CLINICAL TRIALS PROFILE FOR NITROFURANTOIN

505(b)(2) Clinical Trials for nitrofurantoin

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT05055544 ↗	Bearberry in the Treatment of Cystitis	Not yet recruiting	University of Pecs	N/A	2021-10-01	The goal of this study is to assess the efficacy of bearberry in uncomplicated cystitis. Uncomplicated cystitis is a disease related to the infection of the urinary bladder. Typical symptoms are dysuria, urinary urgency, and frequent voiding of small volumes. Urinary tract infections are frequent in women, usually treated with antibiotics, since the disease is usually caused by bacteria. Fosfomycin is a frequently used antibiotic for the treatment of uncomplicated cystitis. This medicine is typically prescribed by MDs. However, since uncomplicated cystitis is quite frequent, not all patients visit the doctor when experiencing the symptoms of this disease. The use of over-the-counter products (medicines and food supplements) to alleviate the symptoms is common. One of the most frequently used medicinal plants for this purpose is bearberry. Bearberry is a medicinal plant traditionally used for the treatment of cystitis. Its use is accepted by the European Medicine Agency as traditional herbal medicinal product for relief of symptoms of mild recurrent lower urinary tract infections such as burning sensation during urination and/or frequent urination in women. Although the experience gained during the traditional use and the laboratory experiments support the supposed beneficial effect of bearberry, its clinical efficacy has not been confirmed in well-designed clinical trials in comparison with standard antibiotic therapy. In this study, the efficacy of bearberry will be assessed in comparison with fosfomycin. Premenopausal women experiencing the symptoms of uncomplicated cystitis will be randomly divided into two groups. Since it will be a double-blind trial, neither the participants nor the experimenters will know who is receiving a particular treatment. In group A, patients will receive a single dose of fosfomycin powder dissolved in water and 2 placebo tablets three times a day for 7 days. In group B, patients will receive a single dose of placebo powder dissolved in water and 2 bearberry tablets three times a day for 7 days. At the beginning of the study (day 0) and on day 7, patients will be asked to fill in a questionnaire concerning their symptoms. At the same times, urine specimens will be collected to inspect the presence of bacteria in the urine. The primary goal of the trial is to assess the improvement of symptoms of uncomplicated cystitis after 7 days of treatment with the intention to analyze whether treatment with bearberry is at least as effective as fosfomycin therapy is. This will be achieved by using a validated questionnaire (Acute Cystitis Symptom Score). The presence of bacteria in urine and the frequency and severity of side effects will also be recorded and compared. During a 90-days follow-up of this study, the recurrence of urinary tract infections will be analyzed. This study will deliver important data on the efficacy and safety of bearberry in the treatment of uncomplicated cystitis.

All Clinical Trials for nitrofurantoin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00361998 ↗	Nitrofurantoin Macrocrystals 3 Days Versus 7 Days in the Treatment of Women With Uncomplicated Cystitis	Withdrawn	Clalit Health Services	Phase 4	2006-09-01	Our guidelines in the community recommend the use of NM for the treatment of women with community acquired UTI. While the length of treatment for uncomplicated cystitis with quinolones or TMP-SMX is three days, NM is recommended for seven days. However, there are not sufficient papers that establish the optimal length of treatment with NM in this population. The aim of this proposal is to evaluate and compare NM 3 day vs. 7 day treatment for the treatment of women with uncomplicated UTI.
NCT00361998 ↗	Nitrofurantoin Macrocrystals 3 Days Versus 7 Days in the Treatment of Women With Uncomplicated Cystitis	Withdrawn	HaEmek Medical Center, Israel	Phase 4	2006-09-01	Our guidelines in the community recommend the use of NM for the treatment of women with community acquired UTI. While the length of treatment for uncomplicated cystitis with quinolones or TMP-SMX is three days, NM is recommended for seven days. However, there are not sufficient papers that establish the optimal length of treatment with NM in this population. The aim of this proposal is to evaluate and compare NM 3 day vs. 7 day treatment for the treatment of women with uncomplicated UTI.
NCT00391651 ↗	Short Course Nitrofurantoin for Acute Cystitis	Completed	Procter and Gamble	Phase 2	2002-01-01	The purpose of this research study is to determine what the cure rates are with a 5 day course of nitrofurantoin versus the more standard 3 day course of trimethoprim/sulfamethoxazone. The study will improve our knowledge of which antibiotic and what length of therapy is best for treatment of UTI, taking into account the problem of antibiotic resistance. Procedures subjects will undergo once they have read and signed the consent are: Questions about their medical and sexual history and current symptoms of UTI. They will be asked to provide a urine sample and then randomly assigned to one of the two treatment groups. will be obtained at each visit. If they were assigned to the nitrofurantoin treatment regimen, they will also be asked to collect a urine sample at home on the third day. If the subject develops recurrent urinary symptoms or does not have resolution of symptoms after completing the initial treatment course, they will be asked to return to the clinic and provide another urine sample for analysis. They will then be treated with another standard antibiotic at no cost to them and will be withdrawn from the study at that time. The study population is women ages 18-45 with acute symptoms of a UTI without a history of UTI in the past 6 weeks.
NCT00391651 ↗	Short Course Nitrofurantoin for Acute Cystitis	Completed	University of Washington	Phase 2	2002-01-01	The purpose of this research study is to determine what the cure rates are with a 5 day course of nitrofurantoin versus the more standard 3 day course of trimethoprim/sulfamethoxazone. The study will improve our knowledge of which antibiotic and what length of therapy is best for treatment of UTI, taking into account the problem of antibiotic resistance. Procedures subjects will undergo once they have read and signed the consent are: Questions about their medical and sexual history and current symptoms of UTI. They will be asked to provide a urine sample and then randomly assigned to one of the two treatment groups. will be obtained at each visit. If they were assigned to the nitrofurantoin treatment regimen, they will also be asked to collect a urine sample at home on the third day. If the subject develops recurrent urinary symptoms or does not have resolution of symptoms after completing the initial treatment course, they will be asked to return to the clinic and provide another urine sample for analysis. They will then be treated with another standard antibiotic at no cost to them and will be withdrawn from the study at that time. The study population is women ages 18-45 with acute symptoms of a UTI without a history of UTI in the past 6 weeks.

Clinical Trial Conditions for nitrofurantoin

Condition Name

Condition Name for nitrofurantoin
Intervention	Trials
Urinary Tract Infections	18
Urinary Tract Infection	5
Healthy	4
Cystitis	4

Condition MeSH

Condition MeSH for nitrofurantoin
Intervention	Trials
Urinary Tract Infections	42
Infections	25
Infection	21
Communicable Diseases	18

Clinical Trial Locations for nitrofurantoin

Trials by Country

Trials by Country for nitrofurantoin
Location	Trials
United States	88
Mexico	7
Spain	6
Pakistan	5
Australia	4

Trials by US State

Trials by US State for nitrofurantoin
Location	Trials
North Carolina	6
Texas	6
Ohio	5
California	5
Pennsylvania	5

Clinical Trial Progress for nitrofurantoin

Clinical Trial Phase

Clinical Trial Phase for nitrofurantoin
Clinical Trial Phase	Trials
PHASE4	7
PHASE2	1
PHASE1	2

Clinical Trial Status

Clinical Trial Status for nitrofurantoin
Clinical Trial Phase	Trials
Completed	22
Recruiting	16
Not yet recruiting	9

Clinical Trial Sponsors for nitrofurantoin

Sponsor Name

Sponsor Name for nitrofurantoin
Sponsor	Trials
GlaxoSmithKline	4
Mylan Pharmaceuticals	3
Altamash Institute of Dental Medicine	3

Sponsor Type

Sponsor Type for nitrofurantoin
Sponsor	Trials
Other	92
Industry	13
NIH	3

Nitrofurantoin Clinical Trials Update, Market Analysis, and Projection

Last updated: April 28, 2026

What is the current clinical-trial landscape for nitrofurantoin?

Nitrofurantoin is an established antibiotic used primarily for uncomplicated urinary tract infections (uUTIs). Public clinical-trial activity is comparatively limited versus newer anti-infective entrants, with most activity clustered around formulation optimization, dosing refinements, and comparative effectiveness in uUTI or recurrent uUTI pathways.

Trial focus areas observed in recent registrations and updates

• Uncomplicated UTI treatment settings: comparative arms versus other standard-of-care agents or placebo/step-down designs where permitted.
• Recurrent UTI: prophylaxis-style or prevention-pathway studies, often anchored on adherence, recurrence endpoints, or safety.
• Formulation and exposure optimization: studies aimed at pharmacokinetics (PK), urine concentrations, tolerability, and adherence.

Practical implication for R&D

• Entry points are largely product-formulation and comparative uUTI efficacy/safety rather than completely novel mechanisms, because the active ingredient is mature and heavily documented.
• Development spend tends to concentrate on programs that can claim non-inferiority with differentiators (tolerability, dosing convenience, reduced adverse events) and that can clear payer and guideline scrutiny tied to antimicrobial stewardship.

How does nitrofurantoin fit the UTI market and competitive set?

Nitrofurantoin sits in the “older oral antibiotic” segment for uUTI. It competes with:

• Fluoroquinolones (often restricted by stewardship due to resistance and safety).
• Trimethoprim-sulfamethoxazole (TMP-SMX) (limited where resistance is high).
• Fosfomycin trometamol (broad use for uncomplicated cystitis in many markets).
• Cephalosporins (selected cases, depending on resistance patterns).
• Newer oral options in some geographies and segments, though nitrofurantoin retains a long-established role where it meets local guidance.

Competitive dynamics

• Stewardship-driven positioning: nitrofurantoin benefits from guidance that favors narrow-spectrum options for uncomplicated cystitis when susceptibility supports use.
• Resistance and susceptibility dependence: market share rises or falls with local antibiogram trends and formulary controls.
• Safety/tolerability constraints: pulmonary toxicity and hepatic injury risks (rare but relevant) influence uptake in long-duration or higher-risk populations.

What does the pricing and reimbursement profile imply for commercial opportunity?

Nitrofurantoin’s commercial profile is shaped by:

• Generics dominance: most markets have broad access through multiple abbreviated pathways, limiting pricing power for new entrants unless a differentiated formulation can justify a premium.
• Formulary controls: many systems prefer lower-cost oral agents for uncomplicated cases. Nitrofurantoin often stays on formulary due to stewardship alignment and efficacy history.
• Utilization drivers: incidence of uncomplicated cystitis, outpatient antibiotic prescribing, and guideline adherence are the key volume levers.

Where opportunity concentrates

• Renal-function-aware positioning: systems that tightly follow renal contraindication guidance (to avoid inadequate urinary concentrations and increased systemic exposure) can still use nitrofurantoin effectively in eligible patients.
• Adherence and dosing simplicity: differentiated dosing regimens or improved tolerability can lift persistence and reduce discontinuation, which matters in payers’ quality frameworks.
• Recurrent UTI pathways: prevention protocols can expand durable use when supported by clinician adoption and outcomes evidence.

What is the market projection for nitrofurantoin through 2030?

A robust numeric projection requires consistent inputs (current market size by geography, segment definitions, pricing trends, and a forecast model tied to utilization). Those inputs are not provided in the request, and a complete, citation-backed projection cannot be produced to Bloomberg-grade standards without that dataset.

Actionable projection framework (non-numeric) For business planning and valuation modeling, structure forecasts around three drivers:

1. Volume: outpatient uUTI incidence and antibiotic prescribing intensity (including stewardship restrictions).
2. Share of eligible prescriptions: influenced by susceptibility patterns and formulary tiering.
3. Net price/mix: influenced by generic competition, tender dynamics, and any brand premium for reformulated products.

Scenario structure to use

• Base case: stable eligible utilization, modest share shifts among fosfomycin/TMP-SMX based on resistance.
• Upside: improved tolerability-adherence products gain incremental share in outpatient uUTI; recurrent UTI prevention protocols expand.
• Downside: formulary moves toward alternatives where local resistance increases or where safety concerns narrow eligible use.

Who is likely to benefit from incremental nitrofurantoin differentiation?

Market access for nitrofurantoin typically rewards entrants that can demonstrate one or more of the following:

• Lower discontinuation due to GI or tolerability with comparable efficacy.
• Simplified dosing that improves adherence versus standard regimens in real-world outpatient settings.
• Clear patient-selection guidance that supports clinician comfort and payer acceptance.
• Evidence for recurrent UTI positioning with safety and recurrence endpoints that match guideline needs.

What endpoints matter in trials for commercial adoption?

For uUTI differentiation and future-label expansion, sponsors typically need:

• Symptom resolution and microbiologic eradication aligned to guideline criteria.
• Time to improvement in outpatient settings.
• Adverse event profiles, especially discontinuation rates and clinically relevant rare toxicities.
• Recurrent UTI endpoints for prevention strategies: recurrence frequency and time-to-event.

How to interpret clinical-trial updates for investment decisions

Given nitrofurantoin’s mature status, investment value concentrates in:

• Phase 3 comparative or non-inferiority programs with endpoints tied to guideline acceptance.
• Bridging PK/PD and formulation programs that can reduce risk for regulatory review and capture payer confidence.
• Competitive positioning trials designed to withstand real-world substitution pressures.

Key Takeaways

• Nitrofurantoin’s clinical development is dominated by formulation optimization, dosing refinements, and comparative uUTI evidence rather than new-mechanism innovation.
• Commercial upside depends on differentiation that affects adherence, tolerability, or patient-selection within stewardship and formulary constraints.
• A numeric market projection through 2030 cannot be produced from the information provided; forecast modeling should anchor on volume, eligible-share, and net price/mix drivers.
• Trials that succeed for nitrofurantoin tend to emphasize symptom resolution, microbiologic endpoints, and discontinuation-safe tolerability, with recurrent UTI studies focused on time-to-recurrence and recurrence frequency.

FAQs

1) Is nitrofurantoin still being studied in clinical trials?

Yes. Recent trial activity focuses primarily on formulation and comparative/optimization studies in uUTI and recurrent UTI contexts, rather than broad novel-mechanism development.

2) What differentiators matter most for a new nitrofurantoin product?

Payers and clinicians respond to adherence and tolerability improvements, supported by PK-informed patient selection and clear clinical endpoints tied to uUTI outcomes.

3) How does stewardship affect nitrofurantoin demand?

Stewardship often favors narrow-spectrum oral options for uncomplicated cystitis when susceptibility supports use, which supports nitrofurantoin’s role in many formularies.

4) What safety signals are commercially relevant?

Rare but impactful toxicities (notably pulmonary and hepatic injury) affect patient selection and duration of use, shaping clinician comfort and formulary eligibility.

5) Why is numeric market projection hard to finalize without full inputs?

Nitrofurantoin market size depends on geography, segment definitions (uUTI vs prophylaxis), and pricing dynamics driven by generics and tendering. Without those inputs, a defensible numeric forecast cannot be produced.

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References

[1] Not provided in the prompt.