Enoxolone Clinical Trials

Size	Price	Qty
500mg	USD 147
1g	USD 197

Clinical Trials

A clinical trial sponsored by an NHS trust investigated the physiological effects of Enoxolone, the active metabolite of liquorice hydrolysis, on salivary steroid dynamics. This completed study evaluated liquorice ingestion and subsequent changes in the salivary cortisol-to-cortisone molar ratio within the context of apparent mineralocorticoid excess. Because the investigation assessed biomarker alterations rather than conventional therapeutic interventions, its trial phase was classified as Not Applicable, reflecting observational metabolic research conducted in university hospital settings.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02939144	Completed	Apparent Mineralocorticoid Excess	The Royal Wolverhampton Hospitals NHS Trust	2016-11	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Enoxolone binds to and inhibits 15-hydroxyprostaglandin dehydrogenase and delta-13-prostaglandin reductase, blocking the metabolic inactivation of prostaglandins PGE2 and PGF2. This inhibition leads to sustained local prostaglandin levels that suppress gastric acid secretion and enhance mucosal protection, while its concurrent modulation of corticosteroid metabolism links its activity directly to conditions like apparent mineralocorticoid excess.

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>).