Gefitinib clinical trials
Gefitinib is named as an intervention in 7 current clinical trials in our China, Italy, USA, Germany, Spain, Canada, South Korea, France, Japan, Taiwan, Denmark, Singapore, UK, Turkey, Netherlands, Sweden, Norway, Belgium and Israel registers. 1 is recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Novartis Pharmaceuticals (2). The most-studied condition is Non-Small Cell Lung Cancer.
Where Gefitinib is approved
All regulators →Of the three regulators tracked here, the first to approve Gefitinib was the US, on 5 May 2003. It is approved in 3 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
What health systems spend on Gefitinib
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Gefitinib works
All drug targets →- Epidermal growth factor receptor erbB1 inhibitor InhibitorTarget: EGFR epidermal growth factor receptor✓ In ChEMBL and the Guide to Pharmacology
- AdenocarcinomaPhase 3
- Bladder transitional cell carcinomaPhase 3
- Head and neck cancerPhase 3
- Lung adenocarcinomaPhase 3
- Non-small cell squamous lung carcinomaPhase 3
- Colorectal carcinomaPhase 2/3
- FeverPhase 2
- Acute myeloid leukemiaPhase 2
- Breast cancerPhase 2
- Breast carcinomaPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL939, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 4941, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Gefitinib
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 3 technology appraisals of Gefitinib. 3 are current, and 2 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Erlotinib and gefitinib for treating non-small-cell lung cancer that has progressed after prior chemotherapy NICE TA374 | Optimised Not recommended | 16 Dec 2015 | Current |
| Gefitinib for the first-line treatment of locally advanced or metastatic non-small-cell lung cancer NICE TA192 | Recommended | 28 Jul 2010 | Current |
| Gefitinib for the second-line treatment of locally advanced or metastatic non-small-cell lung cancer (terminated appraisal) NICE TA175 | Terminated (no company submission) | 22 Jul 2009 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Gefitinib
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 1 product on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: IressaEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Gefitinib
- ATC code
- L01XE02
- ChEMBL
- CHEMBL939
- DrugBank
- DB00317
- PubChem CID
- 123631
- CAS number
- 184475-35-2
- FDA UNII
- S65743JHBS
- Wikidata
- Q417824
- Wikipedia
- Gefitinib
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Gefitinib
7 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Gefitinib across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
1 single-substance product containing Gefitinib on the HPRA medicines list.
- Iressa 250 mg film-coated tabletsAstraZeneca AB · EU/1/09/526/001-002
Supply shortages
No entry for Gefitinib in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Gefitinib
9 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Novartis Pharmaceuticals | 2 |
| Eli Lilly and Company | 1 |
| AstraZeneca | 1 |
| Allist Pharmaceuticals, Inc | 1 |
| Hunan Province Tumor Hospital | 1 |
| Dana-Farber Cancer Institute | 1 |
By country register
A trial with sites in more than one country appears in each of those registers.
Related compounds
Questions about Gefitinib trials
How many clinical trials are testing Gefitinib?
7 current trials in our China, Italy, USA, Germany, Spain, Canada, South Korea, France, Japan, Taiwan, Denmark, Singapore, UK, Turkey, Netherlands, Sweden, Norway, Belgium and Israel registers name Gefitinib as a drug or biological intervention, as of the registry sync on 8 November 2026. Completed and withdrawn studies are not counted.
Are Gefitinib trials recruiting patients?
Yes. 1 of the 7 trials is recruiting: 1 with sites in China. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Gefitinib clinical trials?
Novartis Pharmaceuticals (2), Eli Lilly and Company (1), AstraZeneca (1) and Allist Pharmaceuticals, Inc (1), among 6 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Gefitinib licensed in Ireland?
Yes. The HPRA medicines list includes 1 single-substance product containing Gefitinib, for example Iressa 250 mg film-coated tablets (AstraZeneca AB). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Gefitinib shortage?
Not in the lists we track: Gefitinib has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Gefitinib works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Gefitinib works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Gefitinib (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 8 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.