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

505(b)(2) Clinical Trials for BACTERIOSTATIC 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
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 SODIUM CHLORIDE 0.9% 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.
NCT00111956 ↗	Effects of Tumor Necrosis Factor (TNF)-Alpha Antagonism in Patients With Metabolic Syndrome	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	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.
NCT00985244 ↗	Macrolide Maintenance Therapy in Chronic Obstructive Pulmonary Disease	Completed	Amphia Hospital	N/A	2010-05-01	To assess whether maintenance treatment with macrolide antibiotics in COPD patients with three or more exacerbations in the preceding year of inclusion can decrease the exacerbation rate in the year of treatment.
NCT00985244 ↗	Macrolide Maintenance Therapy in Chronic Obstructive Pulmonary Disease	Completed	Erasmus Medical Center	N/A	2010-05-01	To assess whether maintenance treatment with macrolide antibiotics in COPD patients with three or more exacerbations in the preceding year of inclusion can decrease the exacerbation rate in the year of treatment.
NCT00985244 ↗	Macrolide Maintenance Therapy in Chronic Obstructive Pulmonary Disease	Completed	Stichting Solong	N/A	2010-05-01	To assess whether maintenance treatment with macrolide antibiotics in COPD patients with three or more exacerbations in the preceding year of inclusion can decrease the exacerbation rate in the year of treatment.

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

Condition Name

Condition Name for BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Intervention	Trials
Acne Vulgaris	3
Surgical Site Infection	3
Calcium Hydroxide	2
Urinary Tract Infections	2

Condition MeSH

Condition MeSH for BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Intervention	Trials
Infections	4
Infection	4
Surgical Wound Infection	4
Pneumonia	3

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

Trials by Country

Trials by Country for BACTERIOSTATIC SODIUM CHLORIDE 0.9% 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 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Location	Trials
California	5
Minnesota	2
Ohio	2
Illinois	1
Massachusetts	1

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

Clinical Trial Phase

Clinical Trial Phase for BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
PHASE4	3
PHASE3	1
PHASE2	1

Clinical Trial Status

Clinical Trial Status for BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	19
Not yet recruiting	13
RECRUITING	11

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

Sponsor Name

Sponsor Name for BACTERIOSTATIC SODIUM CHLORIDE 0.9% 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 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Sponsor	Trials
Other	76
Industry	11
NIH	2

Last updated: May 3, 2026

Clinical Trials Update, Market Analysis, and Projections: Bacteriostatic Sodium Chloride 0.9% in Plastic Container

What is Bacteriostatic Sodium Chloride 0.9% (Plastic Container)?

“Bacteriostatic Sodium Chloride 0.9% in plastic container” is a ready-to-use sterile isotonic saline solution (0.9% w/v sodium chloride) formulated for storage and use with a bacteriostatic agent, supplied in a plastic container. In practice, the commercial and clinical context is typically one of two use patterns:

• Clinical/infusion use as a compatible saline diluent or flush medium in regulated settings.
• Ancillary preparation and dosing workflows where saline is required as a solvent/diluent, typically involving compatibility with other injectables.

This product category behaves more like a sterile formulation and supply-chain commodity than a single novel drug entity with a defined, sponsor-owned development pipeline. As a result, clinical-trials updates are often sparse at the “product name” level; most evidence sits in (i) saline general use, (ii) compatibility of container materials, and (iii) compendial quality and sterility/bacteriostasis controls rather than new efficacy endpoints.

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What does the clinical trials landscape look like?

No standardized “clinical trials registry dossier” can be reliably mapped to the exact product name string across markets because:

• “Bacteriostatic sodium chloride 0.9%” is sold under multiple brand/manufacturer identifiers and may include different bacteriostatic preservatives across jurisdictions.
• Trials, when conducted, tend to be filed under indication-neutral saline endpoints (e.g., sterility assurance, microbiological effectiveness, container compatibility) rather than efficacy trials for a therapeutic claim.

Given that limitation, the actionable clinical-trials update for this category is best expressed as regulatory-quality and use-relevant studies rather than phase-based efficacy data.

Trial types that dominate for this product category

1. Microbiological effectiveness / antimicrobial effectiveness testing for the bacteriostatic component under defined challenge conditions (typically framed around preservation of sterility and prevention of microbial growth).
2. Container-closure integrity and extractables/leachables assessments focused on plastic containers (interaction with saline is generally low but polymer additives and permeation can matter).
3. Stability studies across labeled shelf life addressing appearance, pH, osmolality, and microbial control.
4. Compatibility testing with common injectable drugs when used as a diluent/flush medium (compatibility rather than clinical outcomes).

Bottom line on “clinical trials update”

For investment-grade decision-making, the category’s risk drivers usually sit in:

• Manufacturing assurance (sterility assurance, preservation performance, fill/finish controls)
• Regulatory compliance for container material and microbial control
• Shelf-life stability and consistency across lots rather than in phase 1-3 efficacy programs.

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How is the product regulated and what drives approvals/renewals?

Approval and continued market access are driven by:

• Pharmacopeial standards for 0.9% sodium chloride and sterile solution handling.
• Microbiological specifications for bacteriostatic performance.
• Sterile manufacturing and container-closure requirements for plastic containers.
• Labeling and instructions for use, including any constraints tied to bacteriostatic preservation.

Key regulatory anchor points (global)

• USP/Ph. Eur. sterile preparation requirements for sterility assurance and container closure.
• ICH stability frameworks used in most submissions.
• Aseptic processing expectations under GMP.

For market analytics, these translate into a predictable value chain: validated aseptic process, validated bacteriostatic efficacy, and container material qualification.

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Market Analysis: Who buys and why?

What is the addressable demand base?

Demand comes from healthcare settings that require sterile saline solutions as:

• Flush and irrigation media in perioperative and ICU workflows
• Diluents/solvents for injectable drugs (where compatible)
• General supportive care use in inpatient and outpatient settings

In most markets, saline solutions are:

• High-volume
• Replacement/consumable
• Low to moderate brand differentiation
• Price and contract-driven

Bacteriostatic variants are typically used where multi-use storage or preservation conditions are required under labeled instructions.

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How does “bacteriostatic” change the market vs non-bacteriostatic saline?

Bacteriostatic saline can support workflows where the solution is intended for extended use once opened or stored under defined conditions. That shifts purchasing criteria from pure sterility to:

• Preservative performance within the labeled conditions
• User-facing handling instructions and compliance with labeled timing
• Regulatory labeling clarity on limitations (single patient use vs multi-use under preservation rules, depending on jurisdiction)

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What are the major supply constraints and cost drivers?

Primary cost and supply drivers for this category:

• Aseptic fill-finish capacity (personnel, Grade A/B zones, sterilizing filtration where applicable)
• Plastic container supply and qualification (material batches, cleanliness, integrity)
• Bacteriostatic agent sourcing and validated dosing
• Shelf-life and stability program outcomes affecting how much inventory can be carried
• Quality incident risk (sterility failures, microbial control excursions, container-closure defects)

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Pricing and Competitive Structure

Is this a branded drug market or a tender-driven market?

This product category typically operates as a tender-driven procurement market:

• Hospitals and distributors buy through contracts and preferred supplier lists.
• Substitution depends on container type, volume, label claims, and pharmacopeial compliance.
• Commercial differentiation is usually limited to packaging (plastic format, unit size), labeled conditions, and availability.

The investment implication: barriers to entry are process- and compliance-heavy, not marketing-heavy.

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Market Projections (2025-2035)

What should investors assume about growth rates?

For a sterile saline solution category, growth is typically linked to:

• Procedure volume growth (surgical volume, ICU bed days, emergency visits)
• Unit utilization per admission and prescribing practices
• Population growth and aging
• Switching from alternative diluents if compatibility supports them
• Contracting and competitive pricing cycles

Without sponsor-level product registry data mapped to a single “BACTERIOSTATIC SODIUM CHLORIDE 0.9% in plastic container” entity, the most defensible projection approach is category-based, driven by healthcare utilization trends and procurement inflation rather than novel clinical differentiation.

Projection ranges (base-case, category-consumable model)

• Global category growth (value): low to mid single digits annually, driven by utilization and price normalization.
• Global category growth (volume): closer to population and procedure-driven mid to high single digit in mature markets is often offset by substitution and contracting.

Practical business outcome: expect steady demand with periodic price compression from competitive tendering.

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What scenarios matter most for forecasts?

1. Base case (contract stability): moderate volume growth and pricing tied to inflation and procurement.
2. Downside (tender pressure): margin compression from multiple qualified suppliers and increased competition.
3. Upside (supply reliability premium): premium contracts for suppliers with strong sterility and container-closure performance and fewer quality holds.

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Strategic Implications for R&D, Supply, and Investment

Where do development and differentiation actually occur?

Because efficacy claims are usually not innovation-driven, differentiation comes from:

• Container technology (plastic formulation and compatibility, lower leachables risk, improved integrity)
• Shelf-life extension via improved stability and packaging controls
• Preservation performance optimization (validated bacteriostatic effectiveness across labeled conditions)
• Manufacturing robustness (reduced batch failures, faster release testing, stable microbial controls)
• Cost of goods reduction without compromising compliance

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How to underwrite this category

Underwrite using:

• Regulatory compliance track record (inspection outcomes, batch release history, sterility/bioburden excursion rates)
• Supply continuity (container procurement reliability, aseptic capacity utilization)
• Portfolio breadth (volumes, container sizes, packaging configurations)
• Tender presence (share in hospital groups and distribution channels)
• Stability data credibility supporting long shelf life and inventory turns

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Key Takeaways

• “Bacteriostatic sodium chloride 0.9% in plastic container” is a sterile saline category where market value and risk hinge on microbiological control, aseptic manufacturing, and plastic container integrity, not on phase-based clinical efficacy programs.
• Clinical trials evidence for this category tends to be microbiological effectiveness, container-closure integrity, stability, and compatibility rather than randomized therapeutic outcome trials.
• Market growth is expected to track healthcare utilization and procurement cycles, with low to mid single-digit value growth and margin sensitivity to tender competition.
• Differentiation is most attainable through stability/shelf-life extension, container performance, and manufacturing reliability, enabling preferred supplier status and supply reliability premiums.

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FAQs

1. Is this product considered a drug with clinical efficacy trials?
   It is generally treated as a sterile saline formulation where clinical evidence centers on sterility assurance, microbiological effectiveness, stability, and compatibility rather than disease-specific efficacy.

2. What is the main technical risk for bacteriostatic saline?
   The main risk is failure in microbiological control performance under labeled conditions, driven by aseptic process, fill/finish controls, and correct bacteriostatic agent performance.

3. Why does the plastic container matter for this category?
   Plastic container choice affects container-closure integrity and potential extractables/leachables behavior, plus it impacts stability and compliance through validated compatibility.

4. What typically drives purchasing decisions?
   Hospital and distributor purchasing is usually contract and tender driven, prioritizing supply reliability, compliance, labeled usability conditions, volume/pack configuration, and price.

5. What is the most reliable basis for market forecasts?
   Forecasts should be tied to healthcare utilization growth, procurement pricing behavior, and supplier capacity reliability rather than assuming therapeutic innovation-driven demand.

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References

[1] International Council for Harmonisation (ICH). ICH Q1A(R2): Stability Testing of New Drug Substances and Products.
[2] U.S. Pharmacopeia (USP). USP <1>–<85> and sterile product chapters (general chapters covering sterility assurance and related requirements).
[3] European Pharmacopoeia (Ph. Eur.). General requirements for sterile preparations and container-closure integrity.
[4] U.S. FDA. Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing.
[5] FDA. Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics.