Urolithin A Clinical Trials

Size	Price	Qty
10mg	USD 147
100mg	USD 770

Clinical Trials

Multiple clinical trials evaluate the therapeutic potential of Urolithin A across healthy aging, muscle function, glucose metabolism, chronic obstructive pulmonary disease, skin aging, and solid malignancies including non-small cell lung cancer and melanoma. Ranging from Phase 2 interventions to non-interventional dietary studies, these protocols encompass both active and completed recruitment statuses. This research is supported by industry leaders such as Amazentis SA alongside academic and governmental sponsors, including the National Institute on Aging and McGill University Health Centre.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07231783	RECRUITING	Healthy Aging; Muscle Function	Amazentis SA	2025-12-10
NCT07517913	NOT_YET_RECRUITING	Healthy Adult	Amazentis SA	2026-10-01
NCT06274749	RECRUITING	Healthy Volunteer	National Institute on Aging (NIA)	2026-09-09
NCT07161310	RECRUITING	Solid Cancer; Non-Small Cell Lung Cancer; Melanoma	Goethe University	2026-01-02
NCT06022822	RECRUITING	Prostate Adenocarcinoma	National Cancer Institute (NCI)	2024-09-12	PHASE2
NCT06990256	ACTIVE_NOT_RECRUITING	Sleep Disorder; Aging	Huazhong University of Science and Technology	2025-09-16
NCT07377136	ENROLLING_BY_INVITATION	Obesity & Overweight	Charles University, Czech Republic	2025-10-08
NCT04985630	RECRUITING	Healthy Aging; Healthy; Healthy Diet	Amazentis SA	2021-08-30
NCT07451496	RECRUITING	Ageing	National University of Singapore	2025-09-29
NCT07231848	COMPLETED	Healthy Adults	Amazentis SA	2025-11-03
NCT05921266	COMPLETED	Obesity; Vascular Dementia; Cognitive Impairment	University of Oklahoma	2023-10-02
NCT06853197	COMPLETED	Healthy Adults	Amazentis SA	2025-03-17
NCT06556706	COMPLETED	Frailty; Sarcopenia; Aging; Muscle Atrophy	Amazentis SA	2024-08-15
NCT06362018	COMPLETED	Healthy Adults	Amazentis SA	2024-05-07
NCT06324214	UNKNOWN	Copd	McGill University Health Centre/Research Institute of the McGill University Health Centre	2024-03-11	PHASE2
NCT06619457	COMPLETED	Skin Aging	Amazentis SA	2024-09-25
NCT05814705	ACTIVE_NOT_RECRUITING	Healthy; Muscle Disuse Atrophy	McMaster University	2023-06-01
NCT06274749	Recruiting	Healthy Volunteer	National Institute on Aging (NIA)\|National Institutes of Health Clinical Center (CC)	2024-05-15	Not Applicable
NCT06362018	Recruiting	Healthy Adults	Amazentis SA\|Mprex Healthcare Pvt. Ltd.	2024-05-07	Not Applicable
NCT05735886	COMPLETED	Aging	Amazentis SA	2023-01-30
NCT04783207	COMPLETED	Healthy	Amazentis SA	2021-04-21
NCT04066816	COMPLETED	Colo-rectal Cancer; Colon Cancer; Diet Habit	UConn Health	2019-05-20
NCT04783207	Completed	Healthy	Amazentis SA\|Australian Catholic University	2021-04-21	Not Applicable
NCT04160312	COMPLETED	Healthy; Healthy Aging	Amazentis SA	2019-11-08

(data from https://clinicaltrials.gov, updated on 2026-03-31)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Urolithin A acts as a potent stimulator of mitochondrial quality control by inducing selective mitophagy, which clears damaged or dysfunctional mitochondria and restores cellular bioenergetics. This upregulation of mitochondrial renewal enhances cellular resilience and tissue viability, underpinning its clinical relevance in addressing muscle function decline, chronic obstructive pulmonary disease, and age-related metabolic dysfunctions.

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>).