CLINICAL TRIALS PROFILE FOR NITROFURANTOIN MACROCRYSTALLINE

All Clinical Trials for NITROFURANTOIN MACROCRYSTALLINE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02384200 ↗	A Randomized Trial of Preoperative Prophylactic Antibiotics Prior to Kidney Stone Surgery (Percutaneous Nephrolithotomy [PCNL])	Completed	Dartmouth-Hitchcock Medical Center	Phase 4	2015-03-01	When patients are going to have surgery to remove large kidney stones (percutaneous nephrolithotomy [PCNL]), it is not clear whether the patients benefit from a course of prophylactic preoperative oral antibiotics; currently both the use of prophylactic preoperative oral antibiotics and no prophylactic oral antibiotics are considered to be within standard-of-care. This study will randomize patients to preoperative prophylactic antibiotics or no antibiotics to determine if the use of preoperative prophylactic antibiotics decreases the postoperative risk of localized urinary tract infection (UTI) and/or systemic infection that started in the urinary tract (sepsis or urosepsis).
NCT02384200 ↗	A Randomized Trial of Preoperative Prophylactic Antibiotics Prior to Kidney Stone Surgery (Percutaneous Nephrolithotomy [PCNL])	Completed	Duke University	Phase 4	2015-03-01	When patients are going to have surgery to remove large kidney stones (percutaneous nephrolithotomy [PCNL]), it is not clear whether the patients benefit from a course of prophylactic preoperative oral antibiotics; currently both the use of prophylactic preoperative oral antibiotics and no prophylactic oral antibiotics are considered to be within standard-of-care. This study will randomize patients to preoperative prophylactic antibiotics or no antibiotics to determine if the use of preoperative prophylactic antibiotics decreases the postoperative risk of localized urinary tract infection (UTI) and/or systemic infection that started in the urinary tract (sepsis or urosepsis).
NCT02384200 ↗	A Randomized Trial of Preoperative Prophylactic Antibiotics Prior to Kidney Stone Surgery (Percutaneous Nephrolithotomy [PCNL])	Completed	Mayo Clinic	Phase 4	2015-03-01	When patients are going to have surgery to remove large kidney stones (percutaneous nephrolithotomy [PCNL]), it is not clear whether the patients benefit from a course of prophylactic preoperative oral antibiotics; currently both the use of prophylactic preoperative oral antibiotics and no prophylactic oral antibiotics are considered to be within standard-of-care. This study will randomize patients to preoperative prophylactic antibiotics or no antibiotics to determine if the use of preoperative prophylactic antibiotics decreases the postoperative risk of localized urinary tract infection (UTI) and/or systemic infection that started in the urinary tract (sepsis or urosepsis).
NCT02384200 ↗	A Randomized Trial of Preoperative Prophylactic Antibiotics Prior to Kidney Stone Surgery (Percutaneous Nephrolithotomy [PCNL])	Completed	New York University	Phase 4	2015-03-01	When patients are going to have surgery to remove large kidney stones (percutaneous nephrolithotomy [PCNL]), it is not clear whether the patients benefit from a course of prophylactic preoperative oral antibiotics; currently both the use of prophylactic preoperative oral antibiotics and no prophylactic oral antibiotics are considered to be within standard-of-care. This study will randomize patients to preoperative prophylactic antibiotics or no antibiotics to determine if the use of preoperative prophylactic antibiotics decreases the postoperative risk of localized urinary tract infection (UTI) and/or systemic infection that started in the urinary tract (sepsis or urosepsis).
NCT02384200 ↗	A Randomized Trial of Preoperative Prophylactic Antibiotics Prior to Kidney Stone Surgery (Percutaneous Nephrolithotomy [PCNL])	Completed	Ohio State University	Phase 4	2015-03-01	When patients are going to have surgery to remove large kidney stones (percutaneous nephrolithotomy [PCNL]), it is not clear whether the patients benefit from a course of prophylactic preoperative oral antibiotics; currently both the use of prophylactic preoperative oral antibiotics and no prophylactic oral antibiotics are considered to be within standard-of-care. This study will randomize patients to preoperative prophylactic antibiotics or no antibiotics to determine if the use of preoperative prophylactic antibiotics decreases the postoperative risk of localized urinary tract infection (UTI) and/or systemic infection that started in the urinary tract (sepsis or urosepsis).
NCT02384200 ↗	A Randomized Trial of Preoperative Prophylactic Antibiotics Prior to Kidney Stone Surgery (Percutaneous Nephrolithotomy [PCNL])	Completed	The Cleveland Clinic	Phase 4	2015-03-01	When patients are going to have surgery to remove large kidney stones (percutaneous nephrolithotomy [PCNL]), it is not clear whether the patients benefit from a course of prophylactic preoperative oral antibiotics; currently both the use of prophylactic preoperative oral antibiotics and no prophylactic oral antibiotics are considered to be within standard-of-care. This study will randomize patients to preoperative prophylactic antibiotics or no antibiotics to determine if the use of preoperative prophylactic antibiotics decreases the postoperative risk of localized urinary tract infection (UTI) and/or systemic infection that started in the urinary tract (sepsis or urosepsis).
NCT02384200 ↗	A Randomized Trial of Preoperative Prophylactic Antibiotics Prior to Kidney Stone Surgery (Percutaneous Nephrolithotomy [PCNL])	Completed	University of British Columbia	Phase 4	2015-03-01	When patients are going to have surgery to remove large kidney stones (percutaneous nephrolithotomy [PCNL]), it is not clear whether the patients benefit from a course of prophylactic preoperative oral antibiotics; currently both the use of prophylactic preoperative oral antibiotics and no prophylactic oral antibiotics are considered to be within standard-of-care. This study will randomize patients to preoperative prophylactic antibiotics or no antibiotics to determine if the use of preoperative prophylactic antibiotics decreases the postoperative risk of localized urinary tract infection (UTI) and/or systemic infection that started in the urinary tract (sepsis or urosepsis).

Clinical Trial Conditions for NITROFURANTOIN MACROCRYSTALLINE

Condition Name

Condition Name for NITROFURANTOIN MACROCRYSTALLINE
Intervention	Trials
Nephrolithiasis	2
Urinary Tract Infections	2
Sepsis	1
Urinary Tract Infection (UTI)	1

Condition MeSH

Condition MeSH for NITROFURANTOIN MACROCRYSTALLINE
Intervention	Trials
Urinary Tract Infections	3
Nephrolithiasis	2
Kidney Calculi	2
Cystitis	1

Clinical Trial Locations for NITROFURANTOIN MACROCRYSTALLINE

Trials by Country

Trials by Country for NITROFURANTOIN MACROCRYSTALLINE
Location	Trials
United States	6
Netherlands	2
Canada	1

Trials by US State

Trials by US State for NITROFURANTOIN MACROCRYSTALLINE
Location	Trials
California	2
Tennessee	1
Ohio	1
Minnesota	1
Arizona	1

Clinical Trial Progress for NITROFURANTOIN MACROCRYSTALLINE

Clinical Trial Phase

Clinical Trial Phase for NITROFURANTOIN MACROCRYSTALLINE
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1
N/A	1

Clinical Trial Status

Clinical Trial Status for NITROFURANTOIN MACROCRYSTALLINE
Clinical Trial Phase	Trials
Completed	1
Recruiting	1
Terminated	1

Clinical Trial Sponsors for NITROFURANTOIN MACROCRYSTALLINE

Sponsor Name

Sponsor Name for NITROFURANTOIN MACROCRYSTALLINE
Sponsor	Trials
University of California, San Diego	2
Vanderbilt University	1
Saltro	1

Sponsor Type

Sponsor Type for NITROFURANTOIN MACROCRYSTALLINE
Sponsor	Trials
Other	13

Last updated: April 25, 2026

Nitrofurantoin Monohydrate/Macrocrystalline (Nitrofurantoin Macrocrystalline): Clinical-Stage Update, Market Position, and Forecast

What is nitrofurantoin macrocrystalline in clinical and regulatory terms?

Nitrofurantoin macrocrystalline is the oral nitrofurantoin formulation used primarily for uncomplicated urinary tract infection (uUTI)/acute uncomplicated cystitis. It is a long-established antibacterial, with clinical development activity concentrated in:

• Reformulations and bioavailability bridging across generic manufacturers
• Comparative effectiveness and resistance surveillance studies
• Safety updates tied to labeling (notably pulmonary, hepatic, and peripheral neuropathy risk with prolonged use)
• Population-specific analyses (elderly, renal function constraints, pregnancy guidance)

Across jurisdictions, the core clinical claim remains consistent: short-course oral therapy for bacterial cystitis in appropriate patients, with contraindications and cautions tied to renal function.

Where is nitrofurantoin macrocrystalline in the clinical trial pipeline now?

No single, consolidated global clinical-trial “pipeline” view exists for this exact phrase alone because nitrofurantoin products are often indexed by ingredient (nitrofurantoin, nitrofurantoin monohydrate/macrocrystals) rather than brand-level naming. Trial activity is also dominated by generics and formulation-level studies.

Given the drug’s age and established use, the practical “pipeline” focus in recent years is not new mechanism development, but:

• Bioequivalence (BE) trials for generic nitrofurantoin macrocrystals
• Comparator trials where nitrofurantoin is one arm against other uUTI antibiotics
• Post-market observational studies on safety and effectiveness in real-world practice, including outcomes in patients with reduced renal function

Key implication for R&D planning: the competitive bar is not novel clinical efficacy claims; it is regulatory-grade equivalence, formulary differentiation (tolerability and adherence), and compliance with updated safety frameworks.

How do recent clinical evidence and labeling themes shape use?

Clinical decisioning for nitrofurantoin macrocrystalline is driven by patient selection and duration.

Renal function gating

Across major prescribing frameworks, nitrofurantoin is generally recommended for uncomplicated cystitis when renal function is adequate; it is avoided or used with caution when renal function is low because inadequate urinary concentrations reduce effectiveness.

A consistent safety/efficacy rationale is reflected in:

• Updated contraindication/caution language in regulatory product information (varies by country and time)
• Stewardship guidance that restricts use to indications with best evidence (uncomplicated lower UTI rather than complicated infection or pyelonephritis)

Duration and toxicity profile

Risk mitigation in practice targets:

• Avoidance of prolonged courses
• Monitoring or avoidance in at-risk patients (older adults, those with baseline lung disease, hepatic impairment, or neuropathy risk)
• Clear separation between short-course cystitis treatment and therapies used in complicated infections

This safety framing affects market demand patterns: prescribers increasingly match nitrofurantoin to guideline-defined uncomplicated cystitis cohorts.

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Market Analysis: Demand Drivers, Competitive Landscape, and Pricing Pressure

What is the current market structure for nitrofurantoin macrocrystalline?

Nitrofurantoin macrocrystalline is a generic-dominated antibiotic category with multiple manufacturers. The market behaves like a mature, price-competitive commodity segment with:

• High volume in primary care and urgent care settings
• Tender and formulary procurement pressure
• Ongoing BE and manufacturing scale investments rather than novel clinical development

Demand drivers

1. Guideline placement in uncomplicated cystitis
2. Low cost relative to newer agents
3. Antimicrobial stewardship use-cases (narrow indication alignment)
4. Availability in oral dosage forms that support outpatient prescribing

Key constraints

1. Resistance and E. coli susceptibility variability by geography and time
2. Renal function restrictions that limit eligible patients
3. Safety and tolerability concerns that constrain longer-than-indicated use
4. Switching dynamics toward newer agents in some formularies when susceptibility or guideline preferences shift

How do resistance and stewardship shift prescribing mix?

In uUTI, nitrofurantoin competes based on:

• Local E. coli susceptibility
• Guideline algorithms that weigh effectiveness, resistance, and adverse event profile
• Patient factors (renal function, pregnancy status, allergy profile)

When susceptibility drops or stewardship pushes toward broad-spectrum avoidance, nitrofurantoin often retains use due to its focused role in uncomplicated cystitis. When susceptibility is adequate, it is commonly used as a first-line or preferred alternative.

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Forecast: Market Projection for Nitrofurantoin Macrocrystalline

What market trajectory is most consistent for a mature generic like nitrofurantoin macrocrystalline?

For a mature, generic antibiotic, the forecast shape typically follows:

• Volume stability or modest growth driven by sustained guideline inclusion
• Ongoing price erosion driven by generic competition and procurement
• Steady market size with fluctuations by resistance trends and formulary policies

Practical projection logic (commercially actionable)

Because nitrofurantoin macrocrystalline is entrenched, projections should be modeled on three variables:

1. Eligible-patient share (affected by renal function guidance and prescriber behavior)
2. Susceptibility-linked treatment share (affected by resistance patterns and local antibiograms)
3. Unit pricing (affected by generic competition and purchasing agreements)

Directional forecast (no numeric magnitude without dataset)

• Unit demand: stable to slightly down/up depending on regional antibiogram and renal-criteria adoption
• Net revenue: downward pressure or flat due to generics price competition
• Share shifts: modest gains where stewardship favors narrower agents and where nitrofurantoin remains an accessible option

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Competitor and Product Differentiation: Where Value Can Still Be Captured

What levers can manufacturers still use in nitrofurantoin macrocrystalline?

With the clinical mechanism fixed and clinical differentiation limited, competitive advantage tends to come from:

• Formulation reliability and supply
• Cost and contracting execution
• Distribution and formulary access
• BE superiority or stability improvements that reduce patient switching and dosing non-adherence in real-world practice

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Regulatory and Clinical Strategy Implications

What does the clinical trial reality mean for new entrants or label-upgrade programs?

For nitrofurantoin macrocrystalline, new clinical value claims are difficult to support without:

• Large-scale superiority data in uUTI cohorts against current comparators, or
• Regulatory pathways enabling targeted label updates through bridging evidence

Commercially, most activity is likely to remain:

• BE trials for additional generic entrants
• Post-market observational studies to support safety posture in specific populations
• Formulary dossier improvements based on real-world outcomes and guideline alignment

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Key Takeaways

• Nitrofurantoin macrocrystalline is a mature, generic uUTI antibiotic with clinical activity concentrated in formulation-level and real-world studies rather than new mechanism breakthroughs.
• Market dynamics are driven by uncomplicated cystitis guideline placement, renal-function eligibility constraints, local susceptibility/resistance, and stewardship-driven prescribing patterns.
• Forecasts for a commodity generic should be modeled on eligible-patient share, susceptibility-linked treatment share, and unit price erosion from procurement and generic competition.
• Competitive differentiation remains operational (supply, contracting, formulary access) rather than clinical novelty.

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FAQs

1. Is nitrofurantoin macrocrystalline used for pyelonephritis?
   No. It is used for uncomplicated lower UTI/cystitis; dosing and labeling generally avoid use for upper-tract infections.

2. What most affects whether clinicians prescribe nitrofurantoin?
   Renal function eligibility, local E. coli susceptibility patterns, and alignment with uncomplicated cystitis indications.

3. Does the safety profile limit long-term use?
   Yes. Safety risk increases with prolonged or repeated exposure, so practice focuses on short-course therapy.

4. What type of clinical trials are most common for this product category?
   Bioequivalence studies for generics and observational or comparative effectiveness work in real-world uUTI populations.

5. How do stewardship programs influence market performance?
   They typically support narrow-indication agents for uncomplicated cystitis, which can preserve nitrofurantoin’s role when susceptibility is adequate.

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References

[1] FDA. Nitrofurantoin Product Labeling and Safety Communications. U.S. Food and Drug Administration website.
[2] EMA. Public Assessment Reports and Product Information for Nitrofurantoin-Containing Medicinal Products. European Medicines Agency website.
[3] IDSA. Infectious Diseases Society of America Guidelines for the Treatment of Urinary Tract Infections. IDSA guideline documents.
[4] CDC. Antibiotic Resistance Threats in the United States. Centers for Disease Control and Prevention.