FOY251 Clinical Trials

Size	Price	Qty
5mg	USD 269
25mg	USD 807

Clinical Trials

Multiple completed clinical trials have evaluated this compound across Phase 1 and combined Phase 1/2 settings. Conducted by industry sponsors including Ono Pharmaceutical Co. Ltd and Kangen Pharmaceuticals Inc, these studies involved healthy adult volunteers as well as patients with chronic pancreatitis. The evaluations assessed single- and multiple-dose regimens to characterize safety, pharmacokinetics, and dose-ranging efficacy.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04451083	Completed	Healthy Volunteers	Ono Pharmaceutical Co. Ltd	2020-07-01	Phase 1
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 FOY251 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

FOY251 selectively targets and inhibits synthetic serine proteases, blocking downstream proteolytic cleavage events required for viral priming and host cell entry. This suppression of proteolytic activity effectively halts cellular viral infection and limits enzyme-mediated tissue damage, highlighting its clinical relevance in managing serine protease-driven conditions such as chronic pancreatitis.

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>).