Urinary Tract Infection (UTI) Vaccine and Treatment

Urinary Tract Infection (UTI) Vaccine and Treatments 2025

Urinary tract infections (UTIs) are among the most common bacterial infections, affecting hundreds of millions of women and men annually. Most UTIs are caused by uropathogenic E. coli (E. coli). Less common pathogens, such as Enterococcus faecalis and other enterococci, cause infections by infecting an abnormal or catheterized urinary tract. Uncomplicated and Recurring UTI patients in the United States require prophylactic antibiotic regimens, as vaccines are unavailable. UTIs place an economic burden on the U.S. healthcare system, with direct and indirect costs estimated at around $3.5 billion annually.

As of March 2025, the U.S. Centers for Disease Control and Prevention (CDC) say most UTIs can be treated with antibiotics prescribed by a healthcare professional. European guidelines recommend an immunoreactive (vaccine) strategy for preventing UTIs. The Infectious Diseases Society of America announced in February 2025 that it accepts comments on the updated 2025 Guideline on the Management and Treatment of Complicated Urinary Tract Infections (cUTI). This update provides clinical practice guidelines for patients with cUTI, with and without sepsis.

On November 4, 2024, the JAMA Network published a Consensus Statement for UTI clinical guideline development. However, most topics relating to the prevention, diagnosis, and treatment of UTIs lack high-quality prospective data. A mini-review published in January 2025 summarizes the existing state of UTI diagnostics and covers current and upcoming technologies, including rapid molecular-based pathogen identification, next-generation sequencing, and advanced antimicrobial susceptibility testing. However, these methods represent unique challenges, and as they are implemented, they will require the field to adapt to new concepts to avoid misdiagnosis and overtreatment.

As of March 12, 2025, international travelers seeking UTI vaccine appointment requests can submit them at this Vax-Before-Travel link.

Urinary Tract Infection (UTI) Vaccines

Immunotek S.L. Uromune™ (MV140) oral spray for recurrent urinary tract infections has been approved for adults in countries such as Mexico and the United Kingdom.

Uro-Vaxom® (OM-89) is an immunostimulant vaccine consisting of an oral tablet with 18 heat-killed strains of E coli bacteria. Uro-Vaxom activates the immunocompetent cells of the intestinal lining (Peyer’s plaques). In humans, Uro-Vaxom stimulates the white blood cells and promotes the production of antibodies, preUTIsting UTI. A review found that the risk ratio for developing at least one UTI in the female population was significantly lower in the OM-89 group (RR 0.61, 95% CI 0.48–0.78), and the mean of UTIs was about half compared to placebo. It has been used in Europe with minimal documented adverse events and is recommended by the European Association of Urology.

Urinary Tract Infection (UTI) Vaccine Candidates

A Research Article published in March 2021 - Local induction of bladder Th1 responses to combat urinary tract infections - concluded that intravesical vaccination with one or more UPEC antigens to induce bladder Th1 responses represents a superior strategy to combat UTIs, especially in UTI-prone subjects.

Urinary Tract Infection (UTI) Treatment

There are approximately 40 million uUTI prescriptions generated annually in the U.S., and approximately 1% of those UTI infections are caused by pathogens that are resistant to common oral antibiotics. The four leading oral antibiotic treatments for uUTI (slide #6) account for roughly 75% of the prescription market but have resistance rates near or above 20%.

Pivya™ (Pivmecillinam) is an extended-spectrum penicillin antibiotic and a U.S. FDA-approved oral prodrug of mecillinam. Pivya has a unique mechanism of action and targets penicillin-binding protein-2 (PBP-2) in the cell wall of gram-negative bacteria. The Pivya tablet has been used throughout Europe for years and should be available in the U.S. in 2025.

ORLYNVAH™ (sulopenem etzadroxil and probenecid) is a U.S. FDA-approved novel oral penem antibiotic for the treatment of uncomplicated urinary tract infections (uUTIs) caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women. Orlynvah is taken as one oral tablet twice daily for 5 days. 

RECCE® 327 (R327) is an investigational synthetic anti-infective developed for treating severe, potentially life-threatening infections caused by Gram-positive and Gram-negative bacteria, including the full suite of ESKAPE pathogens, even in their superbug forms. 

In various clinical trials, Locus Biosciences is developing LBP-EC01, a CRISPR-enhanced bacteriophage therapy for treating UTIs and other infections caused by the pathogen E. coli. It is a bacteriophage cocktail engineered with a CRISPR-Cas3 construct targeting the E. coli gene. It is not a broad-spectrum antibacterial that kills various bacterial species. The precision medicine product works through a unique dual mechanism of action, utilizing both the natural lytic activity of the bacteriophage and the DNA-targeting activity of CRISPR-Cas3.