4,4'-DDE Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

A clinical trial is currently evaluating 4,4'-DDE for conditions classified under congenital and acquired developmental disabilities. Actively recruiting participants, this study operates without an assigned clinical phase. The research is supported by institutional and academic sponsors, including Giovanni Cioni, Azienda USL Toscana Nord Ovest, Scuola Superiore Sant'Anna di Pisa, and IRCCS Fondazione Stella Maris.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06219447	Recruiting	Congenital and Acquired Developmental Disabilities	Giovanni Cioni\|Azienda USL Toscana Nord Ovest\|Scuola Superiore Sant''Anna di Pisa\|IRCCS Fondazione Stella Maris	2021-02-12	Not Applicable

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

Check the 4,4'-DDE product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

4,4'-DDE functions as a potent antagonist of the androgen receptor, directly binding to the receptor domain and blocking ligand-dependent transcriptional activation. This inhibition disrupts downstream cellular endocrine signaling and hormone-responsive gene expression, which may contribute to altered neurodevelopmental outcomes relevant to congenital and acquired developmental disabilities.

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>).