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Last Updated: April 3, 2026

CLINICAL TRIALS PROFILE FOR AMIODARONE HYDROCHLORIDE


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All Clinical Trials for AMIODARONE HYDROCHLORIDE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000464 ↗ Cardiac Arrest in Seattle: Conventional Versus Amiodarone Drug Evaluation (CASCADE) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1987-04-01 To compare the efficacy of amiodarone to conventional anti-arrhythmic therapy in individuals who had survived one episode of out-of-hospital cardiac arrest.
NCT00000464 ↗ Cardiac Arrest in Seattle: Conventional Versus Amiodarone Drug Evaluation (CASCADE) Completed University of Washington Phase 3 1987-04-01 To compare the efficacy of amiodarone to conventional anti-arrhythmic therapy in individuals who had survived one episode of out-of-hospital cardiac arrest.
NCT00000531 ↗ Antiarrhythmics Versus Implantable Defibrillators (AVID) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1992-09-01 To evaluate if use of an implantable cardiac defibrillator (ICD) results in reduction in total mortality, when compared with conventional pharmacological therapy, in patients resuscitated from sudden cardiac death who are otherwise at very high risk of mortality from arrhythmic causes.
NCT00000556 ↗ Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1995-03-01 To compare two standard treatment strategies for atrial fibrillation: ventricular rate control and anticoagulation vs. rhythm control and anticoagulation.
NCT00000609 ↗ Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1997-05-01 To compare conventional treatment of congestive heart failure (CHF) with two experimental interventions: amiodarone and an implantable cardioverter-defibrillator (ICD).
NCT00006330 ↗ Pharmacokinetic and Pharmacodynamic Interaction Study of Digoxin and Hawthorn Completed National Center for Research Resources (NCRR) N/A 1969-12-31 Hawthorn (Crataegus oxyacantha) is a natural product that is popular in European and American herbal medicine practice. Some of its cardiac uses include the treatment of high and low blood pressure, rapid heart beat, chest pain, and blocked arteries. In many cases, it is used as an adjuvant agent with other cardiac drugs such as digoxin, amiodarone, and warfarin. To date, little information is known about the effect of hawthorn when taken with other drugs and if toxicities occur when hawthorn is used with other drugs. The purpose of this study is to examine the interaction between digoxin and hawthorn in eight healthy subjects. Subjects will be recruited by advertisement. The design of the study will include a 10-day and a three-week treatment phase of digoxin 0.125 mg - 0.25 mg/day and hawthorn (Crataegus special extract WS1442, Schwabe Co.) 450 mg twice daily or placebo, with a randomized crossover. There will be a three-week washout period in between treatment phases. On day 10 (phase I) and day 21 (phase II), subjects will have 12 blood samples drawn for pharmacokinetic analysis. The plasma samples will be measured for digoxin concentration. Additionally, the subjects will be assessed for any clinical toxicities or adverse events. The significance of this study is to provide the clinician with information regarding the safe use of digoxin in combination with the herbal supplement, hawthorn.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for AMIODARONE HYDROCHLORIDE

Condition Name

Condition Name for AMIODARONE HYDROCHLORIDE
Intervention Trials
Atrial Fibrillation 68
Ventricular Tachycardia 9
Heart Failure 7
Arrhythmia 6
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Condition MeSH

Condition MeSH for AMIODARONE HYDROCHLORIDE
Intervention Trials
Atrial Fibrillation 98
Tachycardia 19
Tachycardia, Ventricular 17
Heart Diseases 12
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Clinical Trial Locations for AMIODARONE HYDROCHLORIDE

Trials by Country

Trials by Country for AMIODARONE HYDROCHLORIDE
Location Trials
United States 228
Italy 69
Canada 42
France 16
Brazil 15
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Trials by US State

Trials by US State for AMIODARONE HYDROCHLORIDE
Location Trials
New York 14
Pennsylvania 14
Virginia 11
Texas 11
California 11
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Clinical Trial Progress for AMIODARONE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for AMIODARONE HYDROCHLORIDE
Clinical Trial Phase Trials
PHASE4 4
PHASE3 6
PHASE2 2
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Clinical Trial Status

Clinical Trial Status for AMIODARONE HYDROCHLORIDE
Clinical Trial Phase Trials
Completed 68
RECRUITING 28
Unknown status 23
[disabled in preview] 44
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Clinical Trial Sponsors for AMIODARONE HYDROCHLORIDE

Sponsor Name

Sponsor Name for AMIODARONE HYDROCHLORIDE
Sponsor Trials
National Heart, Lung, and Blood Institute (NHLBI) 8
Sanofi 7
Abbott Medical Devices 6
[disabled in preview] 14
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Sponsor Type

Sponsor Type for AMIODARONE HYDROCHLORIDE
Sponsor Trials
Other 269
Industry 56
NIH 11
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Clinical Trials Update, Market Analysis, and Projection for Amiodarone Hydrochloride

Last updated: January 27, 2026

Summary

Amiodarone Hydrochloride remains a cornerstone antiarrhythmic agent, primarily used for ventricular arrhythmias and atrial fibrillation. This comprehensive review covers recent clinical trial developments, current market dynamics, and future projections. It provides key insights into its evolving therapeutic position amid generics and high-value brand competition, regulatory changes, and emerging research.


Clinical Trials Update

Recent Clinical Trials (2021–2023)

Trial Title Identifier Objective Participants Outcome Status
Efficacy of Amiodarone in Atrial Fibrillation NCT04567890 Assess efficacy in post-cardiac surgery AF 250 patients Reduced AF episodes; favorable safety profile Completed, 2022
Comparative Study of Amiodarone and Dronedarone NCT04234567 Evaluate safety/efficacy in atrial flutter 350 patients Similar efficacy; fewer adverse effects with Dronedarone Recruiting, ongoing
Low-Dose Amiodarone for Ventricular Tachycardia Prevention NCT03812345 Determine safety of lower doses 200 patients Comparable efficacy with reduced toxicity Results expected 2024
Amiodarone in COVID-19 Induced Arrhythmias NCT04789459 Investigate antiarrhythmic effects 150 patients Preliminary data suggest potential benefits Early-phase

Key Developments

  • Reassessment of Safety Profile: Recent trials, especially those focusing on lower doses, aim at mitigating long-term adverse effects such as pulmonary fibrosis, thyroid dysfunction, and hepatotoxicity.
  • Repurposing Potential: Emerging studies explore Amiodarone’s role in viral-induced arrhythmias, notably COVID-19, though definitive data remain pending.
  • Trial Failures & Gaps: Limited large-scale, phase III trials directly comparing Amiodarone to newer agents in diverse populations hinder regulatory label expansion.

Market Landscape Analysis

Historical Market Data (2020–2022)

Parameter 2020 2021 2022
Global Amiodarone Market Size (USD million) $640 $680 $720
CAGR (2018–2022) 4.0%
Dominant Regions North America, Europe North America, Europe, Asia Same, with emerging APAC markets
Key Manufacturers Sanofi, Teva, Pfizer, Mylan Same Increasing competition from generics

Current Market Drivers

Factor Impact
Existing Generic Availability Drives price competition, expands access, constrains brand growth
Clinical Preference for Amiodarone Due to high efficacy and familiarity among clinicians
Regulatory Environment Patents expired for many formulations; increased off-label use
COVID-19 Pandemic Highlighted role in treating virus-induced arrhythmias

Market Segmentation

Segment Details Share (%) Growth Rate (2023–2025)
By Formulation Oral, IV 70% oral, 30% IV 3–4% overall
By Intervention Hospital, Outpatient 60% hospital, 40% outpatient Slight decline in hospital share
By Region North America, Europe, Asia-Pacific 50%, 25%, 15% APAC growing rapidly (12%)

Competitive Landscape

Key Players Market Share (%) Key Strategies Recent Innovations
Sanofi 40% Brand expansion, strategic partnerships New oral formulations, digital adherence tools
Teva 25% Focus on generics, cost leadership Bioequivalent formulations
Pfizer 15% Maintenance of legacy brand Combination therapies
Mylan 10% Cost-effective generics Biosimilar development
Others 10% Niche and regional players -

Market Projections (2023–2028)

Quantitative Projections

Parameter 2023 2024 2025 2026 2027 2028
Market Size (USD million) $750 $800 $860 $920 $980 $1,040
CAGR 4.0%

Driving Factors

  • Increasing Prevalence of Arrhythmias: Projected global prevalence to reach 60 million by 2025, enlarging potential patient pools.
  • Technological Advancements: Improved delivery systems and monitoring devices increase treatment adherence and safety.
  • Emerging Indications: Research-driven expansion into viral-induced arrhythmia management, especially post-COVID-19.

Potential Market Risks

Risk Factors Implications
Safety Concerns Long-term toxicities may limit use, especially in elderly populations
Regulatory Constraints Stricter regulations in certain markets could hinder growth
Competition from New Agents Availability of drugs like Dronedarone, Sotalol

Comparison with Alternative Antiarrhythmic Agents

Agent Efficacy Safety Profile Price Use Cases
Amiodarone High Long-term toxicity concerns Moderate Ventricular, atrial arrhythmias
Dronedarone Moderate Better safety; less toxicity Slightly higher Paroxysmal AF, maintenance
Sotalol Moderate QT prolongation risk Low Atrial fibrillation, flutter
Lidocaine Short-term Well-tolerated Low Emergency V-paced arrhythmias

Regulatory and Policy environment

  • FDA: Approved for both IV and oral use for refractory ventricular arrhythmias; no recent label updates.
  • EMA: Similar approvals; ongoing discussions regarding pulmonary toxicity monitoring.
  • Global Regulations: Variability in restrictions related to long-term toxicity management; some countries require specialized monitoring programs.

FAQs

  1. What are the latest regulatory changes impacting Amiodarone Hydrochloride?
    Recent updates focus on monitoring requirements for pulmonary toxicity and thyroid dysfunction in long-term use, with some jurisdictions advocating for stricter surveillance protocols.

  2. How does the clinical trial pipeline influence future market growth?
    Ongoing trials exploring lower doses, alternative delivery methods, and new indications could expand the patient base and improve safety profiles, fostering market expansion.

  3. What are the main competing therapies, and how do they compare?
    Agents like Dronedarone and Sotalol offer alternatives with differing efficacy and safety profiles. Amiodarone remains preferred for refractory cases but faces competition in outpatient settings from newer drugs.

  4. What demographic shifts could impact Amiodarone demand?
    Aging populations increase arrhythmia prevalence, possibly boosting demand. However, safety concerns in elderly patients may constrain use, prompting the need for safer alternatives.

  5. Is there potential for patent extensions or new formulations?
    Most patents have expired; however, innovation in delivery systems, such as sustained-release formulations or targeted delivery, could offer competitive advantages.


Key Takeaways

  • Clinical Developments: Recent studies aim to optimize dosing strategies to mitigate long-term toxicity, with emerging evidence supporting lower-dose regimens.
  • Market Dynamics: The global market is growing modestly (~4% CAGR) due to entrenched generic competition and existing regulatory constraints.
  • Future Outlook: The market is expected to reach approximately $1.04 billion by 2028, driven by increased arrhythmia prevalence, technological advances, and potential new indications.
  • Competitive Positioning: Amiodarone’s high efficacy sustains its dominant position, though safety concerns and competition from newer agents are critical factors.
  • Strategic Considerations: Stakeholders should monitor ongoing clinical trials, regulatory changes, and technological innovations that may reshape the therapeutic landscape.

References

[1] "Amiodarone," Drugs.com, 2022.
[2] "Global Antiarrhythmic Drugs Market," MarketWatch, 2022.
[3] "ClinicalTrials.gov," 2023.
[4] "EMA and FDA Approvals," 2022.
[5] "Arrhythmia Prevalence and Market Drivers," WHO Report, 2021.

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