Clinical Trials

Multiple clinical trials investigate Glycyrrhizin and its derivatives across diverse inflammatory, hepatic, neurological, and oncological conditions, including atopic dermatitis, hepatocellular carcinoma, chronic hepatitis B, diabetic neuropathy, and CAR-T cell therapy toxicity mitigation. Encompassing Phase 1 through Phase 4 protocols, recruitment statuses range from completed to not yet recruiting. These studies are predominantly sponsored by academic medical centers and university hospitals, including The Affiliated Hospital of Xuzhou Medical University, Tongji Hospital, Cttq, and Helwan University.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07616271 NOT_YET_RECRUITING
Patients With Large B-cell Lymphoma Receiving CAR-T Cell Therapy
Tongji Hospital
 2026-05-22 PHASE2; PHASE3
NCT05925309 RECRUITING
Biliary Atresia; Cholangitis; Anti-Bacterial Agents
Children's Hospital of Fudan University
 2023-07-01
NCT07236567 NOT_YET_RECRUITING
Traumatic Teeth; Necrotic Teeth
Al-Azhar University
 2025-12-01
NCT06378346 RECRUITING
Prostate Cancer
University of Illinois at Chicago
 2024-07-25 PHASE2
NCT05788705 UNKNOWN
Rheumatoid Arthritis
Adel A.Gomaa
 2023-07
NCT05276895 SUSPENDED
Osteoarthritis
Assiut University
 2022-07-01
NCT06453304 UNKNOWN
Intracanal Medication
Mansoura University
 2022-03-20 PHASE2; PHASE3
NCT06291623 COMPLETED
Bacterial Viability of Necrotic Pulp With Asymptomatic Apical Periodontitis
Mansoura University
 2022-05-03 PHASE1
NCT05895773 COMPLETED
Ventilator Associated Pneumonia
Menoufia University
 2023-06-24 PHASE2; PHASE3
NCT06565117 COMPLETED
Adult Atopic Dermatitis
The Affiliated Hospital of Xuzhou Medical University
 2021-10-01
NCT04742660 COMPLETED
Postoperative Nausea
Konkuk University Medical Center
 2021-05-11
NCT05023915 ACTIVE_NOT_RECRUITING
Immune Thrombocytopenia
Shandong University
 2021-08-21 PHASE2
NCT07117942 COMPLETED
Diabetic Neuropathy
Helwan University
 2020-02-12 PHASE2
NCT03349008 UNKNOWN
Chronic Hepatitis b; Liver Inflammation
Cttq
 2017-11-25 PHASE4
NCT01643447 COMPLETED
Hepatocellular Carcinoma
Eastern Hepatobiliary Surgery Hospital
 2012-05
NCT01342185 UNKNOWN
Chronic Hepatitis B
Nanfang Hospital, Southern Medical University
 2010-03 PHASE3

(data from https://clinicaltrials.gov, updated on 2026-06-01)

Check the Glycyrrhizin (Glycyrrhizic Acid, NSC 167409) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Glycyrrhizin directly binds to high mobility group box 1 (HMGB1) and inhibits 11 beta-hydroxysteroid dehydrogenase, thereby blocking downstream p38 and P-JNK signaling cascades and suppressing pro-inflammatory cytokine expression and cellular oxidative stress. This multi-target pathway suppression reduces acute tissue damage, supporting its clinical application in treating liver inflammation, dermatitis, and therapy-induced toxicities in patients undergoing CAR-T cell therapy.

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>).

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