Nifuroxazide Clinical Trials

Size	Price	Qty
50mg	USD 147
1g	USD 670

Clinical Trials

Nifuroxazide is currently being evaluated in several clinical trials for gastrointestinal and hepatic disorders, specifically ulcerative colitis and hepatic encephalopathy secondary to liver cirrhosis. Sponsored by academic and individual investigators, including Cairo University and Mostafa Bahaa, these Phase 2 and Phase 3 studies range in status from actively recruiting to completed. Ultimately, these investigations demonstrate the expanding therapeutic scope of nifuroxazide beyond its traditional antibacterial profile.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05754996	COMPLETED	Hepatic Encephalopathy	Cairo University	2023-03-12	PHASE3
NCT05988528	COMPLETED	Inflammatory Bowel Diseases	Mostafa Bahaa	2023-08-20	PHASE2; PHASE3
NCT05754996	Recruiting	Hepatic Encephalopathy	Cairo University	2023-03-12	Phase 3

(data from https://clinicaltrials.gov, updated on 2025-09-02)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As an orally available nitrofuran derivative, nifuroxazide directly suppresses the activation of STAT1, STAT3, and STAT5 transcription factors, effectively inhibiting interleukin-6-induced STAT3 phosphorylation and downstream target gene expression. This targeted inhibition reduces pro-inflammatory cytokine signaling and cellular proliferation, providing a molecular rationale for its therapeutic evaluation in inflammatory bowel diseases and hepatic encephalopathy.

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>).