Oltipraz Clinical Trials

Size	Price	Qty
10mg	USD 147
50mg	USD 247

Clinical Trials

Multiple clinical trials spanning Phase 1 through Phase 3 have been completed to evaluate the therapeutic potential and safety profile of Oltipraz across various indications. These studies primarily focused on hepatic disorders—including non-alcoholic fatty liver disease, liver fibrosis, and liver cirrhosis—alongside an early-phase safety evaluation for lung cancer risk in smokers. Interventions were sponsored by both academic institutions, such as Northwestern University, and industry entities, including PharmaKing and HK inno.N Corporation.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04142749	COMPLETED	Non-Alcoholic Fatty Liver Disease	PharmaKing	2019-11-15	PHASE3
NCT02068339	COMPLETED	Non-alcholic Fatty Liver Disease	PharmaKing	2014-02	PHASE3
NCT01373554	COMPLETED	Non-alcoholic Fatty Liver Disease	PharmaKing	2011-05	PHASE2
NCT00006457	COMPLETED	Lung Cancer	Northwestern University	2000-08	PHASE1
NCT00956098	COMPLETED	Liver Fibrosis; Liver Cirrhosis	HK inno.N Corporation	2006-02	PHASE2

(data from https://clinicaltrials.gov, updated on 2022-10-06)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Oltipraz binds to and activates nuclear factor erythroid 2-related factor 2, driving the transcriptional upregulation of downstream Phase II detoxification enzymes, specifically glutathione S-transferase. This enzymatic induction accelerates the neutralization of reactive electrophiles and alleviates cellular oxidative stress, counteracting tissue damage in non-alcoholic fatty liver disease, liver fibrosis, liver cirrhosis, and lung cancer.

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>).