CLINICAL TRIALS PROFILE FOR FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

505(b)(2) Clinical Trials for FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

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
New Dosage	NCT02372357 ↗	A New Dosing Regimen for Posaconazole Prophylaxis in Children Based on Body Surface Area	Completed	Institutul Clinic Fundeni	Phase 4	2012-02-01	A new prophylactic posaconazole dosing regimen of 120mg/m² tid is evaluated pharmacologically in children 13 years and younger, suffering from a hematologic malignancy.
New Dosage	NCT02372357 ↗	A New Dosing Regimen for Posaconazole Prophylaxis in Children Based on Body Surface Area	Completed	Institutul Clinic Fundeni Bucharest	Phase 4	2012-02-01	A new prophylactic posaconazole dosing regimen of 120mg/m² tid is evaluated pharmacologically in children 13 years and younger, suffering from a hematologic malignancy.
New Dosage	NCT02372357 ↗	A New Dosing Regimen for Posaconazole Prophylaxis in Children Based on Body Surface Area	Completed	Universitaire Ziekenhuizen Leuven	Phase 4	2012-02-01	A new prophylactic posaconazole dosing regimen of 120mg/m² tid is evaluated pharmacologically in children 13 years and younger, suffering from a hematologic malignancy.
New Indication	NCT04495608 ↗	Fluconazole in Hypercalciuric Patients With Increased 1,25(OH)2D Levels	Recruiting	Hospices Civils de Lyon	Phase 2	2021-01-13	Hypercalciuria is one of the most frequent metabolic disorders associated with nephrolithiasis and/or nephrocalcinosis leading to Chronic Kidney Disease (CKD) and bone complications in adults. Hypercalciuria can be secondary to increased intestinal absorption and/or increased renal distal tubular reabsorption of calcium due to increased active vitamin D, i.e. 1,25(OH)2D, levels. The management of hypercalciuria is challenging. Classic management based on hyperhydration and dietary advice has low impact on calciuria and therefore on CKD progression. Other strategies such as hydrochlorothiazide can be proposed, however with an uncertain medical benefit in view of side effects (hypokalemia, asthenia, potential cutaneous long-term side effects). Azoles are known to inhibit the 1α-hydroxylase and therefore decrease 1,25(OH)2D levels. These antifungal drugs are commonly used in neonates, infants and adults; pharmacokinetic data are well described. Recently, to improve azoles tolerance, fluconazole has been successfully reported to reduce calciuria in patients with CYP24A1 mutation (1 adult) or NPTIIc mutations (1 child), while maintaining a stable renal function. Based on these observations, the investigators hypothesize that fluconazole is effective to decrease and normalize calciuria in patients with hypercalciuria and increased 1,25(OH)2D levels. The primary objective is to demonstrate that fluconazole normalizes or decreases calciuria after 4 months of treatment in patients with hypercalciuria and increased 1,25(OH)2D levels. The secondary objectives aim to describe: - the effects of fluconazole on the evolution over time of the calcium/phosphate metabolism, - the evolution of renal function, - the cohort at Baseline and after 4 months of treatment period, - the safety of fluconazole, - the onset of potential mycological resistances, - and the treatment compliance. This is a prospective, interventional, national, randomized in 2 parallel groups (1:1), controlled versus placebo, double blind trial. This study will involve patients between 10 and 50 years of age suffering from nephrolithiasis and/or nephrocalcinosis with hypercalciuria (> 0.1 mmol/kg/d) and increased 1,25 (OH)2D levels (≥ 150 pmol/l) and 25-OH-D levels (≥50 nmol/L). FLUCOLITH study is a unique opportunity to develop a new indication of a well-known and not expensive drug (e.g. fluconazole) in rare renal diseases, the ultimate objective being the secondary prevention of CKD worsening in these patients. If the results of this proof-of-concept randomized controlled trial are positive, the investigators will propose an extension phase to evaluate the long term efficacy and safety of fluconazole on renal and bone parameters.

All Clinical Trials for FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000627 ↗	Pilot Study to Determine the Feasibility of Fluconazole for Induction Treatment and Suppression of Relapse of Histoplasmosis in Patients With the Acquired Immunodeficiency Syndrome	Completed	Pfizer	N/A	1969-12-31	To evaluate the use of fluconazole as (1) induction therapy in histoplasmosis, (2) maintenance therapy to prevent relapse of histoplasmosis. Histoplasmosis is a serious opportunistic infection in patients with AIDS. Fluconazole is a triazole antifungal agent that has been used successfully in the treatment of experimental histoplasmosis in animals, but has not been completely evaluated in patients for this use. It has been approved by the Food and Drug Administration for certain other fungal infections. Nevertheless, physicians are prescribing it to their patients with histoplasmosis. This is a pilot study to examine the role of fluconazole for treating histoplasmosis in AIDS patients.
NCT00000627 ↗	Pilot Study to Determine the Feasibility of Fluconazole for Induction Treatment and Suppression of Relapse of Histoplasmosis in Patients With the Acquired Immunodeficiency Syndrome	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	To evaluate the use of fluconazole as (1) induction therapy in histoplasmosis, (2) maintenance therapy to prevent relapse of histoplasmosis. Histoplasmosis is a serious opportunistic infection in patients with AIDS. Fluconazole is a triazole antifungal agent that has been used successfully in the treatment of experimental histoplasmosis in animals, but has not been completely evaluated in patients for this use. It has been approved by the Food and Drug Administration for certain other fungal infections. Nevertheless, physicians are prescribing it to their patients with histoplasmosis. This is a pilot study to examine the role of fluconazole for treating histoplasmosis in AIDS patients.
NCT00000639 ↗	A Randomized Double Blind Protocol Comparing Amphotericin B With Flucytosine to Amphotericin B Alone Followed by a Comparison of Fluconazole and Itraconazole in the Treatment of Acute Cryptococcal Meningitis	Completed	Washington University School of Medicine	N/A	1969-12-31	To evaluate the effectiveness and safety of amphotericin B plus flucytosine (5-fluorocytosine) compared to amphotericin B alone for a first episode of acute cryptococcal meningitis in AIDS patients, and to compare the effectiveness and safety of fluconazole versus itraconazole. At least 10 percent of patients with a low CD4 count and HIV infection will develop meningitis due to Cryptococcus neoformans. More effective treatments than the standard therapy need to be explored.
NCT00000639 ↗	A Randomized Double Blind Protocol Comparing Amphotericin B With Flucytosine to Amphotericin B Alone Followed by a Comparison of Fluconazole and Itraconazole in the Treatment of Acute Cryptococcal Meningitis	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	To evaluate the effectiveness and safety of amphotericin B plus flucytosine (5-fluorocytosine) compared to amphotericin B alone for a first episode of acute cryptococcal meningitis in AIDS patients, and to compare the effectiveness and safety of fluconazole versus itraconazole. At least 10 percent of patients with a low CD4 count and HIV infection will develop meningitis due to Cryptococcus neoformans. More effective treatments than the standard therapy need to be explored.

Clinical Trial Conditions for FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Condition Name

Condition Name for FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Intervention	Trials
HIV Infections	42
Candidiasis	21
Mycoses	19
Meningitis, Cryptococcal	16

Condition MeSH

Condition MeSH for FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Intervention	Trials
Candidiasis	77
HIV Infections	45
Mycoses	45
Infections	31

Clinical Trial Locations for FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Trials by Country

Trials by Country for FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Location	Trials
United States	771
China	36
Canada	28
Spain	20
Belgium	15

Trials by US State

Trials by US State for FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Location	Trials
California	57
Texas	55
Florida	46
New York	46
Pennsylvania	40

Clinical Trial Progress for FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
PHASE4	6
PHASE3	4
PHASE2	4

Clinical Trial Status

Clinical Trial Status for FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	189
Recruiting	28
Unknown status	21

Clinical Trial Sponsors for FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Sponsor	Trials
Pfizer	40
National Institute of Allergy and Infectious Diseases (NIAID)	25
National Cancer Institute (NCI)	7

Sponsor Type

Sponsor Type for FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Sponsor	Trials
Other	231
Industry	168
NIH	46

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER Market Analysis and Financial Projection

Last updated: April 25, 2026

Fluconazole in Sodium Chloride 0.9% in Plastic Container: Clinical Trial Update, Market Analysis, and Projection

What is this product and how is it positioned clinically?

Fluconazole in Sodium Chloride 0.9% in Plastic Container is an intravenous (IV) antifungal product: fluconazole formulated in 0.9% sodium chloride and supplied in plastic containers. Clinically, it is used for invasive Candida infections and other fungal infections where IV administration is preferred, including settings such as bloodstream infection, esophagitis, and selected deep-seated infections. Standard practice treats dosing and duration based on infection site, severity, renal function, and susceptibility.

This specific formulation matters commercially because IV fluconazole is a procurement category used in hospital formularies and emergency/critical care pathways, where supply stability and container format affect switching, stock management, and contracting.

---

What do recent clinical-trials signals indicate for IV fluconazole?

A comprehensive, formulation-specific clinical trials update for fluconazole in sodium chloride 0.9% in plastic container is not available in a way that can be attributed uniquely to this exact presentation. Clinical development and updates for IV fluconazole are typically tied to fluconazole itself (molecule), IV versus oral delivery, and formulation changes rather than to a sodium chloride container format as a standalone investigational product.

Practical read-through for business planning (based on how fluconazole is developed and used):

• The clinical evidence base is mature for fluconazole as an antifungal active ingredient.
• Ongoing activity in the class is more likely to focus on:
  • Pharmacokinetics (PK) in special populations (renal impairment, pediatrics, ICU cohorts).
  • Bioequivalence / formulation bridging when manufacturers change excipients, container systems, or concentration.
  • Comparative studies versus other antifungals (often in invasive candidiasis pathways).

Implication for pipeline visibility: in this category, the largest clinical-trials risk is not “lack of efficacy,” but regulatory and manufacturing execution tied to the specific product presentation.

---

What is the market for IV fluconazole and where does this presentation fit?

Market structure

• Fluconazole is a widely used antifungal with a long-established role in Candida infections and step-down therapy.
• The IV segment is driven by:
  • hospital inpatient volume,
  • ICU utilization,
  • sepsis and candidemia protocols,
  • surgery and transplant-related infection management.

Why this formulation matters commercially

• IV procurement is often standardized by hospital pharmacy and group purchasing organization (GPO) contracts.
• Plastic container compatibility is relevant for:
  • supply chain continuity,
  • preparation workflows,
  • system compatibility with pumps and infusion sets,
  • storage and stability handling preferences at hospital sites.

Competitive landscape

• Competition in IV fluconazole is dominated by:
  • generic manufacturers with interchangeable fluconazole strengths/concentrations,
  • branded-to-generic switching dynamics depending on geography and patent status,
  • ongoing substitution under hospital formularies when pricing and supply improve.

Category reality

• Because fluconazole is off-patent in many markets, growth typically comes from:
  • volume capture within institutional formularies,
  • tender wins and contract renewals,
  • conversion from alternate IV antifungals based on protocol changes and budget pressure.

---

How does pricing and tender behavior typically move for IV fluconazole?

For older generics, pricing usually shows:

• downward trend as more suppliers enter and competition intensifies,
• tender-driven volatility tied to short supply shocks or manufacturing outages,
• currency and freight sensitivity for imported products.

For a procurement product like “fluconazole in sodium chloride 0.9%,” the competitive metrics are usually:

• unit price and package size,
• availability on contract,
• return policy and delivery reliability,
• label compliance and plug-and-play compatibility with pharmacy workflows.

This presentation’s commercial success is therefore tied less to clinical differentiation and more to contract execution.

---

Market projection: base case, bullish case, and downside

Because no formulation-specific epidemiology, trials pipeline, or unit sales dataset is provided here, projections must be tied to category drivers. Fluconazole IV demand is largely correlated with:

• invasive candidiasis incidence and hospitalization trends,
• shifts in antifungal prescribing protocols,
• hospital uptake of IV fluconazole for initial therapy and step-down.

Projection framework (category-level) Assume IV fluconazole demand tracks with: 1) inpatient volume growth (with variability by region), and
2) protocol intensity (how often candidemia/esophagitis cases start IV fluconazole versus oral step-down early).

Base case (most likely for an off-patent IV antifungal presentation)

• Low to mid single-digit annual market value growth.
• Volume growth comes mainly from protocol standardization and tender capture, offset by pricing pressure.

Bullish case

• Faster institutional uptake in high-acuity settings and increased conversions from alternative IV antifungals.
• Could produce mid to high single-digit growth, assuming supply stability and favorable tender wins.

Downside case

• Pricing compression accelerates due to new entrants or aggressive contracting.
• Could result in flat to low single-digit value growth, with volume pressure if shortages or substitution away from a specific presentation occur.

---

Commercial outlook: what would drive share for this exact presentation?

Key share levers

• Contract award rate for IV antifungal formularies (tender selection).
• On-time delivery and backorder avoidance (pharmacy continuity).
• Compatibility with automated dispensing and preparation workflows (plastic container handling and infusion readiness).
• Pricing competitiveness at renewal, especially during competitive retenders.
• Regulatory continuity: batch release reliability, labeling compliance, and stability maintenance.

Key risks

• Manufacturer allocation constraints during demand spikes.
• Rapid price erosion in generic-heavy procurement categories.
• Substitution to alternate IV fluconazole concentrations or alternative antifungal agents in specific protocol revisions.

---

Regulatory and lifecycle implications for plastic-container presentations

In sterile IV products, lifecycle events usually cluster around:

• manufacturing changes (site, process, container closure system),
• stability and shelf-life updates,
• labeling updates and risk communications,
• regulatory bridging (bioequivalence is generally not the frame for sterile solutions; the focus is often on chemistry, sterility assurance, and stability data).

For business planning, the practical lens is:

• whether the product can maintain contract coverage without delays at lifecycle change points,
• whether stability and container system performance remain aligned with internal hospital requirements.

---

Key takeaways

• Clinical differentiation is limited at the presentation level; the evidence base for fluconazole is mature and ongoing development is more commonly formulation- and population-focused than presentation-specific.
• The market is institutional and procurement-driven; this product’s success depends on tender wins, pricing, and supply reliability, not on new clinical outcomes.
• Projections for an off-patent IV antifungal formulation typically land in low to mid single-digit annual value growth under a base case, with range depending on protocol intensity and competitive pricing pressure.
• The biggest determinants of share for “fluconazole in sodium chloride 0.9% in plastic container” are contract execution and continuity through regulatory and manufacturing lifecycle events.

---

FAQs

1) Is this product mainly used for Candida infections?

Yes. IV fluconazole is primarily used in clinical pathways for invasive Candida infections and related indications where IV therapy is clinically warranted.

2) Does the plastic container format change efficacy?

Container format generally does not change fluconazole efficacy when formulation and stability criteria are met. It changes operational handling, supply chain logistics, and regulatory lifecycle management.

3) What drives demand in hospitals for IV fluconazole?

Hospital demand is driven by inpatient acuity, sepsis/candidemia detection rates, transplant and surgical volumes, and adherence to antifungal protocols.

4) How competitive is pricing for IV fluconazole?

Pricing is typically highly competitive due to generic supply and tender contracting, which can compress margins even when volume remains steady.

5) What is the main commercialization risk for this presentation?

The main risk is execution: supply availability, contract renewals, and lifecycle/regulatory continuity tied to manufacturing and container system changes.

---

References

[1] FDA. Antimicrobial Drugs. Food and Drug Administration (FDA) drug safety and labeling resources. (Accessed via FDA antimicrobial and label resources).
[2] European Medicines Agency (EMA). Fluconazole product information and assessment frameworks for antifungal medicines. (Accessed via EMA medicine resources).
[3] IDSA (Infectious Diseases Society of America). Guidelines for the management of candidiasis and antifungal therapy recommendations. (Accessed via IDSA guideline publications).