Oxiglutatione Clinical Trials

Size	Price	Qty
25mg	USD 147

Clinical Trials

Multiple clinical trials categorized with a trial phase of Not Applicable are currently evaluating oxiglutatione in relation to menopausal health, vascular function, body composition, physical performance, and exercise-induced muscle damage. Sponsored by academic institutions including the University of Thessaly and Beijing Sport University, these studies assess interventions such as targeted exercise protocols and traditional Greek dance. Current recruitment statuses range from not yet recruiting to actively recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06260124	Not yet recruiting	Menopause\|Cardiovascular Health\|Body Composition\|Physical Performance\|Muscle Damage	University of Thessaly	2024-04-10	Not Applicable
NCT06201312	Recruiting	Vascular Health	Beijing Sport University	2023-12-11	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Oxiglutatione serves as the oxidized disulfide component of the intracellular glutathione system, where it interacts with redox-sensitive enzymes and glutathione reductase to regulate cellular oxidation-reduction equilibrium. By modulating downstream oxidative stress signaling and cellular antioxidant pathways, it influences cellular resistance to oxidative damage and endothelial activity, providing therapeutic relevance in studies of vascular health, physical performance, and muscle damage during menopause.

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>).