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AboutPricing
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 Application2025-09-24
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
mantle-cell lymphoma—D020522C83.1
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
199 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Waldenstrom macroglobulinemiaD008258—C88.015—117
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
B-cell chronic lymphocytic leukemiaD015451—C91.1383——12
LymphomaD008223—C85.9281——11
Mantle-cell lymphomaD020522—C83.1372——10
B-cell lymphomaD016393——352——9
B-cell lymphoma marginal zoneD018442—C88.4251——7
Follicular lymphomaD008224—C82161——7
Non-hodgkin lymphomaD008228—C85.9—21——3
LeukemiaD007938—C95—11——2
Lymphoid leukemiaD007945—C91—11——2
Membranous glomerulonephritisD015433EFO_0004254N03.2—11——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Large b-cell lymphoma diffuseD016403—C83.324———6
NeoplasmsD009369—C8032———4
RecurrenceD012008——22———3
Hematologic neoplasmsD019337——21———2
Covid-19D000086382—U07.1—1———1
ParaproteinemiasD010265—D47.2—1———1
PolyneuropathiesD011115EFO_0009562A69.22—1———1
Monoclonal gammopathy of undetermined significanceD008998EFO_1000836D47.2—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———6————6
Myelodysplastic syndromesD009190—D461————1
Myeloid leukemia acuteD015470—C92.01————1
Myelomonocytic leukemia chronicD015477—C93.11————1
T-cell lymphomaD016399——1————1
Myeloid leukemiaD007951—C921————1
Reactive arthritisD016918EFO_0007460M02.31————1
Indications Without Phase
No data
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
Image (chem structure or protein)Loading
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
695
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
Q32ML5
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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