NEXTERONE (amiodarone hydrochloride)
Nexterone is an antiarrhythmic medication used to manage life-threatening heart rhythm disturbances in patients who have not responded to other therapies. It helps patients with frequently recurring ventricular fibrillation and unstable ventricular tachycardia by stabilizing the heart's electrical activity. This premixed injection is used both to start immediate treatment and to help prevent future episodes of these dangerous arrhythmias.
How NEXTERONE Works
Nexterone works by blocking various ion channels in the heart, including sodium, potassium, and calcium channels, which slows electrical conduction and prolongs the heart's resting period. It also exerts an antisympathetic effect and acts as a vasodilator, which helps reduce the overall workload and oxygen consumption of the heart muscle. These combined actions help stabilize the heart's rhythm and prevent rapid, irregular beats.
Details
- Status
- Prescription
- First Approved
- 2008-12-24
- Patent Cliff
- 2033
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
NEXTERONE Approval History
What NEXTERONE Treats
2 indicationsNEXTERONE is approved for 2 conditions since its original approval in 2008. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Ventricular Fibrillation
- Ventricular Tachycardia
NEXTERONE 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.
Drugs Similar to NEXTERONE
3 of 8FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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.
NEXTERONE FDA Label Details
Indications & Usage
FDA Label (PDF)NEXTERONE is indicated for the treatment of Ventricular Fibrillation; Ventricular Tachycardia.
Pro Intelligence Preview
Deep insights for NEXTERONE
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2033
- • 39 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 8 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.