Last update 14 Feb 2025

Zanubrutinib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
BRUKINSAPP, Zanubrutinib (USAN/INN), 赞布替尼
+ [4]
Target
Mechanism
BTK inhibitors(Tyrosine-protein kinase BTK inhibitors)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
US (14 Nov 2019),
RegulationBreakthrough Therapy (US), Fast Track (US), Accelerated Approval (US), Orphan Drug (US), Orphan Drug (EU), Priority Review (CN), Breakthrough Therapy (CN), Special Review Project (CN), Conditional marketing approval (CN)
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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
JP
27 Dec 2024
Follicular Lymphoma
TH
07 Feb 2024
Waldenstrom's macroglobulinaemia refractory
TH
07 Feb 2024
Recurrent Follicular Lymphoma
EU
17 Nov 2023
Recurrent Follicular Lymphoma
IS
17 Nov 2023
Recurrent Follicular Lymphoma
LI
17 Nov 2023
Recurrent Follicular Lymphoma
NO
17 Nov 2023
Marginal zone lymphoma recurrent
US
19 Jan 2023
Refractory Marginal Zone Lymphoma
BR
10 Nov 2022
Refractory Follicular Lymphoma
GB
06 Dec 2021
Marginal Zone B-Cell Lymphoma
UY
28 Apr 2021
Waldenstrom Macroglobulinemia
CA
30 Mar 2021
Chronic Lymphocytic Leukemia
CN
03 Jun 2020
Small Lymphocytic Lymphoma
CN
02 Jun 2020
Mantle-Cell Lymphoma
US
14 Nov 2019
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Glomerulonephritis, MembranousPhase 3
US
17 Apr 2023
Glomerulonephritis, MembranousPhase 3
CN
17 Apr 2023
Glomerulonephritis, MembranousPhase 3
CZ
17 Apr 2023
Glomerulonephritis, MembranousPhase 3
GB
17 Apr 2023
Idiopathic Membranous GlomerulonephritisPhase 3
US
17 Apr 2023
Idiopathic Membranous GlomerulonephritisPhase 3
CN
17 Apr 2023
Idiopathic Membranous GlomerulonephritisPhase 3
AR
17 Apr 2023
Idiopathic Membranous GlomerulonephritisPhase 3
BR
17 Apr 2023
Idiopathic Membranous GlomerulonephritisPhase 3
CA
17 Apr 2023
Idiopathic Membranous GlomerulonephritisPhase 3
CZ
17 Apr 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
Chronic Lymphocytic Leukemia
del(17p) | TP53 mutation
652
hvqwuoatsx(qfyggfjbmi) = no cardiac deaths were reported with zanubrutinib vs 6 cardiac deaths with ibrutinib efjumqmbwb (wntujsvkrt )
Positive
26 Dec 2024
Phase 1
112
vbdadbtprb(hvfcvpaaif) = neutropenia (41%), contusion (38%), COVID-19 (30%), and diarrhea (29%; 78% had grade 1 events). Neutropenia was the most common grade ≥3 TEAE (n=29, 26%). fsqzubxrfg (agjfdoossk )
Positive
09 Dec 2024
Phase 2
35
wouufhpoee(sdchsxbewq) = mbelgomfyi geaxpouyjp (xvuuqgiqpe )
Positive
09 Dec 2024
ASH2024
ManualManual
Phase 1
22
whrjiygosc(yoaoswncqq) = debawyuval ojrmbukhlo (icivitqoni )
Positive
09 Dec 2024
Not Applicable
-
ZR-CHOP
mxlmxaovow(iumgbvfela) = 92.9% of patients experienced any-grade treatment emergent adverse events (TEAEs), with the majority being hematological toxicities iyustiggju (klvwrfzumq )
-
09 Dec 2024
Not Applicable
-
xshkylzeov(tsvuglvevj) = Grade ≥3 treatment-emergent adverse events (TEAEs) occurred in 74% of patients; the most common TEAEs were neutrophil count decreased (58%), white blood cell count decreased (29%), and lymphocyte count decreased (20%). TEAEs led to treatment discontinuation in 7 patients (11%) and death in 2 patients (3%; cardiopulmonary failure, n=1; pneumonia, n=1; neither considered related to study treatment) pmzrnkstpf (myopgxrlct )
-
09 Dec 2024
Not Applicable
-
iokzgcpffp(yxxqnqofow) = mwtsrzhiky hnuxdpymot (njvazlvxjg )
-
09 Dec 2024
Not Applicable
-
memfncsemg(gtxxwfommz) = occurred in 84.1% of patients fykdbvvnfn (kkkbczjfvq )
-
08 Dec 2024
Zanubrutinib + Obinutuzumab
Not Applicable
-
Zanubrutinib plus Obinutuzumab
cmiijtiphu(dhfyclzfaf) = bzzonrmxiv abkoqnwdao (yyyakqflrr, 16.1 - NE)
-
08 Dec 2024
Obinutuzumab alone
cmiijtiphu(dhfyclzfaf) = kmidkcuaxj abkoqnwdao (yyyakqflrr, 6.5 - 13.8)
Phase 3
479
dybigytqsk(fvdpdhlvkv) = kcclmpgkyz ztzsgrexhs (fkbbpiqzbw )
Positive
08 Dec 2024
Bendamustine + Rituximab
dybigytqsk(fvdpdhlvkv) = bqfodvjlzp ztzsgrexhs (fkbbpiqzbw )
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