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tepotinib 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| tyrosine kinase inhibitors | 5424 | 1100598-32-0 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Tepotinib is a MET (mesenchymal-epithelial transition factor) tyrosine kinase inhibitor being developed for the treatment of solid tumours. It selectively binds to MET and inhibits MET phosphorylation disrupting the oncogenic MET receptor signalling caused by MET gene alterations, including both MET exon 14 (METex14) skipping alterations and MET protein overexpression. This results in cell death in tumour cells overexpressing MET protein or expressing constitutively activated MET protein.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 0.45 | g | O |
ADMET properties:
None
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| azlogd74 | LogD at pH 7.4 | 2.413 | High | 1 | |
| caco2-efflux | Caco-2 efflux ratio (BA/AB) | 4.487 | High | 1 | |
| caco2-intrinsic-papp | Caco-2 intrinsic apparent permeability | 7.516 | 10^-6 cm/s | High | 1 |
| dh-clint | Dog hepatocyte intrinsic clearance | 20.606 | uL/min/10^6 cells | High | 1 |
| dppb | Dog plasma protein binding (% unbound) | 5.520 | % | High | 1 |
| fcs-ppb | Fetal calf serum protein binding (% unbound) | 16.250 | % | High | 1 |
| herg | hERG pIC50 | 5.870 | pIC50 | High | 1 |
| hh-clint | Human hepatocyte intrinsic clearance | 4.853 | uL/min/10^6 cells | High | 1 |
| hlm-clint | Human liver microsomal intrinsic clearance | 46.881 | uL/min/mg protein | High | 1 |
| hppb | Human plasma protein binding (% unbound) | 3.750 | % | High | 1 |
| kinase-safety-class | ACVR2B,AXL,CAMK2D,EIF2AK3,GRK2,ITK,MET,PDK1,PDK2,PDK4,PRKDC | 11 | |||
| kinase-selectivity-class | CAMK2D,EIF2AK3,MET | 3 | |||
| mdck-mdr1-efflux | MDCK-MDR1 efflux ratio | 12.417 | High | 1 | |
| mh-clint | Mouse hepatocyte intrinsic clearance | 29.923 | High | 1 | |
| mppb | Mouse plasma protein binding (% unbound) | 3.910 | High | 1 | |
| nih-mdck-mdr1-efflux | NIH MDCK-MDR1 efflux ratio | 52 | High | 1 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| pppb | Pig plasma protein binding (% unbound) | 9.150 | % | High | 1 |
| rat-kpuu-brain | Rat brain Kpuu | 0.019 | % | High | 1 |
| rh-clint | Rat hepatocyte intrinsic clearance | 26.002 | uL/min/10^6 cells | High | 1 |
| rh-fuinc | Rat hepatocyte fraction unbound in incubation | 19.970 | % | High | 1 |
| rppb | Rat plasma protein binding (% unbound) | 3.630 | % | High | 1 |
| solubility-dd | Solubility at pH 7.4 in DMSO | 61.660 | uM | High | 1 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| March 25, 2020 | PMDA | Merck KGaA | |
| Feb. 3, 2021 | FDA | EMD SERONO INC | |
| Feb. 16, 2022 | EMA | Merck Europe B.V. |
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 |
|---|---|---|---|---|---|---|
| Oedema peripheral | 106.49 | 69.08 | 39 | 317 | 257876 | 90370215 |
| Death | 78.60 | 69.08 | 37 | 319 | 456514 | 90171577 |
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 | 102.69 | 68.75 | 39 | 312 | 136037 | 42484947 |
| Renal impairment | 73.52 | 68.75 | 29 | 322 | 110199 | 42510785 |
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 |
|---|---|---|---|---|---|---|
| Oedema peripheral | 146.88 | 63.19 | 59 | 595 | 328601 | 110260044 |
| Renal impairment | 124.05 | 63.19 | 45 | 609 | 188400 | 110400245 |
| Oedema | 73.95 | 63.19 | 32 | 622 | 209944 | 110378701 |
| Disease progression | 72.50 | 63.19 | 33 | 621 | 244001 | 110344644 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | L01EP02 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS PROTEIN KINASE INHIBITORS Cellular-mesenchymal-epithelial transition factor (c-MET) kinase inhibitors |
| MeSH PA | D000970 | Antineoplastic Agents |
| FDA EPC | N0000175605 | Kinase Inhibitor |
| FDA MoA | N0000185503 | P-Glycoprotein Inhibitors |
| FDA MoA | N0000193929 | Mesenchymal Epithelial Transition Inhibitors |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
Related Drugs by ATC class:
L01EP Cellular-mesenchymal-epithelial transition factor (c-MET) kinase inhibitors 1 drug
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Non-small cell lung cancer | indication | 254637007 | DOID:3908 |
| 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 225MG BASE | TEPMETKO | EMD SERONO INC | N214096 | Feb. 3, 2021 | RX | TABLET | ORAL | 8658643 | July 4, 2028 | TREATING A SOLID TUMOR, INCLUDING LUNG CANCER, WITH A MET ALTERATION(S), OR STABILIZING OR IMPROVING SYMPTOMS ASSOCIATED WITH HAVING A SOLID TUMOR, INCLUDING LUNG CANCER, WITH A MET ALTERATION(S), BY ADMINISTERING AN EFFECTIVE AMOUNT OF TEPOTINIB |
| EQ 225MG BASE | TEPMETKO | EMD SERONO INC | N214096 | Feb. 3, 2021 | RX | TABLET | ORAL | 9403799 | July 4, 2028 | TREATING A SOLID TUMOR, INCLUDING LUNG CANCER, WITH A MET ALTERATION(S), OR STABILIZING OR IMPROVING SYMPTOMS ASSOCIATED WITH HAVING A SOLID TUMOR, INCLUDING LUNG CANCER, WITH A MET ALTERATION(S), BY ADMINISTERING AN EFFECTIVE AMOUNT OF TEPOTINIB |
| EQ 225MG BASE | TEPMETKO | EMD SERONO INC | N214096 | Feb. 3, 2021 | RX | TABLET | ORAL | 8927540 | July 21, 2028 | TREATING A SOLID TUMOR, INCLUDING LUNG CANCER, HAVING A MET KINASE ALTERATION(S) BY ADMINISTERING AN EFFECTIVE AMOUNT OF TEPOTINIB |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| EQ 225MG BASE | TEPMETKO | EMD SERONO INC | N214096 | Feb. 3, 2021 | RX | TABLET | ORAL | Feb. 3, 2026 | NEW CHEMICAL ENTITY |
| EQ 225MG BASE | TEPMETKO | EMD SERONO INC | N214096 | Feb. 3, 2021 | RX | TABLET | ORAL | Feb. 3, 2028 | TREATMENT OF ADULT PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) HARBORING MESENCHYMAL-EPITHELIAL TRANSITION (MET) EXON 14 SKIPPING ALTERATIONS |
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 | 8.77 | SCIENTIFIC LITERATURE | SCIENTIFIC LITERATURE | |||
| Ribosyldihydronicotinamide dehydrogenase [quinone] | Enzyme | Kd | 6.06 | CHEMBL | |||||
| Interleukin-1 receptor-associated kinase 4 | Kinase | INHIBITOR | IC50 | 6.21 | SCIENTIFIC LITERATURE |
External reference:
| ID | Source |
|---|---|
| D11073 | KEGG_DRUG |
| 1IJV77EI07 | UNII |
| 1946826-82-9 | SECONDARY_CAS_RN |
| C4287799 | UMLSCUI |
| CHEBI:755350 | CHEBI |
| 3E8 | PDB_CHEM_ID |
| CHEMBL3402762 | ChEMBL_ID |
| 25171648 | PUBCHEM_CID |
| DB15133 | DRUGBANK_ID |
| CHEMBL4594292 | ChEMBL_ID |
| 9934 | INN_ID |
| C000707607 | MESH_SUPPLEMENTAL_RECORD_UI |
| C582858 | MESH_SUPPLEMENTAL_RECORD_UI |
| 8293 | IUPHAR_LIGAND_ID |
| 1148537007 | SNOMEDCT_US |
| 1148545002 | SNOMEDCT_US |
| 1148549008 | SNOMEDCT_US |
| 4040036 | VANDF |
| 4040037 | VANDF |
| 343294 | MMSL |
| 39305 | MMSL |
| d09709 | MMSL |
| 018627 | NDDF |
| 018628 | NDDF |
| 2477103 | RXNORM |
| 1IJV77EI07 | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| TEPMETKO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 44087-5000 | TABLET | 225 mg | ORAL | NDA | 31 sections |