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Drug ReportsErlotinib
Tarceva(erlotinib)
Erlotinib, Tarceva (erlotinib) is a small molecule pharmaceutical. Erlotinib was first approved as Tarceva on 2004-11-18. It is used to treat non-small-cell lung carcinoma in the USA. It has been approved in Europe to treat non-small-cell lung carcinoma and pancreatic neoplasms. The pharmaceutical is active against epidermal growth factor receptor. In addition, it is known to target solute carrier organic anion transporter family member 2B1.
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YTD
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2Y
5Y
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
digestive system diseasesD004066
respiratory tract diseasesD012140
endocrine system diseasesD004700
Trade Name
FDA
EMA
Erlotinib (discontinued: Erlotinib, Tarceva)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Erlotinib hydrochloride
Tradename
Company
Number
Date
Products
TARCEVAOSI PharmaceuticalsN-021743 DISCN2004-11-18
3 products, RLD
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Labels
FDA
EMA
Brand Name
Status
Last Update
erlotinibANDA2024-11-28
erlotinib hydrochlorideANDA2024-06-10
tarcevaNew Drug Application2018-12-12
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
non-small-cell lung carcinomaD002289
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
L01: Antineoplastic agents
L01E: Protein kinase inhibitors, antineoplastic and immunomodulating agents
L01EB: Epidermal growth factor receptor (egfr) tyrosine kinase inhibitors
L01EB02: Erlotinib
HCPCS
No data
Clinical
Clinical Trials
869 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-small-cell lung carcinomaD00228996233691349416
Lung neoplasmsD008175C34.9084202521050358
NeoplasmsD009369C806838519113
Pancreatic neoplasmsD010190EFO_0003860C25315371388
CarcinomaD002277C80.02953101484
AdenocarcinomaD000230173533554
Adenocarcinoma of lungD00007719271922328
Neoplasm metastasisD009362EFO_000970831661126
Renal cell carcinomaD002292EFO_0000376513116
ExanthemaD00507641117
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Indications Phases 3
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
RecurrenceD0120081728238
Breast neoplasmsD001943EFO_0003869C50919127
GlioblastomaD005909EFO_000051591721
GliomaD005910EFO_00005201010118
GliosarcomaD01831661114
Laryngeal neoplasmsD007822EFO_0003817C329812
Nasopharyngeal carcinomaD0000772747811
Oropharyngeal neoplasmsD0099598711
Laryngeal diseasesD007818J38.78711
Salivary gland neoplasmsD012468EFO_0003826D117510
Show 133 more
Indications Phases 1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Acute diseaseD00020811
PainD010146EFO_0003843R5211
Germ-line mutationD01809511
Multiple primary neoplasmsD00937811
Eye abnormalitiesD005124Q15.911
PneumoniaD011014EFO_0003106J1811
Interstitial lung diseasesD017563EFO_0004244J84.911
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameErlotinib
INNerlotinib
Description
Erlotinib is a quinazoline compound having a (3-ethynylphenyl)amino group at the 4-position and two 2-methoxyethoxy groups at the 6- and 7-positions. It has a role as an antineoplastic agent, a protein kinase inhibitor and an epidermal growth factor receptor antagonist. It is a member of quinazolines, a terminal acetylenic compound, an aromatic ether and a secondary amino compound.
Classification
Small molecule
Drug classtyrosine kinase inhibitors
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Structure (InChI/SMILES or Protein Sequence)
C#Cc1cccc(Nc2ncnc3cc(OCCOC)c(OCCOC)cc23)c1
Identifiers
PDB
CAS-ID183321-74-6
RxCUI
ChEMBL IDCHEMBL553
ChEBI ID114785
PubChem CID176870
DrugBankDB00530
UNII IDJ4T82NDH7E (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
SLCO2B1
SLCO2B1
Organism
Homo sapiens
Gene name
SLCO2B1
Gene synonyms
KIAA0880, OATP2B1, OATPB, SLC21A9
NCBI Gene ID
Protein name
solute carrier organic anion transporter family member 2B1
Protein synonyms
OATP-B, OATP-RP2, OATP2B1, OATPRP2, Organic anion transporter B, Organic anion transporter polypeptide-related protein 2, Organic anion transporting polypeptide 2B1, solute carrier family 21 (organic anion transporter), member 9, Solute carrier family 21 member 9
Uniprot ID
Mouse ortholog
Slco2b1 (101488)
solute carrier organic anion transporter family member 2B1 (Q8BXB6)
Variants
No data
Financial
Revenue by drug
$
£
Tarceva Roche
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 46,312 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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48,956 adverse events reported
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