Iressa
(Gefitinib)ApprovedSmall molecule
AstraZenecaGefitinib is used to treat certain types of lung cancer, particularly in patients whose cancer cells have specific genetic mutations. It works by blocking a protein that helps cancer cells grow.[2] Iressa is currently approved and in use across 27 indications[4].[1]
Iressa is one of 449 small molecule programs targeting Germ Cell Tumor. It is currently in Approved.
27
Indications
251
Total Trials
8
Active Trials
448
Competitors
2
FDA Applications
NDA/BLA/ANDA regulatory filings
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 27 indications
Competition
Competitive Landscape
449 competitors in Non-Small Cell Lung Cancer
#DrugCompanyPhaseTrials
1Iressa
AstraZenecaApproved
Fludara
SanofiPhase 3
IL-2
FFate Therapeutics
Phase 3
JDQ443
NovartisPhase 3
Remeron
OOrganon and Co
Preclinical
Vibramycin
PPfizer's Upjohn has merged with Mylan to form Viatris Inc.
Preclinical
Valemetostat Tosylate
Daiichi SankyoPreclinical
Treatment
GSKPreclinical
Aqupla
Jiangsu Simcere Pharmaceutical Co., Ltd.Preclinical
Ftorafur
TThe First Affiliated Hospital with Nanjing Medical University
Preclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Non-Small Cell Lung Cancer43 trials
Show 40 more trials
Paclitaxel, Carboplatin, and Gefitinib in Treating Patients With Advanced Non-Small Cell Lung Cancer
Unknown status·—·Phase 2·NCT01024712·26 enrolled
Study of Gefitinib Retreatment in Non-Small Cell Lung Cancer (NSCLC)
Completed·—·Phase 2·NCT00824746·23 enrolled
High Dose Gefitinib for the Treatment of Carcinomatous Meningitis in Adult Patients With Non-Small Cell Lung Cancer and Known or Suspected EGFR Mutations
Completed·—·Phase 1·NCT00372515·7 enrolled
Breast Cancer10 trials
Gefitinib With or Without Tamoxifen in Treating Patients With Tamoxifen-Resistant Metastatic Breast Cancer
Completed·—·Phase 2·NCT00080743·2 enrolled
Show 7 more trials
Gefitinib, Trastuzumab, and Docetaxel in Treating Patients With Metastatic Breast Cancer
Completed·—·Phase 1/2·NCT00086957·31 enrolled
Gefitinib9 trials
First Line Gefitinib by FDG-PET Metabolic Response
Unknown status·—·Phase 2·NCT01510990·60 enrolled
Show 6 more trials
Lung Cancer9 trials
Show 6 more trials
Osimertinib and Gefitinib in EGFR Inhibitor naïve Advanced EGFR Mutant Lung Cancer
Active, not recruiting·—·Phase 1/2·NCT03122717·48 enrolled
Advanced NSCLC7 trials
75 more indications
Small Cell Lung Cancer6 trials
Lung Adenocarcinoma5 trials
Prostate Cancer4 trials
Esophageal Cancer4 trials
Kidney Cancer3 trials
First-line Treatment3 trials
Adenocarcinoma3 trials
Glioblastoma Multiforme3 trials
Chemotherapy3 trials
Skin Cancer2 trials
Locally Advanced or Metastatic NSCLC2 trials
Head and Neck2 trials
Bladder Cancer2 trials
Radiotherapy2 trials
Metastatic Colorectal Cancer2 trials
Metastatic Prostate Cancer2 trials
NSCLC2 trials
Growth2 trials
Adjuvant Treatment2 trials
EGFR Mutation2 trials
Gastric Cancer2 trials
Treatment2 trials
Colorectal Cancer2 trials
Squamous Cell Carcinoma2 trials
Refractory Solid Tumors2 trials
Head Neck Cancer2 trials
Anlotinib2 trials
Patients With Advanced Solid Tumors2 trials
Efficacy and Safety2 trials
Efficacy and Safety Study of Gefitinib in Squamous NSCLC Patients Who Failed First-Line Chemotherapy
Completed·—·Phase 2·NCT01485809·36 enrolled
Thyroid Cancer1 trial
Central Nervous System1 trial
Metastatic Head and Neck Cancer1 trial
Endometrial Cancer1 trial
Ductal Carcinoma in Situ1 trial
Pancreatic Cancer1 trial
Recurrent or Metastatic1 trial
Renal Cell Carcinoma1 trial
Colorectal Carcinoma1 trial
Metformin1 trial
Combination of Metformin With Gefitinib to Treat NSCLC
Completed·—·Phase 2·NCT01864681·224 enrolled
Fallopian Tube Cancer1 trial
CNS Tumors1 trial
Gefitinib in Treating Patients With Recurrent or Progressive CNS Tumors
Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT00025675·105 enrolled
Gallbladder Carcinoma1 trial
NSCLC Stage III1 trial
Hepatocellular Carcinoma1 trial
Radiation Therapy1 trial
Pancreatic Carcinoma1 trial
Glioma1 trial
Vinorelbine1 trial
GEfitinib Plus viNOrelbine in Advanced EGFR Mutated NSCLC. GENOA Trial
Unknown status·IIRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy·Phase 2·NCT02319577·80 enrolled
Non-squamous NSCLC1 trial
Leukemia1 trial
Study of Iressa in Patients With Relapsed or Refractory Acute Myelogenous Leukemia
Completed·—·Phase 2·NCT00130702·18 enrolled
Safety and Efficacy1 trial
Gastroesophageal Junction1 trial
Paclitaxel, Cisplatin, Gefitinib, and Radiation Therapy Followed by Surgery and Gefitinib in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction That Can Be Removed By Surgery
Terminated·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT00493025·19 enrolled
Osteosarcoma1 trial
Metastatic NSCLC1 trial
Metastatic Neuroendocrine Tumor1 trial
Synovial Sarcoma1 trial
Gefitinib in Treating Patients With Locally Advanced or Metastatic Synovial Sarcoma
Completed·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 2·NCT00052754·48 enrolled
Head and Neck Cancer1 trial
Regulatory
FDA Approval Timeline[5]
May 5, 2003
IRESSA
NDA NDA021399
Jul 13, 2015
IRESSA
NDA NDA206995
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Iressa drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Gefitinib. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]
Details
Drug Info
Quick Facts
- Mechanism of Action
- Epidermal Growth Factor Receptor Erbb1 Inhibitor[3]
- Modality
- Small molecule[3]
- Highest Phase
- Approved[1]
- Company