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)
Mechanism and Biochemical Profile
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>).
- Glycyrrhetinic acid Solubility in DMSO
- Glycyrrhetinic acid Stock Solution
- Glycyrrhetinic acid Storage
- Glycyrrhetinic acid Stability
- Glycyrrhetinic acid Molecular Weight
- Glycyrrhetinic acid SMILES
- Glycyrrhetinic acid CAS Number
- Glycyrrhetinic acid Chemical Structure (2D and 3D)
- Glycyrrhetinic acid SDS|MSDS