Nafamostat mesilate (FUT-175) Clinical Trials

Size	Price	Qty
10mg	USD 147
100mg	USD 490

Clinical Trials

Nafamostat mesilate is evaluated across multiple early- to late-phase clinical trials targeting COVID-19, acute kidney injury, sepsis-induced coagulopathy, and postreperfusion syndrome during liver transplantation. Sponsored by academic medical centers and clinical research organizations, these studies assess parameters such as viral outcomes, filter patency, and hemodynamic stability. The trial portfolio includes completed studies, active non-recruiting trials, and those with an unknown recruitment status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06276010	RECRUITING	Extracorporeal Membrane Oxygenation Complication	Xiaotong Hou	2024-07-01
NCT06078839	NOT_YET_RECRUITING	Sepsis; Sepsis-induced Coagulopathy; Nafamostat Mesilate	Xu Li	2023-10-01	PHASE4
NCT04483960	UNKNOWN	SARS-CoV-2 Infection (COVID-19)	University of Melbourne	2020-07-28	PHASE3
NCT04473053	COMPLETED	COVID-19	University of Edinburgh	2020-07-03	PHASE1; PHASE2
NCT04352400	UNKNOWN	COVID19	University Hospital Padova	2021-06-04	PHASE2; PHASE3
NCT04390594	TERMINATED	COVID-19	Institut Pasteur de Dakar	2020-08-13	PHASE3
NCT04628143	COMPLETED	COVID-19	Chong Kun Dang Pharmaceutical	2020-12-21	PHASE2
NCT04623021	COMPLETED	COVID-19	Chong Kun Dang Pharmaceutical	2020-09-25	PHASE2
NCT04406415	COMPLETED	Pharmacokinetics	Ensysce Biosciences	2020-09-21	PHASE1
NCT02478242	COMPLETED	Acute Kidney Injury	Kyungpook National University Hospital	2010-07	PHASE4
NCT01761994	COMPLETED	Acute Kidney Injury	Yonsei University	2007-09	PHASE4
NCT01001403	COMPLETED	Liver Transplantation; Postreperfusion Syndrome	Seoul National University Hospital	2009-03	PHASE4

(data from https://clinicaltrials.gov, updated on 2025-09-25)

Check the Nafamostat mesilate (FUT-175) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Nafamostat mesilate acts as a broad-spectrum synthetic serine protease inhibitor that directly binds and inhibits key enzymatic targets, including transmembrane protease serine 2 (TMPRSS2), thrombin, and coagulation factors, thereby blocking downstream proteolytic cascades and host-cell viral entry. This enzymatic suppression diminishes cellular inflammatory cytokine release and pathologically induced microvascular thrombosis, demonstrating direct clinical relevance in mitigating viral disease progression in SARS-CoV-2 infection and preventing clotting complications in acute kidney injury and sepsis.

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>).