Last update 11 Jul 2024

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), Conditional marketing approval (CN), Special Review Project (CN)
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Structure

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
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
Marginal zone lymphoma refractory
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
BR
17 Apr 2023
Idiopathic Membranous GlomerulonephritisPhase 3
TR
17 Apr 2023
Idiopathic Membranous GlomerulonephritisPhase 3
GB
17 Apr 2023
Lymphoid LeukemiaPhase 3-11 Apr 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
42
Zanubrutinib plus rituximab (ZR)
ikdhszviha(ufyzllsaom) = opjsnaekfk awdfmiaslq (zhvkincmtc )
Positive
24 May 2024
Phase 2
71
evfbrcbjql(znxrtknbdp) = droujmaqut vcblicappr (culnlrlktp )
Positive
14 May 2024
evfbrcbjql(znxrtknbdp) = nvbpbjfgdq vcblicappr (culnlrlktp )
Phase 3
Chronic Lymphocytic Leukemia | Small Lymphocytic Lymphoma
First line
Loss of Chromosome 17p | TP53 Mutation
66
poyarcgpcm(aribomvsmo) = qrrnovqyoz ujomgfzhvz (yzmdvsgtig )
Positive
14 May 2024
Phase 2
42
Zanubrutinib + rituximab (ZR) +SHORT COURSE R-DHAOX
pnsjmokggw(uoamfvrhmu) = gajhlnygoa qkvzkyqasm (klbpztntrp )
Positive
14 May 2024
Phase 2
Primary Vitreoretinal Lymphoma
Maintenance
interleukin-10 concentration
-
gnavlpvcfz(kghxzoevif) = ifaemaujuv wtkadqywqu (oalyfomavx )
Positive
14 May 2024
Phase 2
-
Zanubrutinib+Rituximab
wzitpldxbv(abhbyoxlrx) = bwurjhelbc tcyxzpoyol (jablpyuxbl )
Positive
14 May 2024
Not Applicable
-
ukaybrsyez(nbkolhehde): OR = 2.05 (95% CI, 0.72 - 5.84), P-Value = 0.1798
Positive
14 May 2024
Phase 2
Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type
MYD88L265p mutation | CD79B mutation | MYD88L265p and CD79B double mutations ...
48
ZR-CHOP
wkdceseyxl(mlgkzmbbce) = ymthejmssw snnwesbrvq (rohxzzrytl )
Positive
14 May 2024
R-CHOP
wkdceseyxl(mlgkzmbbce) = wsusengjnw snnwesbrvq (rohxzzrytl )
Phase 2
-
Zanubrutinib plus Obinutuzumab (ZO)
pcmtduacxj(alhgxlsite) = swnvcsfovb dlvykgktgw (rlpaigvzyq, 16.1 - NE)
Positive
14 May 2024
Obinutuzumab (O)
pcmtduacxj(alhgxlsite) = ogeuyfkhxf dlvykgktgw (rlpaigvzyq, 6.5 - 13.8)
Phase 3
Chronic Lymphocytic Leukemia
del17p mutations | TP53 population
352
udghyvwdnx(xscvytegou): HR = 0.71 (95% CI, 0.39 - 1.28), P-Value = 0.2578
Positive
14 May 2024
Venetoclax+Ibrutinib
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