Chlorzoxazone Clinical Trials

Size	Price	Qty
50mg	USD 97

Clinical Trials

Multiple clinical trials have evaluated chlorzoxazone as a probe or therapeutic agent within metabolic and hepatic research settings. These completed studies encompass Phase 2 and non-applicable phase designations, investigating conditions such as heavy alcohol consumption, insulin resistance, and iron overload by assessing farnesoid X receptor signaling and cytochrome P450 2E1 activity. Sponsored by academic, government, and industry partners—including Indiana University, the National Institute on Alcohol Abuse and Alcoholism, Intercept Pharmaceuticals, Rennes University Hospital, and the French Ministry of Health—this research underscores the clinical applications of chlorzoxazone.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02654236	Completed	Alcohol Consumption	Suthat Liangpunsakul\|National Institute on Alcohol Abuse and Alcoholism (NIAAA)\|Intercept Pharmaceuticals\|Indiana University	2016-04	Not Applicable
NCT00138684	Completed	Insulin Resistance\|Iron Overload	Rennes University Hospital\|Ministry of Health France	2003-09	Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Chlorzoxazone functions as a centrally acting muscle relaxant and substrate probe that selectively binds to human hepatic cytochrome P450 2E1, suppressing polysynaptic reflex arcs at the level of the spinal cord and subcortical brain regions. This pharmacological action reduces skeletal muscle hyperactivity, rendering it clinically relevant for alleviating muscle spasticity and for evaluating cytochrome P450 2E1 metabolic kinetics in human clinical studies involving alcohol consumption, insulin resistance, and iron overload.

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>).