4-Methylumbelliferone (4-MU) Clinical Trials

Size	Price	Qty
10mg	USD 147

Clinical Trials

Multiple Phase 2 clinical trials evaluate 4-Methylumbelliferone across distinct hepatobiliary and hepatic disorders, including Primary Sclerosing Cholangitis, Chronic Hepatitis B, and Chronic Hepatitis C. A clinical trial sponsored by Stanford University and investigator Aparna Goel is actively recruiting patients with Primary Sclerosing Cholangitis to evaluate oral hymecromone. Additionally, a clinical trial sponsored by the MTmedical Institute of Health assessed the compound in chronic viral hepatitis, though its recruitment status remains unknown.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05295680	Recruiting	Primary Sclerosing Cholangitis	Aparna Goel\|Stanford University	2023-05-10	Phase 2
NCT00225537	UNKNOWN	Chronic Hepatitis C; Chronic Hepatitis B	MTmedical Institute of Health	2005-09	PHASE2

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

Check the 4-Methylumbelliferone (4-MU) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

4-Methylumbelliferone acts as a direct inhibitor of hyaluronic acid synthesis, reducing extracellular matrix glycosaminoglycan production and suppressing downstream signaling pathways essential for cell proliferation, motility, and invasion. By disrupting hyaluronic acid-mediated cellular matrix assembly and signaling, this agent demonstrates therapeutic potential in mitigating inflammatory and fibrotic tissue remodeling associated with primary sclerosing cholangitis and chronic viral hepatitis.

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>).