ORLYNVAH™ (sulopenem)
Uncomplicated Urinary Tract Infection (uUTI)
ApprovedCommercial Launch
Key Facts
Indication
Uncomplicated Urinary Tract Infection (uUTI)
Phase
Approved
Status
Commercial Launch
Company
About Iterum Therapeutics
Iterum Therapeutics is an Irish biopharmaceutical company with a mission to develop differentiated antibiotics against multi-drug resistant pathogens. Its core achievement is the 2024 FDA approval of ORLYNVAH™ (sulopenem), the first oral penem, for uncomplicated urinary tract infections (uUTI) in patients with limited treatment options. The company's strategy leverages the unique oral/IV profile of sulopenem to address serious community and hospital infections, aiming to reduce hospital stays and combat resistance. Following a strategic restructuring after a 2021 regulatory setback, Iterum is now focused on the commercialization and potential label expansion of its approved asset.
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