CLINICAL TRIALS PROFILE FOR PIPERACILLIN

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.

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.
NCT00130754 ↗	Thymoglobuline in Non-myeloablative Allogeneic Stem-cell Transplantation	Completed	Hadassah Medical Organization	Phase 3	2005-02-01	Allogeneic stem cell transplantation is the treatment of choice for a growing number of malignant and non-malignant indications. Until recently, myeloablative in conjunction with immunosuppressive conditioning was considered mandatory for the elimination of malignant hematopoietic cells and to prevent graft rejection. The aim of allogeneic non-myeloablative stem cell transplantation (NST) is to induce host-to-graft tolerance with fast and durable engraftment of donor stem cells, by means of conditioning, which is well-tolerated by patients. The rationale behind the NST strategy is to induce optimal graft-versus-leukemia (GVL) effects for the elimination of all malignant cells by alloreactive immunocompetent cells from a matched donor as an alternative to standard high-dose myeloablative chemo radiotherapy. The NST protocol is therefore mainly based on immunosuppression and thus contains fludarabine, low dose busulfan and anti-T-lymphocyte globulin (ATG). Thymoglobuline is a polyclonal rabbit antiserum specific for human T cells used in organ transplantation for induction of tolerance and rejection prevention and treatment. It was also used in stem-cell transplantation (SCT) for the same purposes (e.g. for generation of tolerance and rejection preclusion) as well as a treatment for graft-versus-host disease (GVHD). Data from myeloablative protocols suggest that ATG before SCT significantly reduces the risk for grade III-IV acute GVHD. This does not translate to a reduction in transplant-related mortality (TRM) because of the increased risk for infections and thus survival is unchanged. Extensive chronic GVHD was also significantly shown to be reduced in patients receiving ATG in the myeloablative setting. However, the role of ATG in the NST protocol was never evaluated in a prospective randomized trial. In view of the preliminary data suggesting of an additive effect of ATG in these circumstances we, the investigators at Hadassah Medical Organization, evaluate the effect of ATG in NST by a prospective randomized trial.
NCT00167999 ↗	Study Evaluating Piperacillin-Tazobactam on Certain Bacteria in Hematology and Oncology Units	Completed	Wyeth is now a wholly owned subsidiary of Pfizer		2005-02-01	To determine the value of increasing use of piperacillin/tazobactam as empiric therapy and restricting extended-spectrum cephalosporins in reducing the cases of ESBL producing Escherichia coli and Klebsiella pneumoniae in hematology and oncology units
NCT00195286 ↗	Study Evaluating Piperacillin/Tazobactam in Complicated Urinary Infections.	Completed	Wyeth is now a wholly owned subsidiary of Pfizer		2004-06-01	The primary objective is to study the efficacy of piperacillin/tazobactam in patients with complicated urinary tract infections

Clinical Trial Conditions for Piperacillin

Condition Name

Condition Name for Piperacillin
Intervention	Trials
Sepsis	6
Pneumonia	5
Septic Shock	5
Urinary Tract Infections	4

Condition MeSH

Condition MeSH for Piperacillin
Intervention	Trials
Infections	28
Infection	25
Communicable Diseases	19
Pneumonia	11

Clinical Trial Locations for Piperacillin

Trials by Country

Trials by Country for Piperacillin
Location	Trials
United States	122
China	28
Italy	16
Canada	15
Germany	15

Trials by US State

Trials by US State for Piperacillin
Location	Trials
Texas	8
Florida	8
California	7
Missouri	6
Ohio	5

Clinical Trial Progress for Piperacillin

Clinical Trial Phase

Clinical Trial Phase for Piperacillin
Clinical Trial Phase	Trials
PHASE4	6
PHASE3	1
PHASE1	1

Clinical Trial Status

Clinical Trial Status for Piperacillin
Clinical Trial Phase	Trials
Completed	48
Unknown status	14
RECRUITING	13

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

Sponsor Type

Sponsor Type for Piperacillin
Sponsor	Trials
Other	182
Industry	47
UNKNOWN	3

Piperacillin (Systemic): Clinical Trials Update and Market Outlook

Last updated: April 26, 2026

What is piperacillin’s current clinical trial footprint?

Piperacillin is an established, off-patent beta-lactam antibiotic (typically used with tazobactam). As a result, the clinical-development pipeline is dominated by:

• formulation work (e.g., stability, compatibility, manufacturing)
• comparative effectiveness studies
• new combinations and resistance-driven stewardship trials
• pediatric dosing, PK/PD, and dose-optimization studies rather than new “brand-new” mechanism development

A complete, up-to-date “clinical trials update” requires a live registry pull (ClinicalTrials.gov/WHO ICTRP) with inclusion filters (recruiting, active, completed; interventional vs observational; geography). No such dataset is provided here, so a fully accurate trial-by-trial update cannot be produced.

What is the market structure for piperacillin-based therapy?

Piperacillin is primarily sold and used as:

• piperacillin/tazobactam (pip-tazo) for hospitalized infections
• a smaller share of uses where piperacillin alone is clinically selected (less common than combination use in modern hospital formularies)

Market economics are driven by:

• hospital purchasing cycles and tender contracts
• antimicrobial stewardship protocols
• formulary positioning versus carbapenems and cephalosporins
• antimicrobial resistance patterns and local antibiograms
• pricing pressure from generics and biosimilar-like competitive dynamics in injectables (generic dominance)

Market drivers and constraints

Factor	Impact on demand	Typical mechanism
Hospital-acquired infections (HAI) incidence	Positive	Empiric coverage need supports pip-tazo utilization
Carbapenem-sparing stewardship	Positive	Pip-tazo used to reduce carbapenem use when susceptibility supports it
Resistance and spectrum narrowing	Negative	Rising ESBL prevalence can shift use toward carbapenems in some settings
Generic pricing	Negative to margins	Competitive tendering reduces unit pricing
Supply continuity risk	Mixed	Injectable shortages can cause temporary substitution dynamics

Pricing and competitive set (high level)

Piperacillin’s commercial position is usually assessed against:

• cefepime
• ceftriaxone
• meropenem and imipenem
• piperacillin/tazobactam generics and authorized equivalents (core category competition)
• local national champions and distribution agreements

A numeric market size, revenue split, and forecast requires a market intelligence base that is not provided here; without it, a credible projection cannot be stated.

How should an investor or R&D team project future demand for piperacillin?

With piperacillin’s mature status and patent-out position, demand projection is mostly a function of utilization rates and guideline adherence rather than a new clinical-efficacy breakthrough.

A practical projection framework should model:

1. Hospital infection admissions and case mix (drivers: adult and critical care volumes)
2. Antimicrobial guideline share for pip-tazo as empiric therapy
3. Susceptibility distributions (ESBL and Pseudomonas resistance trends)
4. Stewardship targets (carbapenem-sparing proportion)
5. Generic price erosion and contract structure

Utilization scenario logic (non-novel, executable)

• If carbapenem-sparing policies remain stable and local susceptibility supports pip-tazo, utilization should hold or rise slightly.
• If ESBL and resistant Gram-negative burden rises enough to shift empirical therapy away from pip-tazo, utilization declines despite stable admission volumes.
• If reimbursement or hospital tendering favors lowest acquisition cost, generic pip-tazo can retain demand even when clinical nuance varies by region.

What are the key clinical endpoints that still matter for piperacillin?

Even when development is not “novel,” most studies cluster around endpoints that affect stewardship and switching decisions:

• time to clinical response (fever resolution or symptom improvement)
• microbiological eradication rates
• length of stay (LOS) impact in real-world settings
• safety and tolerability (especially renal effects in broad hospitalized populations)
• dosing optimization (PK/PD targets, prolonged infusion strategies where applicable)

Are there any notable regulatory or safety themes affecting use?

Piperacillin-class antibiotics are long-established. Ongoing safety themes are usually about:

• hypersensitivity and anaphylaxis risk
• renal function adjustments in hospitalized populations
• electrolyte effects and seizure risk at high exposures (rare, but monitored in labeling contexts)
• interactions driven by broad hospital co-medication patterns

A “clinical trials update” that ties to post-marketing safety signals requires a labeling revision log and pharmacovigilance signal review, which is not provided here.

What can be concluded for market projection without a new pipeline catalyst?

Because piperacillin is not positioned like a late-stage, high-risk development asset, the highest-confidence projection approach is utilization plus pricing and contract modeling. Without a live trial registry and without market sizing inputs, only directional logic can be asserted, not quantified forecasts.

Demand vs price levers

Lever	Direction	Likely magnitude driver
Demand (cases treated)	Stable to modest up/down	Stewardship and local resistance shifts
Price per dose	Down over time	Generic competition and tender renegotiations
Mix (monotherapy vs combination)	Depends on guideline	Pip-tazo generally dominates hospital use
Product continuity	Volatility possible	Manufacturing and distribution constraints in injectables

Where do clinical studies typically concentrate for piperacillin today?

In practice, piperacillin activity remains concentrated in:

• empiric therapy comparisons in hospital syndromic pathways
• pediatric dosing and PK/PD
• special populations (renal impairment, ICU)
• infusion strategy comparisons (e.g., prolonged vs standard infusion) when relevant to outcomes
• resistance-informed observational or pragmatic trials

A fully accurate “current clinical trials update” listing specific studies, statuses, and results requires a current registry snapshot, which is not included in the input for this task.

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Key Takeaways

• Piperacillin’s clinical and commercial story is dominated by mature use patterns and stewardship-driven utilization, not new mechanism breakthroughs.
• A credible clinical trials update and a quantified market projection require live registry and market sizing data; those inputs are not provided here.
• Forward demand is most sensitive to local resistance trends, guideline carbapenem-sparing behavior, and generic tender pricing dynamics.
• Remaining clinical research focus is typically dose optimization, PK/PD, infusion strategy, and comparative effectiveness in hospitalized syndromic care.

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FAQs

1) Is piperacillin still actively developed?

Yes in practice, but activity skews toward formulation, dosing optimization, and comparative or stewardship-linked studies, not new mechanism innovation.

2) Does piperacillin compete mainly with carbapenems?

Yes in hospital empiric and escalation pathways, pip-tazo is often benchmarked against meropenem/imipenem under resistance and guideline constraints.

3) What most affects pip-tazo utilization?

Local susceptibility patterns, ESBL prevalence, and antimicrobial stewardship policies that target carbapenem-sparing while maintaining clinical coverage.

4) What drives pricing and margin pressure?

Generic competition and hospital tendering typically drive price erosion, making margin less about patent protection and more about contract execution and supply continuity.

5) What endpoints matter most for continued evidence generation?

Outcomes tied to stewardship decisions: clinical response timing, microbiological eradication, safety in broad inpatient populations, and LOS or switching outcomes in pragmatic settings.

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References

[1] U.S. Food and Drug Administration. Piperacillin and tazobactam prescribing information (labeling for clinical use and safety information).
[2] European Medicines Agency (EMA). Assessment history and product information for piperacillin/tazobactam and related authorized products.
[3] World Health Organization. WHO Model List of Essential Medicines (beta-lactam antibiotics used in hospital care).
[4] ClinicalTrials.gov. Piperacillin and piperacillin/tazobactam study records (registry snapshot required for a complete “clinical trials update”).