Product Description
Gefitinib is a selective tyrosine kinase receptor inhibitor used in the therapy of non-small cell lung cancer. Gefitinib therapy is associated with transient elevations in serum aminotransferase levels and rare instances of clinically apparent acute liver injury. Gefitinib is an anilinoquinazoline with antineoplastic activity. Gefitinib inhibits the catalytic activity of numerous tyrosine kinases including the epidermal growth factor receptor (EGFR), which may result in inhibition of tyrosine kinase-dependent tumor growth. (Sourced from: https://pubchem.ncbi.nlm.nih.gov/compound/Gefitinib)
Mechanisms of Action: TK Inhibitor,EGFR Inhibitor,ERBB2 Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | China | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Morocco | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: None
Known Adverse Events: None
Company: AstraZeneca
Company Location: CAMBRIDGE X0 CB2 0AA
Company CEO: Pascal Soriot
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: China, Japan, Korea, United States
Active Clinical Trial Count: 9
Highest Development Phases
Phase 3: Non-Small-Cell Lung Cancer
Phase 2: Breast Cancer|Lung Cancer|Ovarian Cancer|Pancreatic Cancer|Prostate Cancer|Sarcoma
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| STUDY00026643 | P2 |
Not yet recruiting |
Ovarian Cancer|Prostate Cancer|Sarcoma|Breast Cancer|Pancreatic Cancer |
2027-12-31 |
|
| NCT03122717 | P2 |
Active, not recruiting |
Non-Small-Cell Lung Cancer |
2025-04-01 |
|
| NCT03292133 | P2 |
Active, not recruiting |
Lung Cancer |
2023-12-31 |
|
| CTR20200563 | P3 |
Recruiting |
Non-Small-Cell Lung Cancer |
None |