Approval Probability
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Adjusted LOA
ML Risk
Sulopenem · 1 trial · 1 indication
Clinical success is defined as complete resolution of cUTI symptoms present at study entry and no new cUTI symptoms; microbiologic success is defined as eradication of the bacterial pathogen found at study entry (reduced to \<1000 CFU/mL)
| Arm | Type | Description |
|---|---|---|
| Sulopenem | EXPERIMENTAL | Sulopenem 1000 mg IV once daily for a minimum of 5 days, followed by sulopenem-etzadroxil/probenecid 500 mg PO twice daily to complete 7-10 total days of treatment |
| Ertapenem | ACTIVE_COMPARATOR | Ertapenem 1000 mg IV once daily for a minimum of 5 days, followed by ciprofloxacin 500 mg PO twice daily or amoxicillin-clavulanate 500 mg PO twice daily to complete 7-10 total days of treatment |
| Name | Type | Description |
|---|---|---|
| Sulopenem | DRUG | Antibiotic therapy for complicated UTI |
| Sulopenem-Etzadroxil/Probenecid | DRUG | Antibiotic therapy for complicated UTI |
| Ertapenem | DRUG | Antibiotic therapy for complicated UTI |
| Ciprofloxacin | DRUG | Antibiotic therapy for complicated UTI |
| Amoxicillin-clavulanate | DRUG | Antibiotic therapy for complicated UTI |
Inclusion Criteria: 1. Adults ≥18 years of age with more than 24 hours of urinary symptoms attributable to a UTI 2. Able to provide informed consent 3. Clinically documented pyelonephritis or complicated urinary tract infection: 1. Pyelonephritis with normal anatomy 2. Complicated UTI as def...
Sulopenem is an investigational small molecule being developed for the treatment of complicated urinary tract infections in adults. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
Sulopenem is a carbapenem antibiotic that targets bacterial cell wall synthesis. It is designed to treat infections caused by gram-negative and gram-positive bacteria, including those resistant to other antibiotics.
Sulopenem is being developed by Iterum Therapeutics plc, a biopharmaceutical company focused on infectious disease. The company's stock is traded under the ticker symbol ITRM.
Sulopenem is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. Its safety and efficacy are still being evaluated in clinical trials.
Sulopenem has one completed Phase 3 trial, NCT03357614, which enrolled 1,395 adults with complicated urinary tract infections. The trial was conducted in the United States, Estonia, Georgia, Hungary, and Latvia.
Sulopenem-etzadroxil is a prodrug form of Sulopenem, designed for oral administration. In clinical trials, Sulopenem is given intravenously, while Sulopenem-etzadroxil is given orally, often combined with probenecid.