Warfarin
As of the edition of 20 October 2026, Warfarin is a small molecule: marketed, first approved in 1959 (ES); acts on VKORC1.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1993
- Kind
- Small molecule
- Brand name
- Coumadin
- First approved
- 1 November 1959 (ES)
- Approvals on record
- 27 in 4 regions
- Holder of the most recent approval
- Bristol Myers Squibb; 6 holders in all
- Registered trials
- 257, 21 stopped early
- Disease areas
- Heart and blood vessels; Nervous system; Nutrition and metabolism; Digestive system; Cancer; Lungs and airways
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
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Warfarin.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| VKORC1 | Vitamin K epoxide reductase complex subunit 1 | Q9BQB6 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 85 | 52 | 7 | 7 |
| Phase 1 | 109 | 94 | 6 | 6 |
| Phase 2 | 10 | 8 | 0 | 2 |
| Phase 3 | 15 | 10 | 1 | 1 |
| Phase 4 | 38 | 21 | 5 | 5 |
| All trials | 257 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Abbott | Acquired holder, Later holder and Lead sponsor of trials | 2003 to now |
| Bristol Myers Squibb | Acquired holder and Lead sponsor of trials | 2003 to now |
| Pharmaceutical Research Assoc | Acquired holder | 2008 to now |
| Dupont Merck | Earlier holder | |
| Eisai | Applicant | |
| Purdue Frederick | Later holder |