Drug Development ProgressIterum Therapeutics is advancing its first compound, sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development for the treatment of multi-drug resistant pathogens.
Market OpportunitySulopenem could be the first new brand antibiotic for uncomplicated urinary tract infections in over 20 years with long term value due to intellectual property extending to 2039+.
Regulatory MilestoneThe NDA resubmission of oral sulopenem for the treatment of uncomplicated urinary tract infections is on target, with a PDUFA date expected, based on a 6-month review timeframe by the FDA.