Dronedarone
As of the edition of 20 October 2026, Dronedarone is a small molecule: marketed, first approved in 2009 (US); acts on CACNA1C, CACNA1D and CACNA1F and 13 more; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2009
- Kind
- Small molecule
- Brand name
- Multaq
- First approved
- 1 July 2009 (US)
- Approvals on record
- 4 in 4 regions
- Holder of the most recent approval
- Sanofi; 2 holders in all
- Registered trials
- 25, 5 stopped early
- Disease areas
- Heart and blood vessels
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.
Companies that need a new molecule because of this drug
6 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product6 company-target rows are on route B because of Dronedarone.
See the 6 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
| Gene | Protein | UniProt |
|---|---|---|
| CACNA1F | Voltage-dependent L-type calcium channel subunit alpha-1F | O60840 |
| SCN1A | Sodium channel protein type 1 subunit alpha | P35498 |
| SCN4A | Sodium channel protein type 4 subunit alpha | P35499 |
| KCNJ2 | Inward rectifier potassium channel 2 | P63252 |
| SCN7A | Sodium channel protein type 7 subunit alpha | Q01118 |
| CACNA1D | Voltage-dependent L-type calcium channel subunit alpha-1D | Q01668 |
| CACNA1S | Voltage-dependent L-type calcium channel subunit alpha-1S | Q13698 |
| CACNA1C | Voltage-dependent L-type calcium channel subunit alpha-1C | Q13936 |
| SCN5A | Sodium channel protein type 5 subunit alpha | Q14524 |
| SCN9A | Sodium channel protein type 9 subunit alpha | Q15858 |
| SCN2A | Sodium channel protein type 2 subunit alpha | Q99250 |
| SCN3A | Sodium channel protein type 3 subunit alpha | Q9NY46 |
| SCN11A | Sodium channel protein type 11 subunit alpha | Q9UI33 |
| SCN8A | Sodium channel protein type 8 subunit alpha | Q9UQD0 |
| HCN4 | Potassium/sodium hyperpolarization-activated cyclic nucleotide-gated channel 4 | Q9Y3Q4 |
| SCN10A | Sodium channel protein type 10 subunit alpha | Q9Y5Y9 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 4 | 3 | 0 | 0 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 2 | 2 | 0 | 0 |
| Phase 3 | 8 | 6 | 0 | 2 |
| Phase 4 | 10 | 4 | 1 | 3 |
| All trials | 25 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Sanofi | Originator, Applicant and Lead sponsor of trials | 2001 to now |