Dofetilide

Generic Name: Dofetilide

Brand Names: Tikosyn

Drug Type: Small Molecule

Chemical Formula: C_₁₉H_₂₇N_₃O_₅S_₂

CAS Number: 115256-11-6

Unique Ingredient Identifier: R4Z9X1N2ND

Background: Dofetilide is a class III antiarrhythmic agent that is approved by the Food and Drug Administration (FDA) for the maintenance of sinus rhythm in individuals prone to the formation of atrial fibrillation and flutter, and for the chemical cardioversion to sinus rhythm from atrial fibrillation and flutter.

Indication: 用于心房扑动、心房颤动、室上性心动过速。

Associated Conditions: Normal Sinus Rhythm, Symptomatic Atrial flutter, Symptomatic, recurrent Atrial Fibrillation

Clinical Trials

Study of LQT-1213 on QTc-induced Prolongation in Healthy Adult Subjects (Part1) and on Congenital Long QT in Patients Diagnosed With Type 1, 2 or 3 Long QT Syndrome (Part 2).

Phase 1

Active, not recruiting

Conditions: Long QT Syndrome

Interventions: Drug: Placebo
Drug: LQT-1213
Drug: Dofetilide 250 μg Cap

First Posted Date: 2023-06-18

Last Posted Date: 2025-02-26

Lead Sponsor: Thryv Therapeutics, Inc.

Target Recruit Count: 28

Registration Number: NCT05906732

Locations: 🇺🇸
Spaulding Clinical Research, LLC, West Bend, Wisconsin, United States

Improvement in Endothelial Dysfunction After Initiation of Anti-arrhythmic Therapy in Atrial Fibrillation Patients

Completed

Conditions: Atrial Fibrillation

Interventions: Drug: Sotalol
Drug: Dofetilide

First Posted Date: 2019-10-16

Last Posted Date: 2021-01-14

Lead Sponsor: Samir Saba

Target Recruit Count: 12

Registration Number: NCT04128878

Locations: 🇺🇸
University of Pittsburgh Medical Center - Presbyterian University Hospital, Pittsburgh, Pennsylvania, United States

CiPA Phase 1 ECG Biomarker Validation Study

Phase 1

Completed

Conditions: Pharmacodynamics
Drug-induced QT Prolongation
Pharmacokinetics

Interventions: Drug: Ranolazine
Drug: Lopinavir / Ritonavir
Drug: Placebo
Drug: Dofetilide and Diltiazem
Drug: Verapamil
Drug: Chloroquine

First Posted Date: 2017-03-03

Last Posted Date: 2020-01-18

Lead Sponsor: Food and Drug Administration (FDA)

Target Recruit Count: 60

Registration Number: NCT03070470

Locations: 🇺🇸
Spaulding Clinical Research, West Bend, Wisconsin, United States

Genetics of QT Prolongation With Antiarrhythmics

Conditions: Long QT Syndrome
Drug Toxicity

Interventions: Drug: Dofetilide and/or sotalol

First Posted Date: 2015-05-12

Last Posted Date: 2022-04-04

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 1000

Registration Number: NCT02439658

Locations: 🇺🇸
Cleveland Clinic, Cleveland, Ohio, United States
🇺🇸
University of Colorado Hospital, Aurora, Colorado, United States
🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States

and more 2 locations

Effect of Oral GS-6615 on Dofetilide-Induced QT Prolongation, Safety, and Tolerability in Healthy Adults

Phase 1

Completed

Conditions: Long QT Syndrome

Interventions: Drug: Placebo to match GS-6615
Drug: GS-6615
Drug: Placebo to match dofetilide
Drug: Dofetilide

First Posted Date: 2015-02-19

Last Posted Date: 2015-05-20

Lead Sponsor: Gilead Sciences

Target Recruit Count: 60

Registration Number: NCT02365532

Locations: 🇺🇸
Spaulding Clinical Research, LLC, West Bend, Wisconsin, United States

Ability of Late Sodium or Calcium Current Block to Balance the ECG Effects of Potassium Current Block

Phase 1

Completed

Conditions: Pharmacokinetics
Pharmacodynamics
Drug-induced QT Prolongation

Interventions: Drug: Dofetilide
Drug: Placebo
Drug: Moxifloxacin
Drug: Mexiletine
Drug: Lidocaine
Drug: Diltiazem

First Posted Date: 2014-12-04

Last Posted Date: 2016-06-08

Lead Sponsor: Food and Drug Administration (FDA)

Target Recruit Count: 22

Registration Number: NCT02308748

Study of the Electrocardiographic Effects of Ranolazine, Dofetilide, Verapamil, and Quinidine in Healthy Subjects

Phase 1

Completed

Conditions: Drug-induced Surface ECG Changes

Interventions: Drug: Placebo
Drug: Ranolazine
Drug: Dofetilide
Drug: Verapamil
Drug: Quinidine sulfate

First Posted Date: 2013-06-10

Last Posted Date: 2018-03-08

Lead Sponsor: Food and Drug Administration (FDA)

Target Recruit Count: 22

Registration Number: NCT01873950

A Study of the Effectiveness of Anti-Arrhythmic Medications After Atrial Fibrillation Ablation

Not Applicable

Completed

Conditions: Atrial Fibrillation

Interventions: Drug: propafenone; flecainide; sotalol; dofetilide
Device: Radiofrequency catheter ablation

First Posted Date: 2006-12-06

Last Posted Date: 2013-03-07

Lead Sponsor: University of Pennsylvania

Target Recruit Count: 110

Registration Number: NCT00408200

Locations: 🇺🇸
Presbyterian Medical Center, Philadelphia, Pennsylvania, United States
🇺🇸
Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

High Intensity Focused Ultrasound (HIFU) Ablation System Study

Phase 3

Suspended

Conditions: Atrial Fibrillation

Interventions: Drug: propafenone
Device: Pulmonary vein ablation
Drug: flecainide
Drug: dofetilide
Drug: sotolol
Drug: Amiodarone

First Posted Date: 2006-10-25

Last Posted Date: 2008-06-17

Lead Sponsor: ProRhythm, Inc.

Target Recruit Count: 240

Registration Number: NCT00392106

Locations: 🇺🇸
Piedmont Hospital, Atlanta, Georgia, United States
🇺🇸
Lahey Clinic, Burlington, Massachusetts, United States
🇺🇸
Stony Brook University Hospital, Stony Brook, New York, United States

and more 18 locations

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy