Drug

Dronedarone

Approved · EMA

Late-stage development

Also known as Multaq, N-(2-butyl-3-(4-(3-(dibutylamino)propoxy)benzoyl)-5-benzofuranyl)-methanesulfonamide, N-(2-butyl-3-(p-(3-(dibutylamino)propoxy)benzoyl)-5-benzofuranyl)methanesulfonamide, Dronedarona.

RxNorm233698 ChEMBLCHEMBL184412UNIIJQZ1L091Y2

Active clinical trials

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Multicenter Prospective Study on the Efficacy, Safety, and Quality of Life Improvements of Dronedarone for Early Rhythm Control in Atrial Fibrillation

Clinical trial2025-12-22Results expected Q2 2028 · ClinicalTrials.gov

Effect of Prolonged Use of Dronedarone on Recurrence in Patients With Non-paroxysmal Atrial Fibrillation After Radiofrequency Ablation

Clinical trial2025-04-01Primary completion · ClinicalTrials.gov

Pragmatic Randomized Clinical Trial of Early Dronedarone Versus Usual Care to Change and Improve Outcomes in Persons With First-Detected Atrial Fibrillation

Clinical trial2024-06-30Completed · ClinicalTrials.gov

Effect of Dronedarone on Atrial Fibrosis Progression and Atrial Fibrillation Recurrence Post Ablation: The EDORA Trial

Clinical trial2022-12-20Terminated · ClinicalTrials.gov

A Phase 2, Proof of Concept, Randomized, Placebo-Controlled, Parallel Group Study to Evaluate the Effect of Ranolazine and Dronedarone When Given Alone and in Combination on Atrial Fibrillation Burden in Subjects With Paroxysmal Atrial Fibrillation

Clinical trial2020-11-06Results posted · ClinicalTrials.gov

Preoperative Colchicine, Dronedarone Or Amiodarone for Prophylaxis Against Postoperative Atrial Fibrillation in Patients Undergoing On-pump CABG; A Comparative Study

Clinical trial2020-04-10Primary completion · ClinicalTrials.gov

Catheter Ablation Compared With Pharmacological Therapy for Atrial Fibrillation - a Randomized Multicentre Study Comparing Atrial Fibrillation Ablation Strategy With Optimized Conventional Pharmacological Strategy After 12 Months Follow-up.

Clinical trial2018-09-01Primary completion · ClinicalTrials.gov

SOAR: Study Observing Antiarrhythmic Remodelling Using LGE-MRI

Clinical trial2016-02-19Results posted · ClinicalTrials.gov

Drug Safety Update: Dronedarone (Multaq▼): cardiovascular, hepatic and pulmonary adverse events – new restrictions and monitoring requirements

Regulatory2014-12-11MHRA

Dronedarone for Patients With Recurrent ICD Shocks Due to Ventricular Arrhythmia Resistant to Their Antiarrhythmic Drug Therapy or Ablation

Clinical trial2014-12-01Primary completion · ClinicalTrials.gov

Efficacy of Propafenone Versus Dronedarone for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation After DC Cardioversion

Clinical trial2013-10-01Completed · ClinicalTrials.gov

Approval: Multaq (EMA)

Regulatory2009-11-25EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Dronedarone

Aliases & brands

MultaqN-(2-butyl-3-(4-(3-(dibutylamino)propoxy)benzoyl)-5-benzofuranyl)-methanesulfonamideN-(2-butyl-3-(p-(3-(dibutylamino)propoxy)benzoyl)-5-benzofuranyl)methanesulfonamideDronedarona

RxNorm CUI

233698

ChEMBL ID

CHEMBL184412

UNII

JQZ1L091Y2

Regulatory jurisdictions

emamhra

Regulatory timeline

2 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2009-11-25

Latest approval

2009-11-25

Authorities

EMA · MHRA

Total events

emaEuropean Medicines Agency· 1 event

2009-11-25Approval

Approval: Multaq (EMA)

Indication: Multaq is indicated for the maintenance of sinus rhythm after successful cardioversion in adult clinically stable patients with paroxysmal or persistent atrial fibrillation (AF).… Show full indication

Multaq is indicated for the maintenance of sinus rhythm after successful cardioversion in adult clinically stable patients with paroxysmal or persistent atrial fibrillation (AF). Due to its safety profile, Multaq should only be prescribed after alternative treatment options have been considered. Multaq should not be given to patients with left ventricular systolic dysfunction or to patients with current or previous episodes of heart failure.

Evidence ↗

mhraMedicines and Healthcare products Regulatory Agency· 1 event

2014-12-11Safety communicationSafety

Drug Safety Update: Dronedarone (Multaq▼): cardiovascular, hepatic and pulmonary adverse events – new restrictions and monitoring requirements

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).