Clinical Trials

A clinical trial sponsored by the Centre Hospitalier Universitaire de Nice is evaluating GC7 Sulfate for therapeutic intervention following resuscitated cardiorespiratory arrest. Lacking an assigned phase designation, the study aims to determine whether target inhibition by GC7 can alleviate post-resuscitation oxidative stress and injury in human subjects. According to trial registry data, the study is currently not yet recruiting, with a planned initiation in 2026.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07468292 NOT_YET_RECRUITING
Cardiac Arrest (CA)
Centre Hospitalier Universitaire de Nice
 2026-07

(data from https://clinicaltrials.gov, updated on 2026-03-16)

Check the GC7 Sulfate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

GC7 Sulfate acts as a targeted inhibitor of deoxyhypusine synthase (DHPS), blocking downstream hypusine synthesis and signaling events to induce the cell cycle inhibitor p21, reduce phosphorylated and total retinoblastoma (Rb) protein levels, and arrest cellular proliferation. This targeted suppression of hypusination pathways and associated cellular stress mechanisms provides the mechanistic basis for investigating its protective efficacy against oxidative stress in clinical cases of resuscitated cardiac arrest.

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.