Pexidartinib
As of the edition of 20 October 2026, Pexidartinib is a small molecule: marketed, first approved in 2019 (US); acts on CSF1R, FLT3 and KIT; US protection ends in 2036.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2019
- Kind
- Small molecule
- Brand name
- Turalio
- First approved
- 2 August 2019 (US)
- Approvals on record
- 2 in 1 region
- Holder of the most recent approval
- Daiichi Sankyo
- Registered trials
- 30, 6 stopped early
- Disease areas
- Cancer; Bones, joints and muscles; Skin and connective tissue; Digestive system; Blood and lymph; Immune system
US protection
US protection ends in 2036.
The last listed US drug-substance patent ends in 2036. The application that gives this date is held by Daiichi Sankyo.
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 product14 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 14 listings behind itRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 1 | 1 | 0 |
| Phase 1 | 13 | 10 | 1 | 2 |
| Phase 2 | 12 | 7 | 1 | 4 |
| Phase 3 | 2 | 1 | 1 | 0 |
| Phase 4 | 1 | 1 | 0 | 0 |
| All trials | 30 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Daiichi Sankyo | Originator and Lead sponsor of trials | 2009 to now |