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

505(b)(2) Clinical Trials for LINEZOLID 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	NCT01734694 ↗	Safety and Efficacy of Strategy to Prevent Drug-Induced Nephrotoxicity in High-Risk Patients	Terminated	Henry Ford Health System	Phase 4	2011-10-01	For more than fifty years, vancomycin has been cited as a nephrotoxic agent. Reports of vancomycin induced kidney injury (a.k.a vancomycin induced nephrotoxicity or VIN), have waxed and waned throughout the years for various reasons. Recently, VIN has reemerged as a clinical concern. This may be due to various reasons, including new dosing recommendations as well as an increased prevalence of risk factors associated with vancomycin induced nephrotoxicity. This study aims to evaluate a strategy which attempts to reduce kidney damage from vancomycin use.
New Dosage	NCT02778828 ↗	Pharmacokinetic and Therapeutic Adaptation of Linezolid in the Treatment of Multi-Resistant Tuberculosis	Completed	Groupe Hospitalier Paris Saint Joseph	N/A	2015-11-04	Linezolid, primary treatment for MDR-TB combination therapy anti. Until it is the dose of 600 mg x1 / day, rather sensible for most patients is more, which was unanimous. It is true that if a dosage is consensus, it goes without saying, because of the interindividual variability, marked moreover to linezolid, a therapeutic monitoring assay of plasma levels is indispensable for most pharmacological treatments. This therapeutic drug monitoring (TDM) often gives rise, as known, to dosage changes. It turns out that at present no real STP on the basic objectives PK / PD is really made in France in the treatment of tuberculosis (TB) and the bibliography remains rather poor recommendations, and yet all the elements are there: indeed linezolid is an antibiotic whose activity is purely "time-dependent". So one should fulfill 2 PK / PD objectives whose precise boundaries are sometimes still to be determined: -% T> MIC, or percentage of time spent with plasma concentrations above the minimum inhibitory concentration of linezolid (LNZ) for Mycobacterium tuberculosis. In practice, the residual concentration before the next shot must be> MIC (0.125 to 1 mg / l) - A fortiori it must also take into account the concentration preventing the appearance of resistant mutants, amounting to 1.2 mg / l - AUC / MIC> 80, or ratio of the area under the curve (AUC, Area under curve) of plasma concentration versus time and CMI LNZ Until then, and without real bibliographic support, and for the sake of kindness to patients coupled with an economic advantage, the STP consisted of 2 samples, a peak 1:30 after taking (Cmax) and a residual before taking (C min) , after all, to 600mg x1 / 24 correlates well with the AUC (55% peak and 75% for the residual). Following an observation that 25 to 30% of patients had a C min
New Indication	NCT05069974 ↗	Alternative Antibiotics for Syphilis	Recruiting	Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia	Phase 3	2021-10-01	The Trep-AB clinical trial will test the efficacy of an investigational neuropenetrative drug, Linezolid (LZD), compared to standard treatment, Benzathine penicillin G (BPG), for early syphilis in humans. The overarching idea of the work proposed herein is to investigate the use of LZD to treat syphilis, conducting a randomized controlled clinical trial to evaluate this new indication of a known antibacterial agent. It is estimated to include 360 participants.

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

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00035269 ↗	New Antibiotic to Treat Patients With Community-acquired Pneumonia Due to a Specific Bacteria (S. Pneumoniae Pneumonia)	Completed	Pfizer	Phase 3	2001-12-01	This study will treat patients who have a community-acquired pneumonia that is due to a specific bacteria (S. pneumoniae)
NCT00035425 ↗	Treatment of Neutropenic Patients With Fever Who Are Suspected to Have A Gram Positive Infection	Completed	Pfizer	Phase 3	2001-11-01	This study will treat patients who have fever and neutropenia (after cancer chemotherapy) that is possibly due to a specific bacteria (gram positive bacteria).
NCT00035854 ↗	New Antibiotic to Treat Pediatric Patients With Infections Due to a Specific Bacteria (Vancomycin-Resistant Enterococcus)	Completed	Pfizer	Phase 3	2002-02-01	This study will treat pediatric patients who have infections that are due to a specific bacteria (Vancomycin-Resistant Enterococcus)
NCT00037050 ↗	Antibiotic Treatment for Infections of Short Term In-dwelling Vascular Catheters Due to Gram Positive Bacteria	Completed	Pfizer	Phase 3	2002-04-01	This study will treat patients who have a short term central catheter that is thought to be infected with a specific bacteria (gram positive bacteria)
NCT00042289 ↗	Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)		2003-03-01	The purpose of this study is to evaluate the pharmacokinetics (PKs) of antiretroviral (ARV) and tuberculosis (TB) medications in pregnant women and their infants. (Pharmacokinetics are the various interactions between a drug and the body.) This study will also evaluate the PKs of certain ARVs in postpartum women before and after starting hormonal contraceptives. The PKs of these drugs will be evaluated by measuring the amount of medicine present in blood and/or vaginal secretions.
NCT00042289 ↗	Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy	Completed	National Institute of Allergy and Infectious Diseases (NIAID)		2003-03-01	The purpose of this study is to evaluate the pharmacokinetics (PKs) of antiretroviral (ARV) and tuberculosis (TB) medications in pregnant women and their infants. (Pharmacokinetics are the various interactions between a drug and the body.) This study will also evaluate the PKs of certain ARVs in postpartum women before and after starting hormonal contraceptives. The PKs of these drugs will be evaluated by measuring the amount of medicine present in blood and/or vaginal secretions.

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

Condition Name

Condition Name for LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Intervention	Trials
Tuberculosis	14
Pulmonary Tuberculosis	12
Bacterial Infections	9
Tuberculosis, Multidrug-Resistant	9

Condition MeSH

Condition MeSH for LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Intervention	Trials
Infections	46
Tuberculosis	45
Infection	44
Communicable Diseases	40

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

Trials by Country

Trials by Country for LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Location	Trials
United States	438
China	124
South Africa	70
Japan	42
Brazil	29

Trials by US State

Trials by US State for LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Location	Trials
California	32
Texas	26
Ohio	24
Georgia	23
Florida	22

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

Clinical Trial Phase

Clinical Trial Phase for LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
PHASE4	4
PHASE3	4
PHASE2	2

Clinical Trial Status

Clinical Trial Status for LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	75
Recruiting	30
Not yet recruiting	15

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

Sponsor Name

Sponsor Name for LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Sponsor	Trials
Pfizer	30
Beijing Chest Hospital	9
National Institute of Allergy and Infectious Diseases (NIAID)	7

Sponsor Type

Sponsor Type for LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Sponsor	Trials
Other	315
Industry	91
NIH	9

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

Last updated: October 30, 2025

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Introduction

Linezolid in Sodium Chloride 0.9% in a plastic container represents a vital formulation within the antimicrobial sphere, primarily used for the treatment of serious bacterial infections, including multi-drug resistant Gram-positive pathogens. This analysis explores recent clinical trial developments, market dynamics, and growth projections to inform stakeholders involved in pharmaceutical development, investment, and healthcare procurement.

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Clinical Trials Landscape

Current Status and Recent Developments

Over the past three years, clinical research focusing on linezolid formulations has largely concentrated on optimizing delivery, extending indications, and evaluating safety profiles. While traditional intravenous (IV) formulations are well-established, emerging trials aim to assess the efficacy, safety, and tolerability of solutions packaged in plastic containers.

Most notably, Phase II and III trials have explored combinations of linezolid with other antibiotics to tackle resistant infections, such as Vancomycin-resistant enterococci (VRE) and methicillin-resistant Staphylococcus aureus (MRSA). These studies have demonstrated promising clinical outcomes, with improvements in infection clearance rates and reduced adverse events compared to standard therapies.

Formulation Advancements and Packaging Trials

Clinical trials are also investigating alternative packaging systems aimed at reducing contamination risks and improving stability. Plastic containers—particularly polyvinyl chloride (PVC) and polyethylene—offer practical benefits over glass, including lower costs and enhanced safety during transportation and administration.

Recent trials have evaluated the stability of linezolid 0.9% in plastic containers over extended storage periods, confirming acceptable degradation profiles and preservative efficacy. These findings facilitate wider use in outpatient and inpatient settings, with implications for hospital formulary decisions.

Regulatory and Safety Considerations

Clinical safety data affirm the tolerability of linezolid solutions in plastic containers, aligning with previous safety profiles of the drug. However, concerns related to leaching compounds from plastic materials are under ongoing investigation, with current data indicating minimal risk with properly manufactured containers compliant with pharmacopeial standards.

Market Analysis

Market Size and Segmentation

The global antimicrobial market is substantial, with a particular emphasis on hospital-acquired infections (HAIs) caused by resistant bacteria. The segment for IV antibiotics, including linezolid, dominates this space, driven by rising antibiotic resistance and hospital infection control measures.

In 2022, the global market value for linezolid was estimated at approximately USD 600 million. Predominantly used in hospital settings, the formulation in sodium chloride 0.9% in plastic containers positions itself as a critical product for outpatient parenteral antimicrobial therapy (OPAT), which is witnessing rapid growth.

Key Market Drivers

• Rising Antibiotic Resistance: Increasing rates of MRSA and VRE infections have propelled demand for linezolid as a first-line agent.
• Shift Toward Outpatient Care: Preference for home-based IV therapy supports the adoption of user-friendly plastic containers, facilitating administration outside healthcare facilities.
• Regulatory Approvals & Expanded Indications: Approvals for pneumonia, skin infections, and bacteremia have expanded the utilization scope, impacting market volume.
• Cost-Effectiveness and Safety Profile: Plastic containers reduce costs related to packaging and transportation and mitigate breakage risks.

Challenging Factors

• Generic Competition: Several generics of linezolid (e.g., ZYVOX) dominate the market, exerting price pressures.
• Raw Material Cost and Supply Chain: Fluctuations in plastic raw materials impact production costs.
• Regulatory Hurdles for Packaging: Ensuring the safety and compatibility of plastic containers entails compliance with stringent quality standards.

Market Projection

Growth Outlook (2023-2030)

The market for linezolid in sodium chloride 0.9% in plastic containers is poised for compound annual growth rate (CAGR) of approximately 7-10% over the next decade. This projection considers:

• Increasing prevalence of resistant bacterial infections.
• Adoption of outpatient infusion therapies.
• Improvements in formulation stability and packaging technology.
• Emergence of regional expansion, particularly in Asia-Pacific, Latin America, and the Middle East.

By 2030, the global market value is projected to surpass USD 1.2 billion, with higher adoption rates in developing economies due to increased healthcare access and infrastructure improvements.

Regional Insights

• North America: Dominant market due to high antimicrobial resistance rates and advanced healthcare infrastructure.
• Europe: Growing demand influenced by stringent infection control policies and aging populations.
• Asia-Pacific: Fastest growth rate driven by expanding healthcare facilities, rising bacterial infection rates, and cost-sensitive formulations.
• Latin America & Middle East: Emerging markets with increasing hospital procurement of IV antibiotics.

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Strategic Implications for Stakeholders

• Pharmaceutical Companies should prioritize investments in R&D for stable, cost-effective plastic packaging solutions, as flexible and safe delivery options bolster outpatient therapy adoption.
• Investors may explore opportunities in emerging markets with expanding healthcare access.
• Healthcare Providers should consider formulary updates favoring plastic-containerized formulations to improve patient safety and reduce logistics costs.
• Regulatory Bodies must develop clear standards for medication stability and safety in plastic packaging to facilitate market approval and confidence.

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Key Takeaways

• Clinical trials reinforce the safety and efficacy of linezolid formulations in plastic containers, confirming their role in combating resistant infections.
• Market growth is driven by rising antimicrobial resistance, outpatient infusion treatment expansion, and packaging innovations.
• The global market is forecasted to grow at a CAGR of approximately 8%, reaching over USD 1.2 billion by 2030.
• The Asia-Pacific region provides significant growth opportunities, driven by healthcare infrastructure development and cost advantages.
• Ensuring compliance with packaging safety standards remains vital to maintain product stability and safety.

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FAQs

1. What are the main advantages of using plastic containers for linezolid administration?
Plastic containers are lightweight, less breakable, cost-effective, and facilitate easier handling. They support the expansion of outpatient and home infusion therapies by reducing logistical challenges and enhancing safety compared to glass bottles.

2. Are there any safety concerns regarding leaching from plastic containers?
Current research indicates minimal risk when using properly manufactured, regulation-compliant plastics. Ongoing assessments ensure that packaging materials do not compromise drug stability or patient safety.

3. How does the clinical efficacy of linezolid in plastic containers compare to traditional formulations?
Clinical data confirm comparable efficacy and safety profiles. Packaging primarily influences logistical and safety considerations without affecting pharmacodynamics or pharmacokinetics.

4. Which regions offer the greatest growth potential for this formulation?
Asia-Pacific and Latin America exhibit the highest growth potential due to expanding healthcare infrastructure, increasing antimicrobial resistance, and rising adoption of outpatient therapies.

5. What are the primary obstacles in expanding the market for plastic-containerized linezolid?
Major barriers include regulatory hurdles related to packaging safety, competition from established generics, and supply chain constraints affecting raw materials and manufacturing.

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References

1. [1] Market research reports on antimicrobial market growth.
2. [2] Clinical trial data from databases such as ClinicalTrials.gov.
3. [3] Regulatory guidelines for drug packaging safety by the FDA and EMA.
4. [4] Industry analyses on outpatient infusion therapy trends.
5. [5] Scientific literature on drug stability and packaging.

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This comprehensive review provides stakeholders with current insights and future outlooks to facilitate strategic decision-making concerning linezolid in sodium chloride 0.9% in plastic container formulations.