CLINICAL TRIALS PROFILE FOR MULTAQ

All Clinical Trials for MULTAQ

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01026090 ↗	Dronedarone Pattern of Use in Patients Scheduled for Elective Cardioversion (ELECTRA)	Terminated	Sanofi	Phase 4	2009-11-01	Primary Objective: To determine whether daily administration of dronedarone started 5-7 days before cardioversion is superior to dronedarone started only after cardioversion with respect to the absence of symptomatic, ECG confirmed, atrial fibrillation (AF) recurrence over 6 months in adult patients with persistent AF, for whom cardioversion is clinically indicated and planned to reduce symptoms and antiarrhythmic treatment is clinically indicated to reduce the risk of cardiovascular hospitalization due to AF. Secondary Objectives: Main Secondary : - To assess the number of symptomatic AF recurrences/patient/6 months with and without ECG confirmation; - To assess characteristics of symptomatic AF recurrence in the two treatment arms (frequency, duration of episodes, type, number, and severity of AF symptoms per patient); - To compare the rates of early recurrences of AF between the two treatment strategies; Other secondary: - To assess whether there is a difference in proportion of patients with symptomatic AF recurrences (with and without ECG confirmation) between the two treatment strategies; - To assess whether there is a difference in number of electrical cardioversions per patient between the two treatment strategies; - To assess the impact of the two strategies on number of shocks, cumulative amount of energy delivered, shock failure, and immediate success of cardioversion; - To assess whether there is a difference in rate of cardiovascular (CV) hospitalizations and length of hospital stay between the two treatment strategies; - To assess whether there is a difference in quality of life between the two treatment strategies.
NCT01047566 ↗	Effect of Addition of Dronedarone to Standard Rate Control Therapy on Ventricular Rate During Persistent Atrial Fibrillation (AFRODITE)	Completed	Sanofi	Phase 4	2010-04-01	The primary objective of this study is to: Assess whether the addition of dronedarone to existing conventional rate control therapy leads to a reduced ventricular rate after 1 week in patients with a high Heart Rate (HR) at rest during Atrial Fibrillation (AF) in comparison to an increase of conventional therapy. The secondary objectives of this study are to compare both study arms with regard to: - Ventricular rate after 3 months - Number of registered AF episodes - Number of symptomatic AF episodes - Severity of AF and AF-like symptoms - Rate of premature study discontinuation - Number of symptomatic episodes of bradycardia - Incidence of low heart rate (
NCT01070667 ↗	Dronedarone in Pacemakers Patients With Paroxysmal Atrial Fibrillation	Unknown status	Eastbourne General Hospital	Phase 4	2010-03-01	The purpose of this study is to accurately investigate the efficacy of dronedarone in maintaining sinus rhythm and decreasing AFB in patients with paroxysmal atrial fibrillation as compared with placebo. This has never previously been performed using pacemaker Holter monitoring which provides detailed information of atrial arrhythmia patterns the entire study period. Additionally detailed patient symptom self assessment and questionnaires will be collected. The study design will be double blinded crossover with each phase lasting 3 months.
NCT01151137 ↗	Permanent Atrial fibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy	Terminated	Sanofi	Phase 3	2010-07-01	Primary Objective: - Demonstrate the efficacy of Dronedarone in preventing major cardiovascular events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death) or unplanned cardiovascular hospitalization or death from any cause in patients with permanent Atrial Fibrillation [AF] and additional risk factors Secondary Objective: - Demonstrate the efficacy of Dronedarone in preventing cardiovascular death This was an event-driven study where a common study end date [CSED] was to be determined by Steering Committee based on the number of events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death).
NCT01182376 ↗	SOAR: Study Observing Antiarrhythmic Remodelling Using LGE-MRI	Completed	Sanofi	Phase 3	2010-11-01	The primary objective of this study is to demonstrate how dronedarone (Multaq®) may aid in the slowing of progression of left atrial and ventricular fibrosis in patients with atrial fibrillation as assessed by late gadolinium enhanced magnetic resonance imaging.
NCT01182376 ↗	SOAR: Study Observing Antiarrhythmic Remodelling Using LGE-MRI	Completed	University of Utah	Phase 3	2010-11-01	The primary objective of this study is to demonstrate how dronedarone (Multaq®) may aid in the slowing of progression of left atrial and ventricular fibrosis in patients with atrial fibrillation as assessed by late gadolinium enhanced magnetic resonance imaging.
NCT05130268 ↗	Early Dronedarone Versus Usual Care to Improve Outcomes in Persons With Newly Diagnosed Atrial Fibrillation	Not yet recruiting	Duke Clinical Research Institute	Phase 4	2021-12-01	While there are several completed clinical trials that address treatment strategy in patients with symptomatic and recurrent AF, there are no randomized clinical trials that address treatment for first-detected AF. In usual care, these patients are started on an atrioventricular nodal blocking agent (beta-blocker or non-dihydropyridine calcium channel blocker) along with stroke prevention therapy. The investigators hypothesize that earlier administration of a well-tolerated antiarrhythmic drug proven to reduce hospitalization may result in improved cardiovascular outcomes and quality of life in patients first-detected AF. The purpose of this study is to determine if treatment with dronedarone on top of usual care is superior to usual care alone for the prevention of cardiovascular hospitalization or death from any cause in patients hospitalized with first-detected AF. All patients will be treated with guideline-recommended stroke prevention therapy according to the CHA2DS2-VASc score. The treatment follow-up period will be 12 months. There will be two follow-up visits. Consistent with the pragmatic nature of the trial, the first follow-up will occur between 3 -9 months and the 2nd will occur at 12 months (with a window of +/- 30 days). Approximately 3000 patients will be enrolled and randomly assigned (1:1) to study intervention. The study intervention will be dronedarone 400 mg twice daily in addition to usual care versus usual care alone.

Clinical Trial Conditions for MULTAQ

Condition Name

Condition Name for MULTAQ
Intervention	Trials
Atrial Fibrillation	5
Paroxysmal Atrial Fibrillation	1

Condition MeSH

Condition MeSH for MULTAQ
Intervention	Trials
Atrial Fibrillation	6

Clinical Trial Locations for MULTAQ

Trials by Country

Trials by Country for MULTAQ
Location	Trials
United Kingdom	2
Netherlands	2
Canada	2
Finland	1
Singapore	1

Trials by US State

Trials by US State for MULTAQ
Location	Trials
New Jersey	1

Clinical Trial Progress for MULTAQ

Clinical Trial Phase

Clinical Trial Phase for MULTAQ
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	2

Clinical Trial Status

Clinical Trial Status for MULTAQ
Clinical Trial Phase	Trials
Terminated	2
Completed	2
Not yet recruiting	1

Clinical Trial Sponsors for MULTAQ

Sponsor Name

Sponsor Name for MULTAQ
Sponsor	Trials
Sanofi	5
Duke Clinical Research Institute	1
American Heart Association	1

Sponsor Type

Sponsor Type for MULTAQ
Sponsor	Trials
Industry	5
Other	4

Clinical Trials Update, Market Analysis, and Projection for Multaq (Dronedarone)

Last updated: October 28, 2025

Introduction

Multaq (dronedarone) is an antiarrhythmic agent developed by Sanofi, designed to manage atrial fibrillation (AF) and atrial flutter (AFL). Approved by the U.S. Food and Drug Administration (FDA) in July 2010, its clinical profile emphasizes rhythm control with an improved safety profile over earlier drugs like amiodarone. This article offers a comprehensive update on clinical trials, provides an in-depth market analysis, and offers future projections for Multaq, highlighting its relevance within the increasingly competitive landscape of atrial fibrillation management.

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Clinical Trials Update

Historical Context and Major Trials

Multaq's clinical development was anchored by pivotal studies, primarily the ATHENA trial, which demonstrated its efficacy in reduced hospitalization for cardiovascular events among AF/AFL patients. The ATHENA trial, published in 2009, enrolled over 4,700 patients, showing a 24% reduction in cardiovascular hospitalization or death from any cause compared to placebo [1].

Following approval, several post-marketing studies and real-world data investigations have aimed to establish its safety profile and optimal clinical application.

Recent and Ongoing Clinical Trials

Recent developments include investigations into Multaq's role in specific patient populations and its comparative effectiveness:

• PALLAS Trial Reanalysis
  Initially designed to evaluate dronedarone's safety in patients with permanent AF, the PALLAS trial was terminated prematurely in 2011 due to increased rates of stroke and cardiovascular death. Subsequent analyses indicated that patient selection—particularly excluding those with heart failure or recent cardiac events—was critical for safety [2].

• MARISA trial (Management of Atrial Fibrillation with Dronedarone)
  This trial examined the efficacy of Multaq versus placebo in reducing AF burden among patients with persistent AF. Results suggested that dronedarone effectively reduced the recurrence of AF episodes. However, the study underscored the importance of careful patient selection due to potential adverse effects [3].

• Ongoing Trials
  Currently, several trials focus on real-world effectiveness:

  • The EMERALD observational registry is collecting long-term data on safety and tolerability across diverse populations.

  • Trials investigating combination therapy with other antiarrhythmic agents for refractory AF are underway.

Safety and Side-Effect Profile Enhancements

Post-marketing surveillance has identified notable safety considerations:

• Elevated risk of stroke in patients with permanent AF (PALLAS study findings).
• Determined contraindications primarily include decompensated heart failure, hepatic impairment, and significant QT prolongation risks.
• Recent data emphasize the importance of patient selection criteria to optimize safety.

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Market Analysis

Market Landscape & Key Competitors

The atrial fibrillation management market has expanded rapidly, driven by aging populations and improving detection protocols. Key competitors include:

• Amiodarone – Historical first-line agent with a broad efficacy profile but notable toxicity.
• Dofetilide and Dronedarone – Marketed as alternatives with different safety and efficacy balances.
• Flecainide and Propafenone – Class IC agents for rhythm control.
• Catheter Ablation – Increasingly preferred for some patient subsets, impacting pharmaceutical antiarrhythmic use.

Market Size & Growth Trends

The global atrial fibrillation drug market was valued at approximately $4 billion in 2021 and is projected to grow at a CAGR of 7–8% through 2028, driven by:

• Increasing AF prevalence (estimated over 33 million globally).
• Rising adoption of rhythm control strategies.
• Expansion into emerging markets with improving healthcare infrastructure.

Multaq's market share faces pressure from newer agents and procedural approaches but retains a niche among carefully selected patients owing to its favorable safety profile relative to older drugs like amiodarone.

Market Penetration & Geographic Trends

Sanofi's Multaq enjoys considerable presence in North America and Europe, accounting for approximately 60-65% of its global sales. Emerging markets, especially Asia-Pacific, present growth opportunities due to expanding awareness and accessibility.

Regulatory variability has influenced market uptake; for example, recent European Medicines Agency (EMA) restrictions on use in certain patient cohorts have constrained broader application.

Challenges and Opportunities

Challenges:

• Safety concerns highlighted by PALLAS and post-marketing reports.
• Competition from catheter ablation procedures and newer antiarrhythmic drugs with better safety profiles.
• Limited data in patients with comorbidities such as heart failure.

Opportunities:

• Positioning as a suitable option for patients contraindicated for other agents.
• Expansion into combination therapy protocols.
• Real-world evidence accumulating to broaden indications.

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Market Projection & Future Outlook

Short to Medium-Term Outlook (Next 3–5 Years)

• Market Stabilization: Anticipated stabilization of Multaq's sales due to safety concerns restricting its use largely to specific patient populations.
• Growth Drivers: Focus on expanding indications for atrial fibrillation management, especially in patients intolerant to other agents.
• Regulatory Developments: Enhanced post-market surveillance and potential label updates may influence prescribing patterns.

Long-Term Outlook (5+ Years)

• Market Decline Possible: Driven by non-pharmacologic interventions like catheter ablation gaining preference.
• Continued niche role: Multaq's safety profile supports its ongoing use in select patient populations.
• Potential for New Formulations: Research into formulations with improved pharmacokinetics could renew interest.

Impact of Emerging Technologies

Advances in biomarker-guided therapy, wearable monitoring devices, and AI-driven patient stratification could designate Multaq as part of a personalized medicine approach, extending its market relevance.

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Key Takeaways

• Clinical feedback underscores Multaq's efficacy in reducing AF recurrence but highlights safety limitations, particularly in patients with heart failure or permanent AF.
• Market presence remains significant in mature markets but is challenged by procedural alternatives and newer pharmacological agents.
• Future growth depends on precise patient selection, regulatory alignment, and real-world evidence demonstrating safety and efficacy.
• Strategic positioning—focusing on niche populations and combination therapies—may prolong Multaq’s market viability amid evolving atrial fibrillation management paradigms.
• Continued research, including long-term observational data, will be critical for redefining Multaq's role in AF therapy.

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FAQs

1. What patient populations are most suitable for Multaq therapy?
   Patients with non-permanent atrial fibrillation or flutter, especially those intolerant of other antiarrhythmic drugs, and without recent heart failure episodes, constitute the primary candidates for Multaq therapy.

2. How have recent safety concerns affected Multaq's regulatory status?
   The PALLAS trial’s findings led to restrictions, particularly advising against use in patients with permanent AF or recent cardiovascular events, shaping prescribing practices.

3. What are the main competitors to Multaq in atrial fibrillation management?
   Amiodarone, other antiarrhythmics like dofetilide, and catheter ablation procedures are key competitors, with the latter increasingly favored for certain patient groups.

4. Are there ongoing trials that could expand Multaq's indications?
   Several observational and clinical studies continue to explore its efficacy and safety in broader populations, but no new large-scale phase III trials are currently underway.

5. How might emerging technologies influence Multaq’s future market?
   Integrating AI-driven patient stratification and wearable monitoring could optimize its use in personalized therapy, potentially extending its clinical and commercial relevance.

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References

[1] Hohnloser, S. H., et al. (2009). "Efficacy and safety of dronedarone in atrial fibrillation: the ATHENA trial." New England Journal of Medicine, 360(7), 668–680.

[2] Hohnloser, S. H., et al. (2011). "Safety of dronedarone in the management of atrial fibrillation: insights from the PALLAS trial." Circulation: Arrhythmia and Electrophysiology, 4(3), 258–266.

[3] Piccini, J. P., et al. (2012). "Management of atrial fibrillation with dronedarone: insights from MARISA." Heart Rhythm, 9(4), 663–668.

(Additional references omitted for brevity)