Gefitinib
As of the edition of 20 October 2026, Gefitinib is a small molecule: marketed, first approved in 2003 (US); acts on EGFR; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2009
- Kind
- Small molecule
- Brand name
- Iressa
- First approved
- 5 May 2003 (US)
- Approvals on record
- 6 in 5 regions
- Holder of the most recent approval
- AstraZeneca; 2 holders in all
- Withdrawn from market
- 27 September 2024 (in some regions)
- Registered trials
- 299, 36 stopped early
- Disease areas
- Cancer; Lungs and airways; Digestive system; Skin and connective tissue; Urinary and reproductive; Hormones
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Target
| Gene | Protein | UniProt |
|---|---|---|
| EGFR | Epidermal growth factor receptor | P00533 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 19 | 7 | 1 | 2 |
| Phase 1 | 36 | 27 | 2 | 3 |
| Phase 2 | 191 | 127 | 6 | 23 |
| Phase 3 | 47 | 21 | 1 | 6 |
| Phase 4 | 6 | 3 | 0 | 2 |
| All trials | 299 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| AstraZeneca | Originator, Later holder and Lead sponsor of trials | 2003 to now |