Dasatinib anhydrous
As of the edition of 20 October 2026, Dasatinib anhydrous is a small molecule: marketed, first approved in 2006 (US); acts on ABL1, BLK and FGR and 9 more; US protection ended in 2026.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2024
- Kind
- Small molecule
- Brand name
- Sprycel
- First approved
- 28 June 2006 (US)
- Approvals on record
- 24 in 6 regions
- Holder of the most recent approval
- Zentiva k.s; 3 holders in all
- Registered trials
- 305, 62 stopped early
- Disease areas
- Cancer; Blood and lymph; Immune system; Skin and connective tissue; Digestive system; Lungs and airways
US protection
US protection ended in 2026.
The last listed US exclusivity ended in 2026.
Handa Therapeutics holds a later exclusivity on its own new formulation or combination product, ending 2026; it does not protect the original drug.
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 product18 listings count towards this date. The exact date and each listing are in the product.
Companies that need a new molecule because of this drug
12 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product12 company-target rows are on route B because of Dasatinib anhydrous.
Targets
| Gene | Protein | UniProt |
|---|---|---|
| ABL1 | Tyrosine-protein kinase ABL1 | P00519 |
| LCK | Tyrosine-protein kinase Lck | P06239 |
| FYN | Tyrosine-protein kinase Fyn | P06241 |
| YES1 | Tyrosine-protein kinase Yes | P07947 |
| LYN | Tyrosine-protein kinase Lyn | P07948 |
| HCK | Tyrosine-protein kinase HCK | P08631 |
| PDGFRB | Platelet-derived growth factor receptor beta | P09619 |
| FGR | Tyrosine-protein kinase Fgr | P09769 |
| SRC | Proto-oncogene tyrosine-protein kinase Src | P12931 |
| FRK | Tyrosine-protein kinase FRK | P42685 |
| BLK | Tyrosine-protein kinase Blk | P51451 |
| SRMS | Tyrosine-protein kinase Srms | Q9H3Y6 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 21 | 9 | 0 | 1 |
| Phase 1 | 81 | 48 | 11 | 22 |
| Phase 2 | 178 | 89 | 34 | 37 |
| Phase 3 | 18 | 10 | 5 | 2 |
| Phase 4 | 7 | 2 | 2 | 0 |
| All trials | 305 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bristol Myers Squibb | Originator and Lead sponsor of trials | 2005 to now |
| Handa Therapeutics | Acquired holder | 2025 to now |