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Last Updated: May 22, 2025

CLINICAL TRIALS PROFILE FOR CEFUROXIME AXETIL


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All Clinical Trials for Cefuroxime Axetil

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000752 ↗ Preventing Frequent Sinus Infections in HIV-Infected Patients Withdrawn Adams Laboratories Phase 2 1969-12-31 To evaluate the additional effectiveness of an anti-inflammatory nasal spray ( beclomethasone dipropionate ) and a broad spectrum antibiotic ( cefuroxime axetil ) over decongestant ( Deconsal II ) alone, when these agents are given individually or in combination for the prevention of recurrent paranasal sinus infection in patients with HIV infection. To compare the clinical utility of paranasal sinus radiographs with computed tomograms (CTs) in the evaluation and management of HIV-infected patients with recurrent paranasal sinus infection. To determine relevant prognostic factors and the microbiologic etiology of maxillary sinusitis in this patient population. Sinusitis is common among HIV-infected patients and is likely to be recurrent or refractory to traditional therapy, particularly in patients with advanced immunosuppression. An intervention aimed at prevention of recurrent sinus disease in HIV-infected patients appears to be warranted.
NCT00000752 ↗ Preventing Frequent Sinus Infections in HIV-Infected Patients Withdrawn Glaxo Wellcome Phase 2 1969-12-31 To evaluate the additional effectiveness of an anti-inflammatory nasal spray ( beclomethasone dipropionate ) and a broad spectrum antibiotic ( cefuroxime axetil ) over decongestant ( Deconsal II ) alone, when these agents are given individually or in combination for the prevention of recurrent paranasal sinus infection in patients with HIV infection. To compare the clinical utility of paranasal sinus radiographs with computed tomograms (CTs) in the evaluation and management of HIV-infected patients with recurrent paranasal sinus infection. To determine relevant prognostic factors and the microbiologic etiology of maxillary sinusitis in this patient population. Sinusitis is common among HIV-infected patients and is likely to be recurrent or refractory to traditional therapy, particularly in patients with advanced immunosuppression. An intervention aimed at prevention of recurrent sinus disease in HIV-infected patients appears to be warranted.
NCT00000752 ↗ Preventing Frequent Sinus Infections in HIV-Infected Patients Withdrawn National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 1969-12-31 To evaluate the additional effectiveness of an anti-inflammatory nasal spray ( beclomethasone dipropionate ) and a broad spectrum antibiotic ( cefuroxime axetil ) over decongestant ( Deconsal II ) alone, when these agents are given individually or in combination for the prevention of recurrent paranasal sinus infection in patients with HIV infection. To compare the clinical utility of paranasal sinus radiographs with computed tomograms (CTs) in the evaluation and management of HIV-infected patients with recurrent paranasal sinus infection. To determine relevant prognostic factors and the microbiologic etiology of maxillary sinusitis in this patient population. Sinusitis is common among HIV-infected patients and is likely to be recurrent or refractory to traditional therapy, particularly in patients with advanced immunosuppression. An intervention aimed at prevention of recurrent sinus disease in HIV-infected patients appears to be warranted.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Cefuroxime Axetil

Condition Name

Condition Name for Cefuroxime Axetil
Intervention Trials
Chronic Bronchitis 1
Erythema Chronicum Migrans 1
Erythema Migrans 1
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Condition MeSH

Condition MeSH for Cefuroxime Axetil
Intervention Trials
Bronchitis, Chronic 2
Glossitis, Benign Migratory 2
Bronchitis 2
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Clinical Trial Locations for Cefuroxime Axetil

Trials by Country

Trials by Country for Cefuroxime Axetil
Location Trials
United States 6
France 2
Belgium 1
Morocco 1
Turkey 1
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Trials by US State

Trials by US State for Cefuroxime Axetil
Location Trials
New Jersey 2
Kentucky 1
Pennsylvania 1
New York 1
California 1
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Clinical Trial Progress for Cefuroxime Axetil

Clinical Trial Phase

Clinical Trial Phase for Cefuroxime Axetil
Clinical Trial Phase Trials
Phase 4 2
Phase 3 2
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Cefuroxime Axetil
Clinical Trial Phase Trials
Completed 5
Terminated 2
Withdrawn 1
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Clinical Trial Sponsors for Cefuroxime Axetil

Sponsor Name

Sponsor Name for Cefuroxime Axetil
Sponsor Trials
University Medical Centre Ljubljana 2
Sanofi 2
PriCara, Unit of Ortho-McNeil, Inc. 2
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Sponsor Type

Sponsor Type for Cefuroxime Axetil
Sponsor Trials
Industry 8
Other 6
NIH 1
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Cefuroxime Axetil: Clinical Trials, Market Analysis, and Projections

Introduction to Cefuroxime Axetil

Cefuroxime Axetil is a small molecule drug belonging to the class of antibiotics known as cephalosporins. It targets penicillin-binding proteins (PBPs) to exert its therapeutic effects, making it effective against a wide range of bacterial pathogens. Approved for various therapeutic areas, including infectious diseases, eye diseases, respiratory diseases, skin and musculoskeletal diseases, and urogenital diseases, Cefuroxime Axetil has a long history of use and has been deemed safe and effective globally[1].

Clinical Trials and Efficacy

Cefuroxime Axetil has undergone extensive clinical trials to establish its efficacy and safety. Here are some key points from these trials:

  • Approval and Clinical Trials: The first approval of Cefuroxime Axetil was in December 1987 in the United States. It has achieved the highest phase of approval globally, indicating extensive clinical trials and a strong safety and efficacy profile[1].
  • Pediatric Use: Clinical trials involving children have shown that Cefuroxime Axetil is effective in treating lower respiratory tract infections. However, there were instances where the drug's absorption and penetration into the lower respiratory mucosa may not have been sufficient to kill all sensitive organisms[3].
  • Specific Indications: Cefuroxime Axetil is indicated for treating acute bacterial exacerbations of chronic bronchitis, uncomplicated skin and skin-structure infections, and other bacterial infections. However, its efficacy in treating sinus infections caused by certain bacteria, such as β-lactamase–producing Haemophilus influenzae or Moraxella catarrhalis, has not been established due to insufficient data[4].

Adverse Reactions and Safety

Clinical trials have also highlighted the safety profile of Cefuroxime Axetil:

  • Gastrointestinal Disturbances: The most common adverse reactions include gastrointestinal disturbances such as diarrhea, nausea, vomiting, and abdominal pain. These reactions were more frequent with higher doses[4].
  • Pediatric Adverse Reactions: In pediatric patients, the drug was generally well-tolerated, but some children discontinued therapy due to gastrointestinal disturbances or issues with the taste and administration of the drug[4].

Market Analysis

The market for Cefuroxime Axetil Tablets is robust and growing, driven by several key factors:

Market Size and Forecast

  • The Cefuroxime Axetil Tablets market was valued at USD 13.19 billion in 2023 and is projected to reach USD 34.16 billion by 2031, growing at a CAGR of 12.66% during the forecast period 2024-2031[2].
  • This significant growth is attributed to the increasing prevalence of bacterial infections, growing awareness of antibiotic resistance, and expanding healthcare expenditure globally[2].

Drivers of Market Growth

  • Increasing Prevalence of Bacterial Infections: The rising incidence of bacterial infections, such as respiratory, skin, and urinary tract infections, is a major driver. This increase is linked to urbanization, lifestyle changes, and the rise in antibiotic resistance[2].
  • Growing Awareness of Antibiotic Resistance: The heightened awareness of antibiotic resistance has led to a greater demand for targeted and effective antibiotic therapies like Cefuroxime Axetil. Educational initiatives promoting responsible antibiotic use are also driving this demand[2].
  • Expanding Geriatric Population: The growing geriatric population and increased healthcare spending are making effective antibiotics more accessible, contributing to market growth[2].

Market Segmentation

  • By Application: The market is primarily categorized by application, including respiratory tract infections, skin and soft tissue infections, urinary tract infections, and other infections. Each of these areas represents a distinct sub-segment within the market[2].
  • By Geography: The market is segmented geographically into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa. Each region has unique characteristics and trends influenced by factors such as antibiotic resistance patterns, population health needs, and healthcare policies[2].

Regional Dynamics

  • North America: Benefits from a robust healthcare infrastructure and high awareness of antibiotic treatments, with stringent regulations governing drug approvals[2].
  • Europe: Presents a mature market with significant demand driven by the prevalence of bacterial infections and a strong focus on antibiotic stewardship[2].
  • Asia-Pacific: Experiencing rapid growth due to increasing access to healthcare and a rising burden of infectious diseases, though it faces challenges related to regulatory standards and counterfeit drugs[2].
  • Middle East and Africa: Displays a growing demand driven by increased healthcare spending and awareness of antibiotics[2].
  • Latin America: Shows potential for growth as healthcare access improves[2].

Projections and Future Outlook

The future outlook for the Cefuroxime Axetil Tablets market is positive, with several factors contributing to its projected growth:

  • Sustained Demand: The increasing prevalence of bacterial infections and the need for effective antibiotics will continue to drive demand for Cefuroxime Axetil[2].
  • Expanding Healthcare Access: As more regions improve their healthcare infrastructure and access to medical care, the demand for antibiotics like Cefuroxime Axetil is expected to rise[2].
  • Regulatory and Educational Initiatives: Continued efforts to promote responsible antibiotic use and improve regulatory standards will support the market's growth[2].

Key Takeaways

  • Extensive Clinical Trials: Cefuroxime Axetil has undergone extensive clinical trials, establishing its safety and efficacy.
  • Broad Therapeutic Use: It is used to treat a wide range of bacterial infections, including respiratory, skin, and urinary tract infections.
  • Robust Market Growth: The market is projected to grow significantly, driven by increasing bacterial infections, growing awareness of antibiotic resistance, and expanding healthcare expenditure.
  • Geographic Variations: The market is influenced by regional factors such as antibiotic resistance patterns, population health needs, and healthcare policies.
  • Future Outlook: The market is expected to continue growing due to sustained demand for effective antibiotics and improving healthcare access.

FAQs

What is Cefuroxime Axetil used for?

Cefuroxime Axetil is primarily used for the treatment of bacterial infections, including respiratory tract infections, skin and soft tissue infections, urinary tract infections, and other bacterial infections[1].

What are the common adverse reactions associated with Cefuroxime Axetil?

Common adverse reactions include gastrointestinal disturbances such as diarrhea, nausea, vomiting, and abdominal pain. In pediatric patients, issues with the taste and administration of the drug are also noted[4].

How is the Cefuroxime Axetil market projected to grow?

The Cefuroxime Axetil Tablets market is projected to reach USD 34.16 billion by 2031, growing at a CAGR of 12.66% during the forecast period 2024-2031[2].

What are the key drivers of the Cefuroxime Axetil market growth?

Key drivers include the increasing prevalence of bacterial infections, growing awareness of antibiotic resistance, and expanding healthcare expenditure globally[2].

How does the market vary geographically?

The market varies significantly across regions such as North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa, influenced by factors like antibiotic resistance patterns, population health needs, and healthcare policies[2].

Sources

  1. A Comprehensive Review of Cefuroxime Axetil's R&D Innovations - Synapse Patsnap
  2. Cefuroxime Axetil Tablets Market Size, Scope, and Forecast - Verified Market Research
  3. Clinical trial of cefuroxime axetil in children - PubMed
  4. CEFTIN (Cefuroxime Axetil) Tablets - FDA
  5. Global Cefuroxime Axetil Tablets Market Size, Scope And Forecast Report - Market Research Intellect
Last updated: 2025-01-04

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