(Probenecid + sulopenem etzadroxil) is under clinical development by Iterum Therapeutics and currently in Pre-Registration for Urinary Tract Infections. According to GlobalData, Pre-Registration drugs for Urinary Tract Infections have an 87% phase transition success rate (PTSR) indication benchmark for progressing into Marketed. GlobalData’s report assesses how (Probenecid + sulopenem etzadroxil)’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

(Probenecid + sulopenem etzadroxil) overview

Probenecid, Sulopenem etzadroxil (Orlynvah) is fixed dose combination. It is formulated as film-coated tablets for oral route of administration. Orlynvah is indicated for the treatment of uncomplicated urinary tract infections caused by the designated microorganisms escherichia coli, klebsiella pneumoniae, or proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options.

Fixed dose combination of sulopenem etzadroxil and probenecid (sulopenem) is under development for the treatment of complicated urinary tract infections, pyelonephritis, uncomplicated urinary tract infections (uUTI), complicated intra-abdominal infections. The drug candidate is a penem beta-lactam antibiotic formulated as bilayer tablet administered through oral route. It is a prodrug of sulopenem that acts by targeting penicillin-binding protein (PBP).

The drug candidate was under development for community-acquired bacterial pneumonia, pelvic inflammatory disease, and bacterial infections like acute bacterial prostatitis, and gonococcal urethritis.

Iterum Therapeutics overview

Iterum Therapeutics is a clinical-stage pharmaceutical company that focuses on the development of differentiated anti-infectives. Its products are primarily targeted towards patients suffering from antibiotic-resistant infections. The company develops anti-infectives for multi-drug resistant (MDR) pathogens for treating serious and life-threatening diseases among others. Iterum Therapeutics mainly develops sulopenem, an oral and IV targeted-spectrum penem antibiotic for the treatment of infections caused by multi-drug resistant, gram-negative bacteria in both the hospital and community environments. The company has operations with research and development facility in the US. Iterum Therapeutics is headquartered in Dublin, Ireland.

For a complete picture of (Probenecid + sulopenem etzadroxil)’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 12 April 2024

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.