Lepirudin
As of the edition of 20 October 2026, Lepirudin is a protein: marketed, first approved in 1998 (US); acts on F2; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1998
- Kind
- Protein
- Brand name
- Refludan
- First approved
- 6 March 1998 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Bayer
- Withdrawn from market
- 24 April 2012 (in some regions)
- Registered trials
- 3, 1 stopped early
- Disease areas
- Cancer; Heart and blood vessels; 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.
Target
| Gene | Protein | UniProt |
|---|---|---|
| F2 | Prothrombin | P00734 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 1 | 0 | 0 |
| Phase 2 | 2 | 1 | 0 | 1 |
| All trials | 3 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bayer | Applicant | 1998 to now |