CLINICAL TRIALS PROFILE FOR BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER

505(b)(2) Clinical Trials for BACTERIOSTATIC WATER FOR INJECTION 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
OTC	NCT07356271 ↗	Effects of Mouthwashes on the Oral Microbiome and Systemic Health	NOT_YET_RECRUITING	University of Plymouth	EARLY_PHASE1	2026-02-01	OVERVIEW While antimicrobial mouthwashes are proven to be clinically effective for management of certain oral microbial diseases, recent studies (Bescos et al 2025, Gallard et al 2025) suggest tha, in addition to targeting bacteria responsible for gum diseases such as gingivitis and periodontitis, they may harm healthy bacteria and disturb the balance and protective role of the oral microbiome (dysbiosis). Most findings on the oral microbiome and mouthwashes involve chlorhexidine use, demonstrating that it may induce dysbiosis and compromise the host oral microenvironment (Bescos et al 2020). A recent study completed in 2025 (Gallardo et al 2025) has shown that CPC mouthwash can also inhibit nitrate synthesis in the mouth. However there remains a need for further research on other agents used in mouthrinses, such as hydrogen peroxide, essential oils, or saline mouthwashes, to determine whether their clinical effectiveness in managing oral disease is accompanied by changes to the oral microbiome. In dentistry, despite this being the place where most people are treated, there are very few research studies that have been performed in primary care settings. Hence this study will be designed for delivery in primary care, to produce 'real-life' data on a patient cohort more typical of general dental practice. This PhD project will select several of the most commonly used over the counter (OTC) mouthwash constituents, used by the general public, that have a limited evidence base, regarding their effects on the oral microbiome in vivo. The first agent to be studied is physiological saline (sodium chloride), as this is the mouthwash advised by dental guidelines for use after tooth extractions, yet there is little evidence to support this approach. No previous studies have previously quantified its effects on clinical outcomes and the oral microbiome. All mouthwashes will be tested in people with, or without, gum disease (gingivitis and periodontitis) to determine which interventions are best used in either health or disease.

All Clinical Trials for BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00067340 ↗	Caries Transmission Prevention in Alaska Native Infants	Terminated	National Institute of Dental and Craniofacial Research (NIDCR)	Phase 3	2003-04-01	The purpose of this study is to conduct a community based, randomized control trial to determine if the use of chlorhexidine mouth rinse and xylitol-sweetened chewing gum will reduce the vertical transmission of caries between Alaska Native mothers to their infants.
NCT00067340 ↗	Caries Transmission Prevention in Alaska Native Infants	Terminated	University of Washington	Phase 3	2003-04-01	The purpose of this study is to conduct a community based, randomized control trial to determine if the use of chlorhexidine mouth rinse and xylitol-sweetened chewing gum will reduce the vertical transmission of caries between Alaska Native mothers to their infants.
NCT00111956 ↗	Effects of Tumor Necrosis Factor (TNF)-Alpha Antagonism in Patients With Metabolic Syndrome	Completed	Massachusetts General Hospital	Phase 2/Phase 3	2004-04-01	Metabolic syndrome is associated with increased inflammatory cytokines and reduced adiponectin, that may be mediated in part by TNF production from abdominal fat. We reasoned that an anti-TNF agent would reduce C-reactive protein (CRP) and increase adiponectin, improving the inflammatory milieu associated with metabolic syndrome.

Clinical Trial Conditions for BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER

Condition Name

Condition Name for BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER
Intervention	Trials
Acne Vulgaris	3
Surgical Site Infection	3
Urinary Tract Infections	2

Condition MeSH

Condition MeSH for BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER
Intervention	Trials
Surgical Wound Infection	4
Infections	4
Infection	4

Clinical Trial Locations for BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER

Trials by Country

Trials by Country for BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER
Location	Trials
United States	18
Egypt	6
France	4
India	3
Netherlands	3

Trials by US State

Trials by US State for BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER
Location	Trials
California	5
Ohio	2
Minnesota	2
Delaware	1
Georgia	1

Clinical Trial Progress for BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
PHASE4	3
PHASE3	1
PHASE2	1

Clinical Trial Status

Clinical Trial Status for BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	19
Not yet recruiting	13
Recruiting	11

Clinical Trial Sponsors for BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER
Sponsor	Trials
Cairo University	2
Ain Shams Maternity Hospital	2
University of California, San Francisco	2

Sponsor Type

Sponsor Type for BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER
Sponsor	Trials
Other	76
Industry	11
NIH	2

Last updated: April 23, 2026

Clinical Trials Update, Market Analysis, and Projection for “Bacteriostatic Water For Injection In Plastic Container”

Summary: “Bacteriostatic Water for Injection in Plastic Container” is a device-adjacent injectable water product positioned for multi-dose use in reconstitution. Public information is fragmented because the product category is regulated through drug/biological labeling and compendial standards rather than a single, trackable “new molecular entity” pipeline. As a result, clinical trial visibility is generally limited to (i) product-specific comparability/quality studies and (ii) stability, sterility assurance, and extractables/leachables work tied to container system and antimicrobial performance. Market dynamics hinge on hospital and compounding demand for diluent, tender pricing, and container format (plastic vs glass) that affects distribution losses, handling safety, and shelf-life economics.

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Is there a meaningful clinical-trials pipeline behind bacteriostatic water for injection?

Clinical development for this category is typically incremental, not novel-efficacy. For “bacteriostatic water for injection,” the core clinical objective is preservation of sterility and multi-dose integrity after vial entry, plus container compatibility and stability. In practice, these products usually do not run pivotal Phase 2/3 efficacy trials because they are excipients/diluents used with other drugs, and their performance is demonstrated through:

• Sterility assurance and antimicrobial effectiveness of the bacteriostatic agent system used in the product
• Multi-dose usability performance (withdrawal, in-use period integrity)
• Container closure integrity
• Stability (chemical and microbial quality over shelf-life and after opening where relevant)
• Compatibility (especially if the product is intended to be used with common reconstituted injectables)
• Extractables/leachables for plastic container systems (risk-based assessment and safety justification)

What this means for a “clinical trials update”: the public record typically shows quality/stability/comparability studies rather than efficacy trials with endpoints like “time to response” or “clinical cure.” For investment and R&D prioritization, the actionable risk is regulatory and manufacturing: sterility validation, in-use hold times, and plastic-material interaction controls.

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What regulatory and technical benchmarks govern performance for plastic-container bacteriostatic water?

1) What standards anchor the product?

Bacteriostatic water for injection products are expected to comply with pharmacopeial and regulatory expectations for water for injection and sterile injectables, including microbial quality and sterility requirements consistent with compendial monographs and relevant guidance.

2) What container system issues matter most in plastic?

For plastic containers, the decision drivers are:

• Container closure integrity (leak resistance through expected transport cycles)
• Compatibility between the aqueous solution and polymer materials
• Extractables and leachables profiling (both initial and under worst-case storage conditions)
• Stability of the bacteriostatic agent and the solution system over shelf-life

These are usually addressed through the chemistry manufacturing controls package and stability program rather than through clinical endpoints.

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How does the market for bacteriostatic water behave?

Demand base

Demand tracks closely with:

• Hospital and health-system purchasing of sterile diluents for multi-dose vial reconstitution
• Specialty pharmacy and compounding operations that require reliable multi-dose withdrawal
• Oncology, infectious disease, immunology and other therapeutic areas that use reconstituted injectables requiring diluent

Procurement mechanics

This category typically behaves like a high-volume, low-innovation commodity with:

• Tender-driven pricing
• Contract volume commitments
• Qualification requirements (sterility assurance and documentation packs)
• Switching barriers driven by supply continuity and packaging format compatibility with clinical workflows

Plastic container vs glass: commercial impact

Plastic container formats generally change unit economics through:

• Reduced shipping breakage risk versus glass
• Handling and safety improvements for end users
• Potential improvements in logistics efficiency
• Differing shelf-life performance based on extractables/leachables and closure integrity

In procurement terms, buyers often weight total supply risk and delivered cost rather than just per-unit price.

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What is the competitive landscape for bacteriostatic water in plastic containers?

The competitive set is typically divided into:

• Large sterile injectable manufacturers with broad portfolios of diluents and reconstitution components
• Specialty sterile product firms that focus on packaging and stability leadership for container systems
• Regional generics suppliers that compete on lead times and tender pricing

Because products are largely substitutable at the category level, competitive differentiation usually comes from:

• Regulatory file strength (data packages for container system and sterility assurance)
• Stability shelf-life and validated in-use periods
• Supply reliability (capacity and redundancy)
• Cost of goods tied to resin and packaging supply chain

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Market projection: what should be modeled for “bacteriostatic water in plastic container”?

Projection framework (category-level)

For a category like this, projections should be modeled using utilization plus supply economics rather than pipeline-driven forecasts.

A practical projection model uses:

1. Volume driver: number of reconstituted dose administrations across therapeutic categories using diluents
2. Share driver: plastic-container penetration in tenders and hospital formulary adoption
3. Price driver: tender pricing and competitive substitution (generic intensity)
4. Supply driver: manufacturing throughput and disruptions (container system constraints)

Base-case directional forecast (category behavior)

• Volume tends to grow with healthcare utilization and expanded use of injectables that require reconstitution.
• Price tends to remain flat to modestly down under generic substitution, with periodic recoveries driven by supply constraints or input costs.
• Plastic share tends to increase where procurement emphasizes safety, breakage reduction, and logistics.

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Key risks to forecast execution for plastic-container bacteriostatic water

Regulatory and quality risks

• Container closure integrity failures in distribution
• Extractables/leachables nonconformance or formulation incompatibility
• Sterility assurance failures or in-process controls drift
• Stability specification excursions tied to polymer interaction or closure performance

Commercial risks

• Tender price compression from multiple equivalent suppliers
• Qualification delays when switching suppliers or container formats
• Supply chain concentration in packaging materials

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Business impact: where diligence should focus

For R&D and regulatory strategy

Focus effort on:

• Sterility assurance strategy validation
• In-use period support data (withdrawal events, container integrity)
• Extractables/leachables risk assessment for the exact plastic container and closure components
• Stability protocol with stress and real-time plans aligned to shelf-life claims

For investment thesis

Underwrite:

• Contract coverage and tender competitiveness
• Capacity resilience across packaging lines
• Track record of supply continuity and quality outcomes

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Key Takeaways

• “Bacteriostatic Water for Injection in Plastic Container” is a sterile diluent category where visible clinical trials are often limited to quality, stability, and sterility assurance work rather than efficacy studies.
• Market outlook is driven by healthcare utilization of reconstituted injectables, tender-led pricing, and plastic-container adoption tied to logistics and safety.
• The highest forecast sensitivity sits in container closure integrity, extractables/leachables, sterility assurance, and shelf-life economics, not in clinical development timelines.

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FAQs

1. Why do clinical trials appear limited for bacteriostatic water?
   Because the product is primarily a sterile diluent/excipient whose performance is established through sterility assurance, container integrity, and stability, not clinical efficacy endpoints.

2. What differentiates suppliers in this category?
   Quality system depth for sterility assurance, stability and in-use performance, regulatory strength for the specific plastic container/closure, and supply reliability for tender commitments.

3. What role does the plastic container play in performance?
   It changes extractables/leachables risk, container closure integrity requirements, and logistics breakage risk versus glass, affecting both regulatory approval and distribution economics.

4. How should market projections be modeled?
   Use utilization volume plus plastic penetration and tender price dynamics, with scenario adjustments for supply constraints and manufacturing throughput.

5. What are the main risks to monitor after launch?
   Specification excursions in stability, container closure failures, extractables/leachables drift, and sterility assurance deviations tied to process control changes.

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References (APA)

[1] U.S. Food and Drug Administration. (n.d.). Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing. Current Good Manufacturing Practice. FDA. https://www.fda.gov/
[2] U.S. Pharmacopeia. (n.d.). USP–NF monographs for sterile water and water for injection-related standards. U.S. Pharmacopeia. https://www.uspnf.com/
[3] European Directorate for the Quality of Medicines. (n.d.). Guidance on container closure systems, extractables and leachables. EDQM. https://www.edqm.eu/
[4] World Health Organization. (n.d.). WHO guidance on sterile pharmaceutical products and quality assurance. WHO. https://www.who.int/
[5] International Council for Harmonisation. (n.d.). ICH Q1A(R2) Stability Testing of New Drug Substances and Products. ICH. https://www.ich.org/