First Oral Penem Antibiotic Now Available in the US for Uncomplicated UTIs

Iterum Therapeutics announced today the US commercial launch ofsulopenem etzadroxil and probenecid (Orlynvah™) tablets, the first oral penem antibiotic available in the country.1 The drug was approved by the US FDA in October 2024 for the treatment of adult women with uncomplicated urinary tract infections (uUTIs) caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis who have limited or no alternative oral antibacterial options.2

The introduction marks the first new branded therapy for uUTIs in more than 25 years. Iterum stated that oral sulopenem offers a needed oral alternative for patients with resistant infections, reducing reliance on intravenous therapies.1

According to epidemiologic data cited in the release, uUTIs are the most common outpatient infection in US women, with 60% experiencing at least one episode in their lifetime and 44% experiencing 3 or more per year. A 2024 study of approximately 150 000 patients found that 57% of initial infections were resistant to at least one antibiotic class, and 13% were resistant to three or more.1

“The availability of ORLYNVAH is tremendous news for clinicians and patients alike,” Marjorie Golden, MD, site chief of infectious disease at Yale New Haven Hospital’s St. Raphael Campus, said in the August 20, 2025, press relesae. “The launch … provides a new treatment option with impressive efficacy data to treat appropriate adult women suffering from difficult-to-treat uUTIs.”1

Iterum CEO Corey Fishman added that the therapy represents “the first oral penem ever approved by the FDA—giving clinicians and patients a much-needed new therapy.”1

Uncomplicated UTIs are typically confined to the lower urinary tract in otherwise healthy women without anatomic abnormalities. Rising antimicrobial resistance has increased treatment complexity, often necessitating more costly or invasive interventions such as emergency visits or hospitalization. Iterum noted that the new oral formulation could ease this burden by offering an outpatient option.1

The company emphasized its ongoing development of sulopenem in both oral and intravenous formulations, which have demonstrated activity against gram-negative, gram-positive, and anaerobic bacteria resistant to other antibiotics. Oral sulopenem has received Qualified Infectious Disease Product and Fast Track designations from the FDA.1

References:

1. Iterum Therapeutics launches ORLYNVAH™, the first and only oral penem antibiotic in the U.S.. News release. Iterum Therapeutics. August 20, 2025. Accessed August 20, 2025. https://www.iterumtx.com/news/press-releases/detail/155/iterum-therapeutics-launches-orlynvah-the-first-and
2. Patient Care Editorial Staff. FDA approves oral sulopenem for the treatment of uncomplicated urinary tract infections. October 25, 2024. https://www.patientcareonline.com/view/fda-approves-oral-sulopenem-for-the-treatment-of-uncomplicated-urinary-tract-infections