Dofetilide Clinical Trials

Size	Price	Qty
10mg	USD 147
200mg	USD 670

Clinical Trials

Multiple clinical trials evaluate dofetilide across cardiovascular conditions, including paroxysmal and persistent atrial fibrillation, ventricular tachycardia, long QT syndrome, and drug-induced QT prolongation. Spanning Phase 1 through Phase 4 alongside observational and comparative designs, these studies are sponsored by academic institutions such as Massachusetts General Hospital and the University of Pennsylvania, as well as corporate developers like Thryv Therapeutics and Boston Scientific Corporation. Across this portfolio, recruitment statuses range from completed and actively recruiting studies to terminated, suspended, or withdrawn investigations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06096337	ACTIVE_NOT_RECRUITING	Persistent Atrial Fibrillation	Boston Scientific Corporation	2023-12-28
NCT05906732	TERMINATED	Long QT Syndrome	Thryv Therapeutics, Inc.	2023-03-12	PHASE1; PHASE2
NCT05906732	Recruiting	Long QT Syndrome	Thryv Therapeutics Inc.	2023-03-12	Phase 1\|Phase 2
NCT03070470	COMPLETED	Drug-induced QT Prolongation; Pharmacokinetics; Pharmacodynamics	Food and Drug Administration (FDA)	2017-03-14	PHASE1
NCT02365532	COMPLETED	Long QT Syndrome	Gilead Sciences	2015-02	PHASE1
NCT02308748	COMPLETED	Drug-induced QT Prolongation; Pharmacokinetics; Pharmacodynamics	Food and Drug Administration (FDA)	2014-05	PHASE1
NCT01873950	COMPLETED	Drug-induced Surface ECG Changes	Food and Drug Administration (FDA)	2013-05	PHASE1
NCT00392106	SUSPENDED	Atrial Fibrillation	ProRhythm, Inc.	2006-04	PHASE3
NCT01097330	Terminated	Defibrillators Implantable\|Tachycardia Ventricular	Population Health Research Institute\|Abbott Medical Devices\|Hamilton Health Sciences Corporation	2010-08	Phase 3
NCT00408200	COMPLETED	Atrial Fibrillation	University of Pennsylvania	2006-11
NCT00540787	COMPLETED	Paroxysmal Atrial Fibrillation	Biosense Webster, Inc.	2003-08-01	PHASE4

(data from https://clinicaltrials.gov, updated on 2026-08-28)

Check the Dofetilide product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Dofetilide selectively binds to and inhibits the hERG potassium channel, blocking the rapid delayed rectifier potassium current during phase 3 of the cardiac action potential. This blockade prolongs action potential duration and myocardial refractory periods, thereby terminating re-entrant electrical circuits to treat clinical conditions such as atrial fibrillation and ventricular tachycardia.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).