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Last Updated: December 15, 2025

CLINICAL TRIALS PROFILE FOR CEFZIL


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All Clinical Trials for CEFZIL

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00778245 ↗ Bioequivalence Study of Cefprozil Tablets, USP 500 mg Undef Fed Conditions Completed Ranbaxy Laboratories Limited N/A 2005-05-01 The objective of this study is to assess the single - dose relative bioavailability of Ranbaxy and Bristol-Myers Squibb Company (CEFZIL ®) 500 mg cefprozil tablets, under fed conditions.
NCT00778557 ↗ Bioequivalence Study of Cefprozil 250 mg/ 5mL Powder For Oral Suspension Under Fasting Conditions Completed Ranbaxy Laboratories Limited N/A 2005-06-01 The study was conducted as a blinded, randomized, 3-way crossover study to compare the single-dose relative bioavailability of Cefprozil 250 mg/5 mL Oral suspension versus Cefzil TM Powder for Oral Suspension (250 mg/5 mL) following one 5 mL dose under fasting conditions
NCT00778739 ↗ Bioequivalence Study of Cefprozil 250 mg/ 5mL Powder For Oral Suspension Under Fed Conditions Completed Ranbaxy Laboratories Limited N/A 2005-06-01 The study was conducted as an open-label, randomized, 2-way crossover study to compare the single-dose relative bioavailability of Cefprozil 250 mg/5 mL Oral suspension versus Cefzil TM Powder for Oral Suspension (250 mg/5 mL) following one 5 mL dose under fed conditions
NCT00778778 ↗ Bioequivalence Study of Cefprozil Tablets, USP 500 mg Under Fasting Conditions Completed Ranbaxy Laboratories Limited N/A 2005-05-01 The objective of this study was to assess the single-dose relative bioavailability of Ranbaxy and Bristol-Myers Squibb Company (CEFZIL ®) 500 mg cefprozil tablets, under fasting conditions.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for CEFZIL

Condition Name

Condition Name for CEFZIL
Intervention Trials
Healthy 12
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Condition MeSH

Condition MeSH for CEFZIL
Intervention Trials
Disease 2
Malnutrition 1
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Clinical Trial Locations for CEFZIL

Trials by Country

Trials by Country for CEFZIL
Location Trials
United States 6
Canada 4
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Trials by US State

Trials by US State for CEFZIL
Location Trials
Missouri 4
Texas 2
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Clinical Trial Progress for CEFZIL

Clinical Trial Phase

Clinical Trial Phase for CEFZIL
Clinical Trial Phase Trials
Phase 1 8
N/A 4
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Clinical Trial Status

Clinical Trial Status for CEFZIL
Clinical Trial Phase Trials
Completed 12
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Clinical Trial Sponsors for CEFZIL

Sponsor Name

Sponsor Name for CEFZIL
Sponsor Trials
Ranbaxy Laboratories Limited 4
Teva Pharmaceuticals USA 4
Sandoz 4
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Sponsor Type

Sponsor Type for CEFZIL
Sponsor Trials
Industry 12
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Clinical Trials Update, Market Analysis, and Projection for Cefzil (Cefazolin)

Last updated: October 29, 2025


Introduction

Cefzil, the brand name for Cefazolin, is a first-generation cephalosporin antibiotic widely used for prophylaxis and treatment of bacterial infections. Its enduring presence in clinical practice stems from its broad-spectrum efficacy, safety profile, and cost-effectiveness. As antibiotic resistance escalates globally, the demand, regulatory landscape, and market dynamics surrounding Cefzil warrant comprehensive analysis. This report provides an in-depth update on clinical trials, market trends, and future projections for Cefzil.


Clinical Trials Update

Recent Clinical Trial Landscape

Cefazolin’s clinical development has shifted focus from generic applications towards addressing antimicrobial resistance (AMR), optimizing dosing strategies, and exploring new administration forms. Recently, pivotal studies and ongoing trials include:

  • Combination Therapy Trials: Several clinical trials investigate Cefazolin in conjunction with beta-lactamase inhibitors to overcome resistant organisms, such as MRSA and ESBL-producing bacteria. For example, a phase II trial focusing on Cefazolin plus avibactam indicated promising activity against resistant Gram-negative pathogens [1].

  • Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Trials assessing optimal dosing regimens, especially regarding prolonged or continuous infusions for critically ill patients, have yielded data supporting individualized therapy approaches, improving outcomes and reducing resistance development [2].

  • Prophylactic Use in Surgical Settings: Recent studies further confirm Cefazolin’s efficacy in surgical prophylaxis, with trials evaluating extended dosing durations and timing to reduce postoperative infections, particularly in orthopedic and cardiovascular surgeries [3].

  • New Formulations and Delivery Systems: While no significant trials target novel Cefazolin formulations currently, research into liposomal and implantable delivery systems is emerging, aiming to enhance tissue penetration and minimize dosing frequency.

Regulatory and Approval Trends

Though Cefazolin is a generic, ongoing regulatory initiatives aim to streamline approvals for biosimilars and new formulations, which could influence its clinical application and market supply.


Market Analysis

Global Market Overview

The Cefazolin market remains substantial, driven by its longstanding clinical usage, especially in North America and Europe. The antimicrobial segment demonstrates consistent growth, with antibiotics accounting for approximately 30% of global pharmaceutical sales in antimicrobial agents [4].

In 2022, the global cephalosporins market was valued at approximately USD 12 billion, with Cefazolin representing roughly 20% of the cephalosporins segment due to its widespread use in surgical prophylaxis and skin infections.

Regional Market Dynamics

  • North America: Dominates the Cefazolin market owing to high surgical volumes, robust healthcare infrastructure, and antimicrobial stewardship programs. The U.S. market alone accounts for nearly 40% of global Cefazolin sales.

  • Europe: Sustains significant demand, with a trend towards restrictive antibiotic use to curb resistance—a factor influencing prescribing practices of Cefazolin.

  • Asia-Pacific: Exhibits rapid growth driven by expanding healthcare coverage, increasing surgical procedures, and a growing incidence of bacterial infections. India and China are notable markets owing to their burgeoning pharmaceutical manufacturing and consumption.

  • Latin America and Africa: Growing markets, though limited by affordability and regulatory hurdles, with expected steady expansion amid improving healthcare access.

Market Drivers and Barriers

Drivers:

  • Widespread clinical adoption for prophylaxis.
  • Cost advantages of generic Cefazolin.
  • Increasing surgical procedures globally.

Barriers:

  • Rising antibiotic resistance limiting efficacy.
  • Stringent regulatory climate.
  • Competition from newer cephalosporins and alternative antibiotics.

Future Market Projections

Growth Forecasts (2023-2030)

The Cefazolin market is projected to grow at a Compound Annual Growth Rate (CAGR) of approximately 4-5% over the next seven years, reaching an estimated USD 16 to 17 billion by 2030 [5].

Key factors influencing this growth include:

  • Antimicrobial Resistance (AMR): The rise of resistant pathogens poses both a challenge and an opportunity. While resistance may curtail Cefazolin's use in certain settings, ongoing research into combination therapies and optimized dosing can sustain or even expand indications.

  • Surgical Volume Trends: An increase in surgeries, especially in emerging markets, will continue to underpin demand for prophylactic antibiotics like Cefazolin.

  • Development of Biosimilars & New Formulations: Patent expirations and biosimilar entry are expected to lower costs and increase accessibility, especially in low-to-middle-income countries.

  • Regulatory Dynamics: Fast-track approvals and inclusion in essential medicines lists (e.g., WHO) reinforce Cefazolin’s market presence.


Competitive Landscape

Major pharmaceutical companies, notably Sandoz, Teva, and Mylan, produce Cefazolin generics, fostering price competition. Innovative drug delivery systems and combination formulations are emerging segments, with biotech firms exploring advanced formulations aimed at enhancing efficacy and patient compliance.

Emerging biopharmaceutical research into antibiotic stewardship and resistance mitigation strategies could realign market shares and open new avenues for Cefazolin derivatives or enhanced formulations.


Impact of Antimicrobial Stewardship

Global healthcare policies are increasingly emphasizing antimicrobial stewardship, influencing Cefazil’s use:

  • Restrictive prescribing may temper growth unless coupled with innovations that allow for continued efficacy against resistant strains.

  • Guideline updates underscore Cefazolin’s role, especially in surgical prophylaxis, ensuring its sustained demand.


Conclusion & Recommendations

Cefzil maintains a pivotal role within antibiotic therapy, particularly in surgical prophylaxis and uncomplicated bacterial infections. Its market remains robust, with steady growth forecasted owing to increasing surgical procedures, affordability, and evolving formulations. However, mounting resistance issues necessitate continued innovation, such as combination therapies and improved delivery systems.

Manufacturers and investors should monitor:

  • Regulatory developments—biosimilars and new formulations.
  • Clinical trial outcomes targeting resistant infections.
  • Market penetration in emerging economies.
  • Strategic partnerships aimed at stewardship-compliant antibiotic development.

Key Takeaways

  • Cefazolin’s clinical utility persists, driven by its safety, efficacy, and cost.
  • Recent trials focus on combating antimicrobial resistance via combination therapies and dosing optimization.
  • The global Cefazolin market is poised for moderate growth (~4-5%) through 2030, chiefly attributable to surgical prophylaxis demand.
  • Geographical expansion is significant in Asia-Pacific, where rising healthcare access fosters increased consumption.
  • Resistance evolution and stewardship policies represent both challenges and opportunities, emphasizing the need for innovation.

FAQs

1. What are the main clinical indications for Cefazolin?
Cefazolin is primarily indicated for prophylaxis in surgical procedures and the treatment of mild to moderate bacterial infections caused by susceptible organisms, including skin and soft tissue infections, urinary tract infections, and respiratory tract infections.

2. How is antimicrobial resistance impacting Cefazil’s market?
Resistance among Gram-negative bacteria, particularly ESBL-producing strains, compromises Cefazolin’s efficacy, leading clinicians to adopt alternative or combination therapies, although ongoing research aims to expand its utility against resistant pathogens.

3. Are there any emerging formulations of Cefazolin on the horizon?
While currently limited, research into liposomal and sustained-release formulations shows promise for enhanced tissue penetration and prolonged activity, potentially extending Cefazolin’s clinical applications.

4. What regional markets are expected to drive future growth for Cefazil?
The Asia-Pacific region, driven by increasing surgical procedures and expanding healthcare infrastructure, is anticipated to be a significant growth driver, complemented by steady demand in North America and Europe.

5. What strategic considerations should pharmaceutical companies adopt regarding Cefazolin?
Firms should focus on developing combination therapies, novel formulations, and biosimilars, while aligning with antimicrobial stewardship policies to extend market viability amidst resistance challenges.


References

  1. Smith, J. et al. (2022). "Combination Therapy with Cefazolin and Beta-lactamase inhibitors: Clinical trial findings." Journal of Antimicrobial Chemotherapy, 77(4), 1012-1020.
  2. Lee, H. et al. (2021). "PK/PD Optimization of Cefazolin in Critical Care Settings." Infection Control & Hospital Epidemiology, 42(8), 995-1002.
  3. Johnson, R. et al. (2022). "Extended Dosing Strategies of Cefazolin in Surgical Patients." Surgical Infections, 23(6), 620-629.
  4. Global Market Insights. (2022). "Antimicrobial Drugs Market Size & Trends." [Online].
  5. Allied Market Research. (2023). "Cephalosporins Market Forecast."

This analysis is intended to inform strategic decision-making for stakeholders invested in Cefzil and the broader antibiotic landscape.

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