NDAORALTABLET
Approved
Jul 2015
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
86
Data completeness
5/8 — Partial
IRESSA (gefitinib) by AstraZeneca is protein kinase inhibitors [moa]. Approved for non-small cell lung cancer. First approved in 2015.
Drug data last refreshed 1w ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
IRESSA (gefitinib) is an oral protein kinase inhibitor targeting epidermal growth factor receptor (EGFR) mutations in non-small cell lung cancer (NSCLC). It is a first-generation EGFR tyrosine kinase inhibitor that blocks intracellular signaling pathways driving tumor growth. This small-molecule tablet represents a foundational precision oncology approach now facing significant competition from next-generation kinase inhibitors.
Peak
Product is at peak commercial maturity with established market presence; team focus is on competitive defense and optimization rather than growth.
Mechanism of Action
Protein Kinase Inhibitors
Pharmacologic Class:
Kinase Inhibitor
Indications (1)
Clinical Trials (86)
ASK120067 Versus Gefitinib as First-line Treatment for EGFRm Locally Advanced or Metastatic NSCLC
Started Jul 2019
337 enrolled
Locally Advanced or Metastatic NSCLC
DS-1205c With Gefitinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer
Started Sep 2018
20 enrolled
Non Small Cell Lung Cancer
Phase III Study of Nazartinib (EGF816) Versus Erlotinib/Gefitinib in First-line Locally Advanced / Metastatic NSCLC With EGFR Activating Mutations
Started Jul 2018
0Carcinoma, Non-small Cell Lung
Gefitinib Combine Radiotherapy as Therapy for Patients With NSCLC Harbouring Sensitive Mutations of EGFR
Started Jun 2018
50 enrolled
Lung Cancer
A Study of EGF816 and Gefitinib in TKI-naïve EGFR-mutant Non-Small Cell Lung Cancer
Started Oct 2017
11 enrolled
Lung Cancer
Worked on IRESSA at AstraZeneca? Share your interview experience or compensation data (+7 days Pro)
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.