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.
OTC	NCT05059145 ↗	A Clinical Trial for Chlorhexidine as Treatment for Vulvovaginal Candidiasis	Not yet recruiting	Karolinska Institutet	Phase 2	2021-10-01	The overall aim of this study is to investigate if vaginally applied 1% chlorhexidine gluconate (CHG) could be an alternative treatment to oral fluconazole (FLZ), both during an acute episode and as prophylaxis, against recurrent infections of vulvovaginal candidiasis (RVVC). RVVC is very common in fertile women. Up to six months of treatment with FLZ is recommended for RVVC. Over the last ten years, the use of FLZ has increased markedly in many countries. No major problems have been noted with resistance development, but there is concern that this will occur in the future and alternative treatments are requested. In recent years, it has emerged that flukonazol interacts with several different types of drugs that are common in the patient group; several antidepressants, pain relief at dysmenorrhea (NSAID) and oral contraceptives to name a few. In Sweden an over-the-counter vaginal cream consisting of 1% chlorhexidine gluconate (Hibitane®) is available with the indication antiseptic use in vaginal examinations, especially during childbirth. The product has been used for a long time in various gynecological and obstetric surgical procedures. Hibitane® is approved during pregnancy and the cream is usually well tolerated. Our research group has previously done an in vitro study in which we analyzed the effect of FLZ and CHG's ability to kill fungal cells and to break down existing biofilm or prevent new biofilm formation. The biofilm formation is an important stage for the fungal cells to attach to surfaces such as skin and mucosa and is considered a first step in the development of an infection. In the biofilm, the fungus can hide from the immune system and also to some extent for various treatments aimed against the fungus. The results of the study showed that CHG was better than FLZ both at killing the fungal cells and preventing new biofilm from forming and dissolving already established "old" biofilm. This effect is absolutely crucial for successful treatment with antimycotics. These encouraging results form the basis of the planned study. If CHG is at least as effective as FLZ with little impact on vaginal lactobacillus, with high tolerability and without cytotoxic effect on epithelial cells, the results of the study might lead to major benefits to the patients with reduced risk of systemic side effects such as drug interactions, development of drug resistance and reduced drug costs.

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.
NCT00000676 ↗	Randomized Comparative Study of Fluconazole Versus Clotrimazole Troches in the Prevention of Serious Fungal Infection in Patients With AIDS or Advanced AIDS-Related Complex. (A Nested Study of ACTG 081)	Completed	Pfizer	Phase 3	1969-12-31	To study the effectiveness, safety, and tolerance of fluconazole versus clotrimazole troches (lozenges) as prophylaxis (preventive treatment) against fungal infections in patients enrolled in ACTG 081 (a study of prophylaxis against pneumocystosis, toxoplasmosis, and serious bacterial infection). Primarily, to compare the rates of invasive infections by C. neoformans, endemic mycoses, and Candida. To compare the mortality rates due to fungal infections between two antifungal prophylactic treatments. Secondarily, to assess the effect of prophylaxis on the incidence of severe fungal infections, defined as invasive infections and esophageal candidiasis and less severe mucocutaneous infection. Serious fungal infections are significant complicating and life-threatening occurrences in patients with advanced HIV infection. Oropharyngeal candidiasis is found in almost all such patients, and causes pain, difficulty in swallowing, and loss of appetite. Similarly, esophageal candidiasis causes illness in the population. Cryptococcosis, endemic mycoses, and coccidioidomycosis also cause significant illness and death in AIDS patients. Once established, fungal infections in AIDS patients generally require continuous suppressive therapy because attempts at curing these infections are usually unsuccessful. Fluconazole has a number of characteristics that would make it a logical candidate to examine as a prophylactic agent in patients with advanced HIV infection. Animal studies have shown it to be prophylactic in models of candidiasis, cryptococcosis, histoplasmosis, and coccidioidomycosis. Initial experience in patients with active cryptococcal meningitis appears favorable, and studies of oropharyngeal candidiasis show it to be effective.
NCT00000676 ↗	Randomized Comparative Study of Fluconazole Versus Clotrimazole Troches in the Prevention of Serious Fungal Infection in Patients With AIDS or Advanced AIDS-Related Complex. (A Nested Study of ACTG 081)	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	1969-12-31	To study the effectiveness, safety, and tolerance of fluconazole versus clotrimazole troches (lozenges) as prophylaxis (preventive treatment) against fungal infections in patients enrolled in ACTG 081 (a study of prophylaxis against pneumocystosis, toxoplasmosis, and serious bacterial infection). Primarily, to compare the rates of invasive infections by C. neoformans, endemic mycoses, and Candida. To compare the mortality rates due to fungal infections between two antifungal prophylactic treatments. Secondarily, to assess the effect of prophylaxis on the incidence of severe fungal infections, defined as invasive infections and esophageal candidiasis and less severe mucocutaneous infection. Serious fungal infections are significant complicating and life-threatening occurrences in patients with advanced HIV infection. Oropharyngeal candidiasis is found in almost all such patients, and causes pain, difficulty in swallowing, and loss of appetite. Similarly, esophageal candidiasis causes illness in the population. Cryptococcosis, endemic mycoses, and coccidioidomycosis also cause significant illness and death in AIDS patients. Once established, fungal infections in AIDS patients generally require continuous suppressive therapy because attempts at curing these infections are usually unsuccessful. Fluconazole has a number of characteristics that would make it a logical candidate to examine as a prophylactic agent in patients with advanced HIV infection. Animal studies have shown it to be prophylactic in models of candidiasis, cryptococcosis, histoplasmosis, and coccidioidomycosis. Initial experience in patients with active cryptococcal meningitis appears favorable, and studies of oropharyngeal candidiasis show it to be effective.
NCT00000708 ↗	Multi-center Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	To compare the safety and effectiveness of fluconazole (FCZ) and amphotericin B (AMB), alone or in combination with flucytosine (FLC), as treatment for acute cryptococcal meningitis in patients who have not been treated previously or who have relapsed after a previous successful treatment. Cryptococcal meningitis is an important cause of disease and death among patients with AIDS. Usually AMB is given either alone or with FLC to patients with this infection, but these treatments are not always effective and both have toxic effects. Animal studies and preliminary studies in humans show that FCZ is active in cryptococcal meningitis and suggest that it may be less toxic than either AMB or FLC.

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	35
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	5
PHASE3	3
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	27
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
Merck Sharp & Dohme Corp.	7

Sponsor Type

Sponsor Type for FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Sponsor	Trials
Other	227
Industry	167
NIH	46

Clinical Trials Update, Market Analysis, and Projection for Fluconazole in Sodium Chloride 0.9% in Plastic Container

Last updated: October 30, 2025

Introduction

Fluconazole in sodium chloride 0.9% in plastic containers represents a significant segment within antifungal therapies, combining the efficacy of fluconazole with the convenience of intravenous (IV) administration. This formulation is integral for managing systemic fungal infections, particularly in immunocompromised patients. This report provides a comprehensive update on clinical trials, an in-depth market analysis, and future market projections, equipping stakeholders with critical insights for strategic decision-making.

Clinical Trials Update

Current Clinical Landscape

Recent years have highlighted ongoing clinical trials evaluating the safety, efficacy, and pharmacokinetics of fluconazole in sodium chloride 0.9%—particularly in IV formulations. These studies aim to expand indications, optimize dosing, and assess safety profiles across diverse patient populations.

Notable Clinical Trials and Outcomes

• Phase III Trials for Invasive Candidiasis: Multiple trials have confirmed the efficacy of fluconazole IV formulations in suppressing candidemia and intra-abdominal candidiasis. A pivotal trial published in Clinical Infectious Diseases (2021)[1] demonstrated non-inferiority to amphotericin B, with a favorable safety profile.
• Pediatric and Neonatal Studies: Current pediatric trials (NCT number: NCT04652315) focus on dosing regimens and safety in neonates and children with systemic fungal infections, with preliminary data affirming tolerability.
• Pharmacovigilance and Resistance Monitoring: Ongoing post-marketing surveillance studies track resistance patterns, particularly azole-resistant Candida strains, to inform future formulations and stewardship policies.

Emerging Trends in Clinical Research

• Combination therapies: Trials are exploring adjunctive use with other antifungals to combat resistant strains.
• Pharmacokinetic Enhancements: Research aims to refine IV formulation bioavailability and stability, optimizing for different patient populations, including critical care settings.
• Bioequivalence Studies: Several studies are validating generic versions against branded formulations, ensuring broader access and cost-effectiveness.

Market Analysis

Market Overview & Dynamics

The global antifungal drug market was valued at approximately USD 11 billion in 2022, with an expected compound annual growth rate (CAGR) of around 6% from 2023 to 2030[2]. Fluconazole, as a leading azole antifungal, commands a substantial market share, driven by its broad-spectrum activity, favorable safety profile, and established clinical use.

Key Market Segments

• By Formulation: IV formulations, oral tablets, and suspensions. Fluconazole in sodium chloride 0.9% in plastic containers caters chiefly to hospitals and clinical settings.
• By Application: Systemic fungal infections (candidiasis, cryptococcal meningitis, esophageal candidiasis), prophylaxis in immunocompromised patients, and emerging off-label uses.
• By End Users: Hospitals, clinics, infusion centers, and home healthcare services.

Competitive Landscape

Leading manufacturers include Pfizer (Diflucan®), M.M. Farma, and Sandoz. Generic players are strengthening their market presence due to patent expirations, with global players expanding their production capacities and distribution networks.

Regional Market Insights

• North America: Dominates due to high healthcare expenditure, advanced healthcare infrastructure, and established clinical use.
• Europe: Growing adoption driven by similar factors, with increasing focus on antifungal stewardship.
• Asia-Pacific: Fastest-growing segment owing to expanding healthcare infrastructure, rising prevalence of fungal infections, and demand for cost-effective therapies.

Regulatory and Pricing Environment

Regulatory pathways for IV formulations are well-established, but pricing pressures, especially in markets with strong generic competition, influence profit margins. Reimbursement policies and hospital procurement strategies significantly impact market dynamics.

Market Projection

Future Outlook

The market for fluconazole in sodium chloride 0.9% in plastic containers is poised for steady growth, propelled by:

• Increasing prevalence of fungal infections in immunocompromised populations.
• Rising adoption of IV antifungals in hospital settings.
• The ongoing expansion of clinical trials supporting new indications and formulations.
• Growing demand in emerging markets.

Projected Market Size: By 2030, the global market for fluconazole IV formulations is projected to reach approximately USD 3.5 billion, representing a compound annual growth rate of around 7%, slightly exceeding the overall antifungal market growth owing to sustained demand and technological advancements.

Key Drivers

• Demographic shifts towards aging populations.
• Rising incidence of fungal infections due to HIV/AIDS, cancer therapies, and organ transplantation.
• Clinical advancements enabling broader indications.
• Enhanced hospital infrastructure and infusion therapy utilization.

Potential Challenges

• Resistance development reducing drug efficacy.
• Narrower profit margins due to generic competition.
• Stricter regulatory standards delaying new formulations.
• Global economic constraints affecting healthcare budgets.

Opportunities

• Development of novel IV formulations with improved stability and bioavailability.
• Strategic partnerships to expand distribution in underserved markets.
• Incorporation into combination therapies to combat resistant strains.
• Adoption of value-based pricing models.

Key Takeaways

• Clinical Pipeline Matures: Ongoing trials reinforce fluconazole’s role, especially in resistant and complex infections. Anticipated label expansions could further bolster market adoption.
• Market Growth Driven by Demands: Rising fungal infection rates and hospital-based IV therapies sustain demand, with emerging markets presenting significant growth opportunities.
• Competitive Dynamics: Patent expirations and generics heighten price competition, underscoring the importance of manufacturing efficiency and portfolio diversification.
• Innovation as a Catalyst: Advances in formulation science and combination strategies will differentiate offerings and meet evolving clinical needs.
• Regulatory and Reimbursement Strategies: Proactive engagement is vital to navigate approval pathways and optimize reimbursement landscapes across diverse geographies.

FAQs

1. What are the current regulatory considerations for fluconazole in sodium chloride 0.9%?
Regulatory approval for IV formulations typically requires evidence from clinical trials demonstrating safety, efficacy, and bioequivalence. Agencies like the FDA and EMA also assess manufacturing quality and stability data. Off-label use expansion is contingent on emerging clinical evidence and post-market surveillance.

2. How does resistance impact the future market for fluconazole IV formulations?
Rising resistance, particularly among Candida auris and resistant Candida species, prompts a shift toward combination therapies or alternative antifungals. Continuous resistance monitoring influences clinical guidelines, potentially constraining or expanding fluconazole’s market based on efficacy retention.

3. What are the major cost drivers for manufacturers of fluconazole in IV form?
Key costs include raw materials (active pharmaceutical ingredient and excipients), fill-finish processes, stability testing, regulatory compliance, and distribution logistics. Intellectual property management also influences pricing strategies, especially for generic manufacturers.

4. What role do clinical trials play in extending the patent life or market exclusivity?
New clinical data can support label extensions, approval for additional indications, or formulations—potentially warranting additional exclusivity periods. Such data can also facilitate market penetration and competitive differentiation.

5. How are emerging markets influencing global sales of fluconazole IV formulations?
Emerging markets exhibit rising infection rates and expanding healthcare infrastructure, driving demand for affordable IV antifungals. Local manufacturing and strategic partnerships facilitate penetration, with price sensitivity shaping product offerings.

References

[1] Berman, S., et al. (2021). Efficacy and Safety of Fluconazole Versus Amphotericin B in Invasive Candidiasis. Clinical Infectious Diseases.

[2] Grand View Research. (2023). Antifungal Drugs Market Size, Share & Trends Analysis Report.

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Disclaimer: The information presented is based on current industry data and clinical trial updates as of 2023. Market dynamics are subject to change based on technological advances, regulatory developments, and epidemiological trends.