Chlorhexidine 2HCl Clinical Trials

Size	Price	Qty
50mg	USD 147

Clinical Trials

Several clinical trials are evaluating chlorhexidine regimens, such as antiseptic bathing and intracanal instillation, to prevent nosocomial and localized infections, including general microbial infections, catheter-related bloodstream infections, apical periodontitis, and neurogenic bladder with urinary retention. Sponsored by academic and corporate entities such as Duke University, Yale University, University of Southern California, and Irrimax Corporation, these Phase 3 and Phase Not Applicable studies encompass both recruiting and not yet recruiting statuses.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06112626	Recruiting	Infections	Duke University\|Massachusetts General Hospital\|Indiana University Health	2024-05-01	Not Applicable
NCT06163469	Recruiting	Neurogenic Bladder\|Urinary Retention	Yale University\|Irrimax Corporation	2024-04-01	Not Applicable
NCT03700788	Not yet recruiting	Apical Periodontitis	University of Southern California	2023-05-30	Phase 3
NCT05995080	Recruiting	Central Venous Catheter Related Bloodstream Infection\|Catheter-Related Infections\|Bloodstream Infection Due to Central Venous Catheter	Istanbul Medeniyet University	2022-05-01	Not Applicable

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

Check the Chlorhexidine 2HCl product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Chlorhexidine acts as a broad-spectrum cationic antiseptic that binds directly to negatively charged bacterial cell walls, disrupting cell membrane integrity and causing rapid leakage of essential cytoplasmic constituents. This membrane-disruptive action inhibits bacterial survival and biofilm formation, directly underlying its clinical effectiveness in preventing central venous catheter-related bloodstream infections, apical periodontitis, and neurogenic bladder-associated healthcare complications.

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>).