DOFETILDE (dofetilide)
Dofetilide is a Class III antiarrhythmic indicated for the conversion of atrial fibrillation (AF) and atrial flutter (AFl) to normal sinus rhythm (NSR), as well as the maintenance of NSR in patients with AF/AFl of greater than one week duration. Because dofetilide can cause life-threatening ventricular arrhythmias (notably Torsades de Pointes), its use is reserved for patients who are highly symptomatic. Of note, dofetilide has not been shown to be effective in patients with paroxysmal atrial fibrillation.
How DOFETILDE Works
Dofetilide is a Vaughan Williams Class III antiarrhythmic agent that selectively blocks the rapid component of the delayed rectifier potassium current ($I_{Kr}$). By inhibiting this current, dofetilide prolongs the cardiac action potential duration and the effective refractory period without affecting sodium channels or alpha/beta-adrenergic receptors. This stabilization of cardiac rhythm helps convert and maintain normal sinus rhythm in patients with specific supraventricular tachyarrhythmias.
Details
- Status
- Prescription
- First Approved
- 2019-01-22
- Routes
- ORAL
- Dosage Forms
- CAPSULE
DOFETILDE Approval History
What DOFETILDE Treats
2 indicationsDOFETILDE is approved for 2 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Atrial Fibrillation
- Atrial Flutter
DOFETILDE Boxed Warning
To minimize the risk of induced arrhythmia, patients initiated or re-initiated on TIKOSYN should be placed for a minimum of 3 days in a facility that can provide calculations of creatinine clearance, continuous electrocardiographic monitoring, and cardiac resuscitation. For detailed instructions regarding dose selection, see DOSAGE AND ADMINISTRATION ....
To minimize the risk of induced arrhythmia, patients initiated or re-initiated on TIKOSYN should be placed for a minimum of 3 days in a facility that can provide calculations of creatinine clearance, continuous electrocardiographic monitoring, and cardiac resuscitation. For detailed instructions regarding dose selection, see DOSAGE AND ADMINISTRATION .
DOFETILDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
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.
What's emerging in DOFETILDE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications DOFETILDE treats. First-in-class if their pivotal trials read out positive.
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Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01873950 results posted | 13-011D SCR-002 | Ph 1 | completed | Study of the Electrocardiographic Effects of Ranolazine, Dofetilide, Verapamil, and Quinidine in Healthy Subjects |
| NCT02308748 results posted | 14-022D SCR-003 | Ph 1 | completed | Ability of Late Sodium or Calcium Current Block to Balance the ECG Effects of Potassium Current Block |
| NCT02365532 | GS-US-372-1666 | Ph 1 | completed | Effect of Oral GS-6615 on Dofetilide-Induced QT Prolongation, Safety, and Tolerability in Healthy Adults |
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.
DOFETILDE FDA Label Details
Indications & Usage
DOFETILDE is indicated for the treatment of Atrial Fibrillation; Atrial Flutter.
To minimize the risk of induced arrhythmia, patients initiated or re-initiated on TIKOSYN should be placed for a minimum of 3 days in a facility that can provide calculations of creatinine clearance, continuous electrocardiographic monitoring, and cardiac resuscitation. For detailed instructions reg...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.