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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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
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 |
|---|---|---|---|---|
| BRUKINSA | BeOne Medicines | N-213217 RX | 2019-11-14 | 1 products, RLD, RS |
| BRUKINSA | BeOne Medicines | N-218785 RX | 2025-06-10 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| brukinsa | New Drug Application | 2025-04-08 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| mantle-cell lymphoma | — | D020522 | C83.1 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
ZANUBRUTINIB, BRUKINSA, BEIGENE | |||
| 2030-01-19 | ODE-274 | ||
| 2028-09-14 | ODE-370 | ||
| 2028-08-31 | ODE-371 | ||
| 2026-11-14 | ODE-276 | ||
| 2026-01-19 | I-817 | ||
| 2024-11-14 | NCE | ||
| 2024-09-14 | I-874 | ||
| 2024-08-31 | I-871 | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Zanubrutinib, Brukinsa, Beigene | |||
| 11786531 | 2043-01-19 | U-3715, U-3716, U-3717, U-3718, U-3719, U-3720 | |
| 11911386 | 2043-01-19 | U-3715, U-3716, U-3717, U-3718, U-3719, U-3720 | |
| 10927117 | 2037-08-15 | DS, DP | |
| 11591340 | 2037-08-15 | U-1745 , U-2145 , U-2537, U-2666 , U-3063 , U-3486 | |
| 11851437 | 2037-08-15 | DS, DP | |
| 11884674 | 2037-08-15 | U-1745, U-2145, U-2537, U-2666, U-3063, U-3486 | |
| 9447106 | 2034-04-22 | DS, DP | U-1745, U-2145, U-2537, U-2666, U-3063, U-3486 |
| 10570139 | 2034-04-22 | U-1745, U-2145, U-2537, U-2666, U-3063, U-3486 | |
| 11142528 | 2034-04-22 | DP | U-1745, U-2145, U-2537, U-2666, U-3063, U-3486 |
HCPCS
No data
Clinical
Clinical Trials
189 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 leukemia | D015451 | — | C91.1 | 10 | 26 | 4 | 1 | 3 | 39 |
| Lymphoid leukemia | D007945 | — | C91 | 7 | 20 | 4 | 1 | 3 | 32 |
| Leukemia | D007938 | — | C95 | 9 | 18 | 4 | 1 | 2 | 31 |
| Heart failure | D006333 | EFO_0003144 | I50 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | — | C85.9 | 17 | 78 | 12 | — | 10 | 111 |
| B-cell lymphoma | D016393 | — | — | 14 | 40 | 5 | — | 2 | 56 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | 8 | 37 | 3 | — | — | 46 |
| Mantle-cell lymphoma | D020522 | — | C83.1 | 8 | 18 | 5 | — | 2 | 29 |
| B-cell lymphoma marginal zone | D018442 | — | C88.4 | 7 | 9 | 2 | — | 2 | 17 |
| Waldenstrom macroglobulinemia | D008258 | — | C88.0 | 2 | 10 | 1 | — | 5 | 16 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 4 | 7 | 2 | — | 1 | 14 |
| Neoplasms | D009369 | — | C80 | 10 | 6 | 1 | — | — | 12 |
| Hodgkin disease | D006689 | — | C81 | — | 1 | 1 | — | — | 2 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | 1 | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Follicular lymphoma | D008224 | — | C82 | 4 | 15 | — | — | 2 | 19 |
| Healthy volunteers/patients | — | — | — | 8 | 1 | — | — | — | 9 |
| Thrombocytopenia | D013921 | HP_0001873 | D69.6 | — | 5 | — | — | — | 5 |
| Thrombocytopenic purpura idiopathic | D016553 | EFO_0007160 | D69.3 | — | 4 | — | — | — | 4 |
| Recurrence | D012008 | — | — | 1 | 3 | — | — | — | 4 |
| Syndrome | D013577 | — | — | 2 | 1 | — | — | — | 3 |
| Intraocular lymphoma | D064090 | — | — | — | 2 | — | — | 1 | 3 |
| Hemolytic anemia autoimmune | D000744 | EFO_1001264 | D59.10 | — | 3 | — | — | — | 3 |
| Hematologic neoplasms | D019337 | — | — | 2 | 1 | — | — | — | 2 |
| Therapeutics | D013812 | — | — | — | 2 | — | — | — | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myelodysplastic syndromes | D009190 | — | D46 | 2 | — | — | — | — | 2 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 2 | — | — | — | — | 2 |
| Myeloid leukemia | D007951 | — | C92 | 2 | — | — | — | — | 2 |
| Preleukemia | D011289 | — | — | 2 | — | — | — | — | 2 |
| Reactive arthritis | D016918 | EFO_0007460 | M02.3 | 2 | — | — | — | — | 2 |
| Liver failure | D017093 | — | K72.9 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
| Myeloproliferative disorders | D009196 | — | D47.1 | 1 | — | — | — | — | 1 |
| Myelomonocytic leukemia chronic | D015477 | — | C93.1 | 1 | — | — | — | — | 1 |
| T-cell lymphoma | D016399 | — | — | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | — | — | — | — | 2 | 2 |
| Cardiac arrhythmias | D001145 | EFO_0004269 | I49.9 | — | — | — | — | 1 | 1 |
| Heart arrest | D006323 | EFO_0009492 | I46 | — | — | — | — | 1 | 1 |
| Supraventricular tachycardia | D013617 | — | I47.1 | — | — | — | — | 1 | 1 |
| Mycoses | D009181 | — | B35-B49 | — | — | — | — | 1 | 1 |
| Psoriasis | D011565 | EFO_0000676 | L40 | — | — | — | — | 1 | 1 |
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | — | — | — | — | 1 | 1 |
| Hidradenitis suppurativa | D017497 | — | L73.2 | — | — | — | — | 1 | 1 |
| Mycosis fungoides | D009182 | — | C84.0 | — | — | — | — | 1 | 1 |
| T-cell lymphoma cutaneous | D016410 | — | C84.A | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Zanubrutinib |
| INN | zanubrutinib |
| 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 class | tyrosine kinase inhibitors: tyrosine kinase inhibitors Bruton's (Btk) inhibitors |
| Image (chem structure or protein) |  |
| 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-ID | 1651179-04-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL3936761 |
| ChEBI ID | — |
| PubChem CID | 135565884 |
| DrugBank | DB15035 |
| UNII ID | AG9MHG098Z (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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2,329 adverse events reported
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