The antibiotic’s approval was based from data of 2 phase 3 trials, SURE 1 (NCT03354598) and REASSURE (NCT05584657), demonstrating its effectiveness against infections caused by Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis.2
What You Need to Know
Orlynvah (sulopenem etzadroxil/probenecid) is the first and only oral penem antibiotic available in the U.S., and the first new branded product for uncomplicated UTIs in more than 25 years.
Phase 3 trials (SURE-1 and REASSURE) demonstrated strong efficacy and favorable microbiological outcomes versus ciprofloxacin and amoxicillin/clavulanate, with good tolerability and no serious safety concerns.
Orlynvah offers clinicians and patients a much-needed oral alternative for multidrug-resistant uncomplicated UTIs, potentially reducing hospital visits and improving quality of life.
For the SURE 1 trial, oral sulopenem was evaluated against ciprofloxacin in patients with uUTIs, focusing on quinolone-susceptible and nonsusceptible uropathogens. In the ciprofloxacin-nonsusceptible group, clinical success was achieved in 83% of the sulopenem group versus 62.6% in the ciprofloxacin group, while microbiological success was noted in 74.1% of patients treated with sulopenem compared with 49.6% for ciprofloxacin, both with statistically significant differences.3
In the mMITT population (all MITT patients with baseline urine cultures positive for Enterobacterales or Staphylococcus saprophyticus at ≥105 colony- forming units (CFU)/mL and ≤2 species of microorganisms), sulopenem was noninferior to ciprofloxacin with combined clinical and microbiologic response rates of 65.6% and 67.9%, respectively.
For the REASSURE study, oral sulopenem against amoxicillin/clavulanate (Augmentin) in a cohort of 2222 adult women with uUTIs. In the amoxicillin/clavulanate-susceptible group, clinical success rates were comparable, with sulopenem at 77.3% and amoxicillin/clavulanate at 76.7%. Microbiological success favored sulopenem at 75.2% compared with 66.7% for amoxicillin/clavulanate, indicating a significant advantage.4
This is the first oral penem antibiotic commercially available in the US and the first new branded product to be introduced in the US for uUTI in more than 25 years, and offers another option for this infection.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 the FDA—giving clinicians and patients a much-needed new therapy,” Iterum Therapeutics CEO Corey Fishman, said in a statement.1
References
1. Iterum Therapeutics launches ORLYNVAH™, the first and only oral penem antibiotic in the U.S. Iterum press release. August 20, 2025. Accessed September 3 2025.
https://www.iterumtx.com/news/press-releases/detail/155/iterum-therapeutics-launches-orlynvah-the-first-and
2. Abene S. FDA Approves Oral Sulopenem (Orlynvah) for Uncomplicated Urinary Tract Infections. Contagion. October 29, 2024. Accessed September 3, 2025.
https://www.contagionlive.com/view/fda-approves-oral-sulopenem-orlynvah-for-uncomplicated-urinary-tract-infections
3. Dunne MW, Das A, Akinapelli K, Zelasky MT, Boucher HW, Aronin AI. Efficacy and safety of oral sulopenem etzadroxil/probenecid versus oral ciprofloxacin in the treatment of uncomplicated urinary tract infections (uUTI) in adult women: Results from the SURE-1 trial. Presented at: ID Week 2020. October 21, 2020. https://d1io3yog0oux5.cloudfront.net/_c686b74a40042109ff06b21eccc8f678/iterumtx/db/395/2729/pdf/SURE+1+Slide+Presentation+IDweek+2020+19OCT_final.pdf
4. Iterum Therapeutics announces positive topline results from its phase 3 REASSURE clinical trial of oral sulopenem in uncomplicated urinary tract infections. News release. Iterum Therapeutics plc. January 30, 2024. Accessed September 3, 2025. https://www.prnewswire.com/news-releases/iterum-therapeutics-announces-positive-topline-results-from-its-phase-3-reassure-clinical-trial-of-oral-sulopenem-in-uncomplicated-urinary-tract-infections-302047483.html
