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Drug ReportsTEPOTINIB
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
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
respiratory tract diseasesD012140
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
TEPMETKOEMD SeronoN-214096 RX2021-02-03
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
tepmetkoNew Drug Application2024-02-23
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
TEPOTINIB HYDROCHLORIDE, TEPMETKO, EMD SERONO INC
2028-02-03ODE-325
2026-02-03NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Tepotinib Hydrochloride, Tepmetko, Emd Serono Inc
85807812030-03-19DS, DP
83296922029-10-30DS, DP
89275402028-07-21U-3078
86586432028-07-04U-3077
90620292028-07-04DP
94037992028-07-04U-3077
89213572028-05-30DS, DP
92843002028-04-29DP
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01E: Protein kinase inhibitors, antineoplastic and immunomodulating agents
— L01EX: Other protein kinase inhibitors in atc
— L01EX21: Tepotinib
HCPCS
No data
Clinical
Clinical Trials
28 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 carcinomaD002289——48———9
NeoplasmsD009369—C8034———7
Lung neoplasmsD008175HP_0100526C34.9013———3
CarcinomaD002277—C80.033———3
Hepatocellular carcinomaD006528—C22.022———2
Liver neoplasmsD008113EFO_1001513C22.022———2
Breast neoplasmsD001943EFO_0003869C50—1———1
Gastrointestinal neoplasmsD005770—C26.9—1———1
Colorectal neoplasmsD015179———1———1
AdenocarcinomaD000230———1———1
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———8————8
Liver diseasesD008107HP_0002910K70-K771————1
Hepatic insufficiencyD048550——1————1
Brain neoplasmsD001932EFO_0003833C711————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTEPOTINIB
INNtepotinib
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 classtyrosine kinase inhibitors
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CN1CCC(COc2cnc(-c3cccc(Cn4nc(-c5cccc(C#N)c5)ccc4=O)c3)nc2)CC1
Identifiers
PDB—
CAS-ID1100598-30-8
RxCUI—
ChEMBL IDCHEMBL3402762
ChEBI ID—
PubChem CID25171648
DrugBankDB15133
UNII ID1IJV77EI07 (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 (Q62125)
Alternate
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,195 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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470 adverse events reported
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