Rivaroxaban
As of the edition of 20 October 2026, Rivaroxaban is a small molecule: marketed, first approved in 2008 (CA); acts on F10.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2012
- Kind
- Small molecule
- Brand name
- Xarelto
- First approved
- 15 September 2008 (CA)
- Approvals on record
- 25 in 6 regions
- Holder of the most recent approval
- Bayer; 3 holders in all
- Registered trials
- 389, 26 stopped early
- Disease areas
- Heart and blood vessels; Nervous system; Lungs and airways; Cancer; Infections; Blood and lymph
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Companies that need a new molecule because of this drug
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Rivaroxaban.
See the 2 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| F10 | Coagulation factor X | P00742 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 140 | 98 | 18 | 5 |
| Phase 1 | 47 | 37 | 3 | 2 |
| Phase 2 | 37 | 29 | 1 | 3 |
| Phase 3 | 99 | 58 | 12 | 12 |
| Phase 4 | 66 | 25 | 19 | 4 |
| All trials | 389 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bayer | Applicant and Lead sponsor of trials | 2002 to now |
| Johnson & Johnson | Applicant, Acquired holder and Lead sponsor of trials | 2006 to now |