Flecainide
As of the edition of 20 October 2026, Flecainide is a small molecule: marketed, first approved in 1966 (CA); acts on SCN5A.
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
- Tambocor
- First approved
- 31 December 1966 (CA)
- Approvals on record
- 9 in 5 regions
- Holder of the most recent approval
- Bausch Health; 5 holders in all
- Registered trials
- 23, 2 stopped early
- Disease areas
- Heart and blood vessels; Inherited and neonatal; Nervous system; Mental 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.
Target
| Gene | Protein | UniProt |
|---|---|---|
| SCN5A | Sodium channel protein type 5 subunit alpha | Q14524 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 9 | 6 | 1 | 0 |
| Phase 2 | 5 | 4 | 1 | 0 |
| Phase 3 | 4 | 2 | 2 | 0 |
| Phase 4 | 5 | 1 | 2 | 2 |
| All trials | 23 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bausch Health | Acquired holder | 1966 to now |
| 3M | Applicant | 1985 to now |
| Alvogen | Acquired holder | 2021 to now |
| Eisai | Applicant |