CLINICAL TRIALS PROFILE FOR NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE

All Clinical Trials for NITROFURANTOIN; 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).

Clinical Trial Conditions for NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE

Condition Name

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

Condition MeSH

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

Clinical Trial Locations for NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE

Sponsor Name

Sponsor Name for NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE
Sponsor	Trials
University of California, San Diego	2
Saltro	1
ZonMw: The Netherlands Organisation for Health Research and Development	1

Sponsor Type

Sponsor Type for NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE
Sponsor	Trials
Other	13

NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE Market Analysis and Financial Projection

Last updated: April 30, 2026

Clinical trials update, market analysis and projection for nitrofurantoin (macrocrystalline)

What is the current clinical development and trial activity for nitrofurantoin (macrocrystalline)?

Nitrofurantoin macrocrystalline is a long-established, marketed antibiotic for urinary tract infections (UTIs). Public registries and major oncology-style “phase-gated” pipelines are not the dominant framing for this asset; the practical clinical “updates” for this product class tend to be post-approval safety/usage studies and comparative effectiveness work rather than new phase registration programs.

Clinical development pattern (macrocrystalline nitrofurantoin)

• Primary use: uncomplicated cystitis and other lower UTI indications where nitrofurantoin is guideline-concordant.
• Trial endpoints commonly used: microbiologic eradication, clinical cure, symptom resolution, recurrence rates, and safety (notably pulmonary, hepatic, neurologic adverse events with prolonged exposure).

What drives the “trial update” narrative in this category

• Comparative trials and real-world evidence studies frequently evaluate:
  • Effectiveness vs. alternative oral agents for uncomplicated cystitis.
  • Dosing strategies and adherence.
  • Subpopulation performance (age, renal function strata, baseline pathogens).
• Separate from macrocrystalline branding, evidence generation typically consolidates around nitrofurantoin as a drug class, with formulation differences (macrocrystalline vs. monohydrate/macrocrystals) influencing absorption timing rather than changing the core antimicrobial mechanism (nitrofurans).

Implication for investors and R&D

• For nitrofurantoin macrocrystalline, “pipeline-style” growth is usually not created by new registrational trials.
• Market upside typically comes from:
  • guideline placement,
  • stewardship-driven prescribing behavior,
  • formulary retention,
  • and competitive displacement at the level of UTI antibiotic mix.

Note: No specific, current-date phase-start or phase-completion trial events for “nitrofurantoin macrocrystalline” could be cited from the provided material set, so a trial-by-trial update is not reported here.

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How big is the nitrofurantoin (macrocrystalline) market and what is the demand structure?

Nitrofurantoin demand is a function of uncomplicated cystitis incidence, outpatient prescribing patterns, and the relative position of nitrofurantoin versus alternatives (trimethoprim-sulfamethoxazole, fosfomycin, fluoroquinolones, beta-lactams).

Demand segmentation that shapes pricing and volume

• Setting: outpatient and urgent care for uncomplicated lower UTIs.
• Patient segment: adult women with acute uncomplicated cystitis is the dominant use case.
• Pathogen and resistance context:
  • E. coli remains the principal pathogen.
  • Nitrofurantoin generally maintains favorable susceptibility versus many older agents, supporting continued guideline usage.

Competition and generic substitution

• Nitrofurantoin has extensive generic availability, making the macrocrystalline product category highly sensitive to:
  • wholesale acquisition cost competition,
  • formulary tiering,
  • payer reimbursement,
  • and manufacturing capacity.

Regulatory and clinical policy effects

• Stewardship guidance in the US has tended to restrict fluoroquinolones and broaden use of narrow-spectrum oral options for uncomplicated cystitis.
• Nitrofurantoin’s role remains tied to safety constraints that affect prescribing in patients with reduced renal function.

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What are the market drivers, constraints, and scenario levers for projections?

Market drivers

• High outpatient incidence of uncomplicated cystitis.
• Guideline-consistent positioning as a first-line or preferred option in many stewardship pathways.
• Favorable resistance profile versus other legacy oral antibiotics.

Market constraints

• Product substitution and price compression due to generic competition.
• Safety considerations tied to renal function and long-term use risk, which can narrow the eligible population.
• Periodic payer scrutiny and antimicrobial stewardship limitations that steer prescribing away from “broader-than-needed” use.

Scenario levers

• Utilization: rates of outpatient UTI diagnosis and testing practices.
• Formulary mix: relative share against fosfomycin and beta-lactams.
• Drug availability and manufacturing: supply disruptions can shift short-term share.
• Guideline updates: changes to recommended agents and renal threshold language.

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How should investors project nitrofurantoin macrocrystalline revenue (volume-based, not pipeline-based)?

For mature, generic, formulation-specific products, revenue projection is typically a volume-share and net pricing problem. The most practical approach is to project:

1. Total addressable uncomplicated cystitis treatment episodes in the target geography.
2. Nitrofurantoin share of treated episodes versus competing agents.
3. Macrocrystalline share within nitrofurantoin formulations (macrocrystalline vs. other nitrofurantoin presentations).
4. Net price trend, driven by generic competition and payer contracting.

Because the prompt requests “market analysis and projection,” a projection should be numbers-led. However, no credible numeric market size, share, or pricing index inputs were included in the provided material set, so quantitative projections cannot be produced without inventing data. Under the operating constraints, a numeric forecast is omitted.

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Regulatory, labeling, and safety factors that affect prescribing and market share

Key prescribing constraints (nitrofurantoin class)

• Renal function eligibility is central to safe use. Prescribers often limit use where renal clearance is reduced.
• Adverse-event monitoring expectations can reduce long-duration or off-label use.

How this impacts macrocrystalline specifically

• Macrocrystalline nitrofurantoin and other nitrofurantoin formulations share core safety themes, so the market impact is more about drug-class prescribing rules than macrocrystalline-only labeling.

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Competitive landscape: where nitrofurantoin macrocrystalline stands in UTI antibiotic choice

Across many formularies and guideline pathways, the choice set for uncomplicated cystitis commonly includes:

• Nitrofurantoin
• Fosfomycin
• Trimethoprim-sulfamethoxazole (where resistance permits)
• Beta-lactams (selected use)
• Fluoroquinolones (restricted use)

In a generic-heavy market, the winner is usually the one with:

• durable formulary placement,
• strong contracting,
• reliable supply,
• and dosing simplicity.

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Key Takeaways

• Nitrofurantoin macrocrystalline is mature and primarily evolves through real-world utilization and comparative evidence rather than new phase-registrational “pipeline” milestones.
• Market performance is driven by uncomplicated cystitis incidence, stewardship-guided antibiotic selection, generic substitution economics, and renal-function prescribing constraints.
• A rigorous market projection requires episode volume, nitrofurantoin share, macrocrystalline formulation share, and net price trends. Those numeric inputs are not present here, so a quantified forecast is not provided.

FAQs

1. Is nitrofurantoin macrocrystalline still prescribed for uncomplicated cystitis?
   Yes. It remains a standard option in uncomplicated cystitis pathways where guideline and stewardship criteria are met.

2. What most limits nitrofurantoin prescribing?
   Renal-function eligibility and safety constraints, especially with prolonged or off-label use.

3. Does the market growth come from new clinical trials?
   For macrocrystalline nitrofurantoin specifically, growth is usually utilization- and formulary-driven, not from new drug approvals.

4. How does generic competition affect pricing?
   It compresses net pricing and makes revenue more dependent on volume and contracting than on innovation.

5. Which antibiotics most compete with nitrofurantoin?
   Typically fosfomycin, beta-lactams, trimethoprim-sulfamethoxazole (where resistance allows), and restricted fluoroquinolones.

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References (APA)

[1] FDA. (n.d.). Nitrofurantoin (drug label information and safety communications). U.S. Food and Drug Administration.
[2] IDSA. (2011). Clinical practice guideline for the treatment of acute uncomplicated cystitis and pyelonephritis in women. Clinical Infectious Diseases.
[3] Sanford Guide. (n.d.). Nitrofurantoin dosing and safety notes. The Sanford Guide.