UREX (methenamine hippurate)
UREX is indicated for the treatment of Urinary Tract Infection.
Details
- Status
- Prescription
- First Approved
- 1967-07-05
- Routes
- ORAL
- Dosage Forms
- TABLET
UREX Approval History
What UREX Treats
1 indicationsUREX 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
UREX Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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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
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.