Stem definition | Drug id | CAS RN |
---|---|---|
tyrosine kinase inhibitors | 5390 | 1513857-77-6 |
Dose | Unit | Route |
---|---|---|
9 | mg | O |
None
Date | Agency | Company | Orphan |
---|---|---|---|
March 26, 2021 | EMA | Incyte Biosciences Distribution B.V. | |
April 17, 2020 | FDA | INCYTE CORP | |
March 23, 2021 | PMDA | Incyte Biosciences Japan GK |
None
MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
---|---|---|---|---|---|---|
Hospice care | 37.18 | 31.55 | 5 | 4 | 5063 | 29569455 |
None
None
Source | Code | Description |
---|---|---|
ATC | L01EN02 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS PROTEIN KINASE INHIBITORS Fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitors |
FDA MoA | N0000175082 | Kinase Inhibitors |
FDA EPC | N0000175605 | Kinase Inhibitor |
FDA MoA | N0000185503 | P-Glycoprotein Inhibitors |
FDA MoA | N0000187061 | Organic Cation Transporter 2 Inhibitors |
FDA MoA | N0000191423 | Multidrug and Toxin Extrusion Transporter 1 Inhibitors |
Disease | Relation | SNOMED_ID | DOID |
---|---|---|---|
Malignant neoplasm of common bile duct (& [carcinoma]) | indication | 187785004 | |
Biliary tract cancer | indication | 363415003 | DOID:4607 |
None
None
Dissociation level | Dissociation constant | Type (acidic/basic) |
---|---|---|
pKa1 | 4.44 | Basic |
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
---|---|---|---|---|---|---|---|---|---|---|
13.5MG | PEMAZYRE | INCYTE CORP | N213736 | April 17, 2020 | RX | TABLET | ORAL | 10131667 | June 12, 2033 | FOR THE TREATMENT OF PREVIOUSLY TREATED, UNRESECTABLE LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA WITH A FIBROBLAST GROWTH FACTOR RECEPTOR 2 (FGFR2) FUSION OR OTHER REARRANGEMENT |
4.5MG | PEMAZYRE | INCYTE CORP | N213736 | April 17, 2020 | RX | TABLET | ORAL | 10131667 | June 12, 2033 | FOR THE TREATMENT OF PREVIOUSLY TREATED, UNRESECTABLE LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA WITH A FIBROBLAST GROWTH FACTOR RECEPTOR 2 (FGFR2) FUSION OR OTHER REARRANGEMENT |
9MG | PEMAZYRE | INCYTE CORP | N213736 | April 17, 2020 | RX | TABLET | ORAL | 10131667 | June 12, 2033 | FOR THE TREATMENT OF PREVIOUSLY TREATED, UNRESECTABLE LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA WITH A FIBROBLAST GROWTH FACTOR RECEPTOR 2 (FGFR2) FUSION OR OTHER REARRANGEMENT |
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
---|---|---|---|---|---|---|---|---|---|
13.5MG | PEMAZYRE | INCYTE CORP | N213736 | April 17, 2020 | RX | TABLET | ORAL | April 17, 2025 | NEW CHEMICAL ENTITY |
4.5MG | PEMAZYRE | INCYTE CORP | N213736 | April 17, 2020 | RX | TABLET | ORAL | April 17, 2025 | NEW CHEMICAL ENTITY |
9MG | PEMAZYRE | INCYTE CORP | N213736 | April 17, 2020 | RX | TABLET | ORAL | April 17, 2025 | NEW CHEMICAL ENTITY |
13.5MG | PEMAZYRE | INCYTE CORP | N213736 | April 17, 2020 | RX | TABLET | ORAL | April 17, 2027 | INDICATED FOR THE TREATMENT OF ADULTS WITH PREVIOUSLY TREATED, UNRESECTABLE LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA WITH A FIBROBLAST GROWTH FACTOR RECEPTOR 2 (FGFR2) FUSION OR OTHER REARRANGEMENT AS DETECTED BY AN FDA-APPROVED TEST |
4.5MG | PEMAZYRE | INCYTE CORP | N213736 | April 17, 2020 | RX | TABLET | ORAL | April 17, 2027 | INDICATED FOR THE TREATMENT OF ADULTS WITH PREVIOUSLY TREATED, UNRESECTABLE LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA WITH A FIBROBLAST GROWTH FACTOR RECEPTOR 2 (FGFR2) FUSION OR OTHER REARRANGEMENT AS DETECTED BY AN FDA-APPROVED TEST |
9MG | PEMAZYRE | INCYTE CORP | N213736 | April 17, 2020 | RX | TABLET | ORAL | April 17, 2027 | INDICATED FOR THE TREATMENT OF ADULTS WITH PREVIOUSLY TREATED, UNRESECTABLE LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA WITH A FIBROBLAST GROWTH FACTOR RECEPTOR 2 (FGFR2) FUSION OR OTHER REARRANGEMENT AS DETECTED BY AN FDA-APPROVED TEST |
Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
---|---|---|---|---|---|---|---|---|---|
Fibroblast growth factor receptor 3 | Kinase | INHIBITOR | IC50 | 9 | SCIENTIFIC LITERATURE | DRUG LABEL | |||
Fibroblast growth factor receptor 1 | Kinase | INHIBITOR | IC50 | 9.40 | SCIENTIFIC LITERATURE | DRUG LABEL | |||
Fibroblast growth factor receptor 2 | Kinase | INHIBITOR | IC50 | 9.30 | SCIENTIFIC LITERATURE | DRUG LABEL | |||
Fibroblast growth factor receptor 4 | Kinase | INHIBITOR | IC50 | 7.52 | SCIENTIFIC LITERATURE |
ID | Source |
---|---|
Y6BX7BL23K | UNII |
C4724807 | UMLSCUI |
CHEMBL4297522 | ChEMBL_ID |
86705695 | PUBCHEM_CID |
DB15102 | DRUGBANK_ID |
D11417 | KEGG_DRUG |
9767 | IUPHAR_LIGAND_ID |
2359268 | RXNORM |
333127 | MMSL |
38333 | MMSL |
d09543 | MMSL |
871699001 | SNOMEDCT_US |
871709004 | SNOMEDCT_US |
4039347 | VANDF |
018334 | NDDF |
C000705477 | MESH_SUPPLEMENTAL_RECORD_UI |
10712 | INN_ID |
Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
---|---|---|---|---|---|---|---|---|
PEMAZYRE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50881-026 | TABLET | 4.50 mg | ORAL | NDA | 29 sections |
PEMAZYRE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50881-027 | TABLET | 9 mg | ORAL | NDA | 29 sections |
PEMAZYRE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50881-028 | TABLET | 13.50 mg | ORAL | NDA | 29 sections |