Gabexate Mesylate Clinical Trials

Size	Price	Qty
5mg	USD 147

Clinical Trials

Multiple clinical trials have evaluated Gabexate Mesylate across Phase 1, Phase 1/Phase 2, and Phase 3 stages in healthy volunteers, chronic pancreatitis, and liver disease. Completed research includes a Phase 1 study in healthy volunteers sponsored by Ono Pharmaceutical Co. Ltd., alongside a Phase 1/Phase 2 pharmacokinetic and dose-ranging study in chronic pancreatitis sponsored by Kangen Pharmaceuticals Inc. In contrast, a Phase 3 trial led by Yonsei University evaluating hepatocyte protection following liver resection in patients with liver disease was terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04451083	Completed	Healthy Volunteers	Ono Pharmaceutical Co. Ltd	2020-07-01	Phase 1
NCT02710266	TERMINATED	Liver Disease	Yonsei University	2012-02-24	PHASE3
NCT02693093	Completed	Chronic Pancreatitis	Kangen Pharmaceuticals Inc	2016-02-24	Phase 1\|Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Gabexate mesylate acts as a potent serine protease inhibitor with an IC50 of 0.19 μM, binding to active sites of proteolytic enzymes to block downstream biochemical cascades and prevent pathological cellular autodigestion. By suppressing inappropriate protease activity and mitigating tissue injury, this compound provides therapeutic hepatocyte protection and alleviates inflammation in clinical contexts such as chronic pancreatitis and liver 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>).