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Last Updated: March 17, 2025

CLINICAL TRIALS PROFILE FOR FLECAINIDE ACETATE


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All Clinical Trials for FLECAINIDE ACETATE

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT03539302 ↗ INhalation of Flecainide to Convert Recent Onset SympTomatic Atrial Fibrillation to siNus rhyThm (INSTANT) Recruiting InCarda Therapeutics Australia Pty Ltd. Phase 2 2018-05-29 The study consists of 3 parts (Part A, Part B and Part C). Part A was an open-label, randomized, multi center design to evaluate the feasibility of administration of inhaled flecainide in two dosing regimens. Part B was an open-label, multicenter design to confirm the safety (including tolerability) and efficacy of the optimal inhaled flecainide dose determined from Part A. Part C is currently ongoing and is an open-label, multi center study with exploratory objectives to explore the feasibility of patient-led self administration of flecainide. Part C also includes an exploratory sub-study to assess the feasibility of implementing a portable cardiac ultrasound (HHE) at screening in an emergent setting.
NCT01117454 ↗ Flecainide for Catecholaminergic Polymorphic Ventricular Tachycardia Completed Vanderbilt University N/A 2011-12-01 The purpose of this study is to test whether the addition of oral flecainide to standard therapy will reduce ventricular ectopy on exercise test compared to placebo plus standard therapy in patients with Catecholaminergic Polymorphic Ventricular Tachycardia.
NCT01117454 ↗ Flecainide for Catecholaminergic Polymorphic Ventricular Tachycardia Completed Vanderbilt University Medical Center N/A 2011-12-01 The purpose of this study is to test whether the addition of oral flecainide to standard therapy will reduce ventricular ectopy on exercise test compared to placebo plus standard therapy in patients with Catecholaminergic Polymorphic Ventricular Tachycardia.
NCT00189319 ↗ To Evaluate the Impact of Oral Flecainide on Quality of Life in Patients With Paroxysmal Atrial Fibrillation Completed MEDA Pharma GmbH & Co. KG Phase 4 2003-09-01 The purpose of this study is to evaluate the management of paroxysmal atrial fibrillation with controlled release flecainide on patient's quality of life.
NCT00002996 ↗ Flecainide in Treating Patients With Chronic Neuropathic Pain Completed National Cancer Institute (NCI) Phase 2 1998-02-01 RATIONALE: Flecainide therapy may help patients with neuropathic pain live more comfortably. PURPOSE: Phase II trial to study the effectiveness of flecainide in treating patients with chronic neuropathic pain from cancer or AIDS.
NCT00002996 ↗ Flecainide in Treating Patients With Chronic Neuropathic Pain Completed Eastern Cooperative Oncology Group Phase 2 1998-02-01 RATIONALE: Flecainide therapy may help patients with neuropathic pain live more comfortably. PURPOSE: Phase II trial to study the effectiveness of flecainide in treating patients with chronic neuropathic pain from cancer or AIDS.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 6 of 6 entries

Clinical Trial Conditions for FLECAINIDE ACETATE

Condition Name

11110-0.100.10.20.30.40.50.60.70.80.911.1Atrial FibrillationCatecholaminergic Polymorphic Ventricular TachycardiaPainParoxysmal Atrial Fibrillation[disabled in preview]
Condition Name for FLECAINIDE ACETATE
Intervention Trials
Atrial Fibrillation 1
Catecholaminergic Polymorphic Ventricular Tachycardia 1
Pain 1
Paroxysmal Atrial Fibrillation 1
[disabled in preview] 0
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Condition MeSH

3111000.511.522.53Atrial FibrillationTachycardia, VentricularTachycardiaNeuralgia[disabled in preview]
Condition MeSH for FLECAINIDE ACETATE
Intervention Trials
Atrial Fibrillation 3
Tachycardia, Ventricular 1
Tachycardia 1
Neuralgia 1
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Clinical Trial Locations for FLECAINIDE ACETATE

Trials by Country

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Trials by Country for FLECAINIDE ACETATE
Location Trials
United States 12
Belgium 1
France 1
Netherlands 1
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Trials by US State

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Trials by US State for FLECAINIDE ACETATE
Location Trials
Utah 1
Texas 1
Tennessee 1
Ohio 1
North Carolina 1
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Clinical Trial Progress for FLECAINIDE ACETATE

Clinical Trial Phase

20.0%20.0%40.0%20.0%00.911.11.21.31.41.51.61.71.81.922.1Phase 4Phase 3Phase 2[disabled in preview]
Clinical Trial Phase for FLECAINIDE ACETATE
Clinical Trial Phase Trials
Phase 4 1
Phase 3 1
Phase 2 2
[disabled in preview] 1
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Clinical Trial Status

60.0%20.0%20.0%000.511.522.53CompletedNot yet recruitingRecruiting[disabled in preview]
Clinical Trial Status for FLECAINIDE ACETATE
Clinical Trial Phase Trials
Completed 3
Not yet recruiting 1
Recruiting 1
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Clinical Trial Sponsors for FLECAINIDE ACETATE

Sponsor Name

trials0112233InCarda Therapeutics, Inc.MEDA Pharma GmbH & Co. KGVanderbilt University[disabled in preview]
Sponsor Name for FLECAINIDE ACETATE
Sponsor Trials
InCarda Therapeutics, Inc. 2
MEDA Pharma GmbH & Co. KG 1
Vanderbilt University 1
[disabled in preview] 3
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Sponsor Type

50.0%37.5%12.5%000.511.522.533.54IndustryOtherNIH[disabled in preview]
Sponsor Type for FLECAINIDE ACETATE
Sponsor Trials
Industry 4
Other 3
NIH 1
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Flecainide Acetate: Clinical Trials Update, Market Analysis, and Projections

Introduction to Flecainide Acetate

Flecainide acetate is an antiarrhythmic drug used primarily to treat various cardiac arrhythmias, including paroxysmal atrial fibrillation (PAF) and ventricular arrhythmias. The drug has been a subject of significant clinical and market interest due to its efficacy and the ongoing efforts to improve its delivery systems.

Clinical Trials Update

RESTORE-1 Phase 3 Trial

The RESTORE-1 Phase 3 trial, conducted by InCarda Therapeutics, was designed to evaluate the efficacy and safety of inhaled flecainide acetate (FlecIH-103) for the treatment of PAF. Although the trial was terminated prematurely due to lower-than-expected efficacy and plasma flecainide levels, it still provided promising data.

  • Efficacy: Despite the early termination, the trial demonstrated a statistically significant cardioversion rate of 31% in the treatment group compared to the placebo group[1][4].
  • Safety: There were no safety concerns associated with the administration of FlecIH-103, and the safety profile was consistent with previous studies[1][4].

Transition to New Delivery System

Following the RESTORE-1 trial, InCarda Therapeutics has transitioned to a novel drug delivery platform. Preliminary interim results from a Phase 1 clinical study in Australia using this new system have been encouraging:

  • Efficiency: The new delivery system achieved peak flecainide plasma concentrations (Cmax) similar to those in the Phase 2 INSTANT trial but with only one-third of the drug amount needed compared to the previous nebulizer method[1][4].
  • Safety and Tolerability: Electrocardiographic changes were transient and within safe ranges, and no new safety signals or serious adverse events were reported[4].

Future Clinical Plans

InCarda plans to complete the ongoing Phase 1 study, including the investigation of additional dose regimens such as booster doses. New safety and efficacy trials are scheduled to initiate in 2025, focusing on both medically supervised settings and portable self-administration[1][4].

Market Analysis

Current Market Size and Growth

The global flecainide acetate market has been growing steadily. As of 2023, the market size was valued at USD 1.4 billion and is projected to reach USD 2.6 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 8.2% from 2024 to 2031[5].

Market Drivers

Several factors are driving the growth of the flecainide acetate market:

  • Increasing Prevalence of Cardiac Arrhythmias: The rising incidence of cardiac arrhythmias, such as atrial fibrillation, is increasing the demand for effective antiarrhythmic drugs like flecainide acetate[5].
  • Improving Healthcare Infrastructure: Enhanced healthcare infrastructure globally is making flecainide acetate more accessible, contributing to market growth[5].
  • R&D Initiatives: Continuous research and development to improve medication formulations and delivery systems are expected to further support market expansion[5].

Market Segmentation

The flecainide acetate market is segmented by product type, end-use/application, and geography. Key regions include North America, South America, Asia & Pacific, Europe, and the Middle East & Africa. The report also analyzes the competitive landscape, including key players and their market shares, sales, revenue, and gross margin[2].

Market Projections

Market Potential

The market for flecainide acetate is expected to grow significantly due to the increasing need for effective antiarrhythmic treatments. InCarda Therapeutics estimates that the inhaled flecainide acetate product alone has a potential market size of over a billion dollars in addressing the unmet medical need for acute management of PAF[4].

Regional Outlook

The market is expected to grow across various regions, with key countries such as the United States, China, Japan, India, and several European nations playing significant roles. The Asia & Pacific region is anticipated to be a major growth area due to the large population and improving healthcare infrastructure[2].

Intellectual Property and Regulatory Considerations

InCarda Therapeutics has intellectual property protection for its inhaled flecainide acetate solution, which could be extended through 2045 with the inclusion of the new delivery system. This extended protection is crucial for maintaining market exclusivity and driving further innovation[4].

Expert Insights

Dr. Luiz Belardinelli, Chief Medical Officer of InCarda Therapeutics, expressed optimism about the potential of inhaled flecainide as a valuable treatment for patients with recent-onset PAF. He highlighted the statistically significant higher conversion rate in the active treatment group and the encouraging safety and tolerability profiles observed in the trials[1][4].

Key Takeaways

  • Clinical Trials: The RESTORE-1 Phase 3 trial showed promising efficacy and safety data for inhaled flecainide acetate despite early termination.
  • New Delivery System: The novel drug delivery platform has demonstrated improved efficiency and safety.
  • Market Growth: The global flecainide acetate market is projected to grow significantly, driven by increasing demand for antiarrhythmic drugs and improving healthcare infrastructure.
  • Market Potential: InCarda Therapeutics estimates a market potential of over a billion dollars for its inhaled flecainide acetate product.
  • Intellectual Property: Extended intellectual property protection through 2045 supports market exclusivity and innovation.

FAQs

What is the current status of the RESTORE-1 Phase 3 trial for inhaled flecainide acetate?

The RESTORE-1 Phase 3 trial was terminated prematurely due to lower-than-expected efficacy and plasma flecainide levels, but it still demonstrated a statistically significant cardioversion rate and a favorable safety profile[1][4].

What are the key findings from the new drug delivery system for inhaled flecainide acetate?

The new delivery system achieved peak flecainide plasma concentrations similar to those in previous trials but with only one-third of the drug amount needed, and it showed transient and safe electrocardiographic changes[1][4].

What is the projected market size for flecainide acetate by 2031?

The global flecainide acetate market is expected to reach USD 2.6 billion by 2031, growing at a CAGR of 8.2% from 2024 to 2031[5].

What are the main drivers of the flecainide acetate market growth?

The market growth is driven by the increasing prevalence of cardiac arrhythmias, improving healthcare infrastructure, and continuous R&D initiatives to improve medication formulations and delivery systems[5].

What is the estimated market potential for InCarda Therapeutics' inhaled flecainide acetate product?

InCarda Therapeutics estimates that the inhaled flecainide acetate product has a market potential of over a billion dollars in addressing the unmet medical need for acute management of PAF[4].

Sources

  1. InCarda Therapeutics Reveals RESTORE-1 Phase 3 Trial Results and Future Development Plans. Synapse.
  2. Global Flecainide acetate (CAS 54153-56-5) Market Report 2019. Valuates Reports.
  3. Clinical Study Protocol. ClinicalTrials.gov.
  4. InCarda Therapeutics Announces Results From the RESTORE-1 Phase 3 Trial and Plans for Continued Development. InCarda Therapeutics.
  5. Flecainide Market Size and Projections. Market Research Intellect.

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