Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05584657 | Oral Sulopenem Versus Amoxicillin/Clavulanate for Uncomplicated Urinary Tract Infection in Adult Women | PHASE3 | COMPLETED | 2,229 | — | — | Oct 18, 2022 | Nov 21, 2023 | Nov 20, 2024 | 167 | United States |
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)
| 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 |
| Name | Type | Description |
|---|---|---|
| Sulopenem etzadroxil/probenecid | DRUG | Oral sulopenem twice daily for 5 days |
| Amoxicillin/clavulanate | DRUG | Oral Augmentin twice daily for 5 days |
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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 2 | PHASE1 | Gepotidacin, Candidate UTI vaccine low dose formulation 1, Candidate UTI vaccine HTD formulation 2 |
| CorMedix Inc. | CRMD | 1 | PHASE2 | Meropenem-Vaborbactam, Antibiotics |
| Pfizer Inc. | PFE | 1 | — | Undisclosed |
| QIAGEN NV | QGEN | 1 | — | Undisclosed |