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Also known as Oral sulopenem
Sulopenem-Etzadroxil/Probenecid · 4 trials · 5 indications
Clinical Success (resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms) AND Microbiologic success (eradication of the baseline pathogen)
Clinical Success (resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms) AND Microbiologic success (eradication of the baseline pathogen)
Clinical response is defined as resolution in signs and symptoms of the index infection and no new symptoms, without the need for additional antibiotics or interventions
Overall Success: Clinical Success (resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms) AND Microbiologic success (eradication of the baseline pathogen)
Overall Success is Clinical Success (resolution of uUTI symptoms present at study entry and no new uUTI symptoms) AND Microbiologic success (eradication of the baseline pathogen)
Concentrations will be determined through analysis of blood samples drawn at 1, 2, 4 and 6 hours after the dose
Concentrations will be determined through analysis of blood samples drawn at 1, 2, 4 and 6 hours after the dose
Concentrations will be determined through analysis of urine samples collected 0-2, 2-4, 4-6, 6-8 and 8-12 hours after the dose
Concentrations will be determined through analysis of urine samples collected 0-2, 2-4, 4-6, 6-8 and 8-12 hours after dose
| Arm | Type | Description |
|---|---|---|
| Sulopenem etzadroxil/probenecid | EXPERIMENTAL | Sulopenem etzadroxil/probenecid 500 mg/500 mg PO twice daily for 5 days |
| Amoxicillin/clavulanate | ACTIVE_COMPARATOR | Amoxicillin/clavulanate PO twice daily for 5 days |
| Sulopenem | EXPERIMENTAL | Sulopenem 1000 mg IV once daily for at least 5 days, followed by Sulopenem-Etzadroxil/Probenecid 500 mg PO twice daily to complete 7-10 days of treatment |
| Ertapenem | ACTIVE_COMPARATOR | Ertapenem 1000 mg IV once daily for at least 5 days, followed by ciprofloxacin 500 mg PO twice daily along with metronidazole 500 mg PO four times daily. If patient is found to have causative pathogens that are resistant to ciprofloxacin they will receive amoxicillin-clavulanate 875 mg PO twice daily instead |
| Sulopenem-etzadroxil/probenecid | EXPERIMENTAL | Sulopenem-etzadroxil/probenecid 500 mg PO twice daily for 5 days |
| Ciprofloxacin | ACTIVE_COMPARATOR | Ciprofloxacin 250 mg PO administered twice daily for 3 days |
| Oral sulopenem | EXPERIMENTAL | Single dose of 500 mg of sulopenem etzadroxil and 500 mg of probenecid given orally as a bilayer tablet. |
| Name | Type | Description |
|---|---|---|
| Sulopenem etzadroxil/probenecid | DRUG | Oral sulopenem twice daily for 5 days |
| Amoxicillin/clavulanate | DRUG | Oral Augmentin twice daily for 5 days |
| Ertapenem | DRUG | Antibiotic for complicated intra-abdominal infection |
| Sulopenem-Etzadroxil/Probenecid | DRUG | Antibiotic for complicated intra-abdominal infection |
| Ciprofloxacin | DRUG | Antibiotic for complicated intra-abdominal infection |
| Metronidazole | DRUG | Antibiotic for complicated intra-abdominal infection |
| Amoxicillin-Clavulanate | DRUG | Antibiotic for complicated intra-abdominal infection |
| Sulopenem | DRUG | Antibiotic for complicated intra-abdominal infection |
| sulopenem etzadroxil and probenecid | DRUG | single dose of 500 mg of sulopenem etzadroxil and 500 mg of probenecid given orally as a bilayer tablet. |
Inclusion Criteria: * Female patients ≥18 years of age with ≥24 hours and ≤96 hours of urinary symptoms attributable to a UTI * Two of the following signs and symptoms of uUTI: urinary frequency, urinary urgency, pain or burning on micturition, suprapubic pain. * A mid-stream urine specimen with ev...
Top 2 of 4 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 2 | PHASE1 | Gepotidacin, UTI vaccine candidate |
| CorMedix Inc. | CRMD | 1 | PHASE2 | Meropenem-Vaborbactam |
Sulopenem etzadroxil/probenecid is an investigational oral antibiotic combination developed by Iterum Therapeutics plc for treating bacterial infections, including urinary tract infections and intra-abdominal infections. It pairs sulopenem etzadroxil, an orally absorbed antibiotic, with probenecid, which extends the drug's activity in the body. It is a small molecule therapy still in clinical development.
Sulopenem etzadroxil/probenecid is being developed to treat bacterial infections, specifically uncomplicated urinary tract infections, urinary tract infections, and complicated intra-abdominal infections. Clinical trials have studied it in adult women with uncomplicated urinary tract infections and in adults with complicated intra-abdominal infections. It is investigational and has not been approved for commercial use.
Sulopenem etzadroxil/probenecid is developed by Iterum Therapeutics plc, which trades on the Nasdaq under the ticker ITRM. Iterum is the sponsor of the clinical trials evaluating this oral antibiotic combination across urinary tract and intra-abdominal infection indications.
Sulopenem etzadroxil/probenecid has completed Phase 3 clinical trials in uncomplicated urinary tract infections and complicated intra-abdominal infections. A Phase 1 pharmacokinetics study in adolescents is currently recruiting. The drug remains investigational and is not FDA approved; it is still in clinical development.
Key trials include NCT05584657, a completed Phase 3 study of oral sulopenem versus amoxicillin/clavulanate in adult women with uncomplicated urinary tract infection, and NCT03358576, a completed Phase 3 study versus ertapenem in complicated intra-abdominal infection. NCT03354598 compared it with ciprofloxacin in uncomplicated urinary tract infection. NCT07092813 is a recruiting Phase 1 pharmacokinetics study in adolescents.