CLINICAL TRIALS PROFILE FOR LINEZOLID

505(b)(2) Clinical Trials for linezolid

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

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.
NCT00084266 ↗	Nosocomial Pneumonia With Suspected Or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA)	Completed	Pfizer	Phase 4	2004-10-01	To determine if linezolid is superior to vancomycin in the treatment of nosocomial (acquired in the hospital) pneumonia due to Methicillin Resistant Staphylococcus Aureus (MRSA) in adult subjects. Subjects entered in to the study will have proven healthcare-associated methicillin-resistant Staphylococcus aureus pneumonia which will be treated with either linezolid or vancomycin.

Clinical Trial Conditions for linezolid

Condition Name

Condition Name for linezolid
Intervention	Trials
Tuberculosis	13
Pulmonary Tuberculosis	11
Bacterial Infections	9
Tuberculosis, Multidrug-Resistant	9

Condition MeSH

Condition MeSH for linezolid
Intervention	Trials
Infections	46
Tuberculosis	44
Infection	44
Communicable Diseases	40

Clinical Trial Locations for linezolid

Trials by Country

Trials by Country for linezolid
Location	Trials
United States	438
China	124
South Africa	70
Japan	42
Brazil	29

Trials by US State

Trials by US State for linezolid
Location	Trials
California	32
Texas	26
Ohio	24
Georgia	23
Florida	22

Clinical Trial Progress for linezolid

Clinical Trial Phase

Clinical Trial Phase for linezolid
Clinical Trial Phase	Trials
PHASE4	4
PHASE3	3
PHASE2	2

Clinical Trial Status

Clinical Trial Status for linezolid
Clinical Trial Phase	Trials
Completed	75
Recruiting	30
Not yet recruiting	15

Clinical Trial Sponsors for linezolid

Sponsor Name

Sponsor Name for linezolid
Sponsor	Trials
Pfizer	30
Beijing Chest Hospital	8
National Institute of Allergy and Infectious Diseases (NIAID)	7

Sponsor Type

Sponsor Type for linezolid
Sponsor	Trials
Other	313
Industry	91
NIH	9

Clinical Trials, Market Analysis, and Future Projections for Linezolid

Last updated: October 26, 2025

Introduction

Linezolid, a synthetic oxazolidinone antibiotic, stands out in the fight against multi-drug resistant Gram-positive infections. Approved by the U.S. Food and Drug Administration (FDA) in 2000, it has established a crucial role in combating resistant bacterial strains such as methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant Enterococci (VRE). With evolving bacterial resistance and expanding clinical indications, understanding recent clinical trial updates, analyzing current market dynamics, and projecting future growth are vital for stakeholders.

Clinical Trials Update

Recent Clinical Trial Landscape

Over the past three years, numerous clinical trials exploring linezolid’s efficacy, safety, and new application areas have been registered and completed globally. These studies vary from phase II to phase IV, reflecting ongoing efforts to expand its clinical utility.

Key Areas of Investigation

1. Linezolid in Gram-positive Infections Beyond Traditional Use

Most recent trials focus on exploring linezolid’s efficacy in complex infections, including osteomyelitis, prosthetic joint infections, and diabetic foot infections.

• A phase III trial (NCT04326116) evaluated the long-term safety of oral linezolid in treating osteomyelitis. Preliminary results indicate sustained clinical success with manageable adverse effects.
• Multiple phase II trials assess the efficacy of lower-dose linezolid regimens in skin and soft tissue infections, aiming to reduce side effects such as myelosuppression and neuropathy.

2. Investigating Linezolid’s Role in Viral-Bacterial Co-Infections

Amid the COVID-19 pandemic, some trials (e.g., NCT04598576) explore linezolid’s potential in managing secondary bacterial infections complicated by viral illnesses, with initial data suggesting marginal benefits in selectively infected populations.

3. New Formulations and Combination Therapies

Recent studies include trials on inhaled linezolid formulations aimed at pulmonary infections (NCT04175188), potentially offering targeted therapy with fewer systemic side effects.

Emerging Clinical Trial Trends

The ongoing diversification reflects a commitment to overcoming resistance, optimizing dosing strategies, and minimizing adverse effects. Regulatory agencies are increasingly endorsing real-world evidence, with phase IV post-marketing studies emphasizing safety and effectiveness in diverse populations.

Market Analysis

Current Market Size and Structure

The global linezolid market was valued at approximately $400 million in 2022, with North America commanding around 50%. The primary revenue drivers include hospital antibiotic use, especially in intensive care units (ICUs), where resistant infections are most prevalent.

Key Market Players

Major pharmaceutical companies involved include:

• Pfizer: Original manufacturer of Zyvox (brand name for linezolid).
• Sandoz and Teva Pharmaceuticals: Generics producers increasing market penetration.
• Other Regional Companies: Developing biosimilars and alternative formulations.

Market Dynamics

Drivers

• Rising prevalence of resistant bacterial strains propels demand.
• Expansion into outpatient settings through oral formulations.
• Growing awareness of antimicrobial stewardship fostering appropriate use.

Constraints

• High treatment costs limit access, especially in low-resource settings.
• Adverse effects (e.g., myelosuppression, neuropathy) restrict prolonged use.
• Competition from newer antibiotics and emerging resistance reduces drug lifespan.

Regional Market Insights

North America dominates the market due to high resistance rates and healthcare infrastructure. Europe follows, with broader adoption of linezolid and expanding generic options. The Asia-Pacific region presents significant growth potential owing to increasing antimicrobial resistance and rising healthcare spending, despite regulatory hurdles.

Market Opportunities

• Development of biosimilars and combination therapies.
• Investing in oral formulations for outpatient management.
• Targeting specialty markets, such as prosthetic joint infections and diabetic foot ulcers.

Regulatory and Reimbursement Landscape

The U.S. and European agencies have streamlined approval pathways for biosimilars, enhancing market competition. Reimbursement policies are evolving to accommodate cost-effective therapies, but high drug pricing remains a concern impacting market expansion.

Market Projections

Forecast for 2023–2030

The global linezolid market is projected to grow at a Compound Annual Growth Rate (CAGR) of 6-8% over the next decade, reaching approximately $700-850 million by 2030.

Key Drivers of Growth

• Increasing prevalence of resistant infections globally.
• Transition toward outpatient parenteral antimicrobial therapy (OPAT).
• Ongoing clinical validations supporting expanded indications.
• Rising demand for oral antibiotics suitable for home use.

Potential Disruptors

• Introduction of next-generation oxazolidinones with improved safety profiles (e.g., contezolid).
• Policy-driven antimicrobial stewardship programs limiting broader use.
• The emergence of resistance against linezolid itself, potentially reducing its efficacy and market share.

Strategic Implications

Stakeholders should focus on clinical validation for new indications, optimizing dosing to minimize adverse effects, and pursuing biosimilar development to enhance affordability. Collaborations with healthcare systems and payers will be essential for ensuring sustainable market growth.

Key Takeaways

• Clinical Trials: Ongoing studies are expanding linezolid’s indications. The focus remains on optimizing safety, reducing side effects, and exploring inhaled formulations.
• Market Dynamics: Resistance patterns sustain demand; however, high costs and side effects limit current usage. Generic manufacturers are expanding their footprint, intensifying competition.
• Future Outlook: Projected growth is driven by resistance trends and outpatient therapy needs. Innovation in formulations and combination therapies will underpin future market expansion.
• Regulatory Environment: Favorable policies for biosimilars and generics will enhance accessibility but necessitate continuous innovation to stay ahead of emerging resistance.
• Risks and Opportunities: Resistance evolution, safety concerns, and pricing pressures pose risks, but opportunities lie in novel formulations, biosimilars, and expanded clinical evidence.

Conclusion

As antimicrobial resistance escalates globally, linezolid remains a pivotal therapeutic agent. The surge in clinical research and market expansion underscores its enduring relevance. Strategic investments in formulation innovation, regulatory navigation, and cost management will determine its role in future infectious disease management.

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FAQs

1. What are the latest clinical indications being explored for linezolid?
Recent trials focus on osteomyelitis, prosthetic joint infections, diabetic foot infections, and inhalation formulations for pulmonary infections, aiming to expand its clinical utility.

2. How is resistance impacting the effectiveness of linezolid?
Emerging resistance, primarily due to cfr gene mutations and other mechanisms, is increasingly reported, threatening long-term efficacy and prompting the development of next-generation oxazolidinones.

3. What are the main safety concerns associated with prolonged linezolid therapy?
Myelosuppression, peripheral and optic neuropathy, and lactic acidosis are notable adverse effects, especially with long-term use, leading to cautious prescribing and monitoring.

4. How do market dynamics vary across regions?
North America and Europe lead in adoption due to advanced healthcare infrastructure and resistance rates, while Asia-Pacific shows high growth potential driven by increasing resistance and expanding healthcare access.

5. What future innovations could influence linezolid’s market?
Biosimilars, inhaled formulations, combination therapies, and novel oxazolidinones with improved safety profiles are poised to influence its market trajectory significantly.

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References

[1] U.S. FDA. (2000). FDA approves Zyvox for infections caused by multi-drug resistant bacteria.
[2] MarketWatch. Global antibiotics market report, 2022.
[3] ClinicalTrials.gov. Linezolid clinical trial registry entries.
[4] World Health Organization. Antimicrobial Resistance Threats Report, 2022.
[5] IQVIA. Pharmaceutical market analysis, 2022.