Sodium oxamate Clinical Trials

Size	Price	Qty
100mg	USD 147
1g	USD 297

Clinical Trials

Several clinical trials evaluate diverse conditions, including schizophrenia spectrum disorders with cannabis use, septic shock, sleep syncope, fetal central nervous system anomalies, and food insecurity interventions. Sponsored primarily by academic medical centers and health networks, these studies encompass Phase II, Phase III, and non-applicable protocol classifications. Current recruitment statuses across the trials range from withdrawn and not yet recruiting to actively recruiting participants.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03883360	Withdrawn	Schizophrenia Spectrum Disorders\|Cannabis Use	University of Maryland Baltimore\|Sheppard Pratt Health System\|University of California Los Angeles	2050-01	Phase 2
NCT03643367	Not yet recruiting	Shock Septic	University of Zurich\|Kantonsspital Münsterlingen\|Triemli Hospital\|Waid City Hospital Zurich	2025-01	Phase 2
NCT05657925	Not yet recruiting	Sleep Syncope	University of Calgary	2024-12-01	Phase 3
NCT05771922	Recruiting	Ultrasound Therapy; Complications Anomaly Central Nervous System Diseases	Woman''s Health University Hospital Egypt	2024-11-30	--
NCT05854212	Not yet recruiting	Food Insecurity\|Dietary Quality\|Behavioral Economics\|Implementation Science	Massachusetts General Hospital	2024-11	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sodium oxamate selectively inhibits lactate dehydrogenase A (LDH-A), thereby downregulating the CDK1/cyclin B1 pathway to induce G2/M cell cycle arrest and elevating mitochondrial reactive oxygen species levels to promote apoptosis. By suppressing LDH-A-driven glycolysis and inducing oxidative cellular stress, this agent provides therapeutic potential for mitigating metabolic and tissue dysfunction in clinical conditions such as septic shock and central nervous system disorders.

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>).