EN4 Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

Multiple clinical trials are currently recruiting participants to evaluate management strategies for neuropathic pain and peripheral nerve conditions, including pain alleviation in Fabry disease and electroacupuncture for distal diabetic peripheral neuropathy and associated nerve conduction changes. Designated with a trial phase of Not Applicable, these studies are sponsored by academic and research entities, including the Swiss National Science Foundation, the University of Zurich, and the Instituto Mexicano del Seguro Social along with affiliated Mexican academic institutions.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04820361	Recruiting	Pain Neuropathic	Albina Nowak MD\|Swiss National Science Foundation\|University of Zurich	2022-07-07	Not Applicable
NCT05521737	Recruiting	Electroacupuncture\|Acupuncture\|Diabetic Polyneuropathy\|Diabetic Peripheral Neuropathy\|Diabetic Peripheral Neuropathic Pain\|Nerve Conduction	Instituto Mexicano del Seguro Social\|National Polytechnic Institute Mexico\|Instituto Nacional de Salud Publica Mexico\|Escuela Superior de Medicina Instituto Politécnico Nacional\|Escuela Nacional de Medicina y Homeopatía Instituto Politécnico Nacional\|Universidad Nacional Autonoma de Mexico\|Facultad de Estudios Superiores Iztacala Universidad Nacional Autónoma de Mexico\|Facultad de Estudios Superiores Zaragoza Universidad Nacional Autónoma de Mexico\|Facultad de Medicina UNAM	2021-11-01	Not Applicable

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

Check the EN4 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

EN4 acts as a selective covalent ligand that binds to cysteine 171 (C171) of c-MYC, thereby blocking c-MYC transcriptional activity and downregulating downstream gene expression. This molecular blockade impairs cell proliferation and tumorigenesis, offering potential relevance to clinical investigations involving neuropathic pain and diabetic peripheral neuropathy.

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>).