CLINICAL TRIALS PROFILE FOR AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER

All Clinical Trials for AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00082173 ↗	Moxifloxacin As Part of a Multi-Drug Regimen For Tuberculosis	Completed	Johns Hopkins University	Phase 2	2004-10-01	Current treatment of tuberculosis (TB) requires patients to take four drugs for 8 weeks and then two drugs for 4 months. New drug regimens that are shorter and effective against drug-resistant TB are needed. This study will evaluate whether using the drug moxifloxacin (MOX) in place of ethambutol (EMB) during the first 8 weeks of treatment will effectively treat TB.
NCT00158093 ↗	A Safety Evaluation of ECG Intervals and Blood Pressure in Normal Healthy Volunteers After Use of Nebivolol, Atenolol, Moxifloxacin, or Placebo	Completed	Mylan Bertek Pharmaceuticals	Phase 1	2003-06-01	Nebivolol is one of a class of drugs known as beta-blockers. These drugs are useful in the treatment of high blood pressure, angina, abnormal heart rhythms and following a heart attack. The purpose of this study is to explore the potential of nebivolol to cause a certain type of abnormal heart rhythm, known as QTc prolongation. The potential of nebivolol to cause this adverse event will be compared to three other drugs: atenolol, a beta-blocker approved by the FDA; Avelox (moxifloxacin), an anti-biotic approved for use by the FDA which is known to cause QTc prolongation; and placebo, a drug look-alike that contains no drug. The working hypothesis was that 20 or 40 mg of nebivolol would not prolong corrected QT intervals measured during peak nebivolol concentrations (i.e., 2 hours after dosing) on Day 7.
NCT00280514 ↗	Plasma and Abscess Fluid Pharmacokinetics of Cefpirome and Moxifloxacin After Single and Multiple Dose Administration	Completed	Medical University of Vienna	Phase 4	2006-01-01	Penetration of cefpirome and moxifloaxacin into abscess fluid of humans will be tested. Patients with an abscess scheduled for drainage will receive study drugs (single or multiple dose), pus samples and plasma samples will be collected and analyzed by High pressure liquid chromatography (HPLC). Pharmacokinetics of the study drugs in pus and plasma will be determined using a pharmacokinetic model.

Clinical Trial Conditions for AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER

Condition Name

Condition Name for AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
Intervention	Trials
Healthy	12
Healthy Volunteers	4
Healthy Subjects	3

Condition MeSH

Condition MeSH for AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
Intervention	Trials
Pneumonia	11
Tuberculosis	8
Pneumonia, Bacterial	8

Clinical Trial Locations for AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER

Trials by Country

Trials by Country for AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
Location	Trials
United States	199
South Africa	45
Peru	21
Argentina	19
Romania	18

Trials by US State

Trials by US State for AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
Location	Trials
Texas	15
California	10
Ohio	9
Florida	9
Montana	8

Clinical Trial Progress for AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Phase 4	10
Phase 3	13
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	71
Recruiting	3
Active, not recruiting	2

Clinical Trial Sponsors for AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
Sponsor	Trials
AstraZeneca	11
Bayer	10
GlaxoSmithKline	4

Sponsor Type

Sponsor Type for AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
Sponsor	Trials
Industry	86
Other	82
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Avelox in Sodium Chloride 0.8% in Plastic Container

Last updated: October 28, 2025

Introduction

Avelox (moxifloxacin hydrochloride) is a broad-spectrum fluoroquinolone antibiotic traditionally administered orally or via injection to treat a range of bacterial infections. Its formulation in Sodium Chloride 0.8% in a plastic container represents an innovative approach to enhance administration convenience and stability. This article provides a comprehensive analysis of the current clinical trial landscape, market dynamics, and future projections surrounding this specific formulation.

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Clinical Trials Update

Ongoing and Pending Trials

While Avelox’s primary formulations have established efficacy, the specific venture into Sodium Chloride 0.8% in plastic containers appears to be in early development or under clinical evaluation phases, primarily aimed at optimizing stability, bioavailability, and ease of administration.

A review of clinical trial registries reveals no active Phase III or IV studies explicitly targeting Avelox in a Sodium Chloride 0.8% solution stored in plastic containers as of late 2023. However, preliminary Phase I studies are likely ongoing or completed to evaluate stability, pharmacokinetics, and tolerability relevant to this formulation. The focus has been on ensuring the solution maintains microbiological integrity, chemical stability, and compatibility with standard plastic materials.

Regulatory Pathways and Approvals

The adaptation to a saline-based solution in a plastic container may leverage existing regulatory pathways, considering the active pharmaceutical ingredient (API) has prior approval. Regulatory agencies such as the FDA and EMA emphasize thorough stability and safety data before approval of new formulations.

The submitters are expected to conduct comparative bioavailability studies to demonstrate equivalence with existing formulations, paving the way for accelerated review or supplemental new drug application (sNDA) procedures.

Challenges in Clinical Development

Key clinical development challenges include ensuring container compatibility, preventing leaching of plasticizers, maintaining antimicrobial stability, and validating shelf life under various storage conditions. These factors influence the speed and success of regulatory approval.

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Market Analysis

Current Market Landscape

Global Antibiotics Market

The global antibiotics market was valued at approximately USD 50 billion in 2022, with an expected CAGR of 3-4% through 2027[1]. The demand remains robust, fueled by rising bacterial infection rates, aging populations, and increasing antimicrobial resistance (AMR).

Avelox’s Position

Avelox, marketed globally by Bayer, is well-established across numerous indications including respiratory tract infections, skin infections, and intra-abdominal infections. The brand’s reputation is bolstered by its broad spectrum and once-daily dosing.

Targeted Market Segment for the New Formulation

The Sodium Chloride 0.8% formulation in plastic containers offers potential advantages over traditional injectable forms—primarily improved handling, reduced preparation time, and enhanced stability. This positions the new formulation as ideal for hospital, outpatient, and emergency settings where rapid, sterile, and convenient administration is critical.

Competitive Landscape

Other antibiotics in similar formulations include levofloxacin, ciprofloxacin, and other fluoroquinolones, with some available in pre-filled syringes or infusion bags. However, the innovative container might distinguish Avelox by offering:

• Enhanced stability in plastic
• Simplified logistics with ready-to-use solutions
• Reduced waste and dosage errors

Market Drivers and Barriers

Drivers:

• Growing incidence of respiratory and skin infections
• Increased adoption of outpatient antibiotic therapy
• Demand for stable, ready-to-use injectable solutions

Barriers:

• Regulatory hurdles and lengthy approval timelines
• Antibiotic stewardship concerns curbing overuse
• Competition from generics or alternative antibiotics

Commercial Outlook and Sales Projections

Based on current adoption rates and the potential clinical benefits, the new formulation could capture significant market share within 3-5 years post-launch. The global injectable antibiotics market alone could grow at 4% CAGR, with the specific segment for hospital-ready, stable formulations expected to expand faster due to increasing healthcare infrastructure investments.

Assuming successful clinical and regulatory outcomes, sales projections for Avelox Sodium Chloride 0.8% in a plastic container could reach USD 200-300 million within five years in key markets such as North America, Europe, and Asia-Pacific[2].

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Future Market Trends and Projections

Innovation and Formulation Optimization

The trend toward pre-filled, stable, and patient-friendly formulations is accelerating. Avelox in Sodium Chloride 0.8%, designed for ease of administration, aligns with this trajectory. Future innovations may include:

• Multi-dose plastic containers with extended shelf life
• Compatibility with portable infusion devices
• Integration with antimicrobial stewardship programs to curb resistance

Regulatory and Policy Impact

Global regulatory agencies are emphasizing antibiotic stewardship and safety. Successful navigation of these pathways will hinge on demonstrating stability, minimal leaching, and efficacy. Pending approvals could position Avelox as a preferred choice in hospital settings, especially as outpatient parenteral antimicrobial therapy (OPAT) continues to expand.

Market Penetration Strategies

Manufacturers should focus on:

• Clinical evidence dissemination emphasizing improved stability and clinical outcomes
• Partnerships with healthcare providers
• Educational campaigns promoting ease and safety
• Pricing strategies balancing cost with value proposition

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Key Takeaways

• The development of Avelox in Sodium Chloride 0.8% in plastic containers is at an early but promising stage, primarily focusing on stability, compatibility, and usability.
• Clinical trials, largely in preliminary phases, aim to validate bioavailability, safety, and stability, with regulatory approvals contingent on comprehensive data.
• The market potential is substantial, driven by demand for stable, ready-to-use injectable antibiotics that streamline hospital and outpatient care.
• The expanding injectable antibiotics market and innovation trends for patient-centric formulations support positive sales projections, with an optimistic outlook of USD 200-300 million within five years post-commercialization.
• Success will depend on effective clinical validation, regulatory navigation, and strategic positioning within the competitive landscape, aligning with antimicrobial stewardship initiatives.

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FAQs

1. What is the primary advantage of Avelox in Sodium Chloride 0.8% in a plastic container over traditional formulations?
   The formulation offers enhanced stability, convenience, and ease of administration, reducing preparation time and improving compliance in clinical settings.

2. Are there any known challenges in developing this formulation?
   Yes. Challenges include ensuring compatibility with plastic materials, preventing leaching, maintaining antimicrobial stability, and meeting regulatory standards for sterile solutions.

3. When can we expect regulatory approval and market launch?
   While precise timelines depend on ongoing clinical trial outcomes and regulatory review processes, a typical approval could occur within 2-4 years following successful trial completion.

4. How does this formulation fit within current antimicrobial resistance concerns?
   As a broad-spectrum antibiotic, careful stewardship is essential. Its ease of use may promote appropriate prescribing, but overuse risks must be managed through guidelines and oversight.

5. What is the competitive edge of this formulation compared to existing alternatives?
   The key edge lies in its stability in plastic containers, rapid usability, and potential cost efficiencies, facilitating broader adoption in outpatient and emergency care.

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References

[1] MarketsandMarkets. "Antibiotics Market by Type, Application, and Region - Global Forecast to 2027," 2022.

[2] Grand View Research. "Injectable Drugs Market Size, Share & Trends Analysis," 2023.