Product Description
Amiodarone is used to treat life-threatening heart rhythm problems called ventricular arrhythmias. This medicine is used in patients who have already been treated with other medicines that did not work well. (Sourced from: https://www.mayoclinic.org/drugs-supplements/amiodarone-oral-route/description/drg-20061854)
Mechanisms of Action: CYP3A Inhibitor,CYP2D6 Inhibitor,CYP2C9 Inhibitor,CYP1A2 Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral,Intravenous
FDA Designation: None *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | China | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Morocco | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: Tachycardia | Tachycardia, Ventricular | Ventricular Fibrillation | Ventricular Fibrillation
Known Adverse Events: Heart Failure | Tachycardia | Tachycardia, Paroxysmal | Tachycardia, Ventricular | Liver Failure | Cardiac Arrest | Shock, Cardiogenic | Hypotension
Company: Sanofi
Company Location: PARIS I0 75008
Company CEO: Paul Hudson
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: United States
Active Clinical Trial Count: 2
Highest Development Phases
Phase 3: Atrial Fibrillation
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
---|---|---|---|---|---|
AMIOMEND | P2 |
Recruiting |
Atrial Fibrillation |
2025-11-01 |
|
2018-004202-25 | P3 |
Active, not recruiting |
Atrial Fibrillation |
2022-05-17 |