Dabigatran
As of the edition of 20 October 2026, Dabigatran is a small molecule: marketed, first approved in 2012 (CH); acts on F2.
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
- Pradaxa
- First approved
- 29 May 2012 (CH)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Boehringer Ingelheim
- Registered trials
- 99, 8 stopped early
- Disease areas
- Heart and blood vessels; Nervous system; Lungs and airways; Infections; Digestive system; Pregnancy and women's health
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 Dabigatran.
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 |
|---|---|---|
| F2 | Prothrombin | P00734 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 47 | 30 | 3 | 3 |
| Phase 1 | 19 | 18 | 1 | 0 |
| Phase 2 | 7 | 4 | 0 | 1 |
| Phase 3 | 13 | 8 | 2 | 1 |
| Phase 4 | 13 | 6 | 2 | 3 |
| All trials | 99 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Boehringer Ingelheim | Applicant and Lead sponsor of trials | 2001 to now |