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Iressa(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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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
respiratory tract diseasesD012140
Trade Name
FDA
EMA
Iressa (generic drugs available since 2022-09-23)
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
gefitinibANDA2023-05-31
iressaNew Drug Application2019-05-14
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
non-small-cell lung carcinoma—D002289—
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
326 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 carcinomaD002289246641712135
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Lung neoplasmsD008175C34.9082610—241
Breast neoplasmsD001943EFO_0003869C501231——24
Head and neck neoplasmsD0062587171—123
NeoplasmsD009369C80964——19
Colorectal neoplasmsD015179581——10
Squamous cell neoplasmsD018307142——7
Adenocarcinoma of lungD000077192—42—17
Brain neoplasmsD001932EFO_0003833C71—43—16
Urinary bladder neoplasmsD001749C67—31——4
Squamous cell carcinoma of head and neckD0000771951—1—13
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Esophageal neoplasmsD004938C1528———9
Prostatic neoplasmsD011471C6117———7
GlioblastomaD005909EFO_000051535———6
Ovarian neoplasmsD010051EFO_0003893C5615———5
Squamous cell carcinomaD00229412——14
Central nervous system neoplasmsD01654323———4
Pancreatic neoplasmsD010190EFO_0003860C2513———3
Kidney neoplasmsD007680EFO_0003865C64—3———3
Fallopian tube neoplasmsD00518513———3
Peritoneal neoplasmsD01053413———3
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LymphomaD008223C85.91————1
Healthy volunteers/patients—1————1
Therapeutic equivalencyD0138101————1
OsteosarcomaD0125161————1
RhabdomyosarcomaD0122081————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Gastrointestinal neoplasmsD005770C26.9————11
Molecular targeted therapyD058990————11
Thyroid neoplasmsD013964EFO_0003841————11
Basal cell carcinomaD002280————11
Adenoid cystic carcinomaD003528————11
Anaplastic thyroid carcinomaD065646————11
Papillary thyroid cancerD000077273————11
Tongue neoplasmsD014062EFO_0003871C02.9————11
Inverted papillomaD018308————11
Parathyroid neoplasmsD010282————11
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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)
Structure (InChI/SMILES or Protein Sequence)
COc1cc2ncnc(Nc3ccc(F)c(Cl)c3)c2cc1OCCCN1CCOCC1
Identifiers
PDB4I22
CAS-ID184475-35-2
RxCUI328134
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
1956
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
Q9UMG5
Mouse ortholog
Egfr (13649)
epidermal growth factor receptor (Q01279)
Alternate
No data
Variants
Clinical Variant
Identifier
Target mutation
Effect
Evaluation
Status
VCV000016609EGFR, 2573T>G, Leu858Argdrug response2021-03-241A
VCV000016613EGFR, 2369C>T, Thr790Metdrug response2021-03-242B
Financial
Iressa - AstraZeneca
$
€
£
₣
Mock data
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 38,195 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,571 adverse events reported
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