Clinical Trials

Numerous clinical trials evaluate dronedarone across Phase 1 through Phase 4 studies, primarily investigating atrial fibrillation, atrial flutter, cardiac arrhythmias, congestive heart failure, and implantable cardioverter-defibrillator shocks. These research initiatives are sponsored by industry leaders, such as Sanofi and Boston Scientific Corporation, as well as academic medical centers including Rabin Medical Center and Eastbourne General Hospital. Recorded recruitment statuses across these protocols include completed, active, and terminated trials.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07270848 NOT_YET_RECRUITING
Atrial Fibrillation (AF)
Inha University Hospital
 2026-01-01 PHASE4
NCT05939076 NOT_YET_RECRUITING
Atrial Fibrillation, Persistent
Region Örebro County
 2023-08-21 PHASE3
NCT06096337 ACTIVE_NOT_RECRUITING
Persistent Atrial Fibrillation
Boston Scientific Corporation
 2023-12-28
NCT04942834 COMPLETED
Atrial Fibrillation, Persistent; Arrhythmias, Cardiac
Ruijin Hospital
 2021-10-01
NCT05655468 UNKNOWN
Atrial Fibrillation
Shanghai East Hospital
 2023-03-29 PHASE4
NCT05130268 COMPLETED
Atrial Fibrillation
American Heart Association
 2021-10-29 PHASE4
NCT07396506 COMPLETED
Atrial Fibrillation (AF)
Shandong New Time Pharmaceutical Co., LTD
 2023-06-05
NCT04704050 TERMINATED
Atrial Fibrillation; Atrial Fibrillation Recurrent
Tulane University School of Medicine
 2021-05-15 PHASE4
NCT07396519 COMPLETED
Atrial Fibrillation (AF)
Shandong New Time Pharmaceutical Co., LTD
 2022-11-14
NCT03905759 UNKNOWN
Postoperative Atrial Fibrillation
doaa rashwan
 2019-04-03 PHASE2; PHASE3
NCT02294955 UNKNOWN
Atrial Fibrillation; Quality of Life
Uppsala University Hospital
 2008-05
NCT01430806 UNKNOWN
ICD; ICD SHOCKS; DRONEDARONE
Rabin Medical Center
 2011-10
NCT01522651 COMPLETED
Atrial Fibrillation
Gilead Sciences
 2012-01-24 PHASE2
NCT01991119 COMPLETED
Atrial Fibrillation
Samsung Medical Center
 2011-05
NCT01182376 COMPLETED
Atrial Fibrillation
University of Utah
 2010-11 PHASE3
NCT01266681 UNKNOWN
Atrial Fibrillation
Eastbourne General Hospital
 2011-03
NCT01199081 COMPLETED
Atrial Fibrillation
Sanofi
 2010-10 PHASE4
NCT01135017 TERMINATED
Atrial Fibrillation
Sanofi
 2010-07 PHASE4
NCT01198873 TERMINATED
Atrial Fibrillation
Sanofi
 2010-09 PHASE4
NCT01026090 TERMINATED
Atrial Fibrillation
Sanofi
 2009-11 PHASE4
NCT01140581 COMPLETED
Atrial Fibrillation
Sanofi
 2010-09 PHASE4
NCT01430806 Unknown status
ICD|ICD SHOCKS|DRONEDARONE
Rabin Medical Center
 2011-10 Not Applicable
NCT01151137 TERMINATED
Atrial Fibrillation
Sanofi
 2010-07 PHASE3
NCT01047566 COMPLETED
Atrial Fibrillation
Sanofi
 2010-04 PHASE4
NCT01306162 COMPLETED
Healthy
Boehringer Ingelheim
 2011-02 PHASE1
NCT01213368 COMPLETED
Atrial Fibrillation
Sanofi
 2010-09 PHASE2
NCT01266681 Unknown status
Atrial Fibrillation
Eastbourne General Hospital
 2011-03 Not Applicable
NCT01199081 Completed
Atrial Fibrillation
Sanofi
 2010-10 Phase 4
NCT01213368 Completed
Atrial Fibrillation
Sanofi
 2010-09 Phase 2
NCT01140581 Completed
Atrial Fibrillation
Sanofi
 2010-09 Phase 4
NCT01070667 Unknown status
Paroxysmal Atrial Fibrillation
Eastbourne General Hospital
 2010-03 Phase 4
NCT01070667 UNKNOWN
Paroxysmal Atrial Fibrillation
Eastbourne General Hospital
 2010-03 PHASE4
NCT00489736 COMPLETED
Atrial Fibrillation
Sanofi
 2007-06 PHASE3
NCT00174785 COMPLETED
Atrial Fibrillation; Atrial Flutter
Sanofi
 2005-06 PHASE3
NCT00697086 COMPLETED
Atrial Fibrillation
Sanofi
 2002-08 PHASE3
NCT00259376 COMPLETED
Atrial Fibrillation; Atrial Flutter
Sanofi
 2001-11 PHASE3
NCT00259428 COMPLETED
Atrial Fibrillation; Atrial Flutter
Sanofi
 2001-11 PHASE3
NCT00696631 TERMINATED
Congestive Heart Failure
Sanofi
 2002-06 PHASE3

(data from https://clinicaltrials.gov, updated on 2025-12-22)

Check the Dronedarone HCl product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Dronedarone acts as a multichannel blocker that directly inhibits transmembrane potassium, sodium, and calcium channels within cardiac myocytes. This ionic blockade suppresses depolarizing currents and prolongs the cardiac action potential duration, thereby restoring stable sinus rhythm and managing clinical conditions such as atrial fibrillation and cardiac arrhythmias.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.