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.

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

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
No NMPA approvals found for this drug.

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.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
MULTAQ 400 MG COMPRIMIDOS RECUBIERTOS CON PELICULA
09591003IP1
COMPRIMIDO RECUBIERTO CON PELÍCULA
Diagnóstico Hospitalario
Commercialized
MULTAQ 400 MG COMPRIMIDOS RECUBIERTOS CON PELICULA
09591003IP
COMPRIMIDO RECUBIERTO CON PELÍCULA
Diagnóstico Hospitalario
Not Commercialized
MULTAQ 400 MG COMPRIMIDOS RECUBIERTOS CON PELICULA
09591003
COMPRIMIDO RECUBIERTO CON PELÍCULA
Diagnóstico Hospitalario
Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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