NDAORALTABLETPriority Review
Approved
Jul 2009
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
19
Mechanism of Action
unknown. Dronedarone has antiarrhythmic properties belonging to all four Vaughan-Williams classes, but the contribution of each of these activities to the clinical effect is unknown.
Pharmacologic Class:
Antiarrhythmic
Clinical Trials (5)
Early Dronedarone Versus Usual Care to Improve Outcomes in Persons With Newly Diagnosed Atrial Fibrillation
Started Oct 2021
339 enrolled
Atrial Fibrillation
Systematic Review and Meta-Analysis of Multaq® for Safety in Atrial Fibrillation
Started Sep 2021
87,810 enrolled
Atrial Fibrillation
Effect of Dronedarone on Atrial Fibrosis Progression and Atrial Fibrillation Recurrence
Started May 2021
22 enrolled
Atrial FibrillationAtrial Fibrillation Recurrent
Study to Evaluate the Effect of Ranolazine and Dronedarone When Given Alone and in Combination in Patients With Paroxysmal Atrial Fibrillation
Started Jan 2012
134 enrolled
Atrial Fibrillation
Drug Interaction Study With Dabigatran Etexilate and Dronedarone in Healthy Subjects
Started Feb 2011
36 enrolled
Healthy
Loss of Exclusivity
LOE Date
Jun 30, 2031
64 months away
Patent Expiry
Jun 30, 2031