ORLYNVAH is available through an exclusive partnership with Alto Pharmacy

In uncomplicated UTI when treatment can't wait

It’s time to rely on the first and only oral penem—ORLYNVAH1,2*

Treat your patients with a novel, next-generation penem at home.1,2 Learn how ORLYNVAH demonstrated clinical response in 2 robust trials.1

Explore REASSURE data

*Only FDA-approved oral penem.

ORLYNVAH is for the treatment of uUTIs caused by E coli, K pneumoniae, or P mirabilis in adult women with limited or no alternative oral antibacterial options.

Limitations of Use: Not for complicated UTI or step-down treatment after IV antibacterials or complicated intra-abdominal infections or as step-down treatment after IV antibacterials.

Demonstrated clinical response
Proven efficacy against ciprofloxacin-resistant pathogens.1,3
View SURE-1 data
ORLYNVAH safety was evaluated in more than 1900 patients
The majority of adverse events were mild.1,3,4
Learn about safety
Convenient, at-home dosing

A one pill, twice-daily, 5-day oral treatment.1

Discover dosing

After 30 years of limited innovation in antibiotic therapy, adult women with uUTIs have a novel oral treatment option.2,5-8

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
  4. Puttagunta S, Aronin SI, Gupta J, Das AF, Gupta K, Dunne MW. Sulopenem versus amoxicillin/clavulanate for the treatment of uncomplicated urinary tract infection. NEJM Evid. 2025;4(7):EVIDoa2400414. doi:10.1056/EVIDoa2400414
  5. Dunne MW, Aronin SI, Yu KC, Watts JA, Gupta V. A multicenter analysis of trends in resistance in urinary Enterobacterales isolates from ambulatory patients in the United States: 2011-2020. BMC Infect Dis. 2022;22(1):194. doi:10.1186/s12879-022-07167-y
  6. Ku JH, Tartof SY, Contreras R, et al. Antibiotic resistance of urinary tract infection recurrences in a large integrated US healthcare system. J Infect Dis. 2024;230(6):e1344-e1354. doi:10.1093/infdis/jiae233
  7. Sastry S, Doi Y. Fosfomycin: Resurgence of an old companion. J Infect Chemother. 2016;22(5):273-280. doi:10.1016/j.jiac.2016.01.010
  8. AMR Action Fund portfolio company UTILITY Therapeutics granted FDA approval for pivmecillinam. News release. AMR Action Fund. Published April 24, 2024. Accessed July 1, 2025. https://www.amractionfund.com/blog/amr-action-fund-portfolio-company-utility-therapeutics-granted-fda-approval-for-pivmecillinam