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 |
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. |