Upamostat (WX-671) Clinical Trials

Size	Price	Qty
5mg	USD 290
25mg	USD 870

Clinical Trials

Upamostat (WX-671) has been evaluated in several clinical trials across oncology and infectious disease indications, spanning Phase II and Phase III development. In oncology, studies sponsored by Heidelberg Pharma AG assessed combination regimens for solid tumors, specifically metastatic breast and pancreatic cancers. Subsequent research sponsored by RedHill Biopharma Limited and the Henry M. Jackson Foundation evaluated SARS-CoV-2 and COVID-19 interventions through adaptive platform protocols, with trial statuses ranging from recruiting and completed to terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05954286	COMPLETED	SARS-CoV-2	Henry M. Jackson Foundation for the Advancement of Military Medicine	2024-01-29	PHASE2
NCT05954286	Recruiting	SARS-CoV-2	Henry M. Jackson Foundation for the Advancement of Military Medicine\|Joint Program Executive Office Chemical Biological Radiological and Nuclear Defense Enabling Biotechnologies\|RedHill Biopharma Limited\|FHI Clinical Inc.	2024-01-29	Phase 2
NCT04723537	TERMINATED	Covid19	RedHill Biopharma Limited	2021-02-16	PHASE2; PHASE3
NCT00615940	COMPLETED	Metastatic Breast Cancer	Heidelberg Pharma AG	2008-07	PHASE2
NCT00499265	COMPLETED	Pancreatic Cancer	Heidelberg Pharma AG	2007-04	PHASE2

(data from https://clinicaltrials.gov, updated on 2026-04-17)

Check the Upamostat (WX-671) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Upamostat (WX-671) selectively binds to and inhibits urokinase-type plasminogen activator (uPA), thereby blocking the conversion of plasminogen to plasmin and halting downstream extracellular matrix degradation and growth factor activation. This targeted inhibition suppresses cell migration, invasive capability, and tissue remodeling, which provides a key rationale for evaluating upamostat in clinical trials for solid tumors like metastatic breast cancer and pancreatic cancer, as well as viral infections such as COVID-19.

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>).