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.
Download report
Favorite
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
Mock data
Subscribe for the real data
Subscribe for the real data
Commercial
Therapeutic Areas
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 |
|---|---|---|---|---|
| BRUKINSA | BeOne Medicines | N-218785 RX | 2025-06-10 | 1 products, RLD, RS |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| brukinsa | New Drug Application | 2026-09-04 |
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
236 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
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 | 12 | 34 | 6 | 1 | 4 | 51 |
| B-cell lymphoma | D016393 | — | — | 9 | 30 | 4 | 1 | 2 | 41 |
| Waldenstrom macroglobulinemia | D008258 | — | C88.0 | 3 | 13 | 1 | 2 | 7 | 23 |
| B-cell leukemia | D015448 | — | — | 1 | 4 | — | 1 | — | 5 |
| Lymphatic diseases | D008206 | — | — | 1 | 1 | — | 1 | — | 2 |
| Hemophagocytic lymphohistiocytosis | D051359 | — | D76.1 | — | — | — | 1 | — | 1 |
| Multiple myeloma | D009101 | — | C90.0 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | — | C85.9 | 8 | 44 | 4 | — | 10 | 62 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | 7 | 36 | 3 | — | — | 44 |
| Mantle-cell lymphoma | D020522 | — | C83.1 | 10 | 23 | 6 | — | 4 | 37 |
| Follicular lymphoma | D008224 | — | C82 | 6 | 20 | 1 | — | 3 | 26 |
| B-cell lymphoma marginal zone | D018442 | — | C88.4 | 7 | 12 | 2 | — | 5 | 22 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 5 | 7 | 3 | — | 1 | 14 |
| Leukemia | D007938 | — | C95 | 5 | 8 | 2 | — | — | 13 |
| Lymphoid leukemia | D007945 | — | C91 | 2 | 7 | 3 | — | 1 | 12 |
| Hodgkin disease | D006689 | — | C81 | — | 1 | 1 | — | — | 2 |
| Hematologic diseases | D006402 | EFO_0005803 | D75.9 | — | — | 1 | — | — | 1 |
Show 1 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 9 | 1 | — | — | — | 10 |
| Neoplasms | D009369 | — | C80 | 7 | 5 | — | — | 1 | 9 |
| Recurrence | D012008 | — | — | 4 | 6 | — | — | — | 8 |
| Thrombocytopenic purpura idiopathic | D016553 | EFO_0007160 | D69.3 | 1 | 4 | — | — | — | 5 |
| Thrombocytopenia | D013921 | HP_0001873 | D69.6 | — | 5 | — | — | — | 5 |
| Hematologic neoplasms | D019337 | — | — | 3 | 2 | — | — | 1 | 4 |
| Interdigitating dendritic cell sarcoma | D054739 | — | C96.4 | 2 | 3 | — | — | — | 3 |
| Hemolytic anemia autoimmune | D000744 | EFO_1001264 | D59.10 | — | 3 | — | — | — | 3 |
| Syndrome | D013577 | — | — | 1 | 1 | — | — | — | 2 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | 1 | 1 | — | — | 1 | 2 |
Show 30 more
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 |
| Reactive arthritis | D016918 | EFO_0007460 | M02.3 | 2 | — | — | — | — | 2 |
| Preleukemia | D011289 | — | — | 1 | — | — | — | — | 1 |
| Liver failure | D017093 | — | K72.9 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
| Burkitt lymphoma | D002051 | — | C83.7 | 1 | — | — | — | — | 1 |
| Precursor t-cell lymphoblastic leukemia-lymphoma | D054218 | — | — | 1 | — | — | — | — | 1 |
| Myelomonocytic leukemia chronic | D015477 | — | C93.1 | 1 | — | — | — | — | 1 |
Show 1 more
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 | — | — | — | — | 3 | 3 |
| Sudden death cardiac | D016757 | EFO_0004278 | — | — | — | — | — | 1 | 1 |
| Heart arrest | D006323 | EFO_0009492 | I46 | — | — | — | — | 1 | 1 |
| Supraventricular tachycardia | D013617 | — | I47.1 | — | — | — | — | 1 | 1 |
| Psoriasis | D011565 | EFO_0000676 | L40 | — | — | — | — | 1 | 1 |
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | — | — | — | — | 1 | 1 |
| Eczema | D004485 | — | L30.9 | — | — | — | — | 1 | 1 |
| Hidradenitis suppurativa | D017497 | — | L73.2 | — | — | — | — | 1 | 1 |
| Pruritus | D011537 | — | L29 | — | — | — | — | 1 | 1 |
| Mycosis fungoides | D009182 | — | C84.0 | — | — | — | — | 1 | 1 |
Show 10 more
Epidemiology
Epidemiological information for investigational and approved indications
View more details
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
Revenue by drug
$
€
£
₣
Brukinsa – BeOne Medicines
Mock data
Subscribe for the real data
Subscribe for the real data
Mock data
Subscribe for the real data
Subscribe for the real data
Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 2,788 documents
View more details
Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
3,750 adverse events reported
View more details
© 2020-2025 Collaborative Drug Discovery Inc. (CDD) | Terms of Use