Clinical Trials

Several clinical trials evaluate glycyrrhetinic acid across conditions such as apparent mineralocorticoid excess, irritant contact dermatitis, primary immune thrombocytopenia, and end-stage renal disease. Spanning Phase 2, Phase 4, and non-applicable phase classifications, these studies feature recruitment statuses ranging from completed and actively recruiting to unknown. Sponsored by academic and medical institutions including Shandong University, the University of Split, Insel Gruppe AG, and The Royal Wolverhampton Hospitals NHS Trust, these efforts highlight clinical interest in the compound's physiological effects on corticosteroid metabolism, inflammatory response, and systemic disease management.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07286487 RECRUITING
Irritant Contact Dermatitis
University of Split, School of Medicine
2026-09-14
NCT03998982 UNKNOWN
Immune Thrombocytopenia
Shandong University
2019-06-25 PHASE4
NCT02939144 Completed
Apparent Mineralocorticoid Excess
The Royal Wolverhampton Hospitals NHS Trust
2016-11 Not Applicable
NCT00384384 COMPLETED
End Stage Renal Disease
Insel Gruppe AG, University Hospital Bern
2006-08 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-09-03)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Glycyrrhetinic acid binds to and inhibits 11beta-hydroxysteroid dehydrogenase and pro-survival pathways, blocking the enzymatic conversion of cortisol and downregulating anti-apoptotic cellular cascades. This blockade suppresses cell proliferation and triggers apoptosis, establishing therapeutic relevance for modulating steroid metabolism in apparent mineralocorticoid excess and mitigating inflammatory processes in contact dermatitis and renal disease.

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>).

Note: Technical data last updated: Sep 1, 2026.