Benzalkonium chloride Clinical Trials

Size	Price	Qty
25mg	USD 97
1g	USD 970

Clinical Trials

Benzalkonium chloride has been evaluated in numerous Phase I through Phase IV clinical trials spanning dermatological, ophthalmic, respiratory, and reproductive applications, such as glaucoma, COPD, wound healing, COVID-19, and skin microbiome composition. Sponsored by academic institutions, specialty hospitals, and pharmaceutical entities including GlaxoSmithKline and the University of California, San Diego, these studies encompass various recruitment statuses, including completed, recruiting, terminated, and unknown.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07000877	RECRUITING	Perioperative Respiratory Adverse Events; Anesthesia Outcomes	Telethon Kids Institute	2025-06-25	PHASE4
NCT06404541	UNKNOWN	Ocular Surface Disease; Dry Eye Syndromes	Kasr El Aini Hospital	2024-01-10	PHASE4
NCT02533154	UNKNOWN	Dry Eye Syndromes	Medical University of Vienna	2015-07-27	PHASE4
NCT05287425	COMPLETED	Nasal and Pharyngeal Microbiome	Medical University of Vienna	2019-08-12	PHASE2
NCT04951349	COMPLETED	Covid19	Turn Therapeutics	2021-01-21	PHASE2
NCT03102450	COMPLETED	Contraception	Laboratoire Innotech International	2017-12-26	PHASE4
NCT02966184	TERMINATED	Status Asthmaticus	Norton Healthcare	2018-09-10	PHASE4
NCT03331770	COMPLETED	Primary Open-angle Glaucoma	Laboratorios Poen	2017-01-06	PHASE4
NCT03323528	COMPLETED	Pharyngitis	Medice Arzneimittel Pütter GmbH & Co KG	2017-02-01	PHASE4
NCT03125785	Unknown status	Congenital Cataract	St. Erik Eye Hospital	2017-06	--
NCT02594449	UNKNOWN	Healthy Volunteers	Lustre Pharmaceutical Lab Co., Ltd	2015-10	PHASE4
NCT02269800	UNKNOWN	Chronic Obstructive Pulmonary Disease	Lustre Pharmaceutical Lab Co., Ltd	2014-10	PHASE4
NCT02012348	COMPLETED	Survival of Bacteria on Skin After Using Different Soaps	University of California, San Diego	2013-12
NCT01951391	COMPLETED	Healthy Skin	University of California, San Diego	2013-09
NCT03104621	COMPLETED	Primary Open-angle Glaucoma	Gangnam Severance Hospital	2013-03	PHASE4
NCT01779284	COMPLETED	Glaucoma	Aristotle University Of Thessaloniki	2012-01	PHASE4
NCT01762982	COMPLETED	Wound Healing	GlaxoSmithKline	2012-02
NCT00845299	COMPLETED	Glaucoma; Ocular Hypertension	Mati Therapeutics Inc.	2009-01	PHASE2
NCT00874887	COMPLETED	Anti-biotic Resistance	Allergan	2009-03	PHASE4
NCT00468988	COMPLETED	Glaucoma	Alcon Research	2007-05	PHASE4
NCT00692952	COMPLETED	Healthy	Shanghai Institute of Planned Parenthood Research	2004-03	PHASE2
NCT00414739	UNKNOWN	Eye Diseases	University of Rostock		PHASE1

(data from https://clinicaltrials.gov, updated on 2025-11-19)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Benzalkonium chloride acts as a cationic surfactant that inserts into bacterial lipid bilayers and disrupts membrane integrity, leading to the leakage of cytoplasmic contents and subsequent cellular lysis. This potent membrane-disrupting antimicrobial activity underpins its clinical application as an antiseptic agent and preservative across dermatological, wound healing, and ophthalmic conditions evaluated in clinical trials.

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>).