Digoxin
As of the edition of 20 October 2026, Digoxin is a small molecule: marketed, first approved in 1955 (ES); acts on ATP1A1, ATP1A2 and ATP1A3 and 1 more.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1988
- Kind
- Small molecule
- Brand name
- Lanoxin
- First approved
- 1 June 1955 (ES)
- Approvals on record
- 15 in 3 regions
- Holder of the most recent approval
- Hikma Pharmaceuticals; 6 holders in all
- Registered trials
- 188, 10 stopped early
- Disease areas
- Cancer; Heart and blood vessels; Nutrition and metabolism; Hormones; Skin and connective tissue; Digestive system
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.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 12 | 11 | 0 | 0 |
| Phase 1 | 146 | 133 | 7 | 4 |
| Phase 2 | 19 | 6 | 4 | 6 |
| Phase 3 | 4 | 2 | 0 | 0 |
| Phase 4 | 7 | 5 | 1 | 0 |
| All trials | 188 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Hikma Pharmaceuticals | Later holder | 2004 to now |
| Advanz Pharma | Acquired holder | 2025 to now |
| Azurity Pharmaceuticals | Acquired holder | 2026 to now |
| GSK | Earlier holder |