Amiodarone
As of the edition of 20 October 2026, Amiodarone is a small molecule: marketed, first approved in 1969 (ES); acts on KCNH2.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1987
- Kind
- Small molecule
- Brand name
- Cordarone
- First approved
- 1 June 1969 (ES)
- Approvals on record
- 10 in 4 regions
- Holder of the most recent approval
- Baxter Healthcare; 5 holders in all
- Registered trials
- 56, 10 stopped early
- Disease areas
- Heart and blood vessels; Infections; Lungs and airways; Cancer; Digestive system; Inherited and neonatal
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 Amiodarone.
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 |
|---|---|---|
| KCNH2 | Voltage-gated inwardly rectifying potassium channel KCNH2 | Q12809 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 14 | 5 | 2 | 4 |
| Phase 1 | 4 | 2 | 1 | 0 |
| Phase 2 | 5 | 2 | 2 | 1 |
| Phase 3 | 16 | 6 | 4 | 3 |
| Phase 4 | 17 | 6 | 4 | 2 |
| All trials | 56 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Applicant | 1985 to now |
| Amphastar Pharmaceuticals | Later holder | 2004 to now |
| Prism Pharma | Later holder and Lead sponsor of trials | 2006 to now |
| Baxter Healthcare | Acquired holder | 2011 to now |
| Sanofi | Applicant |