TRIMETHOPRIM · Teva
To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets, USP and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.
Details
- Status
- Discontinued
- First Approved
- 1980-05-30
- Routes
- ORAL
- Dosage Forms
- TABLET
TRIMETHOPRIM Approval History
What TRIMETHOPRIM Treats
2 indicationsTRIMETHOPRIM is approved for 2 conditions since its original approval in 1982. These indications span multiple therapeutic areas including oncology, immunology, and more.
TRIMETHOPRIM 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 TRIMETHOPRIM
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Teva's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06709196 REINFORCE | 2024-514312-27-00 2024-514312-27-00 | Ph 4 | recruiting | Clinical Trial Testing Whether Targeted Antibiotic Prophylaxis Can Reduce Infections After Cystectomy Compared to Empiric Prophylaxis |
| NCT03746106 results posted | 13060 5R01DK108722-02 | Ph 4 | completed | The Effect of SLC19A3 Inhibition on the Pharmacokinetics of Thiamine |
| NCT03077711 results posted | EH16-216 | Ph 4 | completed | Methenamine Hippurate Versus Trimethoprim in the Prevention of Recurrent UTIs |
| NCT02188472 PENTRIOX | PEN1011 | Ph 1 | completed | Pentriox - Induction of Oxidative Stress |
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.
TRIMETHOPRIM FDA Label Details
Indications & Usage
FDA Label (PDF)To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets, USP and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy. Uri...
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Full clinical data, patents, trials, and competitive landscape for trimethoprim.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.