Zearalenone Clinical Trials

Size	Price	Qty
5mg	USD 97
25mg	USD 237

Clinical Trials

A clinical trial is currently recruiting to evaluate outcomes associated with this compound profile, focusing on pregnancy and neonatal outcomes following antenatal exposure in HIV infections. Operating without a defined phase designation, the study is sponsored by academic and research organizations, including Fondazione Penta UK, the UCL Great Ormond Street Institute of Child Health, and the PENTA Foundation. This observational monitoring effort aims to clarify safety parameters and health outcomes in patients managed for viral disease.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05751031	Recruiting	HIV Infections	Fondazione Penta UK\|UCL Great Ormond Street Institute of Child Health\|PENTA Foundation	2023-02-20	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Zearalenone functions as a non-steroidal estrogenic mycotoxin that directly binds to the estrogen receptor, thereby disrupting downstream hormone-regulated gene expression and intracellular signal transduction. This targeted receptor interaction subsequently alters endocrine-driven cellular signaling, providing functional context for investigating host physiological responses in clinical conditions such as HIV infections.

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>).