Regorafenib
As of the edition of 20 October 2026, Regorafenib is a small molecule: marketed, first approved in 2012 (US); acts on BRAF, FGFR1 and FGFR2 and 11 more; US protection ends in 2032.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2013
- Kind
- Small molecule
- Brand name
- Stivarga
- First approved
- 27 September 2012 (US)
- Approvals on record
- 8 in 5 regions
- Holder of the most recent approval
- Bayer; 4 holders in all
- Registered trials
- 262, 39 stopped early
- Disease areas
- Cancer; Digestive system; Hormones; Urinary and reproductive; Pregnancy and women's health; Lungs and airways
US protection
US protection ends in 2032.
The last listed US drug-substance patent ends in 2032. 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 product2 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
8 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product8 company-target rows are on route B because of Regorafenib.
See the 8 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 |
|---|---|---|
| RAF1 | RAF proto-oncogene serine/threonine-protein kinase | P04049 |
| NTRK1 | High affinity nerve growth factor receptor | P04629 |
| 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 |
| FGFR1 | Fibroblast growth factor receptor 1 | P11362 |
| BRAF | Serine/threonine-protein kinase B-raf | P15056 |
| PDGFRA | Platelet-derived growth factor receptor alpha | P16234 |
| FLT1 | Vascular endothelial growth factor receptor 1 | P17948 |
| FGFR2 | Fibroblast growth factor receptor 2 | P21802 |
| FLT4 | Vascular endothelial growth factor receptor 3 | P35916 |
| KDR | Vascular endothelial growth factor receptor 2 | P35968 |
| FRK | Tyrosine-protein kinase FRK | P42685 |
| TEK | Angiopoietin-1 receptor | Q02763 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 37 | 22 | 2 | 1 |
| Phase 1 | 44 | 28 | 6 | 6 |
| Phase 2 | 159 | 57 | 48 | 27 |
| Phase 3 | 18 | 6 | 6 | 4 |
| Phase 4 | 4 | 3 | 0 | 1 |
| All trials | 262 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bayer | Originator, Applicant and Lead sponsor of trials | 2012 to now |