Numerous clinical trials evaluate dronedarone across Phase 1 through Phase 4 and unassigned study designs, primarily focusing on atrial fibrillation (including paroxysmal, persistent, recurrent, and postoperative subtypes), atrial flutter, congestive heart failure, and implantable cardioverter-defibrillator shocks. Supported by industry leaders like Sanofi and Boston Scientific Corporation alongside academic institutions such as Rabin Medical Center, Eastbourne General Hospital, and Ruijin Hospital, these investigations include Phase 2 dose-ranging evaluations as well as Phase 4 pharmacokinetic and treatment-initiation studies. Trial recruitment statuses across the records encompass completed, active not recruiting, terminated, not yet recruiting, and unknown statuses.
| 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 | Paroxysmal Atrial Fibrillation |
Eastbourne General Hospital |
2010-03 | PHASE4 |
| NCT01070667 | Unknown status | Paroxysmal Atrial Fibrillation |
Eastbourne General Hospital |
2010-03 | Phase 4 |
| 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
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
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>).
Note: Technical data last updated: Sep 1, 2026.