Caffeic Acid Phenethyl Ester Clinical Trials

Size	Price	Qty
50mg	USD 147
200mg	USD 270

Clinical Trials

Several clinical trials are currently recruiting to evaluate broad behavioral and psychological intervention frameworks targeting Autism Spectrum Disorder and adolescent subclinical mental health issues. Classified with a phase designation of Not Applicable, these studies focus on digital interventions, parental coaching, remote educational support, and transdiagnostic prevention programs. The trials are sponsored by academic and clinical institutions, including the Centre Hospitalier Universitaire Vaudois and the University of Bern.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05726708	Recruiting	Autism Spectrum Disorder	Centre Hospitalier Universitaire Vaudois	2023-10-24	Not Applicable
NCT05934019	Recruiting	Mental Health Issue\|Transdiagnostic Mechanisms\|Adolescent Psychology\|Prevention\|Online Intervention\|Psychological Intervention\|Mental Disorder in Adolescence Subclinical	University of Bern	2023-06-09	Not Applicable

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

Check the Caffeic Acid Phenethyl Ester product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Caffeic acid phenethyl ester functions as a potent and specific inhibitor of nuclear factor kappa B (NF-κB) activation, preventing the nuclear translocation of NF-κB and the subsequent transcription of downstream pro-inflammatory cytokines. This molecular blockade attenuates cellular oxidative stress and inflammatory signaling, offering potential therapeutic relevance in neuroinflammatory processes associated with autism spectrum disorders and adolescent mental health conditions.

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>).