Drugs / Dofetilide
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Tikosyn | — | 2004-03-02 | europa.eu ↗ |
| Approved | EU (EMA) | Tikosyn | — | 1999-11-29 | europa.eu ↗ |
| Approved | US (FDA) | TIKOSYN | — | 1999-10-01 | fda.gov ↗ |
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01873950 | May → Jul 2013 | — | Food and Drug Administration (FDA) | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT01505296 | Dec 2011 → Jan 2014 | atrial fibrillation | Valley Health System | Withdrawn | No outcome recorded |
| Phase not applicable2 trials · 1 met primary | ||||||
| — | NCT00408200 | Nov 2006 → Apr 2008 | paroxysmal atrial fibrillation | University of Pennsylvania | Completed | Met primary |
| — | NCT00578617 | Sep 2006 → Feb 2009 | atrial fibrillation | Mayo Clinic | Completed | No outcome recorded |
| Comparator or background therapy10 trials | ||||||
| Phase 1 | NCT03070470 Comparator | Mar → Jun 2017 | — | Food and Drug Administration (FDA) | Completed | No outcome recorded |
| Phase 1 | NCT02365532 Background | Feb → May 2015 | long QT syndrome | Gilead Sciences | Completed | No outcome recorded |
| Phase 1 | NCT02308748 Comparator | May → Jun 2014 | — | Food and Drug Administration (FDA) | Completed | No outcome recorded |
| Phase 1/2 | NCT05906732 Background | Mar 2023 → May 2024 | long QT syndrome | Thryv Therapeutics, Inc. | Terminated | Mixed |
| Phase 3 | NCT04037397 Comparator | Sep 2019 → Oct 2024 | atrial fibrillation | University of Pennsylvania | Completed | No outcome recorded |
| Phase 3 | NCT00589303 Comparator | Dec 2007 → Jul 2011 | atrial fibrillation, heart failure | Mayo Clinic | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT00392106 Comparator | Apr 2006 → Dec 2010 | atrial fibrillation | ProRhythm, Inc. | Suspended | No outcome recorded |
| Phase 4 | NCT00540787 Comparator | Aug 2003 → Jun 2006 | paroxysmal atrial fibrillation | Biosense Webster, Inc. | Completed | No outcome recorded |
| — | NCT06096337 Comparator | Dec 2023 → Feb 2026 overdue | persistent atrial fibrillation | Boston Scientific Corporation | Active not recruiting | No outcome recorded |
| — | NCT00911508 Comparator | Nov 2009 → Dec 2017 | atrial fibrillation | Mayo Clinic | Completed | No outcome recorded |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 17 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Dofetilide | “* procainamide
* quinidine
* disopyramide
* propafenone
* flecainide
* sotalol
* dofetilide
* amiodarone” NCT00589303 ↗13“Propafenone or Flecanide or Sotalol or Dofetilide or Dronedarone or Amiodarone.” NCT04037397 ↗ “Sotalol 240-320mg, Dofetilide 500-1000mcg, Amiodarone 200-400mg” NCT00911508 ↗ “propafenone, flecainide, sotalol, dofetilide” NCT01505296 ↗ “Dofetilide 500mcg” NCT00578617 ↗ |
| Known as | Dofetilida | ChEMBL registry synonym — accepted as the source's own label CHEMBL473 ↗ |
| Known as | Tikosyn | ChEMBL registry synonym — accepted as the source's own label CHEMBL473 ↗ |
| Known as | UK-68,798 | ChEMBL registry synonym — accepted as the source's own label CHEMBL473 ↗ |
| Action | Inhibit | “a pure hERG potassium channel blocker (dofetilide)” PMID 25054430 ↗ Jul 20141“HERG blocker” CHEMBL473 ↗ |
| Modality | Small molecule | — CHEMBL473 ↗ |
| Route | Oral | “single oral dose of dofetilide, quinidine, ranolazine, verapamil and placebo” PMID 26324176 ↗ Aug 2015 |
| Target | KCNH2 | “HERG blocker” CHEMBL473 ↗ |