Oxalacetic acid Clinical Trials

Size	Price	Qty
25mg	USD 147
1g	USD 970

Clinical Trials

A clinical trial evaluated oxalacetic acid to assess metabolic and blood/plasma variables in patients with fibromyalgia undergoing a hospital-based, supervised aerobic exercise intervention. This completed study, categorized with a phase designation of Not Applicable, was sponsored by academic, hospital, and regional health organizations, including Universidad Pablo de Olavide, Hospital Universitario de Valme, and the Andaluz Health Service. The research underscores an interest in exploring the relationship between physical exercise, blood biomarkers, and metabolic management in chronic pain populations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06001034	Completed	Fibromyalgia	José Carlos Rodríguez Bautista\|Universidad Pablo de Olavide\|Hospital Universitario de Valme\|Andaluz Health Service	2022-09-15	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Oxalacetic acid acts as a potent inhibitor of mitochondrial Complex II (succinate dehydrogenase) while serving as a critical intermediate in the citric acid cycle where it condenses with acetyl-CoA to generate citrate. By directly regulating mitochondrial electron transport and cellular metabolic pathways, it modulates energy production and cellular redox states, offering potential clinical utility in restoring metabolic homeostasis in conditions such as fibromyalgia.

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>).