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capmatinib 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| tyrosine kinase inhibitors | 5392 | 1029712-80-8 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Capmatinib is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 0.80 | g | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 2 | Bocci G, Oprea TI, Benet LZ |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | ACVR2B,CAMK2D,EIF2AK3,ERBB2,FLT3,GRK2,PDK1,PDK2,PDK4,PIK3CA,PIK3CD,PIK3CG,PRKDC | 13 | |||
| kinase-selectivity-class | ACVR2A,ACVR2B,AURKA,AURKB,AURKC,AXL,BRAF,CAMK2D,CDK9,CLK4,DYRK1B,EIF2AK3,FLT3,IRAK1,MAP3K21,MAP4K1,MAP4K3,MAPK7,MARK4,MET,NTRK1,PDK1,PIK3CA,PIK3CD,PIK3CG,PRKDC,SIK2,SIK3,STK33,ULK1 | 30 | |||
| mdck-mdr1-bcrp-efflux | MDCK-MDR1-BCRP efflux ratio | 3.499 | High | 1 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| rat-kpuu-brain | Rat brain Kpuu | 0.070 | % | High | 1 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| May 6, 2020 | FDA | NOVARTIS PHARM | |
| June 29, 2020 | PMDA | Novartis Pharma K.K. | |
| June 20, 2022 | EMA | NOVARTIS EUROPHARM LIMITED |
FDA Adverse Event Reporting System (Female)
| 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 |
|---|---|---|---|---|---|---|
| Malignant neoplasm progression | 259.43 | 46.47 | 79 | 897 | 106791 | 90520680 |
| Oedema peripheral | 135.16 | 46.47 | 62 | 914 | 257853 | 90369618 |
| Death | 123.06 | 46.47 | 70 | 906 | 456481 | 90170990 |
| Non-small cell lung cancer | 54.59 | 46.47 | 12 | 964 | 4369 | 90623102 |
FDA Adverse Event Reporting System (Male)
| 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 |
|---|---|---|---|---|---|---|
| Oedema peripheral | 203.12 | 42.61 | 88 | 1002 | 135988 | 42484257 |
| Malignant neoplasm progression | 157.63 | 42.61 | 69 | 1021 | 108331 | 42511914 |
| Oedema | 71.55 | 42.61 | 32 | 1058 | 51969 | 42568276 |
| Death | 59.66 | 42.61 | 66 | 1024 | 471119 | 42149126 |
| Protein deficiency | 48.42 | 42.61 | 8 | 1082 | 264 | 42619981 |
| Non-small cell lung cancer | 47.35 | 42.61 | 13 | 1077 | 4961 | 42615284 |
FDA Adverse Event Reporting System (Geriatric)
| 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 |
|---|---|---|---|---|---|---|
| Malignant neoplasm progression | 300.52 | 36.14 | 102 | 1222 | 174465 | 110413510 |
| Oedema peripheral | 179.53 | 36.14 | 84 | 1240 | 328576 | 110259399 |
| Non-small cell lung cancer | 92.63 | 36.14 | 21 | 1303 | 7914 | 110580061 |
| Death | 79.96 | 36.14 | 66 | 1258 | 698803 | 109889172 |
| Oedema | 52.25 | 36.14 | 32 | 1292 | 209944 | 110378031 |
| Generalised oedema | 44.83 | 36.14 | 16 | 1308 | 30688 | 110557287 |
| Blood creatinine increased | 43.25 | 36.14 | 27 | 1297 | 182862 | 110405113 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | L01EP01 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS PROTEIN KINASE INHIBITORS Cellular-mesenchymal-epithelial transition factor (c-MET) kinase inhibitors |
| FDA EPC | N0000175605 | Kinase Inhibitor |
| FDA MoA | N0000182138 | Cytochrome P450 1A2 Inhibitors |
| FDA MoA | N0000185503 | P-Glycoprotein Inhibitors |
| FDA MoA | N0000190113 | Breast Cancer Resistance Protein Inhibitors |
| FDA MoA | N0000191423 | Multidrug and Toxin Extrusion Transporter 1 Inhibitors |
| FDA MoA | N0000193929 | Mesenchymal Epithelial Transition Inhibitors |
| FDA MoA | N0000193932 | Multidrug and Toxin Extrusion Transporter 2 K Inhibitors |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| CHEBI has role | CHEBI:50908 | hepatotoxic agent |
| CHEBI has role | CHEBI:68495 | apoptosis inducer |
| CHEBI has role | CHEBI:90199 | c-Met tyrosine kinase inhibitor |
Related Drugs by ATC class:
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Metastatic non-small cell lung cancer | indication |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
None
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| EQ 150MG BASE | TABRECTA | NOVARTIS PHARM | N213591 | May 6, 2020 | RX | TABLET | ORAL | 12084449 | Nov. 19, 2027 | USE FOR THE TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH A MESENCHYMAL-EPITHELIAL TRANSITION (MET) EXON 14 SKIPPING MUTATION |
| EQ 200MG BASE | TABRECTA | NOVARTIS PHARM | N213591 | May 6, 2020 | RX | TABLET | ORAL | 12084449 | Nov. 19, 2027 | USE FOR THE TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH A MESENCHYMAL-EPITHELIAL TRANSITION (MET) EXON 14 SKIPPING MUTATION |
| EQ 150MG BASE | TABRECTA | NOVARTIS PHARM | N213591 | May 6, 2020 | RX | TABLET | ORAL | 8901123 | May 20, 2029 | USE FOR THE TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH A MESENCHYMAL-EPITHELIAL TRANSITION (MET) EXON 14 SKIPPING MUTATION |
| EQ 200MG BASE | TABRECTA | NOVARTIS PHARM | N213591 | May 6, 2020 | RX | TABLET | ORAL | 8901123 | May 20, 2029 | USE FOR THE TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH A MESENCHYMAL-EPITHELIAL TRANSITION (MET) EXON 14 SKIPPING MUTATION |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| EQ 150MG BASE | TABRECTA | NOVARTIS PHARM | N213591 | May 6, 2020 | RX | TABLET | ORAL | May 6, 2027 | INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS HAVE A MUTATION THAT LEADS TO MESENCHYMAL-EPITHELIAL TRANSITION (MET) EXON 14 SKIPPING AS DETECTED BY AN FDA-APPROVED TEST |
| EQ 200MG BASE | TABRECTA | NOVARTIS PHARM | N213591 | May 6, 2020 | RX | TABLET | ORAL | May 6, 2027 | INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS HAVE A MUTATION THAT LEADS TO MESENCHYMAL-EPITHELIAL TRANSITION (MET) EXON 14 SKIPPING AS DETECTED BY AN FDA-APPROVED TEST |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Hepatocyte growth factor receptor | Kinase | INHIBITOR | IC50 | 9.88 | SCIENTIFIC LITERATURE | DRUG LABEL | |||
| Cyclin-dependent kinase-like 5 | Kinase | Kd | 5.69 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| D10696 | KEGG_DRUG |
| TY34L4F9OZ | UNII |
| 1865733-40-9 | SECONDARY_CAS_RN |
| 4039388 | VANDF |
| C4053698 | UMLSCUI |
| CHEMBL3188267 | ChEMBL_ID |
| 25145656 | PUBCHEM_CID |
| DB11791 | DRUGBANK_ID |
| CHEMBL3989937 | ChEMBL_ID |
| 9948 | INN_ID |
| C000613976 | MESH_SUPPLEMENTAL_RECORD_UI |
| 7904 | IUPHAR_LIGAND_ID |
| 267901000202109 | SNOMEDCT_US |
| 874907006 | SNOMEDCT_US |
| 876837000 | SNOMEDCT_US |
| CHEBI:756426 | CHEBI |
| A1JRF | PDB_CHEM_ID |
| 334138 | MMSL |
| 38424 | MMSL |
| d09556 | MMSL |
| 018358 | NDDF |
| 018359 | NDDF |
| 2362165 | RXNORM |
| TY34L4F9OZ | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| TABRECTA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0078-0709 | TABLET, FILM COATED | 150 mg | ORAL | NDA | 29 sections |
| TABRECTA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0078-0716 | TABLET, FILM COATED | 200 mg | ORAL | NDA | 29 sections |