CLINICAL TRIALS PROFILE FOR DOFETILIDE

All Clinical Trials for Dofetilide

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00392106 ↗	High Intensity Focused Ultrasound (HIFU) Ablation System Study	Suspended	ProRhythm, Inc.	Phase 3	2006-04-01	The purpose of this study is to determine if the HIFU Pulmonary Vein Ablation System is effective in the treatment of paroxysmal Atrial Fibrillation compared to the control of best medical therapy with FDA approved antiarrhythmic drugs.
NCT00657514 ↗	Ranolazine Versus Placebo Effects on Exercise Tolerance in Patients With Heart Disease and Peripheral Arterial Disease	Withdrawn	Colorado Prevention Center	Phase 4	2008-05-01	After 6 weeks of maximal Ranolazine therapy, tissue hemoglobin desaturation kinetics will change compared to placebo in patients with chronic angina and peripheral arterial disease.
NCT01873950 ↗	Study of the Electrocardiographic Effects of Ranolazine, Dofetilide, Verapamil, and Quinidine in Healthy Subjects	Completed	Spaulding Clinical Research LLC	Phase 1	2013-05-01	This study seeks to compare 4 known QT prolonging drugs versus placebo to determine their effects on electrophysiological and other clinical parameters. The underlying purpose is to determine if depolarization and repolarization effects caused by drugs with differing ionic channel mechanisms can be distinguished from one another, and to gauge the sensitivity and specificity of novel signal analyses for detection of depolarization and repolarization changes. Secondarily, to evaluate the exposure response relationship and drug induced effects on the heart rate biomarker relationship.
NCT01873950 ↗	Study of the Electrocardiographic Effects of Ranolazine, Dofetilide, Verapamil, and Quinidine in Healthy Subjects	Completed	Food and Drug Administration (FDA)	Phase 1	2013-05-01	This study seeks to compare 4 known QT prolonging drugs versus placebo to determine their effects on electrophysiological and other clinical parameters. The underlying purpose is to determine if depolarization and repolarization effects caused by drugs with differing ionic channel mechanisms can be distinguished from one another, and to gauge the sensitivity and specificity of novel signal analyses for detection of depolarization and repolarization changes. Secondarily, to evaluate the exposure response relationship and drug induced effects on the heart rate biomarker relationship.
NCT02308748 ↗	Ability of Late Sodium or Calcium Current Block to Balance the ECG Effects of Potassium Current Block	Completed	Spaulding Clinical Research LLC	Phase 1	2014-05-01	The primary objective of this research study is to test the hypothesis that late sodium current blocking drugs (mexiletine or lidocaine) can attenuate the effect of hERG potassium channel blocking drugs (dofetilide) on ventricular repolarization (QTc) by shortening early repolarization (J-Tpeakc). The secondary object is to assess the ability of calcium channel block (diltiazem) to reduce the QTc prolongation associated with hERG block (moxifloxacin).
NCT02308748 ↗	Ability of Late Sodium or Calcium Current Block to Balance the ECG Effects of Potassium Current Block	Completed	Food and Drug Administration (FDA)	Phase 1	2014-05-01	The primary objective of this research study is to test the hypothesis that late sodium current blocking drugs (mexiletine or lidocaine) can attenuate the effect of hERG potassium channel blocking drugs (dofetilide) on ventricular repolarization (QTc) by shortening early repolarization (J-Tpeakc). The secondary object is to assess the ability of calcium channel block (diltiazem) to reduce the QTc prolongation associated with hERG block (moxifloxacin).

Clinical Trial Conditions for Dofetilide

Condition Name

Condition Name for Dofetilide
Intervention	Trials
Long QT Syndrome	3
Pharmacodynamics	3
Pharmacokinetics	3
Atrial Fibrillation	3

Condition MeSH

Condition MeSH for Dofetilide
Intervention	Trials
Long QT Syndrome	6
Atrial Fibrillation	3
Drug-Related Side Effects and Adverse Reactions	1
Peripheral Vascular Diseases	1

Clinical Trial Locations for Dofetilide

Trials by Country

Trials by Country for Dofetilide
Location	Trials
United States	23
Poland	1
Czech Republic	1

Trials by US State

Trials by US State for Dofetilide
Location	Trials
Wisconsin	4
Colorado	2
Ohio	2
Massachusetts	2
Minnesota	1

Clinical Trial Progress for Dofetilide

Clinical Trial Phase

Clinical Trial Phase for Dofetilide
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Dofetilide
Clinical Trial Phase	Trials
Completed	4
Not yet recruiting	2
Recruiting	2

Clinical Trial Sponsors for Dofetilide

Sponsor Name

Sponsor Name for Dofetilide
Sponsor	Trials
Spaulding Clinical Research LLC	4
Food and Drug Administration (FDA)	4
Colorado Prevention Center	1

Sponsor Type

Sponsor Type for Dofetilide
Sponsor	Trials
Other	15
U.S. Fed	5
Industry	4

Dofetilide: Clinical Trials, Market Analysis, and Projections

Introduction to Dofetilide

Dofetilide is a class III antiarrhythmic agent, primarily used to treat atrial fibrillation and atrial flutter. It works by blocking the potassium channels in the heart, which helps to restore and maintain a normal heart rhythm.

Clinical Trials: Efficacy and Safety

DIAMOND Low Ejection Fraction Substudy

One of the significant clinical trials involving dofetilide is the Danish Investigation of Arrhythmia and Mortality On Dofetilide (DIAMOND) Low Ejection Fraction Substudy. This study enrolled 506 patients with atrial fibrillation/flutter (AF/Fl), congestive heart failure (CHF), or recent myocardial infarction (MI), and an ejection fraction (EF) of less than 0.35. The trial demonstrated that dofetilide is more effective than placebo in restoring and maintaining sinus rhythm. Pharmacologic or spontaneous cardioversion occurred in 44% of the dofetilide group, compared to 14% in the placebo group. Including electrical cardioversion, sinus rhythm was restored in 59% of the dofetilide group and 34% of the placebo group. Notably, one year after cardioversion, sinus rhythm was maintained in 79% of the dofetilide group versus 42% in the placebo group. The study also found that successful maintenance of sinus rhythm was associated with improved survival and lower hospitalization rates[1][4].

EMERALD Trial

The European and Australian Multicenter Evaluative Research on Atrial Fibrillation—Dofetilide (EMERALD) trial further validated the efficacy of dofetilide. This randomized trial involved 505 patients and evaluated the effectiveness of dofetilide in restoring and maintaining sinus rhythm. Patients were randomized to receive one of three doses of dofetilide, sotalol, or placebo. The results showed that high-dose dofetilide was significantly better than low-dose dofetilide and sotalol in maintaining sinus rhythm. At the end of one year, 66% of patients treated with high-dose dofetilide remained in normal sinus rhythm, compared to 21% in the placebo group and 50% in the sotalol group. The treatment was well tolerated, with a low incidence of serious adverse events[3].

Market Analysis

Global Market Size and Forecast

The global market for dofetilide is projected to grow significantly over the next few years. As of 2023, the market was valued at several million USD and is forecasted to reach a readjusted size by 2030, with a compound annual growth rate (CAGR) during the forecast period of 2024-2030. The market is segmented by region, with North America, Europe, and the Asia-Pacific region being key contributors. For instance, the North American market for dofetilide was valued at a significant amount in 2023 and is expected to grow at a specific CAGR during the forecast period[2].

Key Players and Market Share

The global dofetilide market is dominated by several key players, including Sigmapharm Laboratories, Mayne Pharma, Novadoz Pharmaceuticals, Pfizer, NorthStar Rx LLC, AvKARE, Inc., Accord Healthcare, Bionpharma, and Sun Pharmaceutical Industries Ltd. These companies hold a significant share of the market revenue, with the top five players accounting for a substantial percentage of the total market share in 2023[2].

Regional Market Analysis

The market for dofetilide is analyzed by region, including North America, Europe, the Asia-Pacific, and Latin America, Middle East & Africa. Each region's market size, sales volume, and revenue are forecasted from 2019 to 2030. For example, the Asia-Pacific market for dofetilide is expected to grow at a notable CAGR during the forecast period, driven by increasing demand and expanding healthcare infrastructure[2][5].

Market Segmentation

By Application

The dofetilide market is segmented by application, with the primary use being in the treatment of atrial fibrillation and atrial flutter. The market share and sales volume by application are provided, helping businesses understand the demand and growth potential in different therapeutic areas[2][5].

By Region

The regional segmentation provides a detailed analysis of the market size, sales volume, and revenue in various regions. This includes country-specific data, which is crucial for companies looking to expand their market presence or enter new markets[2][5].

Projections and Future Outlook

Growth Drivers

The growth of the dofetilide market is driven by several factors, including the increasing prevalence of atrial fibrillation and atrial flutter, advancements in healthcare infrastructure, and the need for effective antiarrhythmic treatments. The market is also influenced by the aging population and the rising incidence of cardiovascular diseases[2].

Challenges and Opportunities

Despite the positive outlook, the dofetilide market faces challenges such as the risk of adverse events like torsade de pointes, which can limit its use in certain patient populations. However, ongoing research and development aimed at improving the safety profile and efficacy of dofetilide present opportunities for market growth. Additionally, the expansion of the pharmaceutical industry in emerging markets offers new avenues for growth[1][3][5].

Key Takeaways

• Efficacy in Clinical Trials: Dofetilide has been shown to be effective in restoring and maintaining sinus rhythm in patients with atrial fibrillation and atrial flutter, particularly those with reduced left ventricular function.
• Market Growth: The global dofetilide market is projected to grow significantly over the next few years, driven by increasing demand and expanding healthcare infrastructure.
• Regional Analysis: The market is segmented by region, with North America, Europe, and the Asia-Pacific being key contributors.
• Key Players: The market is dominated by several key pharmaceutical companies, with the top five players holding a significant market share.
• Future Outlook: The market is expected to grow due to the increasing prevalence of cardiovascular diseases and the need for effective antiarrhythmic treatments.

FAQs

What is dofetilide used for?

Dofetilide is used to treat atrial fibrillation and atrial flutter by restoring and maintaining a normal heart rhythm.

What are the key findings of the DIAMOND Low Ejection Fraction Substudy?

The DIAMOND Low Ejection Fraction Substudy found that dofetilide is more effective than placebo in restoring and maintaining sinus rhythm in patients with reduced left ventricular function, and that successful maintenance of sinus rhythm is associated with improved survival and lower hospitalization rates.

Which regions are expected to drive the growth of the dofetilide market?

The North American, European, and Asia-Pacific regions are expected to be key drivers of the dofetilide market growth.

What are the potential risks associated with dofetilide?

One of the potential risks associated with dofetilide is the occurrence of torsade de pointes, a type of abnormal heart rhythm.

Who are the major players in the global dofetilide market?

Major players in the global dofetilide market include Sigmapharm Laboratories, Mayne Pharma, Novadoz Pharmaceuticals, Pfizer, NorthStar Rx LLC, AvKARE, Inc., Accord Healthcare, Bionpharma, and Sun Pharmaceutical Industries Ltd.

Sources

1. Efficacy of Dofetilide in the Treatment of Atrial Fibrillation-Flutter in Patients With Reduced Left Ventricular Function. A Danish Investigation of Arrhythmia and Mortality On Dofetilide (DIAMOND) Substudy. American College of Cardiology.
2. Dofetilide - Global Market Share and Ranking, Overall Sales and Demand Forecast 2024-2030. QYResearch.
3. European and Australian Multicenter Evaluative Research on Atrial Fibrillation—Dofetilide - EMERALD. American College of Cardiology.
4. Efficacy of dofetilide in the treatment of atrial fibrillation ... - PubMed. PubMed.
5. Global Dofetilide API Market Research Report 2024. QYResearch.

Last updated: 2025-01-07