TheraRadar
Data updated: May 26, 2026

UREX (methenamine hippurate)

Infectious Disease Approved 1967-07-05

UREX is indicated for the treatment of Urinary Tract Infection.

Source: FDA Label • QUAGEN
1
Indication
--
Phase 3 Trials
58
Years on Market

Details

Status
Prescription
First Approved
1967-07-05
Routes
ORAL
Dosage Forms
TABLET

Companies

Active Ingredient: METHENAMINE HIPPURATE

UREX Approval History

1968
1969
1970
1971
1972
1973
1974
1975
1976
1977
1978
1979
1980
1981
1982
1983
1984
1985
1986
1987
1988
1989
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
9 FDA actions from 1967 to 2015
Mar 2015 SUPPL
Mfg · Manufacturing (CMC)
Mar 2008 SUPPL
Label · Labeling
Jul 1993 SUPPL
Mfg · Manufacturing (CMC)

What UREX Treats

1 indications

UREX is approved for 1 conditions since its original approval in 1967. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Urinary Tract Infection
Source: FDA Label

UREX Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Unlock 8 more competitors across all three rings.
Upgrade to Pro

Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to UREX

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

AMOXICILLIN PEDIATRIC
AMOXICILLIN
1 shared
Teva
Shared indications:
AMPICILLIN SODIUM
AMPICILLIN SODIUM
1 shared
WATSON LABS INC
Shared indications:
ANCOBON
FLUCYTOSINE
1 shared
BAUSCH
Shared indications:
📋

Clinical Trial Registry

2 trials
Trial Sponsor ID Phase Status Title
NCT06953271 META 2265134 Ph 4 not yet recruiting Methenamine Hippurate Following Intradetrusor OnabotulinumtoxinA Injection
NCT03077711 results posted EH16-216 Ph 4 completed Methenamine Hippurate Versus Trimethoprim in the Prevention of Recurrent UTIs
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

Full development history with FDA approval milestones

|
Loading...
Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

UREX FDA Label Details

Indications & Usage

FDA Label (PDF)

UREX is indicated for the treatment of Urinary Tract Infection.

Track UREX with TheraRadar Pro

Watchlist alerts, full database access, CSV exports across 14,000+ drugs.

Upgrade to Pro

Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.