Cetylpyridinium Chloride Clinical Trials

Size	Price	Qty
50mg	USD 97
1g	USD 670

Clinical Trials

Several clinical trials evaluate conditions such as cardiac arrest, out-of-hospital cardiac arrest, coma, and cardiopulmonary resuscitation. Sponsored primarily by academic and clinical institutions, including Assistance Publique - Hôpitaux de Paris and CMC Ambroise Paré, these Phase 2 and phase-unassigned studies feature recruiting, not yet recruiting, and withdrawn recruitment statuses. Specific research focuses on evaluating predictive indicators of recovery in comatose patients as well as assessing brain injury and organ interactions following cardiac arrest.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06044922	Not yet recruiting	Cardiac Arrest	CMC Ambroise Paré	2024-04-15	--
NCT06327334	Not yet recruiting	Cardiac Arrest	CMC Ambroise Paré	2024-04-15	--
NCT04316611	Withdrawn	Out-of-hospital Cardiac Arrest (OHCA)	Assistance Publique - Hôpitaux de Paris\|URC-CIC Paris Descartes Necker Cochin	2023-12	Phase 2
NCT05321459	Recruiting	Coma\|Heart Arrest\|Cardiopulmonary Resuscitation	Assistance Publique - Hôpitaux de Paris\|Ecole Normale Supérieure de Paris	2023-11-15	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Cetylpyridinium chloride functions as a cationic quaternary ammonium compound that binds to negatively charged microbial cell membranes, disrupting lipid bilayer integrity and inducing intracellular component leakage and cell death. By suppressing microbial viability and mucosal colonization, this antimicrobial mechanism provides therapeutic utility in maintaining mucosal antisepsis and reducing secondary infection risks during post-cardiac arrest management and cardiopulmonary resuscitation.

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>).