Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication MULTAQ ® is indicated to reduce the risk of hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation (AF) [see Clinical Studies (14) ] . MULTAQ is an antiarrhythmic drug indicated to reduce the risk of hospitalization for atrial fibrillation (AF) in patients in sinus rhythm with a history of paroxysmal or persistent AF ( 1 , 14 ). FDA label
Also known as DRONEDARONE (SR33589), Multaq®
DRONEDARONE · 7 trials · 2 indications
The change in left atrial fibrosis percentage, as measured on a scale, using MRI imaging, from baseline to the end of treatment.
The primary event is the treatment failure defined as the first recurrence of atrial fibrillation or premature study drug discontinuation for intolerance or lack of efficacy according to the investigator judgement. The primary efficacy analysis is performed on the time from first study drug intake to this primary event. The "Measured Values" table below presents the numbers of patients with the event at the end of the study period.
The primary event is the first hospitalization for cardiovascular reason or death from any cause, whichever is earlier, as assessed by the investigator. The primary efficacy analysis is performed on the time from randomization to this primary event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Half of the patients will be assigned placebo. |
| Multaq® (dronedarone) | EXPERIMENTAL | Half of the patients will be prescribed dronedarone. |
| Dronedarone 400mg bid | EXPERIMENTAL | dronedarone 400mg tablets administered twice a day (bid) and matching over-encapsulated tablets of placebo of amiodarone 200mg |
| Amiodarone 600mg/200mg od | ACTIVE_COMPARATOR | over-encapsulated tablets of amiodarone 200mg (600mg daily for 28 days then 200mg daily) administered once daily (od) and matching placebo of dronedarone 400mg tablets |
| 1 | EXPERIMENTAL | - |
| 2 | PLACEBO_COMPARATOR | - |
| dronedarone 300 mg | EXPERIMENTAL | Dronedarone, 100mg + 200mg tablets twice daily, administered with food. |
| dronedarone 400 mg | EXPERIMENTAL | Dronedarone, 400mg tablets twice daily, administered with food. |
| dronedarone 600 mg | EXPERIMENTAL | Dronedarone, 400mg + 200mg tablets twice daily, administered with food. |
| Name | Type | Description |
|---|---|---|
| dronedarone | DRUG | Dronedarone will be prescribed by the patient's team according to established guidelines. |
| Placebo | DRUG | Placebo will be administered by the patient's team according to established guidelines. |
| dronedarone (SR33589) | DRUG | oral administration |
| amiodarone | DRUG | oral administration |
Inclusion Criteria: * Patients age 18 and older * Must carry a diagnosis of Paroxysmal Atrial Fibrillation for 1 months or longer prior to being enrolled. * AAD: Multaq® (dronedarone) candidate * Patients have given informed consent Exclusion Criteria: * Patients who are unavailable to continue f...
Top 5 of 17 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Regeneron Pharmaceuticals, Inc. | REGN | 3 | PHASE3 | REGN7508, REGN9933 |
| Johnson & Johnson | JNJ | 14 | PHASE3 | Milvexian |
| Novartis AG Sponsored ADR | NVS | 3 | PHASE3 | Abelacimab, PKN605 |
| Milestone Pharmaceuticals, Inc. | MIST | 1 | PHASE3 | Etripamil |
| Bayer | BAYRY | 1 | PHASE2 | BAY 3670549 |
Dronedarone is an antiarrhythmic drug being studied for atrial fibrillation, a common heart rhythm disorder. It is designed to help control heart rhythm and ventricular rate in patients with this condition. It is a small molecule developed by Sanofi and is currently in Phase 3 clinical development.
Dronedarone targets multiple sodium channel subtypes: SCN1A, SCN5A, SCN4A, SCN7A, SCN2A, and SCN9A. It acts as a blocker of these channels, which are involved in cardiac electrical signaling. This mechanism is intended to stabilize heart rhythm in atrial fibrillation.
Dronedarone is being developed by Sanofi, a global pharmaceutical company. Sanofi trades on the New York Stock Exchange under the ticker SNY. The drug is part of Sanofi's cardiovascular pipeline.
Dronedarone is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA for any indication. The Phase 3 program includes completed trials evaluating its efficacy and safety in atrial fibrillation.
Dronedarone has been studied in several completed clinical trials, including NCT01213368, a Phase 2 dose-ranging study in Japanese patients; NCT01182376, a Phase 3 study using LGE-MRI; NCT00697086, a Phase 3 European study; and NCT00489736, a Phase 3 trial comparing dronedarone with amiodarone. All are completed.
Yes, dronedarone is also known by its developmental code SR33589. The names dronedarone and SR33589 refer to the same investigational drug. It is a small molecule being developed by Sanofi for atrial fibrillation.