METHENAMINE HIPPURATE · INGENUS PHARMS LLC
INDICATIONS Methenamine hippurate tablets are indicated for prophylactic or suppressive treatment of frequently recurring urinary tract infections when long-term therapy is considered necessary. This drug should only be used after eradication of the infection by other appropriate antimicrobial agents.
Details
- Status
- Prescription
- First Approved
- 1967-07-05
- Routes
- ORAL
- Dosage Forms
- TABLET
METHENAMINE HIPPURATE Approval History
What METHENAMINE HIPPURATE Treats
1 indicationsMETHENAMINE HIPPURATE is approved for 1 conditions since its original approval in 2003. These indications span multiple therapeutic areas including oncology, immunology, and more.
METHENAMINE HIPPURATE Competitive Set
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Indication competitors
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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 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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.
METHENAMINE HIPPURATE FDA Label Details
Indications & Usage
INDICATIONS Methenamine hippurate tablets are indicated for prophylactic or suppressive treatment of frequently recurring urinary tract infections when long-term therapy is considered necessary. This drug should only be used after eradication of the infection by other appropriate antimicrobial agents. To reduce the development of drug-resistant bacteria and maintain the effectiveness of methenamine hippurate and other antibacterial drugs, methenamine hippurate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.