Ursolic Acid Clinical Trials

Size	Price	Qty
100mg	USD 147
1g	USD 379

Clinical Trials

Ursolic acid has been evaluated across several clinical trials spanning early- to late-stage phases to investigate a range of metabolic, muscular, and oncological conditions, including sarcopenia, prostate cancer, spinal cord injury-associated muscle atrophy, metabolic syndrome X, and primary sclerosing cholangitis. Primarily sponsored by academic and university medical centers—such as Pusan National University Hospital, the University of Miami, and The University of Texas Health Science Center at San Antonio—these trials are currently recorded as completed or withdrawn. Specific investigations focus on assessing muscle function, physical performance, and insulin sensitivity in human subjects.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07562698	COMPLETED	Sarcopenia	Liaquat University of Medical & Health Sciences	2026-05-10
NCT05776862	COMPLETED	Spinal Cord Injuries; Tetraplegia; Paraplegia; Muscle Loss; Atrophy, Muscular; Insulin Resistance	University of Miami	2023-03-27	PHASE2
NCT04403568	WITHDRAWN	Prostate Cancer	The University of Texas Health Science Center at San Antonio	2021-10	EARLY_PHASE1
NCT04421716	COMPLETED	Bioavailability of Phytonutrients	The University of Texas Health Science Center at San Antonio	2020-10-20	EARLY_PHASE1
NCT03216876	WITHDRAWN	Primary Sclerosing Cholangitis	University of California, Davis	2017-09	PHASE1
NCT02337933	COMPLETED	Metabolic Syndrome X	University of Guadalajara	2014-09	PHASE2
NCT02401113	COMPLETED	Sarcopenia	Pusan National University Hospital	2014-11	PHASE2; PHASE3

(data from https://clinicaltrials.gov, updated on 2026-09-02)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ursolic acid acts through the glucocorticoid receptor and inhibits the STAT3 activation pathway, which suppresses matrix metalloproteinase-9 expression and impairs tumor cell proliferation and invasion. This downregulation of oncogenic and metabolic signaling cascades underscores its therapeutic potential in clinical investigations targeting prostate cancer, sarcopenia, and metabolic syndrome.

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>).