Zanubrutinib
Also known as Brukinsa
BeOne Medicines Ltd. ONC BEIGF · B Cell Lymphoma; B-cell Malignancies; CLL; Chronic Lymphocytic Leukemia; Mantle Cell Lymphoma
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Approved
Not recorded
Linked trials
7
From ClinicalTrials.gov
Latest FDA action
Approved
NDA218785,
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- BeOne Medicines Ltd. ONC BEIGF Source: Company record for BeOne Medicines Ltd. (opens in a new tab)
- Indications
- B Cell Lymphoma; B-cell Malignancies; CLL; Chronic Lymphocytic Leukemia; Mantle Cell Lymphoma Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Applications
- NDA 218785 · Standard review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for NDA 218785 (opens in a new tab)
- NDA 213217 · Priority review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for NDA 213217 (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 CompletedFirst trial start 17 Apr 20231 linked trial
- Phase 3 CompletedFirst trial start 20 Aug 20197 linked trials
- Filed Completed
- Approved Current stageFirst approval 14 Nov 2019
Overview
- Mechanism
- Not recorded
- Route
- Not recorded
- Modality
- Not recorded
- Specialties
- Not recorded
Overview text is written by HealthTrade editors.
Key dates
No catalysts yet. Editors add each date together with its source.
FDA designations
No FDA designations are on record for Zanubrutinib. Editors add each one with its source.
Filed application
No filed application is on record for Zanubrutinib. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Zanubrutinib.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT07277231ClinicalTrials.gov record for NCT07277231 (opens in a new tab) | A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia | Phase 3 | Recruiting | 500 (estimated) | Feb 2031 (estimated) | No |
| NCT06742996ClinicalTrials.gov record for NCT06742996 (opens in a new tab) | 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) | Phase 3 | Recruiting | 300 (estimated) | 31 Aug 2028 (estimated) | No |
| NCT06073821ClinicalTrials.gov record for NCT06073821 (opens in a new tab) | Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Participants With Chronic Lymphocytic Leukemia (CLL) | Phase 3 | Active, not recruiting | 652 (estimated) | Feb 2032 (estimated) | No |
| NCT05707377ClinicalTrials.gov record for NCT05707377 (opens in a new tab)ALMOND | A Study to Examine the Efficacy and Safety of Zanubrutinib Given to Adults With Primary Membranous Nephropathy | Phase 2/3 | Active, not recruiting | 178 (actual) | Oct 2027 (estimated) | No |
Publications listing ALMOND (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT05100862ClinicalTrials.gov record for NCT05100862 (opens in a new tab)MAHOGANY | A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphoma | Phase 3 | Active, not recruiting | 799 (actual) | Jul 2028 (estimated) | No |
| NCT04170283ClinicalTrials.gov record for NCT04170283 (opens in a new tab) | A Study to Evaluate Long-term Safety of Zanubrutinib Regimens in Participants With B-Cell Malignancies Who Participated in BeiGene Parent Studies of Zanubrutinib | Phase 3 | Active, not recruiting | 955 (actual) | 31 Dec 2026 (estimated) | No |
Publications listing NCT04170283 (2), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT04002297ClinicalTrials.gov record for NCT04002297 (opens in a new tab)MANGROVE | 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 | Phase 3 | Active, not recruiting | 510 (actual) | 27 Apr 2026 (actual) | No |
Publications listing MANGROVE (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.
Trial quality
About CT-VCALoading trial quality…
FDA actions
Data provided by the U.S. Food and Drug Administration.
FDA recalls load here.
FDA drug shortages load here.
Orange Book patents load here.
FAERS adverse event counts load here.
Papers and preprints load here.
Community discussion loads here.
EU status (EMA)
Authorised
Brukinsa (EMEA/H/C/004978)
- Authorised
- Therapeutic area
- Waldenstrom Macroglobulinemia
- Marketing authorisation holder
- BeOne Medicines Ireland Limited
- Active substance (INN)
- zanubrutinib
- ATC code
- L01EL03
- Latest EMA decision
Matched by active substance: EMA's INN or active substance equals this drug's name.
EMA page for Brukinsa (opens in a new tab)EMA medicine data (opens in a new tab)
Source: European Medicines Agency (EMA), medicines data download. Licence: EMA re-use with acknowledgement. EMA medicines report 2026-10-26.
Related news
Sources
- Drugs@FDA 213217 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT07277231 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT06742996 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT06073821 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT05707377 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT05100862 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT04170283 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT04002297 (opens in a new tab) Licence: public-domain. Fetched
- Drugs@FDA via openFDA NDA218785 (opens in a new tab) Licence: cc0. Fetched
- Drugs@FDA via openFDA NDA213217 (opens in a new tab) Licence: cc0. Fetched
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.