AMIODARONE HYDROCHLORIDE
Amiodarone hydrochloride treats life-threatening heart rhythm issues such as recurring ventricular fibrillation and unstable ventricular tachycardia. It helps patients who have not responded to other therapies or those who are temporarily unable to take oral medications. This injectable form is used for stabilizing a patient's heart rhythm during acute episodes, often until they can be transitioned to long-term oral treatment.
How AMIODARONE HYDROCHLORIDE Works
This drug works by blocking sodium, potassium, and calcium channels while also exerting an antisympathetic effect on the heart. These combined actions slow electrical conduction and prolong the heart's recovery period, which helps prevent irregular rhythms. It also acts as a vasodilator, which reduces the heart's workload and oxygen consumption.
Details
- Status
- Prescription
- First Approved
- 1998-11-30
- Routes
- ORAL, INJECTION
- Dosage Forms
- TABLET, INJECTABLE
Companies
AMIODARONE HYDROCHLORIDE Approval History
What AMIODARONE HYDROCHLORIDE Treats
2 indicationsAMIODARONE HYDROCHLORIDE is approved for 2 conditions since its original approval in 1998. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Frequently recurring ventricular fibrillation
- Hemodynamically unstable ventricular tachycardia
AMIODARONE HYDROCHLORIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04594746 AAA | REB20-1555 | Ph 4 | terminated | Oral Amiodarone for Acute Cardioversion of Atrial Fibrillation Study |
| NCT06067438 | STUDY00021572 NCI-2023-03642, STUDY00021572 | Ph 2 | recruiting | Amiodarone for the Prevention of Atrial Fibrillation After Minimally Invasive Esophagectomy in Patients With Esophageal Cancer |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
AMIODARONE HYDROCHLORIDE FDA Label Details
Indications & Usage
FDA Label (PDF)AMIODARONE HYDROCHLORIDE is indicated for the treatment of Frequently recurring ventricular fibrillation; Hemodynamically unstable ventricular tachycardia.
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Full clinical data, patents, trials, and competitive landscape for amiodarone hydrochloride.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.