Ibutilide Fumarate Clinical Trials

Size	Price	Qty
10mg	USD 147

Clinical Trials

Ibutilide fumarate has been evaluated across multiple clinical trials primarily focusing on atrial fibrillation, persistent atrial fibrillation, pulmonary vein ablation procedures, and drug-induced Long QT syndrome. These studies encompass Phase 2, Phase 4, and non-interventional protocols sponsored by academic medical centers, health organizations, and medical device manufacturers. Recruitment statuses across the portfolio vary—including completed, active, terminated, and unknown—with research evaluating comparative efficacy and drug-induced QT interval lengthening.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04675788	COMPLETED	Long QT Syndrome; Abnormalities, Drug-Induced	Indiana University	2021-09-02	PHASE4
NCT03834883	COMPLETED	Long QT Syndrome; Abnormalities, Drug-Induced	Indiana University	2019-03-26	PHASE4
NCT03834883	Active not recruiting	Long QT Syndrome\|Abnormalities Drug-Induced	Indiana University\|American Heart Association\|Purdue University	2019-03-26	Phase 4
NCT03370536	TERMINATED	Atrial Fibrillation; Persistent Atrial Fibrillation	Vivek Reddy	2017-11-01
NCT02513940	COMPLETED	Long QT Syndrome	Indiana University	2016-05	PHASE4
NCT00589992	UNKNOWN	Atrial Fibrillation; Pulmonary Vein Ablation	Ball Memorial Hospital	2007-10
NCT01447862	COMPLETED	Atrial Fibrillation	Medical University of Vienna	2011-10	PHASE4
NCT01014741	COMPLETED	Persistent Atrial Fibrillation	Vivek Reddy	2009-10
NCT01929083	COMPLETED	Prolonged QT Interval in EKG and Sudden Death	Indiana University	2013-04	PHASE2
NCT01929083	Completed	Prolonged QT Interval in EKG and Sudden Death	Indiana University\|American Heart Association	2013-04	Phase 2
NCT00589992	Unknown status	Atrial Fibrillation\|Pulmonary Vein Ablation	Ball Memorial Hospital\|Abbott Medical Devices	2007-10	Not Applicable

(data from https://clinicaltrials.gov, updated on 2026-03-19)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ibutilide fumarate acts as a Class III antiarrhythmic agent by promoting a slow inward sodium current into cardiac myocytes, which extends the duration of the cellular action potential and prolongs the effective refractory period. This delay in cardiac repolarization suppresses re-entrant circuits, facilitating the rapid pharmacological conversion of acute atrial fibrillation and atrial flutter to normal sinus rhythm.

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>).