Methenamine Hippurate Clinical Trials

Size	Price	Qty
1mg	USD 157

Clinical Trials

Multiple clinical trials evaluate methenamine hippurate for the prevention and management of recurrent urinary tract infections and catheter-associated postoperative infections. These academically sponsored studies encompass a Phase 4 trial currently enrolling by invitation through European partners, including the University of Oslo and Amsterdam UMC. Additionally, a completed trial sponsored by the University of Pennsylvania evaluated short-course prophylaxis for preventing postoperative infections.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04077580	Enrolling by invitation	Recurrent Urinary Tract Infection	University of Oslo\|Amsterdam UMC location VUmc\|UMC Utrecht\|Göteborg University\|Medical University of Lodz	2019-11-01	Phase 4
NCT02358993	Completed	Urinary Tract Infections\|Catheter-Related Infections	University of Pennsylvania	2014-12	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a prodrug, methenamine hippurate undergoes pH-dependent hydrolysis in acidic urine to release formaldehyde, which nonspecifically denatures bacterial proteins and nucleic acids to exert broad-spectrum bactericidal activity. This chemical eradication prevents bacterial colonization in the urinary tract, demonstrating direct clinical relevance for preventing recurrent urinary tract infections and catheter-related urinary tract infections.

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>).