Vernakalant (RSD1235) Hydrochloride Clinical Trials

Size	Price	Qty
5mg	USD 247

Clinical Trials

Several clinical trials have evaluated the therapeutic efficacy and safety of Vernakalant (RSD1235) for cardiac arrhythmias, focusing primarily on patients with atrial fibrillation and atrial flutter. These late-stage, industry-sponsored investigations—including Phase 3 and combined Phase 2/Phase 3 protocols led by Astellas Pharma Inc., Astellas Pharma US Inc., and Advanz Pharma—have all reached completed status. Collectively, these studies provided pivotal clinical data regarding intravenous administration, efficacy, and tolerance in target patient populations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00125320	Completed	Atrial Fibrillation\|Atrial Flutter	Astellas Pharma Inc\|Astellas Pharma US Inc.\|Advanz Pharma	2004-06	Phase 3
NCT00115791	Completed	Atrial Flutter\|Atrial Fibrillation	Astellas Pharma Inc\|Advanz Pharma	2004-06	Phase 3
NCT00476112	Completed	Atrial Flutter	Advanz Pharma\|Astellas Pharma US Inc.	2003-08	Phase 2\|Phase 3
NCT00468767	Completed	Atrial Fibrillation	Advanz Pharma\|Astellas Pharma US Inc.	2003-08	Phase 3

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Vernakalant (RSD1235) Hydrochloride product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Vernakalant acts as a frequency-dependent sodium channel and early-activating potassium channel blocker, which inhibits cardiac voltage-gated ion currents to selectively prolong the atrial refractory period without significantly affecting ventricular repolarization. By suppressing rapid atrial action potential conduction and terminating re-entrant circuits, this mechanism provides the pharmacological basis for converting 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>).