Fostamatinib
As of the edition of 20 October 2026, Fostamatinib is a small molecule: marketed, first approved in 2018 (US); acts on SYK; US protection ends in 2031.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2022
- Kind
- Small molecule
- Brand name
- Tavalisse
- First approved
- 17 April 2018 (US)
- Approvals on record
- 5 in 3 regions
- Holder of the most recent approval
- Kissei Pharmaceutical; 3 holders in all
- Registered trials
- 57, 13 stopped early
- Disease areas
- Immune system; Skin and connective tissue; Bones, joints and muscles; Blood and lymph; Cancer; Lungs and airways
US protection
US protection ends in 2031.
The last listed US drug-substance patent ends in 2031. The application that gives this date is held by Rigel Pharmaceuticals.
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 product10 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 10 listings behind itRequest access. Nothing is shown until you do.
Companies that need a new molecule because of this drug
3 companies on route B because of this drug.
Companies on route B for this drug
In the product3 companies are on route B because of Fostamatinib.
See the 3 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| SYK | Tyrosine-protein kinase SYK | P43405 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 5 | 2 | 1 | 1 |
| Phase 1 | 19 | 15 | 4 | 0 |
| Phase 2 | 22 | 10 | 2 | 10 |
| Phase 3 | 11 | 8 | 1 | 2 |
| All trials | 57 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Rigel Pharmaceuticals | Originator and Lead sponsor of trials | 2018 to now |
| Instituto Grifols | Applicant | 2020 to now |
| Kissei Pharmaceutical | Applicant and Lead sponsor of trials | 2022 to now |