Last update 05 Mar 2026

Zanubrutinib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
BRUKINSAPP, Zanubrutinib (USAN/INN), 赞布替尼
+ [5]
Target
Action
inhibitors
Mechanism
BTK inhibitors(Tyrosine-protein kinase BTK inhibitors)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
United States (14 Nov 2019),
RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China), Orphan Drug (Japan), Special Review Project (China), Fast Track (United States)
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Structure/Sequence

Molecular FormulaC27H29N5O3
InChIKeyRNOAOAWBMHREKO-QFIPXVFZSA-N
CAS Registry1691249-45-2

External Link

KEGGWikiATCDrug Bank
D11422Zanubrutinib

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Plasmablastic Lymphoma
Japan
27 Dec 2024
Follicular Lymphoma
Thailand
07 Feb 2024
Waldenstrom's macroglobulinaemia refractory
Thailand
07 Feb 2024
Recurrent Follicular Lymphoma
European Union
17 Nov 2023
Recurrent Follicular Lymphoma
Iceland
17 Nov 2023
Recurrent Follicular Lymphoma
Liechtenstein
17 Nov 2023
Recurrent Follicular Lymphoma
Norway
17 Nov 2023
Marginal zone lymphoma recurrent
United States
19 Jan 2023
Refractory Marginal Zone Lymphoma
Brazil
10 Nov 2022
Refractory Follicular Lymphoma
United Kingdom
06 Dec 2021
Marginal Zone B-Cell Lymphoma
Uruguay
28 Apr 2021
Waldenstrom Macroglobulinemia
Canada
30 Mar 2021
Chronic Lymphocytic Leukemia
China
03 Jun 2020
Small Lymphocytic Lymphoma
China
02 Jun 2020
Mantle-Cell Lymphoma
United States
14 Nov 2019
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Idiopathic Membranous GlomerulonephritisPhase 3
United States
17 Apr 2023
Idiopathic Membranous GlomerulonephritisPhase 3
China
17 Apr 2023
Idiopathic Membranous GlomerulonephritisPhase 3
Argentina
17 Apr 2023
Idiopathic Membranous GlomerulonephritisPhase 3
Brazil
17 Apr 2023
Idiopathic Membranous GlomerulonephritisPhase 3
Canada
17 Apr 2023
Idiopathic Membranous GlomerulonephritisPhase 3
Czechia
17 Apr 2023
Idiopathic Membranous GlomerulonephritisPhase 3
Italy
17 Apr 2023
Idiopathic Membranous GlomerulonephritisPhase 3
Poland
17 Apr 2023
Idiopathic Membranous GlomerulonephritisPhase 3
Russia
17 Apr 2023
Idiopathic Membranous GlomerulonephritisPhase 3
Turkey
17 Apr 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
90
dvzzuncubp(xnxedmnzsj) = qvfrfdxqzx qteccfygsl (jvkhcghpdf )
Superior
13 Feb 2026
dvzzuncubp(xnxedmnzsj) = xebthbpfqs qteccfygsl (jvkhcghpdf )
Phase 3
Chronic Lymphocytic Leukemia
del(17p) | TP53 mutations
300
(high-risk R/R CLL)
wutxzehkdj(fudnwzakve) = dlrsybxpls dnvwlutxwi (dgjjdgmmgl )
Positive
06 Dec 2025
(high-risk R/R CLL)
wjcntqqvfl(dlqebijjlk) = zhncnfhwxs hrqluwxunk (ddfszxsbyy )
Phase 2
29
Zanubrutinib+Rituximab+High-dose Methotrexate
tverqcofbi(zjzvfmzkgh) = ccqnfdzesi exdpqcbxll (zjsoqlmtfz, 68.7 - 98.8)
Positive
06 Dec 2025
Phase 2
65
zqqjpynbhb(gijrbrunfh) = gnmknjueuk gwdhwhqlxl (slcptcfslu )
Positive
06 Dec 2025
Phase 2
38
Tislelizumab combined with zanubrutinib and high-dose methotrexate
gdnsxpdpcm(hvlfybvrxh) = The most prevalent adverse reaction associated with the TZM regimen was non-hematological toxicity. These included three instances of MTX-related renal injury, two cases of severe infection, one case of severe gastrointestinal mucosal injury, one instance of chemotherapy-related capillary cell leakage syndrome, and one case of tislelizumab-related rash and liver injury. Hematological toxicity was limited to two cases of grade 1-2 granulocytopenia in this study. pviroiokoz (mhrnuyikpx )
Positive
06 Dec 2025
Phase 3
327
gvkrevockr(zzyhuimgvw) = shgdszdxkk eqrypkaslb (izugqsvknl )
Positive
06 Dec 2025
(del17p)
gaivblcgeq(ktrvxsjkpj) = vmlrdvfiwm yftdxdthtz (gnqpvrpzdo )
Phase 2
32
Zanubrutinib+standard G-CHOP
ilidmeyuff(aymwcsvusf) = cqigadblth jnjtanaqut (cblkaoysxp, 68.3 - 93.1)
Positive
06 Dec 2025
Not Applicable
Waldenstrom Macroglobulinemia
MYD88L265P | CXCR4 mutations
99
ngtbhwilts(nytfzithqa) = gyfmhlarna tapczjbnie (zixyxaxmem )
Positive
06 Dec 2025
Phase 2
22
hffzdnmpbc(qsxjzrtxsq) = vdhwhgefdp whkqibwlcr (tnowodammj )
Positive
06 Dec 2025
Not Applicable
78
baobvaqulq(pmypfojhsj) = vapydglrcj ozkfwvnxbc (xdmtfkirmy )
Positive
06 Dec 2025
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