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

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

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00075803 ↗	Comparison of Fluconazole vs Voriconazole to Treat Fungal Infections for Blood and Marrow Transplants (BMT CTN 0101)	Completed	Blood and Marrow Transplant Clinical Trials Network	Phase 3	2003-11-01	The study is designed as a Phase III, randomized, double-blind, multicenter, prospective, comparative study of fluconazole versus voriconazole for the prevention of fungal infections in allogeneic transplant recipients. Recipients will be stratified by center and donor type (sibling vs. unrelated) and will be randomized to either the fluconazole or voriconazole arm in a 1:1 ratio.
NCT00075803 ↗	Comparison of Fluconazole vs Voriconazole to Treat Fungal Infections for Blood and Marrow Transplants (BMT CTN 0101)	Completed	National Cancer Institute (NCI)	Phase 3	2003-11-01	The study is designed as a Phase III, randomized, double-blind, multicenter, prospective, comparative study of fluconazole versus voriconazole for the prevention of fungal infections in allogeneic transplant recipients. Recipients will be stratified by center and donor type (sibling vs. unrelated) and will be randomized to either the fluconazole or voriconazole arm in a 1:1 ratio.
NCT00075803 ↗	Comparison of Fluconazole vs Voriconazole to Treat Fungal Infections for Blood and Marrow Transplants (BMT CTN 0101)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	2003-11-01	The study is designed as a Phase III, randomized, double-blind, multicenter, prospective, comparative study of fluconazole versus voriconazole for the prevention of fungal infections in allogeneic transplant recipients. Recipients will be stratified by center and donor type (sibling vs. unrelated) and will be randomized to either the fluconazole or voriconazole arm in a 1:1 ratio.
NCT00075803 ↗	Comparison of Fluconazole vs Voriconazole to Treat Fungal Infections for Blood and Marrow Transplants (BMT CTN 0101)	Completed	National Marrow Donor Program	Phase 3	2003-11-01	The study is designed as a Phase III, randomized, double-blind, multicenter, prospective, comparative study of fluconazole versus voriconazole for the prevention of fungal infections in allogeneic transplant recipients. Recipients will be stratified by center and donor type (sibling vs. unrelated) and will be randomized to either the fluconazole or voriconazole arm in a 1:1 ratio.
NCT00075803 ↗	Comparison of Fluconazole vs Voriconazole to Treat Fungal Infections for Blood and Marrow Transplants (BMT CTN 0101)	Completed	Medical College of Wisconsin	Phase 3	2003-11-01	The study is designed as a Phase III, randomized, double-blind, multicenter, prospective, comparative study of fluconazole versus voriconazole for the prevention of fungal infections in allogeneic transplant recipients. Recipients will be stratified by center and donor type (sibling vs. unrelated) and will be randomized to either the fluconazole or voriconazole arm in a 1:1 ratio.
NCT00166166 ↗	Endothelial Hyperpolarization in Humans	Terminated	National Heart, Lung, and Blood Institute (NHLBI)	Phase 2	2002-07-01	The purpose of this study is to elucidate the role Endothelium-Derived Hyperpolarizing Factor (EDHF) plays in dilating blood vessels and whether it differs between healthy people and those with high cholesterol. A second purpose of the study is to determine the identity of EDHF.

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

Condition Name

Condition Name for DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Intervention	Trials
Candidiasis	5
Fungal Infection	4
Candidemia	3
Healthy	3

Condition MeSH

Condition MeSH for DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Intervention	Trials
Candidiasis	14
Mycoses	9
Infections	5
Infection	5

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

Trials by Country

Trials by Country for DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Location	Trials
United States	157
Canada	14
Brazil	5
Italy	4
Spain	4

Trials by US State

Trials by US State for DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Location	Trials
California	9
Texas	8
Pennsylvania	8
North Carolina	8
Florida	8

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

Clinical Trial Phase

Clinical Trial Phase for DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Phase 4	7
Phase 3	11
Phase 2	4

Clinical Trial Status

Clinical Trial Status for DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	27
Not yet recruiting	4
Unknown status	3

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

Sponsor Name

Sponsor Name for DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Sponsor	Trials
Pfizer	4
Astellas Pharma Inc	3
National Cancer Institute (NCI)	3

Sponsor Type

Sponsor Type for DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Sponsor	Trials
Other	45
Industry	25
NIH	10

Last updated: May 4, 2026

DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER: Clinical Status, Market Read-Through, and Projection

What is DIFLUCAN in sodium chloride 0.9% in a plastic container from a patent and product standpoint?

“DIFLUCAN in sodium chloride 0.9% in plastic container” is a formulation of fluconazole (Diflucan) supplied as an infusion solution where the solvent is 0.9% sodium chloride and the container is plastic. For forecasting and trial read-through, the key commercial implication is that this is a drug product presentation of a well-established generic/brand molecule, so market dynamics are dominated by formulation availability, pricing, and supply continuity, not by new molecular IP.

What is the clinical trials update for fluconazole infusion in saline in plastic containers?

No complete, decision-grade clinical-trial update can be produced from the information provided. A proper update requires at minimum: (1) a regulator-linked product identifier (US NDA/BLA, EU MA number, or a listed equivalent), or (2) a queryable trial dossier keyed to the exact presentation (fluconazole in 0.9% saline, plastic container). Without that, any “update” would be non-verifiable.

No clinical-trial details, dates, trial phases, endpoints, or recruitment status can be compiled to meet a high-stakes R&D or investment standard.

How should the market be analyzed for this specific presentation?

For a drug presentation like fluconazole in 0.9% saline in a plastic container, market analysis typically resolves into three layers:

1. Indication-driven demand for IV fluconazole

   • Hospitals use IV fluconazole for hospitalized fungal infections and for patients who cannot take oral therapy.
   • Fluconazole demand correlates to hospital admissions, oncology and transplant populations, and antimicrobial stewardship protocols.

2. Presentation-driven procurement and formulary behavior

   • IV infusion products are selected via GPO contracts, formulary policies, and preference for packaging formats that support infusion workflow and storage.
   • Plastic containers can win preference depending on handling, leakage risk, and distribution requirements.

3. Competitive structure

   • Fluconazole is a mature antifungal with substantial generic competition across geographies.
   • For this presentation, the competitive set is “fluconazole IV in saline” products with similar concentration and packaging.

Product-level market model (what can be concluded from the presentation type)

Because the molecule is established and because this is a presentation (saline solvent + plastic container), the commercial trajectory is expected to be shaped by:

• Price erosion driven by generic supply and contracting cycles
• Channel concentration in hospital procurement
• Supply reliability and packaging availability (which can affect short-term tender outcomes)

What market projection can be produced for this presentation?

No defensible quantitative projection can be produced from the information provided. A projection requires at minimum:

• historical sales (units and/or dollars) by geography and channel for this exact product listing, or
• a mapped proxy such as “fluconazole injection” series with packaging subcategories, plus pricing and contract coverage.

Without those data, any numerical forecast would be unsupported.

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Key Takeaways

• “DIFLUCAN in sodium chloride 0.9% in plastic container” is a fluconazole IV infusion presentation (saline solvent; plastic container), where commercial outcomes are presentation- and supply-driven rather than innovation-driven.
• A decision-grade clinical trials update cannot be produced without a product-linked trial mapping to the exact presentation.
• A numerical market projection cannot be produced without historical, product-level sales or a validated proxy tied to this presentation and packaging.

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FAQs

1) Is this product a different active ingredient from DIFLUCAN (fluconazole)?

Yes. It is the same active ingredient, fluconazole, delivered in an IV infusion solution with 0.9% sodium chloride in a plastic container.

2) Do clinical trials for fluconazole apply directly to this exact formulation and container?

Not automatically. Formulation and container changes can affect handling, stability, and labeling, so trials must be mapped to the correct product presentation.

3) What factors most influence hospital purchasing of IV fluconazole presentations?

Procurement contracts, formulary inclusion, price, supply reliability, and packaging compatibility with infusion workflows.

4) What drives long-run growth for mature IV antifungals?

Typically hospital infection incidence, patient mix, and pricing pressure dynamics rather than new molecular efficacy claims.

5) Why is it difficult to forecast sales for a single packaging presentation?

Presentation-level sales reflect tender outcomes and packaging availability, which often diverge from molecule-level demand patterns.

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References

1. No citable sources were provided in the prompt; no external, presentation-linked clinical or market datasets were included.