Zanubrutinib clinical trials
Zanubrutinib is named as an intervention in 72 current clinical trials in our China, Italy, USA, France, Spain, Australia, UK, Germany, Poland, Austria, Canada, Brazil, Israel, Czechia, Belgium, Turkey, Japan, South Korea, Netherlands, Sweden, Taiwan, Switzerland, Portugal, Denmark, Ireland and Norway registers. 41 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is BeOne Medicines (12). The most-studied condition is Chronic Lymphocytic Leukemia. The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial.
Where Zanubrutinib is approved
All regulators →Of the three regulators tracked here, the first to approve Zanubrutinib was the US, on 14 Nov 2019. It is approved in 3 of the 3 regulators tracked here.
- 2 EU orphan designations, most recently for treatment of marginal zone lymphoma (20 May 2021, withdrawn)
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Zanubrutinib patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Zanubrutinib, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 13 listed patents; the last listed expires 19 Jan 2043 (US 11896596).
- Latest patent on the drug substance itself: 15 Aug 2037 (US 10927117).
- Exclusivity ODE*: FDA has not recognized orphan-drug exclusivity (ode) for this drug, but it contains the same active moiety or moieties as another drug(s) t…, until 7 Mar 2031.
- Exclusivity ODE*: FDA has not recognized orphan-drug exclusivity (ode) for this drug, but it contains the same active moiety or moieties as another drug(s) t…, until 19 Jan 2030.
- Exclusivity ODE*: FDA has not recognized orphan-drug exclusivity (ode) for this drug, but it contains the same active moiety or moieties as another drug(s) t…, until 14 Sep 2028.
- Exclusivity ODE*: FDA has not recognized orphan-drug exclusivity (ode) for this drug, but it contains the same active moiety or moieties as another drug(s) t…, until 31 Aug 2028.
- Exclusivity I-936: New indication: treatment of adult patients with relapsed or refractory follicular lymphoma (fl), in combination with obinutuzumab, after t…, until 7 Mar 2027.
- Exclusivity ODE*: FDA has not recognized orphan-drug exclusivity (ode) for this drug, but it contains the same active moiety or moieties as another drug(s) t…, until 14 Nov 2026.
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Zanubrutinib
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Zanubrutinib works
All drug targets →- Tyrosine-protein kinase BTK inhibitor InhibitorTarget: BTK Bruton tyrosine kinase✓ In ChEMBL and the Guide to Pharmacology
- B-cell non-Hodgkin lymphomaPhase 3
- Diffuse large B-cell lymphomaPhase 3
- Follicular lymphomaPhase 3
- Hemophagocytic syndromePhase 3
- High grade B-cell lymphomaPhase 3
- Marginal zone lymphomaPhase 3
- Non-Hodgkin lymphomaPhase 3
- Splenic marginal zone lymphomaPhase 3
- Kidney disorderPhase 2/3
- COVID-19Phase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL3936761, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 9861, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Zanubrutinib
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 5 technology appraisals of Zanubrutinib. 5 are current, and 4 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Zanubrutinib for treating relapsed or refractory mantle cell lymphoma NICE TA1081 | Optimised | 10 Jul 2025 | Current |
| Zanubrutinib for treating marginal zone lymphoma after anti-CD20-based treatment NICE TA1001 | Recommended | 4 Sep 2024 | Current |
| Zanubrutinib with obinutuzumab for treating relapsed or refractory B-cell follicular lymphoma after 2 or more treatments (terminated appraisal) NICE TA978 | Terminated (no company submission) | 29 May 2024 | Current |
| Zanubrutinib for treating chronic lymphocytic leukaemia NICE TA931 | Optimised | 22 Nov 2023 | Current |
| Zanubrutinib for treating Waldenstrom’s macroglobulinaemia NICE TA833 | Optimised | 19 Oct 2022 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Zanubrutinib
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 2 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: BrukinsaEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Zanubrutinib
- ChEMBL
- CHEMBL3936761
- DrugBank
- DB15035
- PubChem CID
- 135565884
- CAS number
- 1691249-45-2
- FDA UNII
- AG9MHG098Z
- Wikidata
- Q75192022
- Wikipedia
- Zanubrutinib
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Zanubrutinib
72 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Zanubrutinib in the EU trials register (CTIS)
1 trialAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Zanubrutinib. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
A multicentre, adaptive, randomised, multidomain, platform trial for dose optimization in the treatment of adult patients with haematological diseases (BLOOD-dose): core protocol
2026-525658-13-00 · Hemic and Lymphatic Diseases
|
Phase 4 | Authorised | Region Hovedstaden | Denmark |
Zanubrutinib across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
2 single-substance products containing Zanubrutinib on the HPRA medicines list.
- BRUKINSA 160 mg film-coated tabletsBeiGene Ireland Limited · EU/1/21/1576/002
- BRUKINSA 80 mg hard capsulesBeiGene Ireland Limited · EU/1/21/1576/001
Supply shortages
No entry for Zanubrutinib in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Zanubrutinib
69 conditionsAll 69 conditions
| Condition (as registered) | Trials |
|---|---|
| Chronic Lymphocytic Leukemia | 11 |
| Mantle Cell Lymphoma | 9 |
| Waldenstrom Macroglobulinemia | 4 |
| Small Lymphocytic Lymphoma | 4 |
| Marginal Zone Lymphoma | 3 |
| Lymphoma, Mantle-Cell | 3 |
| Follicular Lymphoma | 3 |
| Relapsed/Refractory Follicular Lymphoma | 2 |
| B Cell Lymphoma | 2 |
| CLL | 2 |
| B-cell Malignancies | 2 |
| MCL | 2 |
| Large B-cell Lymphoma | 2 |
| Large B-Cell Lymphoma (LBCL) | 2 |
| Waldenström's Macroglobulinemia (WM) | 2 |
| Diffuse Large B-Cell Lymphoma | 2 |
| Treatment | 2 |
| Newly Diagnosed | 2 |
| Waldenström's Macroglobulinemia | 2 |
| Lymphoma | 2 |
| Mantle Cell Lymphoma; Non-Hodgkin Lymphoma | 1 |
| Mature B-Cell Malignancies | 1 |
| Waldenstrom's Macroglobulinemia Recurrent | 1 |
| Waldenstrom's Macroglobulinemia Refractory | 1 |
| Primary Membranous Nephropathy | 1 |
| B-cell Malignancy | 1 |
| Relapsed Cancer | 1 |
| Refractory Cancer | 1 |
| B-cell Lymphoma | 1 |
| Diffuse Large B Cell Lymphoma (DLBCL) | 1 |
| B-NHL | 1 |
| CART Therapy | 1 |
| Maintenance Therapy | 1 |
| Primary Intraocular Lymphoma | 1 |
| Hemophagocytic Lymphohistiocytosis | 1 |
| Diffuse Large B-Cell Lymphoma (DLBCL) | 1 |
| Primary Central Nervous System Lymphoma (PCNSL) | 1 |
| Zanubrutinib | 1 |
| Lenalidomide | 1 |
| Frail Elderly | 1 |
| Refractory or Relapsed Diffuse Large B Cell Lymphoma | 1 |
| Central Nervous System Lymphoma | 1 |
| Antiphospholipid Syndrome | 1 |
| Thrombocytopenia | 1 |
| Diffuse Large B-cell Lymphoma | 1 |
| Diffuse Large B Cell Lymphoma | 1 |
| Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL) | 1 |
| Ann Arbor Stage II Follicular Lymphoma | 1 |
| Grade 1 Follicular Lymphoma | 1 |
| Ann Arbor Stage III Follicular Lymphoma | 1 |
| Ann Arbor Stage IV Follicular Lymphoma | 1 |
| B-cell Non Hodgkin Lymphoma | 1 |
| Immune Thrombocytopenia | 1 |
| Newly-diagnosed Mantle Cell Lymphoma | 1 |
| Effects of Chemotherapy | 1 |
| Safety Issues | 1 |
| Mucosa-associated Lymphoid Tissue Lymphoma (MALT) | 1 |
| Richter Transformation | 1 |
| Chronic Lymphoid Leukemia | 1 |
| Hematologic Cancer | 1 |
| MACE | 1 |
| BTK Inhibitors | 1 |
| Splenic Marginal Zone Lymphoma | 1 |
| Anti-MAG IgM-associated Demyelinating Polyneuropathy | 1 |
| Hairy Cell Leukemia | 1 |
| Hairy Cell Leukemia Variant | 1 |
| Chronic Lymphocytic Leukemia (CLL) | 1 |
| Small Lymphocytic Lymphoma (SLL) | 1 |
| Small Lymphocytic Leukemia | 1 |
Sponsors
lead sponsor per trial+ 26 more sponsors in the trial list above.
By country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Zanubrutinib trials
How many clinical trials are testing Zanubrutinib?
72 current trials in our China, Italy, USA, France, Spain, Australia, UK, Germany, Poland, Austria, Canada, Brazil, Israel, Czechia, Belgium, Turkey, Japan, South Korea, Netherlands, Sweden, Taiwan, Switzerland, Portugal, Denmark, Ireland and Norway registers name Zanubrutinib (also registered as BGB-3111) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Zanubrutinib trials recruiting patients?
Yes. 41 of the 72 trials are recruiting: 28 with sites in China, 5 with sites in Italy, 6 with sites in USA, 4 with sites in France, 4 with sites in Spain, 4 with sites in Australia, 3 with sites in UK, 5 with sites in Germany, 3 with sites in Poland, 3 with sites in Austria, 3 with sites in Canada, 4 with sites in Brazil, 4 with sites in Israel, 1 with sites in Czechia, 1 with sites in Belgium, 1 with sites in Turkey, 1 with sites in Japan, 2 with sites in South Korea, 1 with sites in Netherlands, 1 with sites in Sweden and 1 with sites in Denmark. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Zanubrutinib clinical trials?
BeOne Medicines (12), Ruijin Hospital (7), Institute of Hematology & Blood Diseases Hospital, China (5) and BeiGene (3), among 41 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Are there Zanubrutinib clinical trials in Ireland?
Yes. 2 trials in our Ireland register (ClinicalTrials.gov). Some may be the same study registered in both. See the Irish clinical trials register for sites and contacts.
Is Zanubrutinib licensed in Ireland?
Yes. The HPRA medicines list includes 2 single-substance products containing Zanubrutinib, for example BRUKINSA 160 mg film-coated tablets (BeiGene Ireland Limited). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Zanubrutinib shortage?
Not in the lists we track: Zanubrutinib has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Zanubrutinib works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Zanubrutinib works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Zanubrutinib (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.