Sulopenem Etzadroxil/Probenecid: A Comprehensive Review of an Oral Thiopenem.

OBJECTIVE

To review the pharmacology, pharmacokinetics/pharmacodynamics, development, spectrum of activity, clinical trials, dosing/administration, and role of sulopenem etzadroxil/probenecid in current practice.

DATA SOURCES: PubMed, EMBASE, and ClinicalTrials.gov were queried using the terms Sulopenem, CP-70429, and CP-65207.

STUDY SELECTION AND DATA EXTRACTION: Articles written in English and published from January 1, 1989 to March 1, 2026 relating to development, clinical pharmacology, antimicrobial activity/testing, safety, and clinical trial data of sulopenem were reviewed.

DATA SYNTHESIS: An oral penem prodrug coformulated with probenecid to increase exposure, sulopenem etzadroxil is active against many Enterobacterales, including extended-spectrum β-lactamase (ESBL) and AmpC producers. Sulopenem did not demonstrate noninferiority in the treatment of complicated urinary tract infections (cUTIs) compared with ertapenem followed by susceptibility-guided oral therapy, or complicated intraabdominal infections compared with ertapenem followed by either amoxicillin/clavulanate or ciprofloxacin and metronidazole. Compared with ciprofloxacin in the treatment of uncomplicated UTI (uUTI), sulopenem etzadroxil/probenecid did not demonstrate noninferiority in patients with ciprofloxacin-susceptible isolates. However, higher composite response rates were observed in infections caused by ciprofloxacin-nonsusceptible isolates. Sulopenem etzadroxil/probenecid demonstrated noninferiority compared with amoxicillin/clavulanate for the treatment of uUTI.Relevance to Patient Care and Clinical Practice in Comparison to Existing Drugs:Sulopenem etzadroxil/probenecid is active against commonly isolated uropathogens that may be difficult to treat with traditional oral antibiotics, such as ESBL and AmpC producers. Agents such as gepotidacin and pivmecillinam may provide similar treatment options for uUTI, though these have not been directly compared with sulopenem etzadroxil/probenecid.

CONCLUSIONS

Sulopenem etzadroxil/probenecid provides an additional oral treatment option for uUTI in adult women with limited or no alternative options.