FOSFOMYCIN TROMETHAMINE
FOSFOMYCIN TROMETHAMINE is indicated for the treatment of Urinary Tract Infection; Acute Cystitis; Bacteriuria.
Details
- Status
- Prescription
- First Approved
- 2020-10-06
- Routes
- ORAL
- Dosage Forms
- FOR SOLUTION
FOSFOMYCIN TROMETHAMINE Approval History
What FOSFOMYCIN TROMETHAMINE Treats
3 indicationsFOSFOMYCIN TROMETHAMINE is approved for 3 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Urinary Tract Infection
- Acute Cystitis
- Bacteriuria
FOSFOMYCIN TROMETHAMINE 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.
Drugs Similar to FOSFOMYCIN TROMETHAMINE
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 |
|---|---|---|---|---|
| NCT03697993 results posted | 15-0045 HHSN272201300018I | Ph 4 | terminated | Safety and Efficacy Study of Oral Fosfomycin Versus Oral Levofloxacin to Treat Complicated Urinary Syndromes (FOCUS) |
| NCT02178254 | 13-0064 HHSN272201500005I | Ph 1 | completed | Safety, Tolerability and PK 3-Period Crossover Study Comparing 2 Single Doses of ZTI-01 and Monurol® in Healthy Subjects |
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.
FOSFOMYCIN TROMETHAMINE FDA Label Details
Indications & Usage
FOSFOMYCIN TROMETHAMINE is indicated for the treatment of Urinary Tract Infection; Acute Cystitis; Bacteriuria.
Looking for the branded version?
MONUROL
Full clinical data, patents, trials, and competitive landscape for fosfomycin tromethamine.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.