi on Monday revealed that an approval verdict for tolebrutinib as a treatment for non-relapsing secondary progressive MS will likely come later than expected.The Food and Drug Administration had previously aimed to make a decision by Sept. 28, but pushed that deadline back by three months after Sanofi made a major amendment to its application. Now, the company suspects recent discussions with the FDA indicate a ruling wont come by the revised date of Dec. 28. Sanofi anticipates more guidance from the agency sometime in the first three months of next year.The company said it strongly believes in tolebrutinibs risk-benefit profile. In response to an FDA request, it has submitted an expanded access protocol so eligible patients with non-relapsing secondary progressive MS can get ahold of the drug.The fact that the FDA has requested an extended access program suggests the agency is comfortable with the risk/benefit for now, wrote analysts at the investment bank Jefferies, in a note to clients.The market may well write the asset off, but that seems a bit premature, the analysts added. We wonder if more share price pressure will mean more pressure on management.Tolebrutinib comes as a tablet, and is part of a class of drugs designed to inhibit Brutons tyrosine kinase, an immune system-regulating enzyme that plays a key role in the development of B cells.Those cells make antibodies that alert the body to potential threats. Research suggests a root cause of MS is antibodies mistakenly attacking the protective myelin sheaths that cloak nerve fibers.Sanofi already has one BTK-blocking drug, Wayrilz, on the market for a different autoimmune condition. So does Novartis. BTK inhibitors like Imbruvica, Calquence and Brukinsa are used to treat certain blood cancers as well. The class as a whole carries safety concerns, namely the potential for liver injury, which in recent years led the FDA to issue partial clinical holds on tolebrutinib and similar drugs from Roche, Merck KGaA and InnoCare Pharma.This fall, that Roche drug, fenebrutinib,succeeded in two large MS trials. One recruited primary progressive patients, while the other focused on the far more common relapsing form of the disease. Jefferies analysts described those readouts as a positive surprise, though they also questioned whether Roche had collected enough supportive evidence to file for approval. '

09 Dec 2025

·www.fiercepharma.com

ASH: Lilly oncology chief sees sweet spot for Jaypirca in 2nd-line CLL despite 1st-line trial wins

Jaypirca significantly reduced the risk of progression or death by 80% compared with the traditional regimen of bendamustine and rituximab in patients with previously untreated chronic lymphocytic leukemia. In the world of oncology drug development, the standard playbook is simple: Race to earlier lines of treatment, where patient populations are larger. But Eli Lilly is flipping that script with its blood cancer offering, Jaypirca.Despite holding positive phase 3 data that position its BTK inhibitor Jaypirca for a first-line approval in chronic lymphocytic leukemia (CLL), Jacob Van Naarden, president of Lilly Oncology, maintained that the drug’s primary value proposition remains in serving patients who require second-line treatment. “The main use case of the medicine, I think, remains in second-line,” Van Naarden said in an interview with Fierce Pharma.Lilly is defying the typical earlier-is-better strategy of cancer drug commercialization, but not because Jaypirca’s first-line data are weak. In fact, results from two phase 3 studies unveiled at the American Society of Hematology (ASH) 2025 annual meeting suggest Jaypirca could be a competitive first-line drug in CLL, posing a threat to existing BTK inhibitors from BeOne Medicines, AstraZeneca, and a partnership between AbbVie and Johnson & Johnson.Jaypirca significantly reduced the risk of progression or death by 80% compared with the traditional regimen of bendamustine and rituximab (BR) in patients with previously untreated CLL or small lymphocytic lymphoma (SLL), according to data from the Bruin CLL-313 trial presented at ASH on Dec. 9.At two years, an estimated 93% of patients who received Jaypirca were still alive without progression, versus 71% for those on BR. The median follow-up time of the data was about 28 months.Progression-free survival (PFS) benefits of Jaypirca were consistent across patient subpopulations, with an effect size around or above 70% for every prespecified subgroup analyzed.That data set immediately drew a comparison to results from the phase 3 Sequoia trial of BeOne’s Brukinsa, which recently became the best-selling BTK by quarterly sales. In that first-line CLL/SLL study, Brukinsa improved PFS by 58% compared with, BR with a median follow-up of about 26 months. After a long-term, median five-year follow-up, Brukinsa’s PFS benefit increased to 71%.“These data suggest [Jaypirca] could be an option for 1L CLL patients and may command a larger market presence than was previously anticipated,” Leerink Partners analysts said in a Nov. 24 note when ASH released the top-line Bruin CLL-313 data in a late-breaking abstract. In another phase 3 study, coded Bruin CLL-314, Jaypirca showed a numerically higher overall response rate of 87% compared with 78.5% for AbbVie and J&J’s aging Imbruvica in CLL/SLL patients who were treatment-naïve or were new to a BTK inhibitor. PFS results were not mature in the head-to-head study yet, but so far strongly favored Jaypirca by a risk reduction of 43% in the overall population or 76% in the first-line subgroup, according to investigators’ assessments. The rate of cardiovascular side effects—specifically atrial fibrillation and flutter—which are known problems with Imbruvica, was notably lower in the Jaypirca group, at 2.4% at any grade, versus 13.5% for Imbruvica. Similarly, in the Bruin CLL-313 trial, this rate was 1.4% for the Jaypirca arm and 1.5% for BR. For context, BeOne’s Brukinsa showed a 3.3% rate in Sequoia after a similar follow-up period.Despite the impressive first-line data, Lilly’s Van Naarden argued that Jaypirca’s value lies not in displacing entrenched first-line options, but in serving as a unique option in the second-line setting. “What Jaypirca can do in second-line, none of the other BTKs can do,” he said.Van Naarden has held that view ever since Jaypirca delivered its pivotal data in relapsed or refractory CLL three years ago.CLL patients are typically diagnosed at a relatively old age. And, because of how well BTK drugs can control the disease, the vast majority of CLL patients may get just two lines of therapy before they die of other causes. As a result, doctors want to have a reliable second-line option, Van Naarden explained. Jaypirca, as the first nonvalent, reversible BTK inhibitor, is currently the only BTK med approved for use after other covalent BTK inhibitors. For now, there’s no conclusive evidence on whether a covalent BTK inhibitor can be used after a noncovalent counterpart, an important data gap that Van Naarden acknowledged needs to be addressed. Additional Bruin CLL-313 results might provide some answers to that question, but, with only 13 (9.2%) patients having progressed following Jaypirca by the data cutoff, more follow-up is needed to offer any meaningful information, the Lilly exec noted. Without that, most doctors, while trying to preserve treatment options for relapsed patients, are expected to save Jaypirca for the second line.That is not to say that Jaypirca won’t get any first-line use if approved. Doctors may estimate that some patients might only ever get one line of therapy, while some doctors are comfortable using AbbVie and Roche’s Venclexta in the second-line setting, Van Naarden said. In addition, some docs may want to be mindful of the cardiovascular toxicity profiles of the various options.“When you add it all together, do I think Jaypirca will be the dominant player in first-line? No, I don’t. That’s never been our thesis, and I’m sticking with it,” Van Naarden said. “But I think that these data are good enough that it will make people think about it in certain situations.” Lilly is now bringing the data to the FDA for potential filing discussions. But a couple of uncertainties remain for the company’s regulatory path.First, the two phase 3 trials only included a small number of U.S. patients. In Bruin CLL-313, only seven (2.5%) patients were from North America. In Bruin-CLL-314, the proportion was 7.1%. In rejecting a combo of Roche’s Columvi for the second-line treatment of another blood cancer, diffuse large B-cell lymphoma, the FDA highlighted a lack of representation of the U.S. population, along with inconsistent data in U.S. patients compared with those in Asia.Jaypirca’s situation is different, Van Naarden argued. Columvi’s case was anchored on a large Asian population and data discordance across geographies. Jaypirca’s trials enrolled many patients from Europe, and their data are consistent across regions.There’s also a possibility that the FDA may want to see longer-term data. Overall survival data from Bruin CLL-313 were immature but favored Jaypirca, with a preliminary 74% reduction in the risk of death versus BR despite a 53% crossover rate. However, BR is a weak comparator in the first-line setting, which might explain the low U.S. enrollment. And PFS data from the Imbruvica head-to-head trial, Bruin CLL-314, remained immature.Lilly will submit the data and get the FDA’s reaction, Van Naarden said. “I think the data are objectively strong and, in many ways, better than my expectations going into them.”

Clinical ResultPhase 3Drug ApprovalASH

100 Deals associated with Zanubrutinib

External Link

KEGG	Wiki	ATC	Drug Bank
D11422	Zanubrutinib	L01XE	DB15035

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Plasmablastic Lymphoma	Japan	BeOne Medicines Ltd.	27 Dec 2024
Follicular Lymphoma	Thailand	BeOne Medicines Ltd.	07 Feb 2024
Waldenstrom's macroglobulinaemia refractory	Thailand	BeOne Medicines Ltd.	07 Feb 2024
Recurrent Follicular Lymphoma	European Union	BeiGene Ireland Ltd.	17 Nov 2023
Recurrent Follicular Lymphoma	Iceland	BeiGene Ireland Ltd.	17 Nov 2023
Recurrent Follicular Lymphoma	Liechtenstein	BeiGene Ireland Ltd.	17 Nov 2023
Recurrent Follicular Lymphoma	Norway	BeiGene Ireland Ltd.	17 Nov 2023
Marginal zone lymphoma recurrent	United States	BeOne Medicines Ltd.	19 Jan 2023
Refractory Marginal Zone Lymphoma	Brazil	BeOne Medicines Ltd.	10 Nov 2022
Refractory Follicular Lymphoma	United Kingdom	BeOne Medicines Ltd.	06 Dec 2021
Marginal Zone B-Cell Lymphoma	Uruguay	BeOne Medicines Ltd.	28 Apr 2021
Waldenstrom Macroglobulinemia	Canada	BeOne Medicines Ltd.	30 Mar 2021
Chronic Lymphocytic Leukemia	China	BeiGene (Suzhou) Co. Ltd.	03 Jun 2020
Small Lymphocytic Lymphoma	China	BeiGene (Suzhou) Co. Ltd.	02 Jun 2020
Mantle-Cell Lymphoma	United States	BeOne Medicines Ltd.	14 Nov 2019

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Idiopathic Membranous Glomerulonephritis	Phase 3	United States	BeOne Medicines Ltd.	17 Apr 2023
Idiopathic Membranous Glomerulonephritis	Phase 3	China	BeOne Medicines Ltd.	17 Apr 2023
Idiopathic Membranous Glomerulonephritis	Phase 3	Argentina	BeiGene (Suzhou) Co. Ltd.	17 Apr 2023
Idiopathic Membranous Glomerulonephritis	Phase 3	Brazil	BeOne Medicines Ltd.	17 Apr 2023
Idiopathic Membranous Glomerulonephritis	Phase 3	Canada	BeOne Medicines Ltd.	17 Apr 2023
Idiopathic Membranous Glomerulonephritis	Phase 3	Czechia	BeOne Medicines Ltd.	17 Apr 2023
Idiopathic Membranous Glomerulonephritis	Phase 3	Italy	BeOne Medicines Ltd.	17 Apr 2023
Idiopathic Membranous Glomerulonephritis	Phase 3	Poland	BeiGene (Suzhou) Co. Ltd.	17 Apr 2023
Idiopathic Membranous Glomerulonephritis	Phase 3	Russia	BeOne Medicines Ltd.	17 Apr 2023
Idiopathic Membranous Glomerulonephritis	Phase 3	Turkey	BeOne Medicines Ltd.	17 Apr 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASH2025	Not Applicable	Chronic Lymphocytic Leukemia \| Small Lymphocytic Lymphoma	136	zanubrutinib	istgeqjbgg(etnijhgkyr) = mlanojkmkg fiehrnjtvh (czxuxbuufp ) View more	Positive	06 Dec 2025
				acalabrutinib	istgeqjbgg(etnijhgkyr) = wfcttgpvuq fiehrnjtvh (czxuxbuufp ) View more
ASH2025	Not Applicable	Lymphoplasmacytic Lymphoma	26	Zanubrutinib (treatment-naïve)	ecflwjfmah(oygwnyirni) = Four pts required ZANU dose reductions due to adverse events (grade 1 thrombocytopenia and postsurgical bleeding; grade 2 hypertension; and grade 2 arthralgia), with improved tolerability thereafter; all had responding disease at the time of dose reduction, which continued despite dose reduction. cwdbxtgvve (qqzsrerwrt )	Positive	06 Dec 2025
				Zanubrutinib (relapsed/refractory)
NCT03332017 (ROSEWOOD, ASH2025)	Phase 2	Follicular Lymphoma	214	zanubrutinib + obinutuzumab	okimctfixa(cnxxqxqjbn) = vdwqpktxap qqqawysrqc (jchkzrhpkn ) View more	Positive	06 Dec 2025
				obinutuzumab	okimctfixa(cnxxqxqjbn) = joigddzwdt qqqawysrqc (jchkzrhpkn ) View more
NCT03734016 (ALPINE, ASH2025)	Phase 3	Chronic Lymphocytic Leukemia \| Small Lymphocytic Lymphoma	327	Zanubrutinib	tvckqtrgam(vynqscjaax) = vjgjoecssn extgmgujgu (htikmvynqr ) View more	Positive	06 Dec 2025
				Zanubrutinib (del17p)	kzvwersyct(khjybhjgic) = zulkphflfa pdnbqkfhpi (nitjpxemgk ) View more
ASH2025	Not Applicable	Chronic Lymphocytic Leukemia \| Small Lymphocytic Lymphoma First line	584	Ibrutinib	qqihkdyaef(iasgujcsix) = Ibru was associated with higher rates of AF and HTN; Acala with increased headache incidence; and Zanu with more frequent bleeding and neutropenia event rates ermdkiaouo (qhdskeyepb ) View more	Negative	06 Dec 2025
				Acalabrutinib
ASH2025	Not Applicable	Refractory Marginal Zone Lymphoma	118	Zanubrutinib	iupugmkvro(uxrmyjdeeo) = chsjgunllp ndspucffys (rqxcnhcegq ) View more	Positive	06 Dec 2025
ASH2025	Not Applicable	Marginal Zone B-Cell Lymphoma	78	Zanubrutinib	beoyupzkad(cqonzngobh) = huzrfwszsq vmbsclhtgr (glzpmvyree ) View more	Positive	06 Dec 2025
NCT03734016 (ALPINE, ASH2025)	Phase 3	Chronic Lymphocytic Leukemia del(17p) \| TP53 mutations	300	Zanubrutinib (high-risk R/R CLL)	ddyathyuix(ygabofkyvk) = thquakyypu dqvuuyzwsh (srauftjzpn ) View more	Positive	06 Dec 2025
				Ibrutinib (high-risk R/R CLL)	akefiqtnwt(dzujfpuymo) = qqhnevbwkn hnckvutznx (ioaxwcgtis )
NCT06474481 (ZAP, ASH2025)	Phase 2	Follicular Lymphoma	32	Zanubrutinib+standard G-CHOP	ngdeaabmfo(sfyvdzorlu) = wbjkbtvbde ocrmsvcufz (rfcydrmluj, 68.3 - 93.1) View more	Positive	06 Dec 2025
ASH2025	Phase 2	Mantle-Cell Lymphoma First line	50	Zanubrutinib+Obinutuzumab+Venetoclax	ucqcxotdas(tvujdgzvcw) = znnbgllgea qwkoxqdkjt (qdykwtjdoo, 77 - 97) View more	Positive	06 Dec 2025

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