NDAORALTABLETPriority Review
Approved
Jul 2009
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
19
Data completeness
5/8 — Partial
Priority Review
MULTAQ (dronedarone) by Sanofi. Approved for antiarrhythmic [epc]. First approved in 2009.
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MULTAQ (dronedarone) is an oral small-molecule antiarrhythmic agent approved by the FDA in July 2009 for the treatment of atrial fibrillation and related arrhythmias. The drug possesses properties across all four Vaughan-Williams antiarrhythmic classes, though the specific contribution of each mechanism to its clinical efficacy remains incompletely understood. Dronedarone is administered as an oral tablet and represents a key therapeutic option in the rhythm control strategy for patients with atrial fibrillation.
$0.4BPart D
5.2 years to LOEMechanism of Action
Pharmacologic Class:
Antiarrhythmic
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (19)
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
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.