Stem definition | Drug id | CAS RN |
---|---|---|
agammaglobulinaemia tyrosine kinase (Bruton tyrosine kinase) inhibitors | 5353 | 1691249-45-2 |
Dose | Unit | Route |
---|---|---|
0.32 | g | O |
None
Date | Agency | Company | Orphan |
---|---|---|---|
Nov. 22, 2021 | EMA | BEIGENE IRELAND LTD | |
Nov. 14, 2019 | FDA | BEIGENE USA INC |
None
None
None
None
Source | Code | Description |
---|---|---|
ATC | L01EL03 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS PROTEIN KINASE INHIBITORS Bruton's tyrosine kinase (BTK) inhibitors |
MeSH PA | D000970 | Antineoplastic Agents |
MeSH PA | D004791 | Enzyme Inhibitors |
MeSH PA | D006401 | Hematologic Agents |
MeSH PA | D047428 | Protein Kinase Inhibitors |
FDA EPC | N0000175605 | Kinase Inhibitor |
FDA MoA | N0000193934 | Brutons Tyrosine Kinase Inhibitors |
Disease | Relation | SNOMED_ID | DOID |
---|---|---|---|
Waldenström macroglobulinemia | indication | 190818004 | DOID:0050747 |
Mantle cell lymphoma | indication | 443487006 |
None
None
Dissociation level | Dissociation constant | Type (acidic/basic) |
---|---|---|
pKa1 | 11.85 | acidic |
pKa2 | 2.64 | Basic |
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
---|---|---|---|---|---|---|---|---|---|---|
80MG | BRUKINSA | BEIGENE | N213217 | Nov. 14, 2019 | RX | CAPSULE | ORAL | 10570139 | April 22, 2034 | FOR THE TREATMENT OF PATIENTS WITH WALDENSTROMS MACROGLOBULINEMIA |
80MG | BRUKINSA | BEIGENE | N213217 | Nov. 14, 2019 | RX | CAPSULE | ORAL | 10570139 | April 22, 2034 | RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE PRIOR ANTI-CD20-BASED REGIMEN |
80MG | BRUKINSA | BEIGENE | N213217 | Nov. 14, 2019 | RX | CAPSULE | ORAL | 10570139 | April 22, 2034 | TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
80MG | BRUKINSA | BEIGENE | N213217 | Nov. 14, 2019 | RX | CAPSULE | ORAL | 11142528 | April 22, 2034 | FOR THE TREATMENT OF PATIENTS WITH WALDENSTROMS MACROGLOBULINEMIA |
80MG | BRUKINSA | BEIGENE | N213217 | Nov. 14, 2019 | RX | CAPSULE | ORAL | 11142528 | April 22, 2034 | RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE PRIOR ANTI-CD20-BASED REGIMEN |
80MG | BRUKINSA | BEIGENE | N213217 | Nov. 14, 2019 | RX | CAPSULE | ORAL | 11142528 | April 22, 2034 | TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
80MG | BRUKINSA | BEIGENE | N213217 | Nov. 14, 2019 | RX | CAPSULE | ORAL | 9447106 | April 22, 2034 | FOR THE TREATMENT OF PATIENTS WITH WALDENSTROMS MACROGLOBULINEMIA |
80MG | BRUKINSA | BEIGENE | N213217 | Nov. 14, 2019 | RX | CAPSULE | ORAL | 9447106 | April 22, 2034 | RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE PRIOR ANTI-CD20-BASED REGIMEN |
80MG | BRUKINSA | BEIGENE | N213217 | Nov. 14, 2019 | RX | CAPSULE | ORAL | 9447106 | April 22, 2034 | TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
---|---|---|---|---|---|---|---|---|---|
80MG | BRUKINSA | BEIGENE | N213217 | Nov. 14, 2019 | RX | CAPSULE | ORAL | Aug. 31, 2024 | TREATMENT OF ADULT PATIENTS WITH WALDENSTROM’S MACROGLOBULINEMIA (WM) |
80MG | BRUKINSA | BEIGENE | N213217 | Nov. 14, 2019 | RX | CAPSULE | ORAL | Sept. 14, 2024 | TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE ANTI-CD20-BASED REGIMEN |
80MG | BRUKINSA | BEIGENE | N213217 | Nov. 14, 2019 | RX | CAPSULE | ORAL | Nov. 14, 2024 | NEW CHEMICAL ENTITY |
80MG | BRUKINSA | BEIGENE | N213217 | Nov. 14, 2019 | RX | CAPSULE | ORAL | Nov. 14, 2026 | INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA (MCL) WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
80MG | BRUKINSA | BEIGENE | N213217 | Nov. 14, 2019 | RX | CAPSULE | ORAL | Aug. 31, 2028 | TREATMENT OF ADULT PATIENTS WITH WALDENSTR¿M’S MACROGLOBULINEMIA (WM) |
80MG | BRUKINSA | BEIGENE | N213217 | Nov. 14, 2019 | RX | CAPSULE | ORAL | Sept. 14, 2028 | TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE ANTI-CD20-BASED REGIMEN |
Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
---|---|---|---|---|---|---|---|---|---|
Tyrosine-protein kinase BTK | Kinase | INHIBITOR | IC50 | 9.52 | SCIENTIFIC LITERATURE | DRUG LABEL | |||
Platelet glycoprotein VI | Unclassified | IC50 | 6.29 | CHEMBL |
ID | Source |
---|---|
AG9MHG098Z | UNII |
C4683810 | UMLSCUI |
BA0 | PDB_CHEM_ID |
CHEMBL3936761 | ChEMBL_ID |
135565884 | PUBCHEM_CID |
DB15035 | DRUGBANK_ID |
D11422 | KEGG_DRUG |
9861 | IUPHAR_LIGAND_ID |
2262435 | RXNORM |
326780 | MMSL |
37672 | MMSL |
d09435 | MMSL |
830103007 | SNOMEDCT_US |
830162004 | SNOMEDCT_US |
4038969 | VANDF |
018195 | NDDF |
C000629551 | MESH_SUPPLEMENTAL_RECORD_UI |
10555 | INN_ID |
Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
---|---|---|---|---|---|---|---|---|
BRUKINSA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72579-011 | CAPSULE, GELATIN COATED | 80 mg | ORAL | NDA | 31 sections |
BRUKINSA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72579-011 | CAPSULE, GELATIN COATED | 80 mg | ORAL | NDA | 31 sections |