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Last Updated: July 10, 2025

CLINICAL TRIALS PROFILE FOR PIPERACILLIN


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505(b)(2) Clinical Trials for Piperacillin

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 Combination NCT05721443 ↗ Cetuximab Plus Dalpicilib in Patients With HPV Negative, PD-1 Resistant R/M HNSCC Recruiting Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University Phase 2 2023-04-01 This study is the first clinical study in PD-1 resistant patients with head and neck squamous cell carcinoma with drugs targeting EGFR signaling pathway combined with CDK4/6 inhibitors, which explores the new combination therapies urgently needed in clinical practice and lays a foundation for subsequent studies, with important scientific research significance and clinical value.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Piperacillin

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00003805 ↗ Prevention of Infection in Patients With Hematologic Cancer and Persistent Fever Caused by a Low White Blood Cell Count Completed European Organisation for Research and Treatment of Cancer - EORTC Phase 3 1997-11-01 RATIONALE: Antibiotic therapy may prevent the development of infection in patients with hematologic cancer and the persistent fever caused by a low white blood cell count. It is not yet known which regimen of antibiotics is most effective in preventing infection in these patients. PURPOSE: Randomized phase III trial to study the effectiveness of piperacillin-tazobactam with or without vancomycin in reducing fever in patients who have leukemia, lymphoma, or Hodgkin's disease.
NCT00044746 ↗ Study Evaluating the Safety and Efficacy of Piperacillin/Tazobactam and Ampicillin/Sulbactam in Patients With Diabetic Foot Infections Completed Wyeth is now a wholly owned subsidiary of Pfizer Phase 4 2000-10-01 Phase IV Open-Label Foot Infection Study is being conducted to generate comparative Efficacy and Safety data in Diabetic Inpatients.
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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Piperacillin

Condition Name

Condition Name for Piperacillin
Intervention Trials
Sepsis 5
Septic Shock 5
Enterobacteriaceae Infections 4
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Condition MeSH

Condition MeSH for Piperacillin
Intervention Trials
Infections 27
Infection 25
Communicable Diseases 19
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Clinical Trial Locations for Piperacillin

Trials by Country

Trials by Country for Piperacillin
Location Trials
United States 122
China 27
Italy 16
Germany 15
France 14
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Trials by US State

Trials by US State for Piperacillin
Location Trials
Texas 8
Florida 8
California 7
Missouri 6
Massachusetts 5
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Clinical Trial Progress for Piperacillin

Clinical Trial Phase

Clinical Trial Phase for Piperacillin
Clinical Trial Phase Trials
Phase 4 32
Phase 3 25
Phase 2/Phase 3 6
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Clinical Trial Status

Clinical Trial Status for Piperacillin
Clinical Trial Phase Trials
Completed 48
Unknown status 14
Not yet recruiting 13
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Clinical Trial Sponsors for Piperacillin

Sponsor Name

Sponsor Name for Piperacillin
Sponsor Trials
Wyeth is now a wholly owned subsidiary of Pfizer 9
Merck Sharp & Dohme Corp. 9
M.D. Anderson Cancer Center 5
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Sponsor Type

Sponsor Type for Piperacillin
Sponsor Trials
Other 171
Industry 47
U.S. Fed 2
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Piperacillin: Clinical Trials, Market Analysis, and Projections

Last updated: January 5, 2025

Introduction to Piperacillin

Piperacillin is a broad-spectrum, semisynthetic, ampicillin-derived ureidopenicillin antibiotic known for its bactericidal activity. It is often used in combination with tazobactam, a beta-lactamase inhibitor, to enhance its efficacy against a wider range of bacteria. Here, we will delve into recent clinical trials, market analysis, and future projections for piperacillin.

Clinical Trials and Safety Studies

ACORN Trial: Cefepime vs Piperacillin-Tazobactam

One of the significant clinical trials involving piperacillin is the ACORN (Antibiotic Choice on Renal Outcomes) trial. This randomized clinical trial compared the safety of empiric therapy with cefepime versus piperacillin-tazobactam in patients with suspected infections. The trial, conducted at a single site, enrolled over 2500 patients and used a novel approach by randomizing patients at the prescriber level within the electronic medical record, with an informed consent waiver due to the clinical equipoise of the question. The study found no association between the receipt of cefepime or piperacillin-tazobactam and the primary outcome of acute kidney injury or other renal outcomes[1][4].

Personalized Dosing in Critically Ill Patients

A study published in MDPI focused on personalized piperacillin dosing in critically ill patients with sepsis or septic shock. The study used software-guided empiric dosing and therapeutic drug monitoring (TDM) to achieve optimal therapeutic exposure of piperacillin concentrations. It was found that combining these strategies significantly enhanced therapeutic exposure and reduced potentially harmful concentrations. The study highlighted the variability in piperacillin clearance in critically ill patients and the importance of personalized dosing to achieve adequate serum concentrations[3].

Mechanism of Action and Clinical Use

Mechanism of Action

Piperacillin works by binding to and inactivating penicillin-binding proteins (PBPs) on the bacterial cell wall, leading to the weakening and eventual lysis of the bacterial cell. This mechanism is crucial for its bactericidal activity against a broad spectrum of bacteria, including Gram-positive and Gram-negative pathogens[2].

Clinical Use

Piperacillin, often combined with tazobactam, is used to treat a variety of infections, including those caused by anaerobic pathogens, which cefepime does not cover. This combination is particularly effective in treating infections in hospitalized patients, especially those in intensive care units[4].

Market Analysis and Projections

Global Market Size and Growth

The global piperacillin sodium market has been growing steadily. In 2020, the market size was valued at approximately $196.9 million and is expected to reach $210.5 million by the end of 2027, with a CAGR of 0.9% during 2021-2027[2].

However, more recent projections indicate a more robust growth trajectory. As of 2023, the global piperacillin sodium market was valued at $199 million and is anticipated to reach $250.7 million by 2030, with a CAGR of 3.3% during the forecast period of 2024-2030[5].

Market Segmentation

The market is segmented by type, application, and region. Key segments include:

  • Type: Piperacillin and piperacillin-tazobactam combinations.
  • Application: Primarily used in injections and compound injections.
  • Region: Global market with significant presence in various regions, including North America, Europe, and Asia-Pacific[2].

Key Players

The market is dominated by several major pharmaceutical companies, including:

  • Qilu Pharmaceutical
  • Pfizer Healthcare
  • Fresenius Kabi
  • Aurobindo Pharma
  • Sandoz
  • NCPC
  • REYOUNG
  • Yuhan Corporation
  • LKPC[2].

Factors Driving Market Growth

Several factors are driving the growth of the piperacillin sodium market:

  • Increasing Incidence of Infections: The rising incidence of bacterial infections, particularly in hospital settings, is driving the demand for effective antibiotics like piperacillin.
  • Advancements in Dosing Strategies: Personalized dosing strategies, as highlighted in recent clinical trials, are enhancing the therapeutic efficacy and safety of piperacillin, making it a preferred choice.
  • Market Expansion: The global market is expanding due to increased awareness and adoption of piperacillin in various regions[2][3][5].

Challenges and Restraints

Despite the growth, the market faces several challenges:

  • Antibiotic Resistance: The increasing resistance to antibiotics is a significant concern and can impact the long-term efficacy of piperacillin.
  • Regulatory Hurdles: Strict regulatory requirements and the need for continuous clinical trials to ensure safety and efficacy can be barriers to market growth.
  • Competition: The presence of other antibiotics and the development of new antimicrobial agents can pose competition to piperacillin[2].

Key Takeaways

  • Clinical Trials: Recent trials like the ACORN trial and studies on personalized dosing highlight the safety and efficacy of piperacillin.
  • Market Growth: The global piperacillin sodium market is expected to grow at a CAGR of 3.3% from 2024 to 2030.
  • Mechanism of Action: Piperacillin's bactericidal activity through the inhibition of PBPs makes it a potent antibiotic.
  • Clinical Use: It is particularly effective against anaerobic pathogens and is widely used in hospital settings.

FAQs

What is the primary mechanism of action of piperacillin?

Piperacillin works by binding to and inactivating penicillin-binding proteins (PBPs) on the bacterial cell wall, leading to the weakening and eventual lysis of the bacterial cell.

Which clinical trial compared cefepime and piperacillin-tazobactam?

The ACORN (Antibiotic Choice on Renal Outcomes) trial compared the safety of empiric therapy with cefepime versus piperacillin-tazobactam in patients with suspected infections.

What is the projected market size of piperacillin sodium by 2030?

The global piperacillin sodium market is anticipated to reach $250.7 million by 2030, with a CAGR of 3.3% during the forecast period of 2024-2030.

Why is personalized dosing important for piperacillin in critically ill patients?

Personalized dosing, using software-guided empiric dosing and therapeutic drug monitoring (TDM), is crucial to achieve optimal therapeutic exposure and reduce potentially harmful concentrations of piperacillin in critically ill patients.

Which companies are major players in the piperacillin sodium market?

Key players include Qilu Pharmaceutical, Pfizer Healthcare, Fresenius Kabi, Aurobindo Pharma, Sandoz, NCPC, REYOUNG, Yuhan Corporation, and LKPC.

Sources

  1. Academic.oup.com: "Nut Cracked? Does the ACORN Trial End the Debate Surrounding the Choice of Empiric Therapy for Suspected Infections?"
  2. Openpr.com: "Piperacillin Sodium API Market Expansion: Key Factors Driving Industry Growth and Future Outlook"
  3. MDPI.com: "Personalized Piperacillin Dosing for the Critically Ill"
  4. Jamanetwork.com: "Cefepime vs Piperacillin-Tazobactam for Acute Infection in Hospitalized Adults"
  5. Valuates Reports: "Global Piperacillin Sodium Market Research Report"

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