Clinical Trials

A completed clinical trial sponsored by the University of Cadiz evaluated targeted communication and educational strategies aimed at improving health literacy and core competencies among nursing students. Classified as an interventional study with an unspecified phase, recruitment for the trial is fully complete. The current research landscape reflects this academic initiative and lacks industry-sponsored clinical drug development trials.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06490406 COMPLETED
Health Literacy; Competence; Nursing Students
University of Cadiz
 2020-01-01

(data from https://clinicaltrials.gov, updated on 2024-07-08)

Check the EG1 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

EG1 specifically binds to the DNA-binding domain of Paired box 2 (Pax2), blocking Pax2-mediated transcriptional activation and downstream gene expression required for renal cellular differentiation. This targeted suppression disrupts embryonic kidney development, establishing its relevance in nephrogenesis research despite current clinical records focusing on health literacy and student competence.

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.