Guggulsterone E&Z Clinical Trials

Size	Price	Qty
5mg	USD 147
50mg	USD 370

Clinical Trials

The clinical development landscape for Guggulsterone E&Z remains minimal, featuring a clinical trial that evaluated the role of the farnesoid X receptor in Chronic Hepatitis C viral replication. Sponsored by Hospices Civils de Lyon, a hospital-based institution, the study was assigned a phase designation of Not Applicable and was ultimately terminated. Consequently, there are no active or completed clinical trials available to provide further human data for this agent.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01492998	Terminated	Chronic Hepatitis C	Hospices Civils de Lyon	2010-01	Not Applicable

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

Check the Guggulsterone E&Z product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Guggulsterone E&Z acts as an antagonist ligand for the farnesoid X receptor (FXR), binding directly to the nuclear receptor and suppressing downstream transcriptional signaling cascades. By inhibiting FXR activity, the compound modulates cellular lipid metabolism and host nuclear pathways, which is clinically relevant to understanding host-factor requirements for viral replication in Chronic Hepatitis C.

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>).