Diammonium Glycyrrhizinate Clinical Trials

Size	Price	Qty
25mg	USD 97
1g	USD 970

Clinical Trials

Multiple clinical trials are currently recruiting participants across oncology, infectious respiratory conditions, and early-phase safety evaluations. These active studies include a Phase 2 efficacy trial in acute nasopharyngitis sponsored by G.ST Antivirals GmbH, a Phase 1 single ascending dose study in healthy volunteers supported by Trellis Bioscience LLC and the National Institute of Allergy and Infectious Diseases, and a diagnostic performance trial focused on malignant tumors conducted by Peking Union Medical College Hospital.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06375772	Recruiting	Acute Nasopharyngitis	G.ST Antivirals GmbH	2024-04-02	Phase 2
NCT05408091	Recruiting	Healthy Volunteers	Trellis Bioscience LLC\|National Institute of Allergy and Infectious Diseases (NIAID)	2023-09-14	Phase 1
NCT06030817	Recruiting	Malignant Tumor	Peking Union Medical College Hospital	2023-08-11	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Diammonium glycyrrhizinate exerts anti-inflammatory and cytoprotective effects by suppressing the activation of nuclear factor-kappa B (NF-κB) and reducing the expression of downstream mediators, including tumor necrosis factor-alpha (TNF-α) and intercellular adhesion molecule 1 (ICAM-1). This molecular suppression attenuates inflammatory tissue injury and cellular oxidative stress, providing therapeutic relevance for clinical indications such as acute nasopharyngitis and malignant tumors.

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>).