Sodium ascorbate Clinical Trials

Size	Price	Qty
50mg	USD 147
1g	USD 370

Clinical Trials

Sodium ascorbate is undergoing evaluation in several clinical trials ranging from Early Phase 1 through Phase 2 for various inflammatory, metabolic, surgical, and oncological indications. These studies—with statuses spanning completed, active, recruiting, and not yet recruiting—are sponsored by academic medical centers such as the University of Iowa and governmental entities including the National Institutes of Health and Melbourne Health. Key conditions under investigation include soft tissue sarcomas, ovarian cancer, severe pneumonia, type 2 diabetes, septic shock, and outcomes following coronary artery bypass graft surgery.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05842382	Not yet recruiting	Pneumonia	Clinical Research Centre Malaysia\|Ain Medicare Sdn Bhd	2023-12	Phase 2
NCT04796636	UNKNOWN	Sepsis, Severe; Septic Shock	Melbourne Health	2021-09-27	PHASE1
NCT04634227	Recruiting	Sarcoma\|Soft Tissue Sarcoma\|Unresectable Soft Tissue Sarcoma\|Metastatic Bone Tumor\|Bone Sarcoma	Mohammed Milhem MBBS\|University of Iowa	2020-11-24	Early Phase 1
NCT03508726	Active not recruiting	Soft Tissue Sarcoma	Mohammed Milhem\|University of Iowa	2019-06-27	Phase 1\|Phase 2
NCT02107976	Recruiting	Diabetes Type 2	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)\|National Institutes of Health Clinical Center (CC)	2019-06-14	Phase 1
NCT03123107	Completed	Coronary Artery Bypass Graft Surgery	Geisinger Clinic\|Wilkes University	2017-07-06	Phase 1
NCT02460783	Completed	Alzheimer''s Disease\|Obesity\|Diabetes Mellitus	National Institute on Aging (NIA)\|National Institutes of Health Clinical Center (CC)	2015-06-22	Not Applicable
NCT00228319	COMPLETED	Ovarian Cancer	Jeanne Drisko, MD, CNS, FACN	2002-10	PHASE1; PHASE2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sodium ascorbate functions as an electron donor that scavenges reactive oxygen species and acts as an essential cofactor for Fe(II)/2-oxoglutarate-dependent dioxygenases, thereby suppressing oxidative stress and regulating hypoxia-inducible factor pathways. This biochemical activity reduces cellular oxidative damage and restores redox homeostasis, underlying its therapeutic evaluation in clinical conditions such as severe pneumonia, septic shock, soft tissue sarcomas, and type 2 diabetes.

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>).