Sorafenib
As of the edition of 20 October 2026, Sorafenib is a small molecule: marketed, first approved in 2005 (US); acts on BRAF, FLT1 and FLT3 and 4 more; US protection ends in 2027.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2021
- Kind
- Small molecule
- Brand name
- Nexavar
- First approved
- 20 December 2005 (US)
- Approvals on record
- 8 in 6 regions
- Holder of the most recent approval
- Laboratorio Stada S.L.; 4 holders in all
- Registered trials
- 660, 119 stopped early
- Disease areas
- Cancer; Digestive system; Urinary and reproductive; Pregnancy and women's health; Blood and lymph; Skin and connective tissue
US protection
US protection ends in 2027.
The last listed US drug-substance patent ends in 2027. The application that gives this date is held by Bayer.
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 product1 listing counts 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
1 company-target row on route B because of this drug.
Companies on route B for this drug
In the product1 company-target row is on route B because of Sorafenib.
See the 1 company-target row on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
| Gene | Protein | UniProt |
|---|---|---|
| RAF1 | RAF proto-oncogene serine/threonine-protein kinase | P04049 |
| PDGFRB | Platelet-derived growth factor receptor beta | P09619 |
| BRAF | Serine/threonine-protein kinase B-raf | P15056 |
| 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 | 61 | 30 | 6 | 10 |
| Phase 1 | 158 | 120 | 5 | 27 |
| Phase 2 | 368 | 214 | 29 | 73 |
| Phase 3 | 62 | 40 | 4 | 8 |
| Phase 4 | 11 | 3 | 2 | 1 |
| All trials | 660 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bayer | Originator, Applicant and Lead sponsor of trials | 2002 to now |