MedPath

Dronedarone

Generic Name
Dronedarone
Brand Names
Multaq
Drug Type
Small Molecule
Chemical Formula
C31H44N2O5S
CAS Number
141626-36-0
Unique Ingredient Identifier
JQZ1L091Y2

Overview

Dronedarone is a Class III antiarrhythmic drug that works to restore the normal sinus rhythm in patients with paroxysmal or persistent atrial fibrillation. Atrial fibrillation is a common sustained arrhythmia where the treatment primarily focuses on stroke prevention and symptom management. It is managed by rate control, rhythm control, prevention of thromboembolic events, and treatment of the underlying disease. Similar to amiodarone, dronedarone is a multichannel blocker that works to control rhythm and rate in atrial fibrillation. It meets criteria of all four Vaughan Williams antiarrhythmic drug classes by blocking sodium, potassium, and calcium ion channels and inhibiting β-adrenergic receptors. Dronedarone is a related benzofuran compound to amiodarone but its chemical structure lacks iodine moieties which are associated with amiodarone-induced thyroid problems. Additionally, the methyl sulfonyl group in its structure renders dronedarone to be more lipophilic with a shorter half-life than amiodarone. This ultimately leads to reduced tissue accumulation of the drug and decreased risk for organ toxicities, such as thyroid and pulmonary toxicities. Commonly marketed as Multaq®, dronedarone was approved by the FDA in July 2009 and Health Canada in August 2009. A safety concern for the risk of drug-induced hepatocellular injury has been issued following marketing of dronedarone.

Background

Dronedarone is a Class III antiarrhythmic drug that works to restore the normal sinus rhythm in patients with paroxysmal or persistent atrial fibrillation. Atrial fibrillation is a common sustained arrhythmia where the treatment primarily focuses on stroke prevention and symptom management. It is managed by rate control, rhythm control, prevention of thromboembolic events, and treatment of the underlying disease. Similar to amiodarone, dronedarone is a multichannel blocker that works to control rhythm and rate in atrial fibrillation. It meets criteria of all four Vaughan Williams antiarrhythmic drug classes by blocking sodium, potassium, and calcium ion channels and inhibiting β-adrenergic receptors. Dronedarone is a related benzofuran compound to amiodarone but its chemical structure lacks iodine moieties which are associated with amiodarone-induced thyroid problems. Additionally, the methyl sulfonyl group in its structure renders dronedarone to be more lipophilic with a shorter half-life than amiodarone. This ultimately leads to reduced tissue accumulation of the drug and decreased risk for organ toxicities, such as thyroid and pulmonary toxicities. Commonly marketed as Multaq®, dronedarone was approved by the FDA in July 2009 and Health Canada in August 2009. A safety concern for the risk of drug-induced hepatocellular injury has been issued following marketing of dronedarone.

Indication

Dronedarone is indicated for the management of atrial fibrillation (AF) in patients in sinus rhythm with a history of paroxysmal or persistent AF to reduce the risk of hospitalization.

Associated Conditions

  • Atrial Fibrillation

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2023/07/11
Phase 3
Not yet recruiting
Region Örebro County
2022/12/19
Phase 4
Recruiting
Shanghai East Hospital
2022/03/15
N/A
Completed
2021/11/23
Phase 4
Completed
2021/01/11
Phase 4
Terminated
2019/04/05
Phase 2
UNKNOWN
doaa rashwan
2014/11/19
Not Applicable
UNKNOWN
2013/11/25
Not Applicable
Completed
2012/01/31
Phase 2
Completed
2011/09/08
Not Applicable
UNKNOWN

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Physicians Total Care, Inc.
54868-3086
ORAL
400 mg in 1 1
12/28/2011
Cardinal Health 107, LLC
55154-8104
ORAL
400 mg in 1 1
12/15/2022
sanofi-aventis U.S. LLC
0024-4142
ORAL
400 mg in 1 1
10/31/2023

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
N/A
N/A
N/A
N/A
N/A
N/A

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
MULTAQ® Film-coated Tablet 400mg
SIN13849P
TABLET, FILM COATED
400 mg
8/20/2010

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Dronedarone Hydrochloride Tablets
国药准字H20253735
化学药品
片剂
3/25/2025
Dronedarone Hydrochloride Tablets
国药准字HJ20210084
化学药品
片剂
12/20/2021
Dronedarone Hydrochloride Tablets
国药准字H20253890
化学药品
片剂
4/15/2025
Dronedarone Hydrochloride Tablets
国药准字H20243515
化学药品
片剂
4/17/2024
Dronedarone Hydrochloride Tablets
国药准字H20193291
化学药品
片剂
10/23/2019
Dronedarone Hydrochloride Tablets
国药准字H20254075
化学药品
片剂
5/13/2025

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.
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