TheraRadar
Data updated: May 26, 2026

METHENAMINE HIPPURATE

Infectious Disease Approved 2003-06-20

METHENAMINE HIPPURATE is indicated for the treatment of Urinary Tract Infection.

Source: FDA Label • INGENUS PHARMS LLC
6
Indications
--
Phase 3 Trials
22
Years on Market

Details

Status
Prescription
First Approved
2003-06-20
Routes
ORAL
Dosage Forms
TABLET

METHENAMINE HIPPURATE Approval History

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
11 FDA actions from 2003 to 2025
Mar 2025 ORIGINAL
Update
Dec 2023 ORIGINAL
Update
May 2023 SUPPL
Label · Labeling

What METHENAMINE HIPPURATE Treats

1 indications

METHENAMINE HIPPURATE is approved for 1 conditions since its original approval in 2003. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Urinary Tract Infection
Source: FDA Label

METHENAMINE HIPPURATE 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 METHENAMINE HIPPURATE

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.

METHENAMINE HIPPURATE FDA Label Details

Indications & Usage

METHENAMINE HIPPURATE is indicated for the treatment of Urinary Tract Infection.

Looking for the branded version?

UREX

Full clinical data, patents, trials, and competitive landscape for methenamine hippurate.

See UREX

Data Sources

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