Sulopenem

The Sulopenem Etzadroxil/Probenecid market forecast report analyzes its potential and market share for uncomplicated Urinary Tract Infection (uUTI) in major markets up to 2032. Developed by Iterum Therapeutics, Sulopenem is a broad-spectrum antibiotic effective against drug-resistant bacteria. Despite a Phase III trial completion for uUTI, FDA approval is pending additional data. The report offers insights into clinical advancements, market competition, and future assessments.

Gram-negative bacterial resistance in the U.S. is rising, complicating UTI treatment. Oral carbapenems like tebipenem and sulopenem offer broad-spectrum activity but face FDA hurdles. Tebipenem HBr showed promise in trials but failed FDA's micro-ITT analysis. Sulopenem's trials missed endpoints, delaying its approval. Oral carbapenems could revolutionize UTI management but raise resistance concerns.

Iterum Therapeutics received an FDA letter about deficiencies in the sulopenem etzadroxil/probenecid application for uncomplicated UTIs, delaying labeling and post-marketing discussions. The FDA did not detail the issues, stating this isn't a final decision. A review completion goal is set for July 25. Iterum plans to address the deficiencies with the FDA.

Iterum Therapeutics concluded a late-cycle FDA meeting for sulopenem etzadroxil/probenecid, aimed at treating uncomplicated UTIs in patients with quinolone non-susceptible pathogens. The FDA deemed an Advisory Committee meeting unnecessary, targeting a July 25 action date. ITRM shares rose 22.8% to $1.51 premarket.

Orlynvah, approved by the FDA on October 25, 2024, is a combination of sulopenem etzadroxil and probenecid for treating uncomplicated urinary tract infections in adult women. It's the first oral penem in the U.S., effective against ESBL-producing pathogens. Administered twice daily with food for 5 days, it carries warnings for hypersensitivity, CDAD, and gout exacerbation.

Iterum Therapeutics plc announced two data presentations at IDWeek™ 2020, showcasing results from SURE-1 and SURE-2 trials on urinary tract infections. Oral sulopenem showed superiority over ciprofloxacin in treating uUTI. The company focuses on developing antibiotics against multi-drug resistant pathogens, with sulopenem in Phase 3 clinical trials.