TIKOSYN (dofetilide)
Tikosyn (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 whose arrhythmia has lasted longer than one week. Due to the risk of inducing life-threatening ventricular arrhythmias, Tikosyn is reserved for patients who are highly symptomatic. It has not been shown to be effective in patients with paroxysmal atrial fibrillation.
How TIKOSYN Works
Dofetilide is a Vaughan Williams Class III antiarrhythmic that selectively blocks the cardiac ion channel carrying the rapid component of the delayed rectifier potassium current ($I_{Kr}$). At clinically relevant concentrations, it does not affect other repolarizing potassium currents (such as $I_{Ks}$ or $I_{K1}$), sodium channels, or alpha/beta-adrenergic receptors. This selective blockade prolongs the action potential duration and effective refractory period, facilitating the conversion and maintenance of normal sinus rhythm.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1999-10-01
- Routes
- ORAL
- Dosage Forms
- CAPSULE
TIKOSYN Approval History
What TIKOSYN Treats
2 indicationsTIKOSYN is approved for 2 conditions since its original approval in 1999. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Atrial Fibrillation
- Atrial Flutter
TIKOSYN 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 .
TIKOSYN 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 TIKOSYN's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications TIKOSYN 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.
TIKOSYN FDA Label Details
Indications & Usage
FDA Label (PDF)TIKOSYN 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.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment