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AboutPricing
Drug ReportsGefitinib
Iressa(gefitinib)
Gefitinib, Iressa (gefitinib) is a small molecule pharmaceutical. Gefitinib was first approved as Iressa on 2003-05-05. 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. The pharmaceutical is active against epidermal growth factor receptor.
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Clinical
Drug
Target
Variants
Financial
Trends
Safety
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5D
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3M
6M
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
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
Gefitinib, Iressa (discontinued: Iressa)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Gefitinib
Tradename
Company
Number
Date
Products
IRESSAAstraZenecaN-206995 RX2015-07-13
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
gefitinibANDA2024-04-22
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
L01EB01: Gefitinib
HCPCS
Code
Description
J8565
Gefitinib, oral, 250 mg
Clinical
Clinical Trials
421 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 carcinomaD00228943108541032220
Lung neoplasmsD008175C34.90308534627164
CarcinomaD002277C80.081931631
NeoplasmsD009369C80111151431
AdenocarcinomaD0002301071321
Small cell lung carcinomaD05575222115
Indications Phases 3
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Prostatic neoplasmsD011471C61210111
GlioblastomaD005909EFO_0000515489
RecurrenceD012008527
Ovarian neoplasmsD010051EFO_0003893C56166
Pancreatic neoplasmsD010190EFO_0003860C25155
Kidney neoplasmsD007680EFO_0003865C6455
Central nervous system neoplasmsD016543234
Nervous system neoplasmsD009423234
Renal cell carcinomaD002292EFO_0000376144
Ovarian epithelial carcinomaD00007721644
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Disease progressionD018450112
Oropharyngeal neoplasmsD009959112
Laryngeal neoplasmsD007822EFO_0003817C32112
Laryngeal diseasesD007818J38.7112
LymphomaD008223C85.911
MalnutritionD044342EFO_0008572E40-E4611
Healthy volunteers/patients11
Therapeutic equivalencyD01381011
Meningeal carcinomatosisD055756EFO_100101211
MeningitisD008581EFO_0000584G0311
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Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.011
Acute diseaseD00020811
Lymphoid leukemiaD007945C9111
Germ-line mutationD01809511
Multiple primary neoplasmsD00937811
Molecular targeted therapyD05899011
Bronchial neoplasmsD001984EFO_100084911
Basal cell carcinomaD00228011
Adenoid cystic carcinomaD00352811
Anaplastic thyroid carcinomaD06564611
Show 16 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameGefitinib
INNgefitinib
Description
Gefitinib is a member of the class of quinazolines that is quinazoline which is substituted by a (3-chloro-4-fluorophenyl)nitrilo group, 3-(morpholin-4-yl)propoxy group and a methoxy group at positions 4,6 and 7, respectively. An EGFR kinase inhibitor used for the treatment of non-small cell lung cancer. It has a role as an epidermal growth factor receptor antagonist and an antineoplastic agent. It is an aromatic ether, a member of monochlorobenzenes, a member of monofluorobenzenes, a secondary amino compound, a tertiary amino compound, a member of quinazolines and a member of morpholines.
Classification
Small molecule
Drug classtyrosine kinase inhibitors
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
COc1cc2ncnc(Nc3ccc(F)c(Cl)c3)c2cc1OCCCN1CCOCC1
Identifiers
PDB
CAS-ID184475-35-2
RxCUI
ChEMBL IDCHEMBL939
ChEBI ID49668
PubChem CID123631
DrugBankDB00317
UNII IDS65743JHBS (ChemIDplus, GSRS)
Target
Agency Approved
EGFR
EGFR
Organism
Homo sapiens
Gene name
EGFR
Gene synonyms
ERBB, ERBB1, HER1
NCBI Gene ID
Protein name
epidermal growth factor receptor
Protein synonyms
avian erythroblastic leukemia viral (v-erb-b) oncogene homolog, cell growth inhibiting protein 40, cell proliferation-inducing protein 61, EGFR vIII, epidermal growth factor receptor tyrosine kinase domain, erb-b2 receptor tyrosine kinase 1, Proto-oncogene c-ErbB-1, Receptor tyrosine-protein kinase erbB-1
Uniprot ID
Mouse ortholog
Egfr (13649)
epidermal growth factor receptor (Q01279)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
£
Iressa AstraZeneca
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Estimated US medical usage
Gefitinib
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 46,920 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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10,737 adverse events reported
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