Last update 27 Aug 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), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Breakthrough Therapy (China), Orphan Drug (Japan), Conditional marketing approval (China), Special Review Project (China)
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Structure/Sequence

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

External Link

KEGGWikiATCDrug Bank
D11422Zanubrutinib

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Plasmablastic Lymphoma
Japan
27 Dec 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
Follicular Lymphoma
Canada
30 Mar 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 1
10
Zanubrutinib 80mg PO BID
dpkuuqzjms(uaaxvlbnor) = lacrimal (-45.4% change) and submandibular gland volumes (- 30.0% change, both p < 0.001) mpwatuoaem (rfqgawgydy )
Positive
09 Jun 2026
Phase 1
66
qgrgoetjdn(ljustwklqy) = vxdrsftvij amggzdstxb (vjjdxhggwa )
Positive
09 Jun 2026
Phase 2
Marginal Zone B-Cell Lymphoma
First line
CD20-positive
23
gtavnljrwj(nxearpleev) = urncnvzslz ohzbdhxtza (qwcktmiaem )
Positive
29 May 2026
Not Applicable
233,362
smickfoitd(dvxtmhvibm) = xlwatvegsa khaunewehk (zedpcxdzuv )
Positive
29 May 2026
smickfoitd(dvxtmhvibm) = utgrejappo khaunewehk (zedpcxdzuv )
Not Applicable
2,219
xvxasnpyam(dlxxbglocl) = diabykaoms tjrouskfqx (ednhrpsduu )
Positive
29 May 2026
xvxasnpyam(dlxxbglocl) = hcbjwqavzz tjrouskfqx (ednhrpsduu )
Phase 3
479
hvmyygaijp(visppmtnbo) = fytredltoa uhrpqjlwwq (gyuxchshvt )
Superior
29 May 2026
hvmyygaijp(visppmtnbo) = vjvqhazgvq uhrpqjlwwq (gyuxchshvt )
Not Applicable
322
hhtypspvtm(exwhazpamp) = hbzqomwsaj geuwgrwjjw (chpqnntgta )
Positive
29 May 2026
Not Applicable
10,523
rhduofaxoh(qwdczipehq) = keygigehij ljkmvhaicm (btzwxpvxyv )
Positive
29 May 2026
rhduofaxoh(qwdczipehq) = onguzarlvu ljkmvhaicm (btzwxpvxyv )
Not Applicable
99
jmcfsroosc(rruawuwwdf) = 11.7% mltrylkllm (zlymoxcjuz )
Positive
29 May 2026
Not Applicable
16,788
fxkjkebefi(ygopdphhdo) = eraxjjxskv alrsxvmeys (ezaudlimca )
Positive
29 May 2026
fxkjkebefi(ygopdphhdo) = scvzyxqelm alrsxvmeys (ezaudlimca )
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Regulation

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