Iterum Launches UTI Drug, First Oral Penem Antibiotic Commercially Available in US

Human urinary system kidneys with bladder anatomy on doctor hands. Treatment of urinary tract infections, urinary incontinence or urinary retention. Urology concept. | Image Credit: © Orawan - stock.adobe.com

Dublin, Ireland-based Iterum Therapeutics announced on Aug. 20, 2025 the commercial launch of its sulopenem etzadroxil and probenecid oral tablets, under the brand name Orlynvah, following FDA approval for treatment of adult women with uncomplicated urinary tract infections (uUTIs) (1).

New and long-awaited treatment

uUTIs are defined as common bladder infections that are confined predominantly to the lower urinary tract in women who are otherwise healthy and have no structural abnormalities (1). The infections are typically caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis, and Iterum’s sulopenem etzadroxil/probenecid treatment was green-lighted by FDA in October 2024 for women who have limited or no other alternative oral antibacterial options.

Iterum said that Orlynvah is the first oral penem antibiotic to become commercially available in the United States; it is also the first new, branded product to be introduced for the treatment of uUTIs in the US in more than 25 years (1).

A ‘paradigm shift’?

“Our mission is to create new antibiotics for patients and to be a treatment alternative to address substantial unmet medical needs in the community,” said Corey Fishman, Iterum Therapeutics CEO, in a company press release (1). “For many people with multidrug-resistant uUTIs, options have been exhausted. We’re proud to introduce Orlynvah—the first oral penem ever approved by [FDA]—giving clinicians and patients a much-needed new therapy.”

Marjorie Golden, MD, site chief of Infectious Disease at St. Raphael Campus Yale New Haven Hospital, said the commercialization of Iterum’s antibiotic is a game-changer.

“For patients who currently have limited treatment options, Orlynvah provides a long overdue oral alternative that allows for treatment in the community,” Golden said in the Iterum press release (1). “This paradigm shift in the management of patients with uUTI[s] will not only reduce emergency department visits and hospital admissions, but it will also favorably impact patients’ quality of life.”

Potential impacts of resistant uUTIs

According to Iterum, 60% of women experience a urinary tract infection (UTI) in their lifetimes, with 44% experiencing three or more episodes annually (1). Among 150,000 patients with uUTIs in 2024, a US study said, 57% of initial infections were resistant to at least one antibiotic class, and 13% were resistant to three or more.

While UTIs are already the most common outpatient infection among US women, Iterum said that without new and effective therapies, resistant uUTIs may contribute to inflated healthcare costs, not to mention increasing the number courses of therapy, or amount of emergency room visits and hospitalizations, that women may experience (1).

“The availability of Orlynvah is tremendous news for clinicians and patients alike,” Golden said (1). “The launch of Orlynvah provides a new treatment option with impressive efficacy data to treat appropriate adult women suffering from difficult-to-treat uUTIs.”

More companies focusing on UTIs

Other treatments for various forms of UTIs are in development. Amid lingering questions about the future of messenger RNA (mRNA)-based vaccines in the US, German biopharmaceutical company CureVac, which specializes in the development of mRNA-based vaccines and therapeutics, has been reported to be developing prophylactic vaccines for UTIs (2).

For complicated UTIs (cUTIs), which carry a high risk of clinical complications including but not limited to sepsis and septic shock, an investigational oral treatment has been developed by GSK and Spero Therapeutics (3). This treatment (tebipenem HBr), also in oral form, had a Phase III trial stopped early for efficacy in May 2025 based on the recommendation of an Independent Data Monitoring Committee.

In the US, an estimated 2.9 million cases of cUTIs are treated annually (3).

References

1. Iterum Therapeutics. Iterum Therapeutics Launches Orlynvah, the First and Only Oral Penem Antibiotic in the US. Press Release. Aug. 20, 2025.
2. Barton, C. Looking Beyond mRNA-based COVID-19 Vaccines to Innovative Therapeutics. PharmTech.com, June 24, 2025.
3. GSK. PIVOT-PO Phase III Study for tebipenem HBr Stopped Early for Efficacy Following Review by Independent Data Monitoring Committee. Press Release. May 28, 2025.