Last Updated: May 10, 2026

CLINICAL TRIALS PROFILE FOR METHENAMINE HIPPURATE


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All Clinical Trials for METHENAMINE HIPPURATE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01958073 ↗ Vaginal Estrogen for the Prevention of Recurrent Urinary Tract Infection in Postmenopausal Women Completed American Urogynecologic Society Phase 4 2013-10-01 The investigators would like to know if the use of vaginally applied estrogen can prevent the problem of repeated urinary tract infections (UTI) in women who have gone through menopause. The investigators will use two forms of vaginal estrogen that are available by prescription (a ring and a cream) and compare their efficacy to that of a placebo (without any active ingredient). The investigators are going to look at if the vaginal estrogen can prevent UTIs altogether and also the number of UTIs each group experiences over a 6 month period. After 6 months, all subjects will receive vaginal estrogen and the women on the non-active treatment will be able to choose whether they would like to use either the estrogen ring or cream. The investigators will then be able to compare the number of UTIs on and off active vaginal estrogen treatment within those subjects who started on the placebo. The investigators are also going to look at quality of life before and during treatment using questionnaires and whether subjects stop using the treatments or do not use them as directed (compliance).
NCT01958073 ↗ Vaginal Estrogen for the Prevention of Recurrent Urinary Tract Infection in Postmenopausal Women Completed New York University Langone Medical Center Phase 4 2013-10-01 The investigators would like to know if the use of vaginally applied estrogen can prevent the problem of repeated urinary tract infections (UTI) in women who have gone through menopause. The investigators will use two forms of vaginal estrogen that are available by prescription (a ring and a cream) and compare their efficacy to that of a placebo (without any active ingredient). The investigators are going to look at if the vaginal estrogen can prevent UTIs altogether and also the number of UTIs each group experiences over a 6 month period. After 6 months, all subjects will receive vaginal estrogen and the women on the non-active treatment will be able to choose whether they would like to use either the estrogen ring or cream. The investigators will then be able to compare the number of UTIs on and off active vaginal estrogen treatment within those subjects who started on the placebo. The investigators are also going to look at quality of life before and during treatment using questionnaires and whether subjects stop using the treatments or do not use them as directed (compliance).
NCT01958073 ↗ Vaginal Estrogen for the Prevention of Recurrent Urinary Tract Infection in Postmenopausal Women Completed NYU Langone Health Phase 4 2013-10-01 The investigators would like to know if the use of vaginally applied estrogen can prevent the problem of repeated urinary tract infections (UTI) in women who have gone through menopause. The investigators will use two forms of vaginal estrogen that are available by prescription (a ring and a cream) and compare their efficacy to that of a placebo (without any active ingredient). The investigators are going to look at if the vaginal estrogen can prevent UTIs altogether and also the number of UTIs each group experiences over a 6 month period. After 6 months, all subjects will receive vaginal estrogen and the women on the non-active treatment will be able to choose whether they would like to use either the estrogen ring or cream. The investigators will then be able to compare the number of UTIs on and off active vaginal estrogen treatment within those subjects who started on the placebo. The investigators are also going to look at quality of life before and during treatment using questionnaires and whether subjects stop using the treatments or do not use them as directed (compliance).
NCT01958073 ↗ Vaginal Estrogen for the Prevention of Recurrent Urinary Tract Infection in Postmenopausal Women Completed University of California, San Diego Phase 4 2013-10-01 The investigators would like to know if the use of vaginally applied estrogen can prevent the problem of repeated urinary tract infections (UTI) in women who have gone through menopause. The investigators will use two forms of vaginal estrogen that are available by prescription (a ring and a cream) and compare their efficacy to that of a placebo (without any active ingredient). The investigators are going to look at if the vaginal estrogen can prevent UTIs altogether and also the number of UTIs each group experiences over a 6 month period. After 6 months, all subjects will receive vaginal estrogen and the women on the non-active treatment will be able to choose whether they would like to use either the estrogen ring or cream. The investigators will then be able to compare the number of UTIs on and off active vaginal estrogen treatment within those subjects who started on the placebo. The investigators are also going to look at quality of life before and during treatment using questionnaires and whether subjects stop using the treatments or do not use them as directed (compliance).
NCT02358993 ↗ Short-course Methenamine Hippurate for Prevention of Post-operative UTI Completed University of Pennsylvania N/A 2014-12-01 The investigators will determine the efficacy of an innovative short regimen of methenamine hippurate on prevention of post-operative UTI in patients requiring short-term catheterization after pelvic reconstructive surgery through a single-blind, randomized controlled trial. Primary outcome will be the rate of symptomatic UTI within 3 weeks of catheter removal. The investigators will study cost-effectiveness, antibiotic resistance profiles, and adverse drug effects. Findings may reduce antibiotic use and nosocomial UTIs.
NCT03818321 ↗ Urinary Track Infection Prevention After Urogynecological Surgery Recruiting TriHealth Inc. Phase 2 2019-06-17 This study is randomized double-blinded placebo-controlled trial to access oral Methenamine Hippurate (MH) in combination with cranberry capsules is superior to cranberry capsules alone in prevention of UTI in patients with transient post-operative urinary retention requiring a Foley catheter after pelvic reconstructive surgery.
NCT03996057 ↗ Methenamine in a Non-antibiotic, Multimodal Approach to UTI Prevention Not yet recruiting Washington University School of Medicine Phase 4 2020-09-01 Urinary tract infections (UTIs) are the most common bacterial infection and are especially common in postmenopausal women, who often experience recurrent UTIs. Women with recurrent UTIs are commonly treated with antibiotics, but side effects, collateral damage to commensal bacteria, and antimicrobial resistance result from frequent antibiotic use. It is paramount that researchers develop non-antibiotic treatment strategies for UTIs. Several non-antibiotic strategies may be successful in preventing recurrent UTIs in postmenopausal women, including low-dose vaginal estrogen, d-mannose, and methenamine hippurate. Methenamine hippurate (MH) is interesting as it causes few side effects, kills bacteria by denaturing bacterial proteins, RNA, and DNA, and does not develop resistance. Several studies have demonstrated the efficacy of daily methenamine on the incidence of UTI. However, women often require multiple therapies in order to prevent recurrence. There are currently few guidelines to help clinicians identify optimal treatment regimens for non-antibiotic prevention of UTI. The purpose of this pilot study is to examine the feasibility of developing a sequential, multiple assignment, randomization trial (SMART); and examine the treatment effect of MH in combination with vaginal estrogen (VET) and D-mannose on prevention of UTI. The investigators plan to examine the efficacy of the addition of MH to low dose VET and d-mannose in the UTI prevention through randomization to MH + VET + D-mannose vs continuing VET + D-mannose alone. The primary outcome will be the proportion of patients who have symptomatic, culture-proven UTI during a 3 month treatment period. The investigators hypothesize that women on low dose VET, d-mannose, and MH will be less likely to have recurrent UTI than those with VET and d-mannose alone. This study uses a pragmatic, longitudinal approach that mimics patients' clinical experiences and physicians' decision points during management of UTI prophylaxis. Through this randomized, controlled pilot study, this proposal would allow the investigators to examine the feasibility of conducting a larger-scale, adaptive study trial, and estimate the treatment effect of a non-antibiotic regimen augmented with MH in women who continue to develop recurrence.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for METHENAMINE HIPPURATE

Condition Name

Condition Name for METHENAMINE HIPPURATE
Intervention Trials
Urinary Tract Infections 4
Recurrent Urinary Tract Infection 2
UTI 1
UTI - Lower Urinary Tract Infection 1
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Condition MeSH

Condition MeSH for METHENAMINE HIPPURATE
Intervention Trials
Urinary Tract Infections 9
Infections 5
Infection 5
Communicable Diseases 3
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Clinical Trial Locations for METHENAMINE HIPPURATE

Trials by Country

Trials by Country for METHENAMINE HIPPURATE
Location Trials
United States 6
United Kingdom 2
Norway 1
Netherlands 1
Sweden 1
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Trials by US State

Trials by US State for METHENAMINE HIPPURATE
Location Trials
Rhode Island 1
Texas 1
Ohio 1
Pennsylvania 1
New York 1
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Clinical Trial Progress for METHENAMINE HIPPURATE

Clinical Trial Phase

Clinical Trial Phase for METHENAMINE HIPPURATE
Clinical Trial Phase Trials
PHASE4 1
PHASE2 1
Phase 4 4
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Clinical Trial Status

Clinical Trial Status for METHENAMINE HIPPURATE
Clinical Trial Phase Trials
NOT_YET_RECRUITING 3
Completed 2
Recruiting 2
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Clinical Trial Sponsors for METHENAMINE HIPPURATE

Sponsor Name

Sponsor Name for METHENAMINE HIPPURATE
Sponsor Trials
University of Texas Southwestern Medical Center 1
University of California, San Diego 1
University Hospitals of North Midlands NHS Trust 1
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Sponsor Type

Sponsor Type for METHENAMINE HIPPURATE
Sponsor Trials
Other 17
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Methenamine Hippurate: Clinical Trials Update, Market Analysis, and Projections

Last updated: April 27, 2026

What is the current clinical-trials landscape for methenamine hippurate?

Methenamine hippurate is an established urinary antiseptic used to reduce recurrence of urinary tract infections (UTIs). Its clinical profile is anchored in older efficacy evidence and routine real-world use rather than a steady stream of late-stage, brand-defining phase III programs.

Active or recently reported interventional trials

A complete, up-to-date trial inventory with consistent phase labeling and trial status cannot be produced from the available sources in this run. This response therefore does not enumerate specific trial IDs, phase, endpoints, enrollment, or timelines.

Where current evidence typically sits

  • Efficacy claims in clinical practice rely on recurrence reduction and safety/tolerability in long-term use populations (often prophylaxis settings for recurrent UTIs).
  • Contemporary registries tend to show fewer new late-stage development programs than for novel antibiotics, because methenamine is off-patent and is used across multiple generics in many markets.

Impact for investors and R&D planners: the measurable near-term upside is more likely to come from label expansion, new regimen studies, combination strategies, or guideline-driven adoption rather than from a large single “registration” trial pipeline.


How does the methenamine hippurate market work today?

Methenamine hippurate sits in a mature, generic, off-patent segment of urinary antiseptics and UTI prevention therapies. Market activity is driven by recurrent UTI prevalence, physician adoption of prophylaxis frameworks, and competitive substitution versus antibiotics and newer prophylactic agents.

Demand drivers

  1. Recurrent UTI epidemiology
    • Recurrent UTIs increase lifetime treatment burden and create sustained demand for prophylaxis and recurrence-reduction products.
  2. Antibiotic stewardship
    • Methenamine’s antiseptic mechanism is used in prevention strategies aimed at reducing continuous antibiotic exposure in selected patients.
  3. Safety and dosing practicality
    • Long-term oral use supports adoption in outpatient prophylaxis settings.

Competitive set (practical comparables)

Methenamine hippurate competes in recurrent UTI prevention, typically against:

  • Antibiotic prophylaxis regimens (continuous or post-coital)
  • Non-antibiotic prophylaxis approaches used by clinicians (product- and guideline-dependent)
  • Emerging and newer branded options in some geographies, where coverage and reimbursement shape access

Pricing power and brand economics

  • In off-patent generics, pricing is constrained by multiple suppliers and tendering dynamics.
  • Revenue growth tends to track volume and guideline adoption more than premium pricing.

What market projection is supportable for the next 5 years?

A defensible quantitative projection requires current market size, channel shares, and forecast methodology tied to cited sources. No such market data is available in the sources provided in this run. This response therefore does not publish a numeric 5-year forecast.

Directionally supportable scenario framing (non-quantified)

Even without numeric forecast bounds, the following drivers determine whether the segment expands or stagnates:

  • Guideline uptake for non-antibiotic prophylaxis frameworks
  • Penetration in recurrent UTI patient subgroups (e.g., women with recurrent UTIs)
  • Formulation and distribution expansion across geographies
  • Competitive substitution if newer branded prevention options gain payer preference
  • Safety signal management through post-marketing pharmacovigilance

Actionable implication: the upside case is adoption-led (guidelines, payer criteria, and clinician preference), not pipeline-led (new phase III wins).


Which policy and guideline dynamics most affect adoption?

Antibiotic resistance policy and recurrent UTI prophylaxis guidance

Clinical and stewardship guidance globally has increasingly emphasized minimizing continuous antibiotic exposure for prophylaxis when alternatives can meet recurrence-reduction goals. Methenamine hippurate is used as an antiseptic option in that context.

Regulatory and stewardship environment

  • Off-patent status limits the incentive for major brand-specific development, but it supports broad access and low cost entry.
  • Stewardship-driven recommendations can still shift utilization patterns toward antiseptic prophylaxis.

What is the commercial bottom line for 2026–2031?

Given generic supply structure and the absence of a newly characterized late-stage pipeline from the available sources in this run, the commercial thesis concentrates on:

  • Volume growth tied to recurrent UTI burden and guideline adoption
  • Class utilization (switching to antiseptic prophylaxis where recommended)
  • Payer and formulary inclusion across key markets
  • Limited pricing upside due to generic competition

Key Takeaways

  • Methenamine hippurate is an off-patent urinary antiseptic whose clinical value is largely established; current development momentum is unlikely to resemble the late-stage pipeline dynamics of novel antibiotics.
  • Market growth is likely adoption-led (guidelines and stewardship-driven prophylaxis decisions) rather than premium-driven.
  • A numeric 5-year market forecast and specific trial listing cannot be produced from the available cited sources in this run.

FAQs

  1. Is methenamine hippurate still used for recurrent UTI prevention?
    Yes. It remains used as an oral prophylactic antiseptic in recurrent UTI prevention frameworks.

  2. Does the drug have a large, modern phase III pipeline?
    The available information in this run does not support identifying a new late-stage, registration-grade pipeline.

  3. What are the main competitive substitutes?
    Antibiotic prophylaxis regimens and other non-antibiotic prevention approaches used in recurrent UTI care.

  4. What drives adoption commercially?
    Guideline and antibiotic stewardship alignment, formulary placement, and clinician comfort with long-term prophylaxis.

  5. What most affects revenue growth in a generic market?
    Volume and access (tendering, reimbursement, and formulary inclusion), with limited pricing power.


References

[1] APA format list not available because no sources were provided in this run.

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