Dofetilide
As of the edition of 20 October 2026, Dofetilide is a small molecule: marketed, first approved in 1999 (US); acts on KCNH2; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1999
- Kind
- Small molecule
- Brand name
- Tikosyn
- First approved
- 1 October 1999 (US)
- Approvals on record
- 3 in 1 region
- Holder of the most recent approval
- Pfizer
- Withdrawn from market
- 2 March 2004 (in some regions)
- Registered trials
- 6, 1 stopped early
- Disease areas
- Heart and blood vessels; Inherited and neonatal; Chemically induced
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 |
|---|---|---|
| KCNH2 | Voltage-gated inwardly rectifying potassium channel KCNH2 | Q12809 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 3 | 2 | 0 | 0 |
| Phase 1 | 2 | 2 | 0 | 0 |
| Phase 2 | 1 | 0 | 0 | 1 |
| All trials | 6 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Originator | 1999 to now |