Entecavir anhydrous
As of the edition of 20 October 2026, Entecavir anhydrous is a small molecule: marketed, first approved in 2005 (US); no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2006
- Kind
- Small molecule
- Brand name
- Baraclude
- First approved
- 29 March 2005 (US)
- Approvals on record
- 7 in 4 regions
- Holder of the most recent approval
- Bristol Myers Squibb
- Registered trials
- 184, 28 stopped early
- Disease areas
- Digestive system; Infections; Cancer; Immune system; Blood and lymph; 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.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 30 | 11 | 3 | 2 |
| Phase 1 | 16 | 11 | 0 | 5 |
| Phase 2 | 47 | 23 | 1 | 12 |
| Phase 3 | 22 | 15 | 1 | 4 |
| Phase 4 | 69 | 24 | 4 | 5 |
| All trials | 184 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bristol Myers Squibb | Originator and Lead sponsor of trials | 2001 to now |