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Drug

Amiodarone

Regulatory activity · MHRA
Emerging researchLate-stage developmentSteady momentum
Also known as 2-n-Butyl-3',5'-diiodo-4'-N-diethylaminoethoxy-3-benzoylbenzofuran, Cordarone, Nexterone, Pacerone+5 more

2-n-Butyl-3',5'-diiodo-4'-N-diethylaminoethoxy-3-benzoylbenzofuran, Cordarone, Nexterone, Pacerone, Amiodarona, 2-Butyl-3-(3,5-diiodo-4-(2-diethylaminoethoxy)benzoyl)benzofuran, 2-Butyl-3-benzofuranyl 4-(2-(diethylamino)ethoxy)-3,5-diiodophenyl ketone, Amiodarone Hydrochloride, Amiodaronum.

RxNorm703ChEMBLCHEMBL633ATCC01BD01UNIIN3RQ532IUT
4
Research papers
14
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

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

Clinical trial2026-06-30Results expected Q1 2028 · ClinicalTrials.gov

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

Clinical trial2026-06-03Results expected Q1 2028 · ClinicalTrials.gov

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

Clinical trial2026-06-01Primary completion · ClinicalTrials.gov

Short Term Anti-aRrhythmic Therapy for Post-Operative AF in Cardiac Surgery Patients (START-POAF) Pilot Trial

Clinical trial2026-05-27Results expected Q3 2028 · ClinicalTrials.gov

A Prospective, Randomized Controlled Trial Evaluating the Efficacy of Amiodarone in the Prevention of Postoperative Atrial Fibrillation in Patients Undergoing Minimally Invasive Esophagectomy

Clinical trial2026-05-22Results expected Q3 2027 · ClinicalTrials.gov

Drug Safety Update: Amiodarone: reminder of risks of treatment and need for patient monitoring and supervision

Regulatory2026-05-20MHRA

A Randomized, Double-Blind, Controlled Trial of Combined Amiodarone and N-Acetylcysteine Versus Amiodarone Plus Placebo for the Prevention of Atrial Fibrillation in High Risk Patients Undergoing Thoracic Surgery

Clinical trial2026-05-19Results expected Q2 2027 · ClinicalTrials.gov

A Single-center, Non-randomized, Open-label, Self-controlled Phase I Drug-drug Interaction Clinical Study to Evaluate the Pharmacokinetics of JMKX003142 With Amiodarone, and Febuxostat in Chinese Healthy Subjects

Clinical trial2026-04-30Primary completion · ClinicalTrials.gov

A randomized, controlled study of amiodarone for prevention of atrial fibrillation after transthoracic esophagectomy.

Research2010-04-09The Journal of thoracic and cardiovascular surgery

A randomized trial evaluating amiodarone for prevention of atrial fibrillation after pulmonary resection.

Research2009-09-01The Annals of thoracic surgery

A comparison of rate control and rhythm control in patients with atrial fibrillation.

Research2002-12-01The New England journal of medicine

Dual-chamber pacing or ventricular backup pacing in patients with an implantable defibrillator: the Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial.

Research2002-12-01JAMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Amiodarone
Aliases & brands
2-n-Butyl-3',5'-diiodo-4'-N-diethylaminoethoxy-3-benzoylbenzofuranCordaroneNexteronePaceroneAmiodarona2-Butyl-3-(3,5-diiodo-4-(2-diethylaminoethoxy)benzoyl)benzofuran2-Butyl-3-benzofuranyl 4-(2-(diethylamino)ethoxy)-3,5-diiodophenyl ketoneAmiodarone HydrochlorideAmiodaronum
RxNorm CUI
703
ChEMBL ID
CHEMBL633
ATC codes
C01BD01
UNII
N3RQ532IUT
Regulatory jurisdictions
mhra

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Authorities
MHRA
Total events
1
mhraMedicines and Healthcare products Regulatory Agency· 1 event
2026-05-20Safety communicationSafety
Drug Safety Update: Amiodarone: reminder of risks of treatment and need for patient monitoring and supervision
Evidence ↗

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

77 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
77
registered trials across all phases
LATEST COMPLETION 2024
14
Active studies
13
Recruiting
69
Late-stage (III+)
28
Completed
35
Discontinued
PHASE DISTRIBUTIONn = 77
Phase 12Phase 26Phase 2 / 32Phase 327Phase 424Phase N / A16

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Assessment of Intra-Operative Atrial Fibrillation Inducibility As a Screening Tool to Prevent Post-Operative Atrial Fibrillation With Prophylaxis Amiodarone

RecruitingPH IVStanford Universityn=6002050

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

Not yet recruitingPH IVMassachusetts General Hospitaln=2422028

Multicenter Randomized Clinical Trial To Evaluate Two Different Amiodarone Regimens To Maintain Sinus Rhythm After Electrical Cardioversion In Persistent Atrial Fibrillation

RecruitingPH IVFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Paun=3122028

Multicenter, Randomized Clinical Trial to Evaluate the Cardioverter Capacity of Amiodarone Pre-electrical Cardioversion in Persistent Atrial Fibrillation

Not yet recruitingPH IVInstitut Investigacio Sanitaria Pere Virgilin=1222026

Oral Amiodarone for Acute Cardioversion of Atrial Fibrillation Study

TerminatedPH IVUniversity of Calgaryn=32026

Recent completions

Trials that read out recently, adding to the completed evidence base.

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

CompletedPH IVPolice General Hospital, Thailandn=242024

Amiodarone or Verapamil in COVID-19 Hospitalized Patients With Symptoms

CompletedPH II/IIINicolaus Copernicus Universityn=8042021

CAT-PVC Trial Catheter Ablation Versus Amiodarone for Therapy of Premature Ventricular Contractions in Patients With Structural Heart Disease: a Randomized Trial

CompletedPH IIIUniversity of Leipzign=802021

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

CompletedPH IIIKey trialUniversity of Washingtonn=3,0242016

Ablation vs. Amiodarone for Treatment of Atrial Fibrillation in Patients With Congestive Heart Failure and an Implanted ICD/CRTD

CompletedPH IVTexas Cardiac Arrhythmia Research Foundationn=2032015

Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation

CompletedPH IIIIcahn School of Medicine at Mount Sinain=5232015

Research activity

4 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20022010
Major research themes5
Cardiac Pacing, Artificial1Defibrillators, Implantable1Electric Countershock1Pacemaker, Artificial1Pneumonectomy1
Journals, researchers & institutions
Top journals
  • JAMA1
  • The Annals of thoracic surgery1
  • The Journal of thoracic and cardiovascular surgery1
  • The New England journal of medicine1
Leading researchers
  • Greene HL2
  • Hammoud ZT2
  • Kesler KA2
  • Rieger KM2
  • Tisdale JE2
  • Wall DS2
  • Wroblewski HA2
  • Young JV2
Leading institutions
free-text, unnormalised
  • AFFIRM Clinical Trial Center1
  • School of Pharmacy & Pharmaceutical Sciences1
  • School of Pharmacy and Pharmaceutical Sciences1
  • The Cleveland Clinic Foundation1

Related drugs

2 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Digoxin

Studied across 4 of the same disease areas as Amiodarone in the shared literature.

4 shared diseases1 shared paper
Warfarin

Studied across 4 of the same disease areas as Amiodarone in the shared literature.

4 shared diseases1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.