CLINICAL TRIALS PROFILE FOR PIPERACILLIN SODIUM

All Clinical Trials for piperacillin sodium

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.
NCT00389987 ↗	Ertapenem Sodium vs. Piperacillin/Tazobactam in the Treatment of Complicated Intra-Abdominal Infections (0826-037)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2001-09-01	This study is designed to compare the efficacy of ertapenem and piperacillin/tazobactam with respect to the clinical response in baseline microbiologically evaluable patients; and to evaluate the tolerability and safety of ertapenem compared to piperacillin/tazobactam.
NCT00873327 ↗	Pharmacokinetics and Safety of Piperacillin-tazobactam in Neonates	Completed	Phillip Brian Smith	Phase 1	2009-10-01	This is a phase I open label multi-dose study to investigate the pharmacokinetics and safety of piperacillin-tazobactam in infants < 61 days of age with suspected sepsis. There will be four cohorts of 8 infants each: 1. < 32 weeks gestational age (GA) and < 14 days postnatal age (PNA) 2. < 32 weeks gestational age and >=14 days postnatal age 3. >=32 weeks gestational age and < 14 days postnatal age 4. >=32 weeks gestational age and >=14 days postnatal age. The study requires administration of 6 doses of study drug along with other antimicrobials per standard of care followed by 1 week of safety monitoring. Four 200 µL pK samples will be obtained at steady state. The risks are reasonable vs. the benefits and have been minimized appropriately. There may be benefit to the subjects (administration of broad spectrum empirical antimicrobial therapy), and information from the study may benefit a large number of other infants in whom the drug is currently being administered despite the lack of PK data in this population.
NCT01370616 ↗	Ertapenem Sodium (MK-0826) Versus Piperacillin/Tazobactam Sodium for the Treatment of Diabetic Foot Infections in Chinese Adults (MK-0826-061)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2011-09-02	This study compared ertapenem sodium to piperacillin/tazobactam sodium for the treatment of moderate to severe diabetic foot infections. The primary hypothesis was that treatment with ertapenem sodium is non-inferior to treatment with piperacillin/tazobactam sodium, in achieving clinical improvement or cure.
NCT01760109 ↗	Piperacillin Sodium and Sulbactam Sodium for Injection(2:1) for Treatment of Respiratory and Urinary System Infection	Completed	Xiangbei Welman Pharmaceutical Co., Ltd	Phase 4	2011-07-01	In the proposed study, the investigators plan to evaluate the efficacy and safety of Piperacillin Sodium and Sulbactam Sodium for Injection(2:1) for the treatment of respiratory and urinary tract acute bacterial infection.
NCT01805856 ↗	Antimicrobial Prophylaxis in Thyroid and Parathyroid Surgery	Completed	Ito Hospital	N/A	2010-11-01	The effectiveness of antimicrobial prophylaxis (AMP) for prevention of surgical site infection (SSI) following thyroid and parathyroid surgery remains uncertain. Present prospective randomized control study (Ito-RCT1) assessed the effectiveness of AMP in clean neck surgery associated with thyroid and parathyroid disease.

Clinical Trial Conditions for piperacillin sodium

Condition Name

Condition Name for piperacillin sodium
Intervention	Trials
Respiratory Tract Infections	2
Infection	2
Urinary Tract Infections	2
Bone Marrow Suppression	1

Condition MeSH

Condition MeSH for piperacillin sodium
Intervention	Trials
Infections	5
Infection	5
Communicable Diseases	5
Urinary Tract Infections	2

Clinical Trial Locations for piperacillin sodium

Trials by Country

Trials by Country for piperacillin sodium
Location	Trials
United States	7
Canada	2
China	2
Israel	1
Turkey	1

Trials by US State

Trials by US State for piperacillin sodium
Location	Trials
Texas	1
North Carolina	1
Missouri	1
Kansas	1
Indiana	1

Clinical Trial Progress for piperacillin sodium

Clinical Trial Phase

Clinical Trial Phase for piperacillin sodium
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	3
Phase 2	2

Clinical Trial Status

Clinical Trial Status for piperacillin sodium
Clinical Trial Phase	Trials
Completed	7
Unknown status	3
Not yet recruiting	1

Clinical Trial Sponsors for piperacillin sodium

Sponsor Name

Sponsor Name for piperacillin sodium
Sponsor	Trials
Merck Sharp & Dohme Corp.	2
Xiangbei Welman Pharmaceutical Co., Ltd	2
Phillip Brian Smith	1

Sponsor Type

Sponsor Type for piperacillin sodium
Sponsor	Trials
Other	9
Industry	4

Clinical Trials Update, Market Analysis, and Projection for Piperacillin Sodium

Last updated: October 28, 2025

Introduction

Piperacillin Sodium, a widely used broad-spectrum β-lactam antibiotic, plays a critical role in managing severe bacterial infections, particularly in conjunction with β-lactamase inhibitors such as tazobactam. Its efficacy against Pseudomonas aeruginosa, Enterobacteriaceae, and other Gram-negative bacilli positions it as a primary choice in hospital-acquired infections, neoplastic conditions, and immunocompromised patients. As antimicrobial resistance escalates globally, evaluating the clinical trial landscape and market dynamics for Piperacillin Sodium offers vital insights for stakeholders.

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Clinical Trials Landscape for Piperacillin Sodium

Current Clinical Trials and Developments

The clinical development pipeline for Piperacillin Sodium centers mainly on optimizing formulations, combination therapies, and addressing resistance patterns. According to ClinicalTrials.gov, as of Q1 2023, there are over 15 active or recruiting trials globally exploring:

• Combination therapies with β-lactamase inhibitors for resistant infections.
• Enhanced formulations for improved pharmacokinetics and reduced dosing frequency.
• Empirical therapy evaluations in specialized populations such as pediatrics and immunocompromised hosts.
• Resistance mechanism studies to understand evolving bacterial defenses.

For instance, a trial registered under NCT04586789 investigates the efficacy of Piperacillin-Tazobactam combined with novel β-lactamase inhibitors against multidrug-resistant Enterobacteriaceae. Importantly, these trials reflect an ongoing effort to combat rising antimicrobial resistance, which threatens Piperacillin Sodium’s continued clinical utility.

Regulatory Approvals and Perspectives

While Piperacillin Sodium has been FDA-approved since the 1980s, newer formulations and combination strategies are under review. The European Medicines Agency (EMA) has recently endorsed the expanded use of Piperacillin-Tazobactam in pediatric populations, indicating regulatory support for novel indications and formulations. Ongoing phase IV studies aim to establish post-marketing safety and efficacy in diverse clinical settings, crucial for maintaining its market position.

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Market Analysis of Piperacillin Sodium

Current Market Size and Segmentation

The global antibiotics market, estimated at approximately USD 48 billion in 2022, encompasses Piperacillin Sodium as a prominent player within the hospital antibiotics segment. The bulk of the sales derives from applications in hospital-acquired pneumonia, intra-abdominal infections, and sepsis. The Asia-Pacific region exhibits rapid growth due to expanding healthcare infrastructure and a rising burden of infectious diseases.

Key players include renowned pharmaceutical firms such as Pfizer (tazobactam combination products), Baxter, and Sandoz. Pfizer’s prolonged presence in this space is reinforced by its patent protections and aggressive marketing strategies. However, patent expiries and the emergence of biosimilars threaten revenue stability.

Driving Factors and Challenges

Drivers:

• Rising prevalence of multidrug-resistant infections, particularly in intensive care units, sustains demand.
• Expanding hospitalizations for infectious diseases.
• Clinical guideline endorsements advocating Piperacillin-Tazobactam as first-line empiric therapy.

Challenges:

• Antimicrobial resistance (AMR) reduces drug efficacy over time, prompting development of new agents.
• Regulatory scrutiny over antimicrobial stewardship, impacting prescribing patterns.
• Pricing pressures associated with biosimilar entrants and generic versions.

Market Projections (2023–2030)

Analysts project that the global Piperacillin Sodium market will grow at a compounded annual growth rate (CAGR) of approximately 4.2% over the next seven years, reaching USD 2.7 billion by 2030. This growth trajectory hinges on:

• Increased adoption of Piperacillin-Tazobactam in both developed and emerging markets.
• Innovations in formulations and combination therapies to circumvent resistance.
• Rising investments in antimicrobial research and development (R&D).

Emerging areas such as biomarker-guided therapy and personalized medicine are expected to refine Piperacillin Sodium’s clinical application, further expanding market avenues.

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Market Opportunities and Strategic Outlook

Innovation and Product Extensions

The development of novel β-lactamase inhibitors in combination with Piperacillin Sodium represents a promising frontier. Several pipeline candidates aim to restore efficacy against resistant strains, thereby extending Piperacillin’s lifecycle. Strategic collaborations and licensing agreements are vital for pharmaceutical firms seeking to stay competitive.

Regulatory and Policy Environment

Adopting stringent antimicrobial stewardship programs worldwide can influence treatment protocols, necessitating continuous evidence generation to support optimal use of Piperacillin Sodium. Navigating diverse regulatory landscapes requires tailored approaches, especially in markets with strict approval processes.

Competitive Dynamics

The ascent of biosimilars and generics poses both threats and opportunities. While cheaper options may pressure pricing, quality assurance and clinical differentiation can sustain premium positioning. Investment in R&D to enhance formulations (e.g., long-acting preparations) can also help maintain market share.

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Conclusion

Piperacillin Sodium remains a cornerstone antibiotic with robust clinical utility and significant market presence. Its future, however, depends on navigating the complex landscape of antimicrobial resistance, regulatory adaptations, and innovation integration. Ongoing clinical trials focusing on combination therapies and formulations will strongly influence its efficacy and market longevity.

Key Takeaways

• The clinical development pipeline emphasizes combating antimicrobial resistance through novel combination therapies and formulations.
• The global market is projected to grow at over 4% CAGR, driven by rising infections in healthcare settings and expanded indications.
• Strategic investments in R&D, regulatory navigation, and partnerships are essential to sustain Piperacillin Sodium's market relevance.
• Resistance management remains a significant challenge; addressing it through innovation is critical.
• Stakeholders should monitor emerging clinical trial data and policy changes to optimize portfolio strategies.

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FAQs

1. How does antimicrobial resistance impact the future use of Piperacillin Sodium?
Rising resistance, especially among Gram-negative bacteria, diminishes Piperacillin Sodium’s efficacy. Developing combination therapies with new β-lactamase inhibitors and stewardship efforts are vital to prolong its clinical relevance.

2. Are there ongoing clinical trials exploring new formulations of Piperacillin Sodium?
Yes, several trials are investigating long-acting formulations, improved delivery systems, and combination therapies aimed at enhancing pharmacokinetics and efficacy.

3. What are the primary markets driving Piperacillin Sodium sales?
The United States, Europe, and emerging markets in Asia-Pacific are the principal drivers, owing to high healthcare expenditure, infection prevalence, and expanding hospital infrastructure.

4. How might biosimilars and generics influence Piperacillin Sodium’s market share?
They could exert downward pressure on pricing and margins. Differentiation through formulation innovations and clinical value will be necessary to sustain premium positioning.

5. What role does regulatory policy play in shaping the Piperacillin Sodium market?
Regulatory agencies influence approval pathways, labeling, and stewardship guidelines. Proactive engagement with regulators ensures timely approvals and aligns clinical development with legislative expectations.

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References:

[1] ClinicalTrials.gov. "Trials Investigating Piperacillin-Tazobactam," 2023.
[2] Pfizer Inc. Corporate Data on Piperacillin-Tazobactam, 2022.
[3] Markets and Markets. "Antibiotics Market Forecast." 2023.
[4] EMA. "Piperacillin-Tazobactam Expanded Use," 2022.