Clinical Trials

A clinical trial evaluated Efaproxiral Sodium in patients with brain and central nervous system tumors. Sponsored by the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins in collaboration with the National Cancer Institute, the study was designed as an imaging companion protocol to assess the compound's impact on cranial MRI parameters. Although designated with a trial phase of Not Applicable, the study's recruitment status was recorded as withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT00433472 Withdrawn
Brain and Central Nervous System Tumors
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|National Cancer Institute (NCI)
 Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Efaproxiral Sodium acts as a synthetic allosteric modifier of hemoglobin, binding directly to the hemoglobin protein to decrease its oxygen-binding affinity and facilitate allosteric oxygen release in peripheral tissues. By increasing tissue oxygen tension, the compound enhances the oxygenation of hypoxic tumor cells, thereby radiosensitizing solid malignancies such as brain and central nervous system tumors during radiation therapy.

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>).

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Note: Technical data last updated: Sep 1, 2026.