Irsogladine Clinical Trials

Size	Price	Qty
50mg	USD 97

Clinical Trials

Multiple Phase 1 clinical trials with completed recruitment status have evaluated irsogladine for gastroprotective indications, specifically targeting gastric and peptic ulcers. Sponsored by pharmaceutical and academic organizations, including Boryung Pharmaceutical Co. Ltd and The Catholic University of Korea, these studies assessed safety parameters and drug interaction profiles.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02759224	Completed	Gastric Ulcer	Boryung Pharmaceutical Co. Ltd	2016-04-15	Phase 1
NCT02581696	Completed	Peptic Ulcer	Boryung Pharmaceutical Co. Ltd\|The Catholic University of Korea	2015-08	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Irsogladine binds to the M1 muscarinic acetylcholine receptor, facilitating gap-junctional intercellular communication and suppressing angiogenic pathways within mucosal tissues. This enhancement of cellular communication and regulation of microvascular dynamics maintains tissue integrity, directly supporting its clinical application in gastric ulcer and peptic ulcer treatment.

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>).