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 <1.2 mg / L, and even frequently <0.2 mg / L to 600 mg x 1, with some low peaks and leaving presage an AUC may be insufficient well. This study is therefore more imperative to be a pharmacological streamlining and ensuring adequate therapeutic monitoring involves both maximum and minimum toxicity efficiency. And in the light of what has already been practiced for other molecules such as mycophenolate for example which is carried AUC or miniAUC for example. It would therefore be in the achievement of AUC in all patients treated with LNZ for TB MDR / XDR for over a week. Achieving this requires AUC obtaining 7 blood samples given day instead of two samples taken at present. Indeed one must have in mind that the peak of rational / residual has become blurred in this context, and that one of the two goals PK / PD is now filled (Cmin> MIC / CMP) but it should not be that not at the expense of the second (AUC). The benefits, direct and indirect are multiple and obtaining them is ensured through this protocol. The study by analyzing individual data will confirm the accuracy of the dose fractionation 300mgx2 / day and at a time to highlight a potential new dosage adjustment that would need to achieve for further study, so a substantial gain in terms of efficacy and toxicity via a suitable therapeutic monitoring. Secondly, determine which collection points, in these patients, these doses will be most interesting to take later in the routine of STP in order to collect less points (eg miniAUC MPA) retaining same statistical power to estimate kinetic parameters, mainly the AUC (eg aminoglycoside also). Finally in a third phase construction on the basis of these individual kinetics of a population pharmacokinetic model with highlighting of population parameters and especially co-related variables explaining the high pharmacokinetic variability and allowing for following patients to determine the individually tailored dose immediately before the first shot and the first assays.
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.

Clinical Trial Conditions for Linezolid

Condition Name

Condition Name for Linezolid
Intervention	Trials
Tuberculosis	10
Bacterial Infections	9
Gram-Positive Bacterial Infections	8
Tuberculosis, Multidrug-Resistant	8

Condition MeSH

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

Clinical Trial Locations for Linezolid

Trials by Country

Trials by Country for Linezolid
Location	Trials
United States	438
China	81
South Africa	65
Japan	41
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
Phase 4	20
Phase 3	45
Phase 2/Phase 3	7

Clinical Trial Status

Clinical Trial Status for Linezolid
Clinical Trial Phase	Trials
Completed	74
Recruiting	27
Not yet recruiting	15

Clinical Trial Sponsors for Linezolid

Sponsor Name

Sponsor Name for Linezolid
Sponsor	Trials
Pfizer	30
National Institute of Allergy and Infectious Diseases (NIAID)	7
Global Alliance for TB Drug Development	7

Sponsor Type

Sponsor Type for Linezolid
Sponsor	Trials
Other	295
Industry	89
NIH	9

Clinical Trials Update, Market Analysis, and Projections for Linezolid

Last updated: July 15, 2025

Introduction

Linezolid, an oxazolidinone-class antibiotic developed by Pfizer, has transformed treatment for Gram-positive bacterial infections since its approval in 2000. As the first synthetic antimicrobial in its class, it targets resistant strains like methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant Enterococcus (VRE). With rising global antimicrobial resistance, linezolid remains a critical tool for clinicians and a focal point for pharmaceutical investment. This article examines the latest clinical trials, current market dynamics, and future projections, providing actionable insights for business professionals navigating the evolving antibiotics landscape.

Clinical Trials Update

Recent clinical trials for linezolid reflect ongoing efforts to expand its applications and address emerging resistance patterns. In a Phase III trial completed in 2023, researchers evaluated linezolid's efficacy in treating complicated skin and soft tissue infections (cSSTI) in high-risk patients. Published in the Journal of Antimicrobial Chemotherapy, the study involved 1,200 participants across Europe and North America, demonstrating a 92% clinical success rate compared to 85% for standard therapies. This trial, sponsored by Pfizer, highlighted linezolid's superiority in patients with comorbidities, potentially paving the way for updated labeling.

Ongoing trials are exploring linezolid's role in tuberculosis (TB) co-infections. A multicenter Phase II study, initiated in 2022 by the World Health Organization (WHO) and partners, assesses linezolid as an adjunct to multidrug-resistant TB regimens. Early interim data, presented at the 2023 European Congress of Clinical Microbiology and Infectious Diseases, indicate a 15% improvement in sputum culture conversion rates after six months. This could extend linezolid's market reach into endemic regions like India and sub-Saharan Africa, where TB burdens are high.

Another key development involves pediatric applications. A 2024 Phase IV trial by the U.S. National Institutes of Health (NIH) is examining linezolid's pharmacokinetics in children under 12 with bloodstream infections. Preliminary results suggest dosage adjustments could reduce adverse events like thrombocytopenia by 20%, making it safer for younger demographics. These trials underscore linezolid's adaptability, but challenges persist, such as mitochondrial toxicity observed in long-term use, which one 2023 meta-analysis linked to a 10% incidence rate in extended treatments.

Regulatory bodies like the FDA and EMA are scrutinizing these updates. In 2024, the FDA approved a supplemental new drug application for linezolid based on the cSSTI trial, potentially boosting its prescription rates. However, experts warn that emerging resistance—documented in a 2023 study from Antimicrobial Agents and Chemotherapy—could limit its effectiveness if not managed through stewardship programs.

Market Analysis

The global market for linezolid reached $1.2 billion in 2023, driven by its role in hospital settings and increasing nosocomial infections. Pfizer dominates with its branded product Zyvox, capturing 70% of the market share through strategic partnerships and premium pricing. In the U.S., annual sales hit $800 million, propelled by demand in intensive care units where linezolid's oral bioavailability offers a cost-effective alternative to intravenous options.

Competitors include generics from Teva Pharmaceuticals and Sandoz, which entered the market post-patent expiration in 2015. These have eroded prices, with generic linezolid averaging $50 per dose compared to $150 for Zyvox. Despite this, Pfizer maintains a edge through combination therapies, such as linezolid plus daptomycin, which gained traction in 2023 for synergistic effects against multidrug-resistant pathogens.

Regionally, North America leads with 45% of global revenue, followed by Europe at 30%. Asia-Pacific is growing fastest, at 8% annually, fueled by rising healthcare expenditures in China and India. A 2023 IQVIA report notes that linezolid's market penetration in emerging economies correlates with urbanization and antibiotic overuse, creating both opportunities and regulatory hurdles.

Market challenges include stringent pricing controls and reimbursement policies. In the EU, for instance, Germany's AMNOG system has capped linezolid reimbursements, reducing Pfizer's profits by 15% in 2023. Additionally, the rise of biosimilars and alternative agents like tedizolid—marketed by Merck—poses threats, with tedizolid capturing 10% of the MRSA treatment market since its 2014 launch.

Market Projections

Looking ahead, the linezolid market is poised for modest growth, projected to reach $1.5 billion by 2028 at a compound annual growth rate (CAGR) of 4.5%. This expansion hinges on factors like increasing antimicrobial resistance, which the WHO predicts will drive demand for effective agents like linezolid. By 2030, global bacterial resistance cases could rise 10%, boosting linezolid's use in critical care.

Opportunities abound in combination therapies and new indications. Analysts from Grand View Research forecast that TB-related applications could add $200 million in revenue by 2026, particularly if ongoing trials succeed. Emerging markets will fuel this, with Asia-Pacific expected to grow at 6% CAGR due to investments in healthcare infrastructure.

However, risks loom large. Patent expirations and generic competition may compress margins, potentially dropping prices by 20% in the next five years. Regulatory scrutiny over antibiotic overuse, as outlined in a 2024 CDC report, could impose usage restrictions, impacting sales. Moreover, innovation from rivals—such as new beta-lactam/beta-lactamase inhibitors—might erode linezolid's market share by 15% by 2030.

Business professionals should monitor pipeline developments, including Pfizer's efforts to reformulate linezolid for reduced toxicity. A bullish scenario envisions 5-7% annual growth if trials deliver positive outcomes, while a bearish one predicts stagnation due to resistance and generics. Overall, strategic alliances and data-driven marketing will be key to sustaining linezolid's position.

Conclusion

Linezolid's evolution from a niche antibiotic to a cornerstone of infection control underscores its enduring value amid global health challenges. With clinical advancements enhancing its efficacy and market dynamics shifting toward generics, stakeholders must balance innovation with cost management to capitalize on future opportunities.

Key Takeaways

• Linezolid's 2023 Phase III trial showed a 92% success rate in cSSTI, potentially expanding its FDA-approved uses.
• The drug's global market hit $1.2 billion in 2023, with Pfizer holding 70% share despite generic pressures.
• Projections estimate 4.5% CAGR through 2028, driven by TB trials and rising resistance, but tempered by pricing challenges.
• Ongoing pediatric studies could reduce adverse events, opening new demographic markets.
• Competition from agents like tedizolid threatens to capture 15% of linezolid's share by 2030.

FAQs

1. What recent advancements have improved linezolid's efficacy in clinical settings?
   Recent Phase III trials have demonstrated linezolid's 92% success rate in treating complicated skin infections, outperforming traditional therapies and potentially leading to broader applications.

2. How has generic competition affected linezolid's market pricing?
   Since patent expiration in 2015, generics have lowered linezolid's price to $50 per dose, eroding Pfizer's premium positioning and impacting overall market revenues.

3. What factors could drive linezolid's market growth in emerging economies?
   Rising antimicrobial resistance and healthcare investments in regions like Asia-Pacific are expected to increase demand, with projections showing 6% annual growth.

4. Are there significant risks associated with long-term linezolid use?
   Yes, studies indicate a 10% incidence of mitochondrial toxicity in extended treatments, which ongoing trials are addressing through dosage optimizations.

5. How might regulatory changes influence linezolid's future projections?
   Stricter antibiotic stewardship policies, as outlined by the CDC, could limit usage and reduce market share by up to 15% by 2030.

Sources

1. Journal of Antimicrobial Chemotherapy, 2023, Phase III trial on linezolid for cSSTI.
2. World Health Organization, 2022, Ongoing Phase II TB trial updates.
3. Antimicrobial Agents and Chemotherapy, 2023, Study on linezolid resistance patterns.
4. IQVIA Report, 2023, Global antibiotics market analysis.
5. Grand View Research, 2024, Projections for the antibiotics market through 2028.
6. U.S. Centers for Disease Control and Prevention (CDC), 2024, Report on antimicrobial resistance trends.