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Cordarone

(Amiodarone)

ApprovedSmall molecule

WWyeth-Lederle Vaccines

Amiodarone is used to treat serious heart rhythm problems (arrhythmias) by helping the heart maintain a normal, steady heartbeat. It's typically prescribed when other medications haven't worked or for life-threatening irregular heartbeats.[2] Cordarone is currently approved and in use across 11 indications[4].[1]

Cordarone is one of 202 small molecule programs targeting Cardiac Arrhythmia. It is currently in Approved.

11

Indications

75

Total Trials

12

Active Trials

201

Competitors

4

FDA Applications

NDA/BLA/ANDA regulatory filings

1

Patents

Pipeline

Status by Indication[4][1]

Indication

Cardiac ArrhythmiaActive, not recruiting

Cardiac ArrestUnknown status

Ebola Hemorrhagic FeverApproved

CardiomyopathyActive, not recruiting

AL AmyloidosisApproved

Supraventricular TachycardiaApproved

Coronary Artery BypassCompleted

Atrial FibrillationCompleted

RecurrentTerminated

Surgery, CardiacNot yet recruiting

Cardiac ArrhythmiaApproved

Active, not recruiting

Cardiac ArrestPhase 3

Unknown status

Ebola Hemorrhagic FeverApproved

Approved

CardiomyopathyApproved

Active, not recruiting

AL AmyloidosisApproved

Approved

Supraventricular TachycardiaApproved

Approved

Coronary Artery BypassApproved

Completed

Atrial FibrillationApproved

Completed

RecurrentPreclinical

Terminated

Surgery, CardiacApproved

Not yet recruiting

Showing 10 of 11 indications

Competition

Competitive Landscape

136 competitors in Atrial Fibrillation

#DrugCompanyPhaseTrials

Cordarone

WWyeth-Lederle Vaccines

Calquence

Rituxan

Coumadin

Brukinsa

BBeOne Medicines

Imbruvica

PPharmacyclics LLC.

Versed

CConrado Roberto Hoffmann Filho

Ondexxya

UUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology

Romazicon

CConrado Roberto Hoffmann Filho

Statin

Bristol-Myers Squibb

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 3Recruiting

Cardiac Arrest

NCT06835491

Q4 2027

Phase 3Recruiting

Atrial Fibrillation

NCT06722196

Q4 2028

ApprovedNot yet recruiting

Surgery, Cardiac

NCT05543278

Q1 2032

Phase 3Not yet recruiting

Atrial Fibrillation (AF)

NCT07887022

Clinical

Trials by Indication[1]

Atrial Fibrillation38 trials

Use of Amiodarone in Atrial Fibrillation Associated With Severe Sepsis or Septic Shock

Terminated·TThe University of Texas Health Science Center at San Antonio·Phase 4·NCT02668432·9 enrolled

Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM)

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 3·NCT00000556

Effectiveness of Repeated Amiodarone Dosing Regimen Versus Standard Dosing Regimen in Atrial Fibrillation Patient With Rapid Ventricular Response

Completed·—·Phase 4·NCT06262932·24 enrolled

Show 35 more trials

A Study Comparing Vernakalant Therapy to Amiodarone Therapy in Acute Management of Recent Onset Atrial Fibrillation (AF) (MK-6621-055)

Withdrawn·AAdvanz Pharma·Phase 4·NCT01627106

AMIOdarone vs. Catheter Ablation for Prevention of Recurrent Symptomatic Atrial Fibrillation

Terminated·PPopulation Health Research Institute·Phase 4·NCT02341105·10 enrolled

Prevention of Atrial Fibrillation Following Esophagectomy

Completed·IIndiana University·Phase 4·NCT00420017·80 enrolled

Prophylaxis to Reduce Postoperative Atrial Fibrillation in Cardiac Surgery

Completed·MMaineHealth·Phase 3·NCT00953212·304 enrolled

Amiodarone and N-Acetylcysteine or Amiodarone Alone for Preventing Atrial Fibrillation After Thoracic Surgery

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 3·NCT02750319·184 enrolled

Efficacy & Safety of Dronedarone Versus Amiodarone for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation

Completed· Sanofi logo

Sanofi·Phase 3·NCT00489736·504 enrolled

Comparison of Two Strategies for the Management of Atrial Fibrillation After Cardiac Surgery

Unknown status·UUniversity Hospital, Caen·Phase 4·NCT04223739·380 enrolled

Study of Amiodarone Given Before Lung Surgery to Prevent Atrial Fibrillation After Lung Resection

Terminated·—·Phase 3·NCT00300495·19 enrolled

Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation

Completed·IIcahn School of Medicine at Mount Sinai·Phase 3·NCT02132767·523 enrolled

Comparison of Treatment of Atrial Fibrillation (AF) Between Surgical Ultrasonic Technology or Drug Therapy for Patients With AF Requiring Mitral Valve Surgery

Terminated·—·N/A·NCT01649544·6 enrolled

Nifekalant Versus Amiodarone in New-Onset Atrial Fibrillation After Cardiac Surgery

Recruiting·—·Phase 3·NCT05169866·274 enrolled

Control Versus Liberal Cardiac Frequency in Patients in Sepse With Atrial Fibrillation of High Ventricular Response

Unknown status·UUniversity of Sao Paulo General Hospital·Phase 3·NCT03715556·126 enrolled

MAGNAM Trial, Magnesium Versus Amiodarone in Atrial Fibrillation in Critical Care

Recruiting·SSunnybrook Health Sciences Centre·Phase 3·NCT05287191·200 enrolled

Evaluate the Pharmacokinetics and Safety of MK-4448 in Participants With Nonvalvular Atrial Fibrillation or Atrial Flutter

Completed·PPortola Pharmaceuticals·Phase 2·NCT01229254·189 enrolled

Prophylaxis Against Postoperative Atrial Fibrillation in Patients Undergoing On-pump CABG

Unknown status·Ddoaa rashwan·Phase 2/3·NCT03905759·48 enrolled

Comparing the Effects of Amiodarone, Sotalol, and Placebo in Maintaining Sinus Rhythm in Patients With Atrial Fibrillation Converted to Sinus Rhythm

Completed·UUS Department of Veterans Affairs·Phase 3·NCT00007605·706 enrolled

Prevention of Atrial Fibrillation Following Noncardiac Thoracic Surgery

Completed·IIndiana University·Phase 4·NCT00127712·130 enrolled

The Effect of Short Term Amiodarone Treatment After Catheter Ablation for Atrial Fibrillation

Completed·RRigshospitalet, Denmark·N/A·NCT00826826·212 enrolled

n-3 Polyunsaturated Fatty Acids (PUFAs) in the Prevention of Atrial Fibrillation

Completed·AAzienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia·Phase 3·NCT01198275·199 enrolled

Catheter Ablation Compared With Pharmacological Therapy for Atrial Fibrillation (CAPTAF Trial)

Unknown status·UUppsala University Hospital·N/A·NCT02294955·152 enrolled

Cardiac Resynchronization in Atrial Fibrillation Trial - a Pilot Study

Unknown status·NNational Institute of Cardiology, Warsaw, Poland·Phase 4·NCT01850277·60 enrolled

Combined Amiodarone and Electrical Cardioversion for Postoperative Atrial Fibrillation After Cardiac Surgery

Terminated·WWeill Medical College of Cornell University·N/A·NCT01558128·1 enrolled

Antiarrhythmic Drugs Assessment in Preventing Atrial Fibrillation

Unknown status·XXinhua Hospital, Shanghai Jiao Tong University School of Medicine·Phase 4·NCT02145546·600 enrolled

Atrial Fibrillation Without Hemodynamic Instability in the Intensive Care Unit

Completed·OOttawa Hospital Research Institute·Phase 4·NCT01461733·25 enrolled

Effect of Amiodarone on the Procedure Outcome in Long-standing Persistent Atrial Fibrillation Undergoing Pulmonary Vein Antral Isolation

Completed·TTexas Cardiac Arrhythmia Research Foundation·Phase 3·NCT01173809·176 enrolled

Treatment of Postoperative Atrial Fibrillation - Comparison of Amiodarone and Placebo.

Unknown status·RRambam Health Care Campus·Phase 3·NCT02715687·400 enrolled

A Phase III Superiority Study of Vernakalant vs Amiodarone in Subjects With Recent Onset Atrial Fibrillation

Completed·AAdvanz Pharma·Phase 3·NCT00668759·254 enrolled

Efficacy and Safety of Intravenous + Oral Vs. Oral Amiodarone in Preventing Recurrence After Catheter Ablation in Patients with Persistent Atrial Fibrillation

Not yet recruiting·SShanghai Chest Hospital·N/A·NCT06742866·418 enrolled

BiodEgradable Soaked Amiodarone paTch Use for the Prevention of Atrial Fibrillation After Cardiac Surgery

Recruiting·JJilin Heart Hospital·Phase 3·NCT06722196·500 enrolled

Evaluation of Cardioverter Capacity of Amiodarone Pre-electrical Cardioversion in Persistent Atrial Fibrillation

Not yet recruiting·IInstitut Investigacio Sanitaria Pere Virgili·Phase 4·NCT06645249·122 enrolled

Time-dependent Amiodarone Treatment in Atrial Fibrillation

Completed·IInstituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud·Phase 4·NCT03432663·60 enrolled

Prevention of Postop Atrial Fibrillation Through Intraoperative Inducibility of Atrial Fibrillation and Amiodarone Treatment

Recruiting·SStanford University·Phase 4·NCT03868150·600 enrolled

Amiodarone Prophylaxis for Atrial Fibrillation in Patients Undergoing Surgery for Lung Cancer

Unknown status·—·Phase 4·NCT00724581·275 enrolled

Continuous Versus Episodic Amiodarone Treatment for the Prevention of Permanent Atrial Fibrillation

Completed·UUniversity Medical Center Groningen·N/A·NCT00392431·220 enrolled

Minocycline Plus Amiodarone Versus Amiodarone Alone for the Prevention of Atrial Fibrillation After Cardiac Surgery (MINA)

Withdrawn·BBaystate Medical Center·Phase 2·NCT01422148

Cardiac Arrest6 trials

Cardiac Arrest in Seattle: Conventional Versus Amiodarone Drug Evaluation (CASCADE)

Completed·UUniversity of Washington·Phase 3·NCT00000464

Prophylactic Anti-aRrhythmic Therapy With Amiodarone in Critically Ill Patients Admitted for an Out-of-hospital Cardiac Arrest With Initial Shockable Rhythm

Recruiting·VVersailles Hospital·Phase 3·NCT06835491·674 enrolled

In-hospital Cardiac Arrest - Dynamics and State Transitions

Completed·SSt. Olavs Hospital··NCT00920244·285 enrolled

Show 3 more trials

Amiodarone, Lidocaine or Neither for Out-Of-Hospital Cardiac Arrest Due to Ventricular Fibrillation or Tachycardia

Completed·UUniversity of Washington·Phase 3·NCT01401647·3,024 enrolled

AMSA and Amiodarone Study in Cardiac Arrest

Completed·FFondazione IRCCS Policlinico San Matteo di Pavia··NCT04997980·629 enrolled

Prophylactic Amiodarone for Shockable Cardiac Arrest

Unknown status·WWon Young Kim·Phase 3·NCT04845607·302 enrolled

Arrhythmia2 trials

Amiodarone to Prevent Post-Operative Arrhythmias

Completed·UUniversity of Calgary·Phase 3·NCT00251706·600 enrolled

Modeling of Amiodarone Effect on Heart Rate Control in Critically Ill Patients With Atrial Tachyarrhythmias

Completed·GGroupe Hospitalier Pitie-Salpetriere··NCT03413150·80 enrolled

Coronary Artery Bypass2 trials

Reduction of Atrial Fibrillation Study in Patients Undergoing Coronary Artery Bypass Grafting. (RASCABG 1 Study)

Completed·UUniversity of Aarhus·Phase 4·NCT00287209·250 enrolled

Effect of Prophylaxy of Amiodarone and Propranolol and Amiodarone With Propranolol in Prevention of Atrial Fibrillation Post Coronary Artery Bypass Graft

Completed·SShiraz University of Medical Sciences·N/A·NCT00654290·240 enrolled

Ventricular Tachycardia2 trials

Pilot Study of Catheter Ablation for Ventricular Tachycardia in Patients With an Implantable Cardioverter Defibrillator

Terminated·—·N/A·NCT01576042·27 enrolled

Catheter Ablation Versus Amiodarone for Shock Prophylaxis in Defibrillator Patients With Ventricular Tachycardia

Terminated·PPopulation Health Research Institute·Phase 3·NCT01097330·12 enrolled

24 more indications

Post-Operative Atrial Fibrillation2 trials

Vernakalant Versus Amiodarone for Post-operative Atrial Fibrillation in Cardiac Surgery Patients

Not yet recruiting·UUniversity of Calgary·Phase 3·NCT04748991·50 enrolled

Prophylaxis for Patients at Risk to Eliminate Post-operative Atrial Fibrillation

Unknown status·OOttawa Hospital Research Institute·N/A·NCT04392921·80 enrolled

Paroxysmal atrial fibrillation1 trial

Flecainide Versus Amiodarone in the Cardioversion of Paroxysmal Atrial Fibrillation at the Emergency Department, in Patients With Coronary Artery Disease Without Residual Ischemia

Recruiting·HHippocration General Hospital·Phase 3·NCT05549752·80 enrolled

Safety and Efficacy1 trial

Safety and Efficacy of Oral Versus Intravenous Amiodarone in the Treatment of AF

Unknown status·WWestern Galilee Hospital-Nahariya·Phase 3·NCT01817439·104 enrolled

Implantable Cardioverter Defibrillator (ICD)1 trial

Dose Ranging Study of Celivarone With Amiodarone as Calibrator for the Prevention of Implantable Cardioverter Defibrillator (ICD) Interventions or Death

Completed· Sanofi logo

Sanofi·Phase 2·NCT00993382·486 enrolled

Cardiac Surgical Procedures1 trial

Repeated Amiodarone Dosing In Cardiac surgicaL Procedures

Terminated·—·Phase 4·NCT05004077·3 enrolled

Ablation1 trial

Pulmonary Vein Ablation Versus Amiodarone in the Elderly

Terminated·AAbbott Medical Devices·N/A·NCT01276093·59 enrolled

Medication1 trial

Shortening Duration of Antiarrhythmic Medication for SVT in Infants

Completed·TTampere University Hospital··NCT04837261·107 enrolled

Heart Disease1 trial

Catheter Ablation Versus Amiodarone for Therapy of Premature Ventricular Contractions in Patients With Structural Heart Disease

Completed·UUniversity of Leipzig·Phase 3·NCT02924285·80 enrolled

Single Dose1 trial

Bioavailability of Dabigatran and Amiodarone After Multiple Oral Administrations of Dabigatran Etexilate With or Without Amiodarone as Single Dose in Healthy Male and Female Volunteers

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02171026·24 enrolled

Cardiac Arrhythmia1 trial

Prevention of Post-Operative Cardiac Arrhythmias

Unknown status·JJeffrey Moak·Phase 4·NCT04234906·870 enrolled

Heart Failure1 trial

Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT)

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 3·NCT00000609

Treatment1 trial

Ablation vs Amiodarone for Treatment of AFib in Patients With CHF and an ICD

Completed·TTexas Cardiac Arrhythmia Research Foundation·Phase 4·NCT00729911·203 enrolled

Efficacy and Safety1 trial

Evaluation of the Efficacy and Safety of Nifekalant Hydrochloride (NIF) Injection.

Unknown status·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 4·NCT03855826·756 enrolled

Cardioversion1 trial

Amiodarone Compared to Dronedarone , Post Cardioversion Maintenance of Sinus Rhythm

Unknown status·—·N/A·NCT01266681·100 enrolled

Ultrasound1 trial

High Intensity Focused Ultrasound (HIFU) Ablation System Study

Suspended·PProRhythm, Inc.·Phase 3·NCT00392106·240 enrolled

Prevention1 trial

Amiodarone for the Prevention of Reperfusion Ventricular Fibrillation

Completed·MMayo Clinic·N/A·NCT00587483·342 enrolled

Congestive Heart Failure1 trial

A Randomized, Placebo-Controlled, Double-Blind, Double Dummy Trial To Determine The Relative Effect Of Pm101 Versus Placebo And Amiodarone IV On Blood Pressure In Subjects With Stable Congestive Heart Failure

Withdrawn·PPrism Pharmaceuticals·Phase 2·NCT00739193

Cardiomyopathy1 trial

Prospective Assessment of Premature Ventricular Contractions Suppression in Cardiomyopathy(PAPS)

Unknown status·HHunter Holmes Mcguire Veteran Affairs Medical Center·Phase 4·NCT03228823·5 enrolled

Recurrent1 trial

INTERVENE: Indian Trial of Endocardial Ventricular Substrate Ablation to Prevent Recurrent VT Events

Terminated·IIcahn School of Medicine at Mount Sinai·N/A·NCT02301390·53 enrolled

Intravenous1 trial

Effects of Epinephrine and Intravenous (I.V.) Needle on Cardiopulmonary Resuscitation (CPR) Outcome

Completed·PPetter Andreas Steen·Phase 2·NCT00121524·904 enrolled

COVID-191 trial

Amiodarone or Verapamil in COVID-19 Hospitalized Patients With Symptoms

Completed·NNicolaus Copernicus University·Phase 2/3·NCT04351763·804 enrolled

Atrial Fibrillation (AF)1 trial

Multicenter and Randomized Study on Atrial Fibrillation Prevention After Cardiac Surgery With a 3-Way Comparison Between Standard of Care, Posterior Pericardiotomy and a Treatment Bundle (Colchicine, Amiodarone and Posterior Pericardiotomy)

Not yet recruiting·EElsan·Phase 3·NCT07887022·636 enrolled

Atrial Fibrillation New Onset1 trial

Usefulness of Amiodarone for the Prevention of New Onset Atrial Fibrillation After Transcatheter Aortic Valve Implantation: a Randomized Controlled Trial

Completed·AAna Belen Rivas Paterna·Phase 3·NCT03991754·121 enrolled

Surgery, Cardiac1 trial

Pragmatic Amiodarone Trial to Reduce Postoperative Atrial Fibrillation in Patients Undergoing Cardiac Surgery

Not yet recruiting·MMassachusetts General Hospital·Approved·NCT05543278·242 enrolled

Regulatory

FDA Approval Timeline[5]

Dec 24, 1985

CORDARONE

NDA NDA018972

Aug 3, 1995

CORDARONE

NDA NDA020377

Feb 4, 2004

AMIODARONE HYDROCHLORIDE

NDA NDA021594

Dec 24, 2008

NEXTERONE

NDA NDA022325

Sources

References

[1]
ClinicalTrials.gov — 75 trial records for Amiodarone. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Cordarone drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Amiodarone compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Amiodarone. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA022325). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Cordarone. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Wyeth-Lederle Vaccines company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: HERG Blocker[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: WWyeth-Lederle Vaccines

Patent Landscape[6]

Patent Cliff

Mar 13, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10177951Mar 13, 2029

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