Tepmetko(tepotinib)
Tepmetko (tepotinib) is a small molecule pharmaceutical. Tepotinib was first approved as Tepmetko on 2021-02-03. It has been approved in Europe to treat non-small-cell lung carcinoma. The pharmaceutical is active against hepatocyte growth factor receptor.
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FDA Novel Drug Approvals 2021
Commercial
Trade Name
FDA
EMA
Tepmetko
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Tepotinib hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TEPMETKO | EMD Serono | N-214096 RX | 2021-02-03 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| tepmetko | New Drug Application | 2021-02-25 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
TEPOTINIB HYDROCHLORIDE, TEPMETKO, EMD SERONO INC | |||
| 2028-02-03 | ODE-325 | ||
| 2026-02-03 | NCE | ||
HCPCS
No data
Clinical
Clinical Trials
23 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Non-small-cell lung carcinoma | D002289 | 2 | 5 | — | — | — | 5 | ||
| Neoplasms | D009369 | C80 | 2 | 2 | — | — | — | 4 | |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 2 | 2 | — | — | — | 2 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 1 | — | — | — | 1 |
| Gastrointestinal neoplasms | D005770 | C26.9 | — | 1 | — | — | — | 1 | |
| Colorectal neoplasms | D015179 | — | 1 | — | — | — | 1 | ||
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 1 | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 8 | — | — | — | — | 8 | ||
| Hepatic insufficiency | D048550 | 1 | — | — | — | — | 1 | ||
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | TEPOTINIB |
| INN | tepotinib |
| Description | Tepotinib, sold under the brand name Tepmetko, is an anti-cancer medication used for the treatment of adults with non-small cell lung cancer (NSCLC).
|
| Classification | Small molecule |
| Drug class | tyrosine kinase inhibitors |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | CN1CCC(COc2cnc(-c3cccc(Cn4nc(-c5cccc(C#N)c5)ccc4=O)c3)nc2)CC1 |
Identifiers
| PDB | — |
| CAS-ID | 1100598-32-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL3402762 |
| ChEBI ID | — |
| PubChem CID | 25171648 |
| DrugBank | DB15133 |
| UNII ID | 1IJV77EI07 (ChemIDplus, GSRS) |
Target
Agency Approved
MET
MET
Organism
Homo sapiens
Gene name
MET
Gene synonyms
NCBI Gene ID
Protein name
hepatocyte growth factor receptor
Protein synonyms
HGF receptor, HGF/SF receptor, Proto-oncogene c-Met, Scatter factor receptor, SF receptor, Tyrosine-protein kinase Met
Uniprot ID
Mouse ortholog
Met (17295)
hepatocyte growth factor receptor (P16056)
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 718 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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81,034 adverse events reported
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