Rifaximin Clinical Trials

Size	Price	Qty
50mg	USD 147
1g	USD 670

Clinical Trials

Several clinical trials are evaluating the therapeutic utility of rifaximin across gastrointestinal and metabolic conditions, including small intestinal bacterial overgrowth, minimal hepatic encephalopathy, motility disorders, and abdominal symptoms in cystic fibrosis. Spanning Phase II, Phase III, and unassigned protocols, these studies are supported by academic and industry sponsors such as Envivo Bio Inc, MetroHealth Medical Center, and Wake Forest University Health Sciences. Recruitment statuses range from recruiting and not yet recruiting to withdrawn, reflecting ongoing investigation into gut microbiota modulation.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05408910	Not yet recruiting	Cystic Fibrosis\|Abdominal Pain\|Small Bowel Disease	Wake Forest University Health Sciences\|Nationwide Children''s Hospital\|University of Minnesota\|University of Texas Southwestern Medical Center	2024-07	Phase 2\|Phase 3
NCT06298409	Recruiting	Small Intestinal Bacterial Overgrowth	Envivo Bio Inc	2024-02-15	--
NCT04244877	Withdrawn	Cirrhosis Liver\|Minimal Hepatic Encephalopathy\|Small Intestinal Bacterial Overgrowth\|Gastrointestinal Motility Disorder	MetroHealth Medical Center	2021-09-15	Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Rifaximin selectively binds to the beta subunit of bacterial DNA-dependent RNA polymerase, thereby blocking transcription and inhibiting bacterial RNA synthesis. This inhibition halts bacterial cell growth locally within the gastrointestinal tract, providing therapeutic efficacy in managing gastrointestinal disorders such as small intestinal bacterial overgrowth and minimal 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>).