Quizartinib
As of the edition of 20 October 2026, Quizartinib is a small molecule: marketed, first approved in 2023 (US); acts on CSF1R, FLT3 and KIT and 3 more; US protection ends in 2030.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2023
- Kind
- Small molecule
- Brand name
- Vanflyta
- First approved
- 20 July 2023 (US)
- Approvals on record
- 3 in 2 regions
- Holder of the most recent approval
- Daiichi Sankyo; 2 holders in all
- Registered trials
- 42, 4 stopped early
- Disease areas
- Blood and lymph; Cancer; Immune system
US protection
US protection ends in 2030.
The last listed US exclusivity ends in 2030. 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 product8 listings count 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
3 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product3 company-target rows are on route B because of Quizartinib.
See the 3 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
| Gene | Protein | UniProt |
|---|---|---|
| CSF1R | Macrophage colony-stimulating factor 1 receptor | P07333 |
| RET | Proto-oncogene tyrosine-protein kinase receptor Ret | P07949 |
| PDGFRB | Platelet-derived growth factor receptor beta | P09619 |
| KIT | Mast/stem cell growth factor receptor Kit | P10721 |
| PDGFRA | Platelet-derived growth factor receptor alpha | P16234 |
| FLT3 | Receptor-type tyrosine-protein kinase FLT3 | P36888 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 1 | 0 | 0 |
| Phase 1 | 17 | 13 | 3 | 1 |
| Phase 2 | 18 | 6 | 8 | 2 |
| Phase 3 | 5 | 2 | 2 | 1 |
| All trials | 42 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Daiichi Sankyo | Originator, Applicant and Lead sponsor of trials | 2016 to now |