Ajmaline Clinical Trials

Size	Price	Qty
25mg	USD 147

Clinical Trials

Multiple clinical trials evaluate ajmaline across conditions such as Brugada syndrome 1S, electrocardiographic Brugada patterns, and sudden death risk. Primarily sponsored by academic and medical centers—including Cardiocentro Ticino, St George's University of London, and IRCCS Policlinico S. Donato—these Phase II, interventional, and unclassified studies range in recruitment status from actively recruiting to terminated or unknown. Individual investigations focus on assessing electrocardiographic and genetic responses during ajmaline challenge testing, epicardial ablation, and implantable defibrillator algorithm optimization.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04504591	Terminated	Brugada Syndrome 1S	Angelo Auricchio\|Cardiocentro Ticino	2017-12-14	--
NCT02933437	Unknown status	Brugada Syndrome\|Sudden Death	St George''s University of London	2017-10-22	Phase 2
NCT03106701	Recruiting	ECG Brugada Pattern	IRCCS Policlinico S. Donato	2017-03-14	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ajmaline functions as a class Ia antiarrhythmic agent by binding to and blocking voltage-gated sodium channels in cardiac tissue, thereby inhibiting sodium influx during Phase 0 depolarization and prolonging the myocardial action potential duration and refractory period. This suppression of cardiac membrane excitability slows conduction velocity, making it clinically relevant for unmasking diagnostic electrocardiographic patterns and managing ventricular arrhythmias in conditions such as Brugada syndrome.

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>).