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Drug ReportsZanubrutinib
Brukinsa(zanubrutinib)
Brukinsa (zanubrutinib) is a small molecule pharmaceutical. Zanubrutinib was first approved as Brukinsa on 2019-11-14. It is used to treat mantle-cell lymphoma in the USA. It has been approved in Europe to treat waldenstrom macroglobulinemia. It is known to target tyrosine-protein kinase BTK.
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FDA Novel Drug Approvals 2019
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
cardiovascular diseasesD002318
hemic and lymphatic diseasesD006425
immune system diseasesD007154
Trade Name
FDA
EMA
Brukinsa (discontinued: Brukinsa)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Zanubrutinib
Tradename
Company
Number
Date
Products
BRUKINSABeOne MedicinesN-218785 RX2025-06-10
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
brukinsaNew Drug Application2025-07-30
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
mantle-cell lymphomaD020522C83.1
Agency Specific
FDA
EMA
Expiration
Code
ZANUBRUTINIB, BRUKINSA, BEIGENE
2030-01-19ODE-274
2028-09-14ODE-370
2028-08-31ODE-371
2026-11-14ODE-276
2026-01-19I-817
2024-11-14NCE
2024-09-14I-874
2024-08-31I-871
Patent Expiration
Patent
Expires
Flag
FDA Information
Zanubrutinib, Brukinsa, Beigene
117865312043-01-19U-3715, U-3716, U-3717, U-3718, U-3719, U-3720
119113862043-01-19U-3715, U-3716, U-3717, U-3718, U-3719, U-3720
109271172037-08-15DS, DP
115913402037-08-15U-1745 , U-2145 , U-2537, U-2666 , U-3063 , U-3486
118514372037-08-15DS, DP
118846742037-08-15U-1745, U-2145, U-2537, U-2666, U-3063, U-3486
94471062034-04-22DS, DPU-1745, U-2145, U-2537, U-2666, U-3063, U-3486
105701392034-04-22U-1745, U-2145, U-2537, U-2666, U-3063, U-3486
111425282034-04-22DPU-1745, U-2145, U-2537, U-2666, U-3063, U-3486
ATC Codes
L: Antineoplastic and immunomodulating agents
L01: Antineoplastic agents
L01E: Protein kinase inhibitors, antineoplastic and immunomodulating agents
L01EL: Bruton's tyrosine kinase (btk) inhibitors
L01EL03: Zanubrutinib
HCPCS
No data
Clinical
Clinical Trials
195 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
B-cell chronic lymphocytic leukemiaD015451C91.1112741340
Waldenstrom macroglobulinemiaD008258C88.031111619
B-cell leukemiaD0154481112
Lymphatic diseasesD0082061112
Heart failureD006333EFO_0003144I5011
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LymphomaD008223C85.9126151083
B-cell lymphomaD01639311364248
Large b-cell lymphoma diffuseD016403C83.3736344
Mantle-cell lymphomaD020522C83.19195331
Follicular lymphomaD008224C826171323
Lymphoid leukemiaD007945C914142119
B-cell lymphoma marginal zoneD018442C88.48112219
LeukemiaD007938C95612218
Non-hodgkin lymphomaD008228C85.9592115
NeoplasmsD009369C80851111
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
RecurrenceD012008569
Healthy volunteers/patients819
ThrombocytopeniaD013921HP_0001873D69.655
Thrombocytopenic purpura idiopathicD016553EFO_0007160D69.344
Hematologic neoplasmsD019337323
Hemolytic anemia autoimmuneD000744EFO_1001264D59.1033
SyndromeD013577112
Interdigitating dendritic cell sarcomaD054739C96.4222
ParaproteinemiasD010265D47.2122
TherapeuticsD01381222
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myelodysplastic syndromesD009190D4622
Myeloid leukemia acuteD015470C92.022
Myeloid leukemiaD007951C9222
Reactive arthritisD016918EFO_0007460M02.322
PreleukemiaD01128911
Liver failureD017093K72.911
Hepatic insufficiencyD04855011
Myelomonocytic leukemia chronicD015477C93.111
T-cell lymphomaD01639911
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Atrial fibrillationD001281EFO_0000275I48.022
Sudden death cardiacD016757EFO_000427811
Heart arrestD006323EFO_0009492I4611
Supraventricular tachycardiaD013617I47.111
PsoriasisD011565EFO_0000676L4011
Atopic dermatitisD003876EFO_0000274L2011
EczemaD004485L30.911
Hidradenitis suppurativaD017497L73.211
PruritusD011537L2911
Mycosis fungoidesD009182C84.011
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameZanubrutinib
INNzanubrutinib
Description
Zanubrutinib, sold under the brand name Brukinsa, is an anticancer medication used for the treatment of mantle cell lymphoma (MCL), Waldenström's macroglobulinemia (WM), marginal zone lymphoma (MZL), and chronic lymphocytic leukemia (CLL). Zanubrutinib is classified as a Bruton's tyrosine kinase (BTK) inhibitor. It is given by mouth.
Classification
Small molecule
Drug classtyrosine kinase inhibitors: tyrosine kinase inhibitors Bruton's (Btk) inhibitors
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Structure (InChI/SMILES or Protein Sequence)
C=CC(=O)N1CCC([C@@H]2CCNc3c(C(N)=O)c(-c4ccc(Oc5ccccc5)cc4)nn32)CC1
Identifiers
PDB
CAS-ID1651179-04-2
RxCUI
ChEMBL IDCHEMBL3936761
ChEBI ID
PubChem CID135565884
DrugBankDB15035
UNII IDAG9MHG098Z (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
BTK
BTK
Organism
Homo sapiens
Gene name
BTK
Gene synonyms
AGMX1, ATK, BPK
NCBI Gene ID
Protein name
tyrosine-protein kinase BTK
Protein synonyms
agammaglobulinaemia tyrosine kinase, Agammaglobulinemia tyrosine kinase, ATK, B-cell progenitor kinase, BPK, Bruton agammaglobulinemia tyrosine kinase, Bruton tyrosine kinase, Bruton's tyrosine kinase, dominant-negative kinase-deficient Brutons tyrosine kinase
Uniprot ID
Mouse ortholog
Btk (12229)
tyrosine-protein kinase BTK (Q61365)
Variants
No data
Financial
No data
Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2,610 adverse events reported
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