Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
sulopenem etzadroxil and probenecid · 1 trial · 1 indication
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 |
|---|---|---|
| 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 and probenecid | DRUG | single dose of 500 mg of sulopenem etzadroxil and 500 mg of probenecid given orally as a bilayer tablet. |
Inclusion Criteria: 1. Patient's parent/both parents or guardian must provide written informed consent and a statement of assent from the adolescent patient (if required by Institutional Review Board \[IRB\] according to local regulations and guidelines) must be obtained prior to any study-related ...
Sulopenem etzadroxil/probenecid is an investigational oral antibiotic being developed for uncomplicated urinary tract infections, complicated intra-abdominal infections, and other urinary tract infections. It is a small molecule in Phase 3 clinical development for infectious disease indications.
Sulopenem etzadroxil/probenecid is being developed by Iterum Therapeutics plc, a biopharmaceutical company traded on the stock exchange under the ticker ITRM. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating bacterial infections.
Sulopenem etzadroxil/probenecid is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to determine its safety and effectiveness for treating infections.
Sulopenem etzadroxil/probenecid has been studied in several clinical trials. NCT03354598 compared it to ciprofloxacin for uncomplicated urinary tract infection in adult women. NCT03358576 evaluated it against ertapenem for complicated intra-abdominal infection. NCT05584657 tested it versus amoxicillin/clavulanate for uncomplicated urinary tract infection. NCT07092813 is studying its pharmacokinetics in adolescents.
Yes, Sulopenem etzadroxil/probenecid is also known as sulopenem etzadroxil and probenecid. The drug is a combination product containing these two components, which are administered together orally to treat bacterial infections.
Sulopenem etzadroxil/probenecid is an antibiotic that works by inhibiting bacterial cell wall synthesis. It is a penem antibiotic, and the probenecid component helps increase its concentration in the body by reducing renal excretion. The drug is being studied for its activity against various bacterial pathogens causing urinary tract and intra-abdominal infections.