Eupatilin Clinical Trials

Size	Price	Qty
5mg	USD 97
25mg	USD 327

Clinical Trials

A Phase 4 clinical trial with an unknown recruitment status, sponsored by an academic hospital (Seoul National University Boramae Hospital), evaluates eupatilin compared to rebamipide for preventing gastrointestinal mucosal injury in patients receiving non-steroidal anti-inflammatory drugs and low-dose steroids. This study represents a late-stage therapeutic assessment for conditions including rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, other musculoskeletal disorders, gastric ulcers, enteritis, and NSAID-associated gastropathy or enteropathy.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04885751	UNKNOWN	Rheumatoid Arthritis; Osteoarthritis; Ankylosing Spondylitis; Other Musculoskeletal Disorder; Gastric Ulcer; Enteritis; NSAID-Associated Gastropathy; NSAID (Non-Steroidal Anti-Inflammatory Drug) Induced Enteropathy	Seoul National University Boramae Hospital	2021-06-01	PHASE4

(data from https://clinicaltrials.gov, updated on 2021-05-13)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Eupatilin acts as a peroxisome proliferator-activated receptor alpha (PPARα) agonist, binding to PPARα to suppress pro-inflammatory cytokine expression and attenuate oxidative cellular stress. This functional response protects mucosal epithelial integrity and limits cellular injury, providing clinical utility in mitigating NSAID-induced gastropathy, gastric ulcers, and enteropathy in patients with inflammatory joint disorders.

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>).