ORLYNVAH is available through an exclusive partnership with Alto Pharmacy

ORLYNVAH—The power of a penem in a novel oral formulation

Women with limited treatment options can treat their uUTI with a penem at home1,2

ORLYNVAH is the first and only oral penem in the United States. It is for adult women with uncomplicated UTI (urinary tract infection) caused by E coli, K pneumoniae, or P mirabilis in adult women with limited or no alternative oral antibacterial options.

ORLYNVAH showed activity against1:

In Clinical Trials
  • Escherichia coli
  • Klebsiella pneumoniae
  • Proteus mirabilis

Sulopenem showed in vitro activity against:

The efficacy of ORLYNVAH in treating these bacteria has not been established in adequate and well-controlled clinical trials.

In Vitro Studies
Gram-negative bacteria
  • Citrobacter freundii
  • Citrobacter koseri
  • Enterobacter cloacae species complex
  • Klebsiella aerogenes
  • Klebsiella oxytoca
  • Proteus vulgaris
  • Providencia alcalifaciens
  • Providencia stuartii
Gram-positive bacteria
  • Staphylococcus saprophyticus
  • Streptococcus agalactiae

How ORLYNVAH works​​

ORLYNVAH is a novel treatment with a mechanism of action that offers a unique combination of sulopenem etzadroxil and probenecid in a single bilayer tablet. The addition of probenecid increases the bioavailability of sulopenem in the body.1

ORLYNVAH bilayer tablet.

Sulopenem etzadroxil1

  • Is converted after ingestion to sulopenem, the active drug

  • Sulopenem kills bacteria by attaching to penicillin-binding proteins, stopping the bacteria from building their cell walls

Probenecid1

  • Helps sulopenem to remain in blood plasma for longer, improving the bioavailability of sulopenem

Who is right for ORLYNVAH?
Consider ORLYNVAH for patients like these
View patient profiles
Demonstrated clinical response
Proven efficacy against ciprofloxacin-resistant pathogens1,3
View SURE-1 data
References:
  1. ORLYNVAH. Package insert. Iterum Therapeutics U.S. Limited: Chicago, IL; 2025.
  2. Iterum Therapeutics receives U.S. FDA approval of ORLYNVAH™ (oral sulopenem) for the treatment of uncomplicated urinary tract infections. Iterum Therapeutics plc. Published October 25, 2024. Accessed July 1, 2025. https://www.iterumtx.com/news/press-releases/detail/136/iterum-therapeutics-receives-u-s-fda-approval-of
  3. Dunne MW, Aronin SI, Das AF, et al. Sulopenem or ciprofloxacin for the treatment of uncomplicated urinary tract infections in women: a phase 3, randomized trial. Clin Infect Dis. 2023;76(1):66-77. doi:10.1093/cid/ciac738