Drugs / Zanubrutinib
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (5) | US (FDA) | BRUKINSA | — | 2021-08-31 – 2024-03-07 | fda.gov ↗ |
| Approved | EU (EMA) | Brukinsa | — | 2021-11-22 | europa.eu ↗ |
| Approved | US (FDA) | BRUKINSA | — | 2019-11-14 | fda.gov ↗ |
Trials 189 · started per year
today
US approved 2019
EU approved 2021
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 125 trials | ||||||
| Phase 1 | NCT06675123 | Jun 2026 → Mar 2028 expected | mantle cell lymphoma | City of Hope Medical Center | Recruiting | No outcome recorded |
| Phase 1 | NCT07548255 | Apr 2026 → Mar 2029 expected | mantle cell lymphoma | Ruijin Hospital | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07315373 | Dec 2025 → Dec 2028 expected | autoimmune thrombocytopenia | Peking University People's Hospital | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07141511 | Sep 2025 → Feb 2026 | — | BeOne Medicines | Completed | No outcome recorded |
| Phase 1 | NCT06824701 | Sep 2025 → Jan 2032 expected | B-cell non-Hodgkin lymphoma | University of Utah | Active not recruiting | No outcome recorded |
| Phase 1 | NCT06859008 | Aug 2025 → Jan 2029 expected | MALT lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma, diffuse large B-cell lymphoma, mantle cell lymphoma +2 | City of Hope Medical Center | Recruiting | No outcome recorded |
| Phase 1 | NCT06735664 | Aug 2025 → Dec 2027 expected | Richter transformation | City of Hope Medical Center | Recruiting | No outcome recorded |
| Phase 1 | NCT06730542 | Apr 2025 → Apr 2030 expected | central nervous system cancer | Juan P. Alderuccio, MD | Recruiting | No outcome recorded |
| Phase 1 | NCT06547944 | Jan 2024 → Dec 2025 overdue | chronic lymphocytic leukemia/small lymphocytic lymphoma | Institute of Hematology & Blood Diseases Hospital, China | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05665530 | Sep 2023 → Jun 2025 | Richter transformation, T-cell non-Hodgkin lymphoma, acute myeloid leukemia, chronic lymphocytic leukemia/small lymphocytic lymphoma +5 | Prelude Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT05547399 | Jun → Dec 2022 | — | BeiGene | Completed | No outcome recorded |
| Phase 1 | NCT04850495 | Nov 2021 → Jun 2026 overdue | diffuse large B-cell lymphoma | Yazeed Sawalha | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04551963 | Nov 2020 → Feb 2022 | B-cell neoplasm | BeiGene | Completed | No outcome recorded |
| Phase 1 | NCT04436107 | Sep 2020 → Mar 2024 | diffuse large B-cell lymphoma | BeiGene | Completed | No outcome recorded |
| Phase 1 | NCT04470908 | Jul → Nov 2020 | — | BeiGene | Completed | No outcome recorded |
| Phase 1 | NCT04277637 | Mar 2020 → May 2027 expected | neoplasm of mature B-cells | BeOne Medicines | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03561298 | Jun 2018 | — | BeiGene | Completed | No outcome recorded |
| Phase 1 | NCT03465059 | May → Oct 2018 | — | BeiGene | Completed | No outcome recorded |
| Phase 1 | NCT03432884 | Jan → Apr 2018 | — | BeiGene | Completed | No outcome recorded |
| Phase 1 | NCT03301181 | Sep → Nov 2017 | — | BeiGene | Completed | No outcome recorded |
| Phase 1 | NCT04163783 | Mar → Apr 2017 | — | BeiGene | Completed | No outcome recorded |
| Phase 1 | NCT03189524 | Jul 2016 → Aug 2020 | B-cell neoplasm | BeiGene | Completed | No outcome recorded |
| Phase 1 | NCT02795182 | Jun 2016 → Dec 2020 | leukemia, lymphoma | BeiGene | Completed | No outcome recorded |
| Phase 1 | NCT04163523 | May → Jul 2016 | — | BeiGene | Completed | No outcome recorded |
| Phase 1 | NCT02569476 | Jan 2016 → Sep 2020 | B-cell neoplasm | BeiGene | Completed | No outcome recorded |
| Phase 1/26 trials | ||||||
| Phase 1/2 | NCT06634589 | Nov 2024 → Dec 2028 expected | B-cell neoplasm | BeOne Medicines | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06029309 | May 2024 → May 2028 expected | mantle cell lymphoma | Alvaro Alencar, MD | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06375733 | Mar 2024 → Dec 2026 expected | large B-cell lymphoma | Genfleet Therapeutics (Shanghai) Inc. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04282018 | Apr 2020 → Aug 2024 | chronic lymphocytic leukemia/small lymphocytic lymphoma, diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma +1 | BeiGene | Completed | No outcome recorded |
| Phase 1/2 | NCT04172246 | Jan 2020 → May 2023 | neoplasm of mature B-cells | BeiGene | Completed | No outcome recorded |
| Phase 1/2 | NCT02343120 | Sep 2014 → Mar 2021 | B-cell neoplasm | BeiGene | Completed | No outcome recorded |
| Phase 2133 trials | ||||||
| Phase 2 | NCT07674810 | Dec 2026 → Apr 2027 expected | B-cell chronic lymphocytic leukemia | M.D. Anderson Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07638722 | Oct 2026 → Apr 2034 expected | MALT lymphoma, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma | SWOG Cancer Research Network | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07550855 | Sep 2026 → Mar 2028 expected | follicular lymphoma | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07341191 | Jun 2026 → Dec 2029 expected | mantle cell lymphoma | Canadian Cancer Trials Group | Recruiting | No outcome recorded |
| Phase 2 | NCT07682415 | Jun 2026 → Dec 2029 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | Yi Shuhua | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07671378 | Jun 2026 → Dec 2027 expected | B-cell chronic lymphocytic leukemia | The First Affiliated Hospital with Nanjing Medical University | Recruiting | No outcome recorded |
| Phase 2 | NCT07608978 | Jun 2026 → Dec 2028 expected | diffuse large B-cell lymphoma | The First Affiliated Hospital with Nanjing Medical University | Recruiting | No outcome recorded |
| Phase 2 | NCT07690761 | Jun 2026 → Dec 2028 expected | hairy cell leukemia variant | Bnai Zion Medical Center | Enrolling by invitation | No outcome recorded |
| Phase 2 | NCT07602322 | May 2026 → May 2028 expected | large B-cell lymphoma | Ruijin Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07594899 | May 2026 → May 2029 expected | large B-cell lymphoma | Ruijin Hospital | Not yet recruiting | No outcome recorded |
| Show all 133 trials opens the full record — a long page | ||||||
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT05707377 | Apr 2023 → Oct 2027 expected | idiopathic membranous glomerulonephritis | BeOne Medicines | Active not recruiting | No outcome recorded |
| Phase 314 trials | ||||||
| Phase 3 | NCT07321652 | Apr 2026 → Sep 2028 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | Alliance for Clinical Trials in Oncology | Recruiting | No outcome recorded |
| Phase 3 | NCT07277231 | Jan 2026 → Feb 2031 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | BeOne Medicines | Recruiting | No outcome recorded |
| Phase 3 | NCT05735834 | May 2024 → May 2029 expected | splenic marginal zone lymphoma | International Extranodal Lymphoma Study Group (IELSG) | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06073821 | Nov 2023 → Feb 2032 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | BeOne Medicines | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05976763 | Oct 2023 → Aug 2038 expected | mantle cell lymphoma | Alliance for Clinical Trials in Oncology | Recruiting | No outcome recorded |
| Phase 3 | NCT05100862 | Mar 2022 → Jul 2028 expected | marginal zone lymphoma | BeOne Medicines | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05179733 | Mar 2022 → Dec 2025 | diffuse large B-cell lymphoma | Ruijin Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT05320575 | Feb 2022 → Aug 2023 | hemophagocytic syndrome | Beijing Friendship Hospital | Completed | No outcome recorded |
| Phase 3 | NCT05020392 | Sep 2021 → Oct 2023 | B-cell chronic lymphocytic leukemia, Burkitt lymphoma, diffuse large B-cell lymphoma, follicular lymphoma +1 | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Unknown | No outcome recorded |
| Phase 3 | NCT05164770 | Mar 2021 → Dec 2023 | high grade B-cell lymphoma, high grade B-cell lymphoma with MYC and/ or BCL2 and/or BCL6 rearrangement, mantle cell lymphoma | Shandong Provincial Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT04170283 | Jan 2020 → Nov 2027 expected | B-cell neoplasm | BeiGene | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04002297 | Aug 2019 → Mar 2027 expected | mantle cell lymphoma | BeOne Medicines | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03734016 | Nov 2018 → Aug 2022 | chronic lymphocytic leukemia/small lymphocytic lymphoma | BeiGene | Completed | No outcome recorded |
| Phase 3 | NCT03336333 | Oct 2017 → May 2021 overdue | chronic lymphocytic leukemia/small lymphocytic lymphoma | BeiGene | Active not recruiting | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT07474961 | Mar 2027 → Dec 2036 expected | Waldenstrom macroglobulinemia, plasma cell myeloma | Anne Louise Tølbøll Sørensen | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07270835 | Nov 2025 → Apr 2027 expected | neoplasm of mature B-cells, secondary hemophagocytic lymphohistiocytosis | The First Affiliated Hospital of Soochow University | Recruiting | No outcome recorded |
| Phase 4 | NCT07169331 | Oct 2025 → Oct 2028 expected | Waldenstrom macroglobulinemia | BeiGene | Recruiting | No outcome recorded |
| Phase not applicable6 trials | ||||||
| — | NCT07299331 | Jan 2026 → Apr 2031 expected | marginal zone lymphoma | Zhengzhou University | Not yet recruiting | No outcome recorded |
| — | NCT07126678 | Jul 2025 → Jul 2028 expected | follicular lymphoma | The First Affiliated Hospital with Nanjing Medical University | Recruiting | No outcome recorded |
| — | NCT06942507 | May 2025 → Apr 2027 expected | Waldenstrom macroglobulinemia | Peking Union Medical College Hospital | Not yet recruiting | No outcome recorded |
| — | NCT06445257 | Sep 2023 → Apr 2026 | primary central nervous system lymphoma | Huai'an First People's Hospital | Unknown | No outcome recorded |
| — | NCT05797948 | Jul 2022 → Jun 2024 | B-cell non-Hodgkin lymphoma | The First Affiliated Hospital of Soochow University | Unknown | No outcome recorded |
| — | NCT05117814 | Sep 2021 → Jan 2023 | central nervous system non-hodgkin lymphoma | Peking University People's Hospital | Unknown | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT04052854 | — | Waldenstrom macroglobulinemia | BeiGene | No longer available | No outcome recorded |
Also used as a comparator or background therapy in 14 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02914938 Background | Oct 2016 → Mar 2023 | chronic lymphocytic leukemia/small lymphocytic lymphoma, follicular lymphoma, high grade B-cell lymphoma, mantle cell lymphoma +1 | MEI Pharma, Inc. | Terminated | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT07052695 Background | Nov 2025 → Dec 2028 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | Inhye Ahn | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06697184 Background | Jan 2025 → Nov 2029 expected | B-cell chronic lymphocytic leukemia, mantle cell lymphoma | BeOne Medicines | Recruiting | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT07271667 Background | Apr 2026 → Nov 2027 expected | B-cell chronic lymphocytic leukemia | Curis, Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT07350850 Comparator | Dec 2025 → Dec 2028 expected | primary central nervous system lymphoma | Tongji Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06958705 Background | Dec 2025 → Dec 2027 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | The First Affiliated Hospital with Nanjing Medical University | Recruiting | No outcome recorded |
| Phase 2 | NCT06520098 Background | Oct 2025 → Jun 2030 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | VA Office of Research and Development | Recruiting | No outcome recorded |
| Phase 2 | NCT06524375 Background | Aug 2024 → Oct 2026 expected | B-cell chronic lymphocytic leukemia | Genentech, Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04840602 Comparator | Jan 2022 → Mar 2028 expected | Waldenstrom macroglobulinemia | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT07377578 Comparator | Feb 2026 → May 2031 expected | mantle cell lymphoma | Guangzhou Lupeng Pharmaceutical Company LTD. | Recruiting | No outcome recorded |
| Phase 3 | NCT06742996 Background | Mar 2025 → Aug 2028 expected | mantle cell lymphoma | BeOne Medicines | Recruiting | No outcome recorded |
| Phase 3 | NCT06522555 Background | Jul 2024 → Aug 2028 expected | diffuse large B-cell lymphoma | Ruijin Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT04662255 Comparator | Apr 2021 → Jan 2027 expected | mantle cell lymphoma | Loxo Oncology, Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03053440 Comparator | Jan 2017 → Jun 2022 | Waldenstrom macroglobulinemia | BeiGene | Completed | No outcome recorded |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 204 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Zanubrutinib | “Using the combined regimen of CHiR (chidamide, zanubrutinib, and lenalidomide) to treat newly diagnosed elderly patients with MYC- and BCL2-expressing positive diffuse large...” NCT06764017 ↗197“Targeting Bruton's tyrosine kinase (BTK), the novel BTK inhibitor zanubrutinib (highly selective, low toxicity) combined with obinutuzumab (enhanced antibody-dependent...” NCT07165769 ↗ “Part A: This is a randomized, placebo-controlled, double blind, single dose study to evaluate the safety and tolerability of a single oral supratherapeutic dose of zanubrutinib...” NCT03432884 ↗ “Zanubrutinib, as a new generation of BTK inhibitors, has shown more potent antitumor activity and lower adverse reactions than ibrutinib in head-to-head clinical studies” NCT06890585 ↗ “Commercially available cBTKi (ibrutinib or acalabrutinib, or zanubrutinib) will be administered in accordance with its prescribing label.” NCT06524375 ↗ “Covalent BTK inhibitor (Ibrutinib 560 mg qd, Zanubrutinib 160 mg bid, or Orelabrutinib 150 mg qd) orally on Days 1-21.” NCT07350850 ↗ “Zanubrutinib: Oral administration starts on Day 1 of Cycle 1 and continues continuously at 160 mg twice daily.” NCT07259122 ↗ “Ibrutinib is the first-generation BTK inhibitror and Zanubrutinib is the second-generation BTK inhibitor.” NCT05020392 ↗ “5 cycles of R-CHOP combined with MTX + Zanubrutinib, followed by 1 cycle of R-MTX-Zanubrutinib” NCT06594432 ↗ “ME Type: Glofitamab + Local Radiotherapy + BTK inhibitor (e.g., Zanubrutinib)” NCT07602322 ↗ “Venetoclax 400 mg/d + Zanubrutinib 160 mg orally twice daily until cycle 21.” NCT05478512 ↗ “a covalent BTK inhibitor (e.g., ibrutinib, acalabrutinib, zanubrutinib)” NCT06675123 ↗ “1. Zanubrutinib: 160mg orally twice daily;” NCT06918015 ↗ “* Drug: zanubrutinib Oral Capsule” NCT06033820 ↗ “Drug: Zanubrutinib” NCT04743687 ↗ |
| Known as | BGB-3111 | “A Two-Part Phase 1 Study to Investigate A) Safety and Tolerability of Supratherapeutic dose of Zanubrutinib (BGB-3111) and B) Effect of Zanubrutinib on Cardiac Repolarization...” NCT03432884 ↗9“A Phase 1, Open-label, Single-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Zanubrutinib (BGB-3111) in Subjects With Varying Degrees of Hepatic Impairment” NCT03465059 ↗ “Zanubrutinib (BGB-3111, Brukinsa®, BeiGene) is a second-generation irreversible BTKi developed by Chinese company BeiGene.” NCT05922839 ↗ “The investigational medicinal products (IMP) are Zanubrutinib (BGB- 3111) and BGB-11417.” NCT06547866 ↗ “Zanubrutinib (BGB-3111)” NCT03206970 ↗ |
| Known as | Brukinsa | “Zanubrutinib (BGB-3111, Brukinsa®, BeiGene) is a second-generation irreversible BTKi developed by Chinese company BeiGene.” NCT05922839 ↗ |
| Known as | Zanu | “Participants in this group will receive combination therapy of Zanubrutinib (Zanu) and Tafasitamab (Tafa) for up to 24 cycles, followed by maintenance therapy with Zanubrutinib...” NCT06029309 ↗ |
| Known as | Zanubrutinib (BGB-3111) | “Zanubrutinib (BGB-3111)” NCT06558604 ↗ |
| Action | Inhibit | “Zanubrutinib is a more selective, next-generation BTK inhibitor.” PMID 38502198 ↗ May 2024 |
| Modality | Small molecule | “Zanubrutinib is an oral small molecule BTK inhibitor” NCT05164770 ↗ |
| Route | Oral | “Oral administration by capsule” NCT02343120 ↗ |
| Target | BTK | “Zanubrutinib is a more selective, next-generation BTK inhibitor.” PMID 38502198 ↗ May 2024 |