Axitinib
As of the edition of 20 October 2026, Axitinib is a small molecule: marketed, first approved in 2012 (US); acts on FLT1, FLT4 and KDR; US protection ends in 2030.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2012
- Kind
- Small molecule
- Brand name
- Inlyta
- First approved
- 27 January 2012 (US)
- Approvals on record
- 7 in 5 regions
- Holder of the most recent approval
- Pfizer; 3 holders in all
- Registered trials
- 192, 27 stopped early
- Disease areas
- Cancer; Urinary and reproductive; Pregnancy and women's health; Digestive system; Lungs and airways; Skin and connective tissue
US protection
US protection ends in 2030.
The last listed US drug-substance patent ends in 2030. The application that gives this date is held by Pfizer.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product2 listings count towards this date. The exact date and each listing are in the product.
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Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 22 | 15 | 2 | 1 |
| Phase 1 | 34 | 25 | 3 | 5 |
| Phase 2 | 124 | 61 | 31 | 20 |
| Phase 3 | 12 | 6 | 4 | 1 |
| All trials | 192 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Originator, Applicant and Lead sponsor of trials | 2002 to now |