ORLYNVAH is available through an exclusive partnership with Alto Pharmacy

Challenges with treating uncomplicated UTIs today

Providers and patients with uUTI are faced with antibiotic resistance and limited new treatments1-5

40MILLION
annual prescriptions
Uncomplicated urinary tract infections (uUTIs) are common and account for approximately 40 million prescriptions annually6,7
44%
experience recurrent infections
Up to 44% of women who have an initial urinary tract infection (UTI) will experience recurrent infections (≥2/6 months or ≥3/year)8
29%
rate of resistance

Rates of resistance to commonly prescribed antibiotics to treat uUTIs have continued to grow for decades, with rates as high as 29%3,9

Pills.

Current treatment landscape

Rising rates of antibiotic-resistant uncomplicated UTIs are impacting treatment.1-3,9

  • A significant portion of outpatient uUTIs are due to multidrug-resistant pathogens3,9

  • Obtaining urine cultures does not always happen, which can complicate treatment decisions10,11

  • The most commonly used therapies are antibiotics such as nitrofurantoin and trimethoprim/sulfamethoxazole1

    • Antibiotic treatment can last from 1-7 days, depending on disease severity12

  • IV carbapenems are effective and have been relied on to treat multidrug-resistant pathogens13

Urine sample cup.

A closer look at uUTI

An uncomplicated UTI is an infection of the urinary tract in a healthy patient with an anatomically and functionally normal urinary tract.14

  • 50% to 60% of women will experience at least 1 uncomplicated UTI in their lifetime15

  • A patient experiencing 3 or more UTIs in 12 months or 2 or more in 6 months is considered to have recurrent UTIs14

  • The most common pathogens responsible for UTIs are16,17:

    • Escherichia coli

    • Klebsiella pneumoniae

    • Proteus mirabilis

After 30 years of limited innovation in antibiotic therapy, adult women with uUTIs have a novel oral treatment option.2-6

Why ORLYNVAH?
Power of a penem in an oral formulation18
Learn about ORLYNVAH
Consistent clinical response
Demonstrated clinical efficacy against amoxicillin/clavulanate in a Phase 3 clinical trial18,19
Explore REASSURE data
References:
  1. Trautner BW, Kaye KS, Gupta V, et al. Risk factors associated with antimicrobial resistance and adverse short-term health outcomes among adult and adolescent female outpatients with uncomplicated urinary tract infection. Open Forum Infect Dis. 2022;9(12):ofac623. doi:10.1093/ofid/ofac623
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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
  7. Data on file. Iterum Therapeutics, U.S. Limited.
  8. Gupta K, Trautner BW. Diagnosis and management of recurrent urinary tract infections in non-pregnant women. BMJ. 2013:346:f3140. doi:10.1136/bmj.f3140
  9. Sanchez GV, Babiker A, Master RN, Luu T, Mathur A, Bordon J. Antibiotic resistance among urinary isolates from female outpatients in the United States in 2003 and 2012. Antimicrob Agents Chemother. 2016;60(5):2680-2683. doi:10.1128/AAC.02897-15
  10. Dunne MW, Puttagunta S, Aronin SI, Brossette S, Murray J, Gupta V. Impact of empirical antibiotic therapy on outcomes of outpatient urinary tract infection due to nonsusceptible Enterobacterales. Microbiol Spectr. 2022;10(1):e0235921. doi:10.1128/spectrum.02359-21
  11. Walker E, Lyman A, Gupta K, Mahoney MV, Snyder GM, Hirsch EB. Clinical management of an increasing threat: outpatient urinary tract infections due to multidrug-resistant uropathogens. Clin Infect Dis. 2016;63(7):960-965. doi:10.1093/cid/ciw396
  12. Bates BN. Interpretation of urinalysis and urine culture for UTI treatment. Published November 15, 2023. Accessed July 1, 2025. https://www.uspharmacist.com/article/interpretation-of-urinalysis-and-urine-culture-for-uti-treatment
  13. Song S, Kim C, Lim D. Clinical efficacy of ertapenem for recurrent cystitis caused by multidrug-resistant extended-spectrum β-lactamase-producing escherichia coli in female outpatients. Korean J Urol. 2014;55(4):270-275. doi:10.4111/kju.2014.55.4.270
  14. Pathophysiology of an UTI: urinary tract infection case study. The Ohio State University. Accessed May 28, 2025. https://u.osu.edu/utieducation/pathophysiology-of-uti/
  15. Medina M, Castillo-Pino E. An introduction to the epidemiology and burden of urinary tract infections. Ther Adv Urol. 2019;11:1756287219832172. doi:10.1177/1756287219832172
  16. Palusiak A. Proteus mirabilis and Klebsiella pneumoniae as pathogens capable of causing co-infections and exhibiting similarities in their virulence factors. Front Cell Infect Microbiol. 2022;12:991657. doi:10.3389/fcimb.2022.991657
  17. Mancuso G, Midiri A, Gerace E, Marra M, Zummo S, Biondo C. Urinary tract infections: The current scenario and future prospects. Pathogens. 2023;12(4):623. doi:10.3390/pathogens12040623
  18. ORLYNVAH. Package insert. Iterum Therapeutics U.S. Limited: Chicago, IL; 2025.
  19. 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