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Last Updated: February 17, 2025

CLINICAL TRIALS PROFILE FOR CEFEPIME HYDROCHLORIDE


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All Clinical Trials for Cefepime Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00020865 ↗ Levofloxacin Compared With Cefepime in Treating Cancer Patients With Fever and Neutropenia Unknown status National Cancer Institute (NCI) Phase 3 2001-09-01 RATIONALE: Levofloxacin may be effective in reducing fever and controlling other symptoms of neutropenia in patients who are being treated for cancer. It is not yet known whether levofloxacin is more effective than cefepime in reducing fever and controlling symptoms of neutropenia. PURPOSE: Randomized phase III trial to compare the effectiveness of levofloxacin with that of cefepime in reducing fever and controlling symptoms of neutropenia in patients who are being treated for cancer.
NCT00020865 ↗ Levofloxacin Compared With Cefepime in Treating Cancer Patients With Fever and Neutropenia Unknown status Jonsson Comprehensive Cancer Center Phase 3 2001-09-01 RATIONALE: Levofloxacin may be effective in reducing fever and controlling other symptoms of neutropenia in patients who are being treated for cancer. It is not yet known whether levofloxacin is more effective than cefepime in reducing fever and controlling symptoms of neutropenia. PURPOSE: Randomized phase III trial to compare the effectiveness of levofloxacin with that of cefepime in reducing fever and controlling symptoms of neutropenia in patients who are being treated for cancer.
NCT00044759 ↗ Study Comparing the Safety and Efficacy of Piperacillin/Tazobactam to Cefepime in Patients With Hematologic Malignancy or Lymphoma Completed Wyeth is now a wholly owned subsidiary of Pfizer Phase 3 1969-12-31 To compare the safety and efficacy of piperacillin/tazobactam (4 g/500 mg) administered intravenously every 6 hours to cefepime (2 g) administered intravenously every 8 hours for the empiric treatment of neutropenic fever in patients with a hematologic malignancy or lymphoma.
NCT00137787 ↗ Comparing Ciprofloxacin (CPFX) With Cefepime (CFPM) in Febrile Neutropenic Patients With Hematologic Diseases Completed Bayer Phase 3 2005-04-01 The aim of this study is to investigate whether intravenous ciprofloxacin is as effective as cefepime for the initial treatment of febrile neutropenia developed in patients with hematologic diseases.
NCT00137787 ↗ Comparing Ciprofloxacin (CPFX) With Cefepime (CFPM) in Febrile Neutropenic Patients With Hematologic Diseases Completed Center for Supporting Hematology-Oncology Trials Phase 3 2005-04-01 The aim of this study is to investigate whether intravenous ciprofloxacin is as effective as cefepime for the initial treatment of febrile neutropenia developed in patients with hematologic diseases.
NCT00358202 ↗ Cefepime vs. Ceftriaxone to Treat Nursing Home-Acquired Pneumonia Completed Elan Pharmaceuticals Phase 4 2002-03-01 Randomized trial of nursing home residents with pneumonia to assess if intramuscular cefepime is a safe, efficacious, and cost-effective alternative to once daily intramuscular ceftriaxone for the treatment of elderly nursing home residents who develop pneumonia and do not require hospitalization.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Cefepime Hydrochloride

Condition Name

Condition Name for Cefepime Hydrochloride
Intervention Trials
Febrile Neutropenia 5
Complicated Urinary Tract Infection 5
Acute Pyelonephritis 5
Healthy Subjects 3
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Condition MeSH

Condition MeSH for Cefepime Hydrochloride
Intervention Trials
Infections 17
Communicable Diseases 15
Infection 14
Urinary Tract Infections 11
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Clinical Trial Locations for Cefepime Hydrochloride

Trials by Country

Trials by Country for Cefepime Hydrochloride
Location Trials
United States 73
Spain 10
India 8
Poland 8
Brazil 6
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Trials by US State

Trials by US State for Cefepime Hydrochloride
Location Trials
Texas 10
California 7
New York 5
Florida 5
Pennsylvania 4
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Clinical Trial Progress for Cefepime Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Cefepime Hydrochloride
Clinical Trial Phase Trials
Phase 4 14
Phase 3 20
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Cefepime Hydrochloride
Clinical Trial Phase Trials
Completed 27
Not yet recruiting 10
Terminated 8
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Clinical Trial Sponsors for Cefepime Hydrochloride

Sponsor Name

Sponsor Name for Cefepime Hydrochloride
Sponsor Trials
Wockhardt 6
M.D. Anderson Cancer Center 5
Venatorx Pharmaceuticals, Inc. 4
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Sponsor Type

Sponsor Type for Cefepime Hydrochloride
Sponsor Trials
Other 60
Industry 37
NIH 5
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Cefepime Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

Cefepime hydrochloride, a fourth-generation cephalosporin antibiotic, has been a crucial component in the treatment of various bacterial infections. This article delves into the recent updates on clinical trials, market analysis, and future projections for cefepime hydrochloride, particularly focusing on its combination with taniborbactam.

Clinical Trials Update

Cefepime-Taniborbactam Trials

The combination of cefepime and taniborbactam has been under intense scrutiny in recent clinical trials. The CERTAIN-1 Phase 3 study, published in the New England Journal of Medicine, demonstrated the efficacy of cefepime-taniborbactam in treating complicated urinary tract infections (cUTI) and acute pyelonephritis (AP), including cases with bacteremia. This study showed that cefepime-taniborbactam was superior to meropenem, another commonly used antibiotic, with a similar safety profile[4].

  • Trial Design: The CERTAIN-1 study was a multinational, double-blind, noninferiority clinical trial involving 1,041 patients. Patients were randomized to receive either cefepime-taniborbactam or meropenem. The primary efficacy endpoint was a composite of clinical cure and microbiological response at the test of cure visit[4].

  • Outcomes: At the Late Follow-up (LFU) visit, cefepime-taniborbactam demonstrated sustained statistical superiority over meropenem for the composite endpoint, with a response rate difference of 12.1%[4].

FDA Update

Despite the positive clinical trial results, the FDA has requested additional data for the approval of cefepime-taniborbactam. The Complete Response Letter (CRL) did not identify any clinical safety or efficacy issues but required further chemistry, manufacturing, and controls (CMC) data and related information about the drug's testing methods and manufacturing process[1].

Market Analysis

Current Market Size and Growth

The global cefepime hydrochloride market is expected to experience significant growth. As of the latest reports, the market is projected to expand at a remarkable Compound Annual Growth Rate (CAGR) from 2023 to 2030. This growth is driven by increasing demand for cefepime hydrochloride, particularly in hospital and retail pharmacy settings[2].

  • Applications: The primary applications of cefepime hydrochloride include the treatment of cUTI, AP, and other infections caused by gram-negative bacteria. The market's growth is also influenced by factors such as product pricing, country-level GDP, and market dynamics of parent and child markets[2].

Competitive Landscape

The cefepime hydrochloride market is competitive, with several key players involved. These companies are evaluated based on their product offerings, financial statements, strategic approaches, and geographical penetration. The competitive landscape section of market reports highlights the strengths, weaknesses, opportunities, and threats (SWOT analysis) of the top players in the market[2].

Regional Insights

The market is analyzed at both global and regional levels. The report includes insights on the dominance of particular brands in each country and region, as well as the overall market dynamics. This comprehensive analysis helps in understanding the lucrative opportunities and challenges in different geographical areas[2].

Market Projections

Forecast Period

From 2023 to 2030, the cefepime hydrochloride market is expected to see exponential growth. Here are some key projections:

  • Revenue Growth: The market is anticipated to develop significant revenue during the forecast period, driven by increasing demand and favorable market conditions[2].

  • Capacity and Production: The global and Chinese capacity, production, and production value of cefepime hydrochloride are expected to increase. This growth will be influenced by factors such as market demand, raw material availability, and manufacturing capabilities[5].

  • Market Share: The market share of cefepime hydrochloride is expected to expand globally and in China, with major players continuing to dominate the market. The report provides detailed forecasts on market share, supply, and consumption[5].

Economic Impact

The macroeconomic environment, both globally and in China, will play a significant role in shaping the cefepime hydrochloride market. Factors such as government spending, research and development growth, and economic outlook will influence market dynamics. The report provides an in-depth analysis of these factors and their impact on the market[5].

Industry Dynamics

Challenges and Opportunities

The cefepime hydrochloride market faces several challenges, including the need for continuous innovation to combat antibiotic resistance and regulatory hurdles. However, there are also significant opportunities, such as the growing demand for effective antibiotics and the potential for expansion into new markets[5].

Regulatory Environment

Regulatory approvals and compliance are critical for the cefepime hydrochloride market. The recent CRL from the FDA for cefepime-taniborbactam highlights the importance of meeting stringent regulatory requirements. Companies must work closely with regulatory bodies to ensure timely approvals and market entry[1].

Key Takeaways

  • Clinical Trials: Cefepime-taniborbactam has shown superior efficacy over meropenem in treating cUTI and AP, with a similar safety profile.
  • Market Growth: The global cefepime hydrochloride market is expected to grow significantly from 2023 to 2030, driven by increasing demand and favorable market conditions.
  • Regulatory Environment: Regulatory approvals are crucial, and companies must address CMC and other regulatory requirements to ensure market entry.
  • Competitive Landscape: The market is competitive, with major players dominating the landscape and continuously evolving their strategies.

FAQs

What is the current status of the cefepime-taniborbactam new drug application?

The FDA has issued a Complete Response Letter (CRL) requesting additional CMC and related data but did not identify any clinical safety or efficacy issues[1].

How does cefepime-taniborbactam compare to other antibiotics in clinical trials?

Cefepime-taniborbactam has shown superior efficacy to meropenem in treating cUTI and AP, with a similar safety profile, according to the CERTAIN-1 Phase 3 study[4].

What are the key drivers of the cefepime hydrochloride market growth?

The market growth is driven by increasing demand, particularly in hospital and retail pharmacy settings, as well as favorable market conditions and economic factors[2].

Who are the major players in the cefepime hydrochloride market?

Major players include companies like Venatorx Pharmaceuticals, Melinta Therapeutics, and Menarini Group, among others, which are evaluated based on their product offerings, financial statements, and strategic approaches[2].

What are the challenges faced by the cefepime hydrochloride market?

The market faces challenges such as the need for continuous innovation to combat antibiotic resistance, regulatory hurdles, and economic fluctuations[5].

Sources

  1. Venatorx and Melinta Provide Update on Status of U.S. New Drug Application for Cefepime-Taniborbactam. Venatorx.
  2. Cefepime Hydrochloride for Injection Market Size, Growth & Trends. Verified Market Reports.
  3. Drug Trials Snapshots: EXBLIFEP - FDA. FDA.
  4. New England Journal of Medicine Publishes Positive Results of Cefepime-Taniborbactam from Phase 3 CERTAIN-1 Study of Patients with Complicated Urinary Tract Infection. Melinta.
  5. Cefepime Hydrochloride Market Size, Share, Trend. Prof Research.

More… ↓

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