Sunitinib
As of the edition of 20 October 2026, Sunitinib is a small molecule: marketed, first approved in 2006 (US); acts on FLT1, FLT3 and FLT4 and 4 more; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2008
- Kind
- Small molecule
- Brand name
- Sutent
- First approved
- 26 January 2006 (US)
- Approvals on record
- 12 in 5 regions
- Holder of the most recent approval
- Pfizer; 3 holders in all
- Registered trials
- 392, 83 stopped early
- Disease areas
- Cancer; Urinary and reproductive; Pregnancy and women's health; Digestive system; Skin and connective tissue; Lungs and airways
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Companies that need a new molecule because of this drug
4 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product4 company-target rows are on route B because of Sunitinib.
See the 4 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 |
|---|---|---|
| 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 |
| FLT1 | Vascular endothelial growth factor receptor 1 | P17948 |
| FLT4 | Vascular endothelial growth factor receptor 3 | P35916 |
| KDR | Vascular endothelial growth factor receptor 2 | P35968 |
| FLT3 | Receptor-type tyrosine-protein kinase FLT3 | P36888 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 45 | 30 | 1 | 7 |
| Phase 1 | 71 | 57 | 3 | 11 |
| Phase 2 | 246 | 146 | 18 | 57 |
| Phase 3 | 22 | 13 | 1 | 6 |
| Phase 4 | 8 | 5 | 0 | 2 |
| All trials | 392 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Originator, Applicant and Lead sponsor of trials | 2003 to now |