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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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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 carcinomaD002289100248691250431
Lung neoplasmsD008175C34.907417441847307
NeoplasmsD009369C8068417111118
Pancreatic neoplasmsD010190EFO_0003860C25315371388
CarcinomaD002277C80.0153961456
AdenocarcinomaD000230112823440
Adenocarcinoma of lungD00007719282922439
Neoplasm metastasisD009362EFO_000970851861332
Renal cell carcinomaD002292EFO_0000376412114
ExanthemaD00507641117
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Brain neoplasmsD001932EFO_0003833C7113226137
Squamous cell carcinomaD00229415214336
Head and neck neoplasmsD00625816162131
Colorectal neoplasmsD0151795163123
Squamous cell carcinoma of head and neckD0000771951115123
Liver neoplasmsD008113EFO_1001513C22.0713118
Squamous cell neoplasmsD0183073113217
Hepatocellular carcinomaD006528C22.0411114
Rectal neoplasmsD01200486112
Esophageal neoplasmsD004938C1547112
Show 15 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
RecurrenceD0120081122229
Breast neoplasmsD001943EFO_0003869C50918126
GlioblastomaD005909EFO_000051591721
GliomaD005910EFO_0000520119118
GliosarcomaD01831661215
Bronchiolo-alveolar adenocarcinomaD002282112114
Central nervous system neoplasmsD01654346110
Salivary gland neoplasmsD012468EFO_0003826D11749
CholangiocarcinomaD018281C22.1459
Gallbladder neoplasmsD005706EFO_0004606C23358
Show 123 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Acute diseaseD00020811
Lymphoid leukemiaD007945C9111
Second primary neoplasmsD01660911
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
Image (chem structure or protein)Loading
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 47,058 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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49,114 adverse events reported
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