HIPREX (methenamine hippurate)
HIPREX is indicated for the treatment of Urinary Tract Infection.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1976-09-09
- Routes
- ORAL
- Dosage Forms
- TABLET
HIPREX Approval History
What HIPREX Treats
1 indicationsHIPREX is approved for 1 conditions since its original approval in 1976. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Urinary Tract Infection
HIPREX 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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3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04709601 results posted | STU-2020-0725 | Ph 4 | terminated | Efficacy and Mechanism of Action of Methenamine Hippurate (Hiprex™) in Women With Recurring Urinary Tract Infections. |
| 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.
HIPREX FDA Label Details
Indications & Usage
FDA Label (PDF)HIPREX 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.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment