Hexylene glycol Clinical Trials

Size	Price	Qty
100mg	USD 99

Clinical Trials

Multiple clinical trials evaluate therapeutic interventions for Werner Syndrome and essential hypertension. A Phase 2 trial sponsored by PRG Science & Technology Co. Ltd. investigates safety and tolerability regarding bone mineral density loss, while a Phase Not Applicable trial sponsored by Newel Health SRL focuses on hypertension management. Currently, these studies remain in a not-yet-recruiting status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05847179	Not yet recruiting	Werner Syndrome	PRG Science & Technology Co. Ltd.	2025-01-01	Phase 2
NCT06091176	Not yet recruiting	Essential Hypertension\|Primary Hypertension	Newel Health SRL	2024-11-01	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Hexylene glycol functions as an oxygenated amphiphilic solvent that disrupts cellular membrane integrity and destabilizes lipid bilayers in susceptible microorganisms. This membrane-disrupting activity induces cell lysis and confers broad antibacterial and antifungal effects, supporting its clinical relevance as a functional excipient or topical agent in research settings associated with Werner Syndrome and essential hypertension.

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>).