Gilteritinib
As of the edition of 20 October 2026, Gilteritinib is a small molecule: marketed, first approved in 2018 (JP); acts on AXL and FLT3; US protection ends in 2032.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2020
- Kind
- Small molecule
- Brand name
- Xospata
- First approved
- 21 September 2018 (JP)
- Approvals on record
- 6 in 5 regions
- Holder of the most recent approval
- Astellas; 3 holders in all
- Registered trials
- 66, 7 stopped early
- Disease areas
- Cancer; Blood and lymph; Lungs and airways; Immune system; Heart and blood vessels; Infections
US protection
US protection ends in 2032.
The last listed US drug-substance patent ends in 2032. The application that gives this date is held by Astellas.
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 product1 listing counts towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
2 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product2 company-target rows are on route B because of Gilteritinib.
See the 2 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 10 | 2 | 3 | 0 |
| Phase 1 | 18 | 7 | 8 | 3 |
| Phase 2 | 27 | 6 | 17 | 4 |
| Phase 3 | 11 | 4 | 7 | 0 |
| All trials | 66 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Astellas | Applicant and Lead sponsor of trials | 2014 to now |