CLINICAL TRIALS PROFILE FOR UNASYN

All Clinical Trials for Unasyn

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00760006 ↗	Preventing Complications in Cleft Palate Repair With Antibiotics	Completed	Children's Hospital of Pittsburgh	Phase 2	2008-05-01	The primary objective of this study is to determine the efficacy of administering a single dose of preoperative antibiotics to prevent complications in patients undergoing primary closure of a cleft secondary palate. Secondary objective of this study is to evaluate the effects of preoperative antibiotics administered on post operative outcome following primary closure of cleft secondary palate. The study aims to assess the efficacy of prophylactic antibiotics in cleft surgery to - decrease the incidence of surgical sight infections - speed the progression of postoperative healing - improve the final quality of wound healing achieved - decrease the rate of palatal fistula formation
NCT00760006 ↗	Preventing Complications in Cleft Palate Repair With Antibiotics	Completed	Joseph Losee	Phase 2	2008-05-01	The primary objective of this study is to determine the efficacy of administering a single dose of preoperative antibiotics to prevent complications in patients undergoing primary closure of a cleft secondary palate. Secondary objective of this study is to evaluate the effects of preoperative antibiotics administered on post operative outcome following primary closure of cleft secondary palate. The study aims to assess the efficacy of prophylactic antibiotics in cleft surgery to - decrease the incidence of surgical sight infections - speed the progression of postoperative healing - improve the final quality of wound healing achieved - decrease the rate of palatal fistula formation
NCT00879190 ↗	Ampicillin / Sulbactam vs. Ampicillin / Gentamicin for Treatment of Chorioamnionitis	Completed	Stanford University	Phase 2/Phase 3	2009-05-01	Chorioamnionitis is an infection of the placenta and amniotic membranes (bag of waters) surrounding the baby inside of a pregnant woman prior to delivery. This infection is somewhat common and is routinely treated with antibiotics given to the mother both before and after the baby is born. Currently it is not known what is the best choice of antibiotics to treat this type of infection, but commonly used treatments include Unasyn (ampicillin/sulbactam) or ampicillin/gentamicin. We plan to compare these two different antibiotic regimens to see if one is better than the other at treating and preventing bad outcomes from chorioamnionitis in women and babies.
NCT01118403 ↗	Antibiotic Prophylaxis for Early Ventilator-associated Pneumonia in Neurological Patients	Withdrawn	Hospital Pablo Tobón Uribe	Phase 4	2011-03-01	This study seeks to assess whether coma patients really benefit from the use of antibiotics as a prophylactic for reducing the incidence of early ventilator-associated pneumonia in this population group. For this we consider the use of ampicillin sulbactam antibiotic which has a low ability to induce resistance, efficacy and safety observed during the time that has been used, even in patients with neurosurgical pathology, and to be broadly available in our environment. Our hypothesis is that neurological patients in coma state, requiring mechanical ventilation, the application of antibiotic prophylaxis compared with placebo reduces the incidence of early ventilator-associated pneumonia.
NCT01189487 ↗	The Study of Unasyn-S 12g/Day for Community Acquired Pneumonia (CAP)	Completed	Pfizer	Phase 3	2010-10-01	Unasyn-S 12g/day (3 g four times a day) is the commonly used dosage depending on the severity for US, EU, China, Taiwan and Korea for over 20 years, however, Unasyn-S 12g/day has not yet been approved in Japan. The purpose of this trial is to evaluate the clinical efficacy and safety in Japanese adult subjects with community acquired pneumonia receiving ampicillin sodium/sulbactam sodium, 12g/day (3 g four times a day ) IV.
NCT01793688 ↗	Special Use-Result Surveillance of Unasyn-S (Kit) for Intravenous Use - A Surveillance on High-dose (>6 g Daily) Administration -	Completed	Pfizer		2013-03-12	The purpose of the survey is to study the followings under practical use, regarding the safety and effectiveness in high-dose administration (exceeding 6 g per day) of UNASYN-S and UNASYN-S KIT for intravenous use (UNASYN). 1. Adverse Drug Reaction(s) that cannot be expected from precautions (Unexpected Adverse Drug Reaction) 2. Incidence status of adverse drug reactions 3. Factors that may affect the safety and effectiveness

Clinical Trial Conditions for Unasyn

Condition Name

Condition Name for Unasyn
Intervention	Trials
Acinetobacter Bacteremia	1
Pneumonia, Bacterial	1
Acinetobacter Pneumonia	1
Post-Op Wound Infection	1

Condition MeSH

Condition MeSH for Unasyn
Intervention	Trials
Pneumonia	4
Fractures, Bone	2
Bacterial Infections	1
Bacteremia	1

Clinical Trial Locations for Unasyn

Trials by Country

Trials by Country for Unasyn
Location	Trials
Japan	15
United States	4
Colombia	1

Trials by US State

Trials by US State for Unasyn
Location	Trials
Texas	1
Ohio	1
California	1
Pennsylvania	1

Clinical Trial Progress for Unasyn

Clinical Trial Phase

Clinical Trial Phase for Unasyn
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	1
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Unasyn
Clinical Trial Phase	Trials
Completed	4
Withdrawn	1
Not yet recruiting	1

Clinical Trial Sponsors for Unasyn

Sponsor Name

Sponsor Name for Unasyn
Sponsor	Trials
Pfizer	2
Assaf-Harofeh Medical Center	1
Monaldi Hospital	1

Sponsor Type

Sponsor Type for Unasyn
Sponsor	Trials
Other	12
Industry	2

Clinical Trials Update, Market Analysis, and Projection for Unasyn (Ampicillin/Sulbactam)

Last updated: October 28, 2025

Introduction

Unasyn (ampicillin/sulbactam) is a combination antibacterial agent approved for the treatment of various bacterial infections, notably respiratory tract infections, skin and soft tissue infections, and intra-abdominal infections. As a broad-spectrum antibiotic combining a penicillin derivative with a β-lactamase inhibitor, Unasyn has maintained a critical role in infectious disease management. This article provides a comprehensive update on its clinical trial landscape, market dynamics, and future projections, assisting industry stakeholders in strategic decision-making.

Clinical Trials Landscape: Recent Developments and Ongoing Research

Current Clinical Trial Status

Unasyn’s primary indications are well-established based on decades of clinical use, with limited recent trials solely focused on its efficacy profile. However, emerging research aims to optimize its application, address resistance challenges, and explore novel formulations.

According to ClinicalTrials.gov, less than ten active clinical trials involve Unasyn globally, with studies primarily centered around:

• Combination therapy effectiveness in multidrug-resistant infections.
• Pediatric and immunocompromised patient populations.
• Comparative efficacy studies against newer antibiotics in hospital settings.

Innovations and Formulation Advances

Recent research efforts have targeted alternative formulations with extended-release properties to improve patient adherence and therapeutic efficiency. These studies face regulatory scrutiny, with several in preclinical or early-phase clinical stages.

Antimicrobial Resistance (AMR) and Clinical Trials

A significant area of clinical inquiry involves Unasyn's role amid rising β-lactamase-producing bacteria. While no large-scale trials are assessing Unasyn as monotherapy for resistant strains, ongoing studies consider its combination with other agents for resistant infections.

Regulatory and Post-Marketing Surveillance

Despite its age, Unasyn benefits from ongoing post-marketing data collection, particularly regarding safety in vulnerable groups. While recent trials are limited, surveillance studies reinforce its safety profile, focusing on adverse events, resistance trends, and pharmacokinetics.

Market Analysis

Global Market Size and Segmentation

The global antibacterial drug market was valued at approximately USD 41.8 billion in 2022, expected to reach USD 58.9 billion by 2030, with antibiotics accounting for a significant share [1].

Unasyn occupies a niche within this broader market, particularly in hospital settings, due to its broad-spectrum activity and intravenous administration. The segment’s key drivers include:

• Hospital-acquired infections (HAIs).
• Use in immunocompromised hosts.
• Increased prevalence of multidrug-resistant organisms.

Key Market Players and Competitive Landscape

Although Unasyn remains a branded product under Pfizer, its competitive landscape includes generic formulations of ampicillin/sulbactam from other manufacturers like Sandoz and Teva. The market faces competition from newer β-lactam/β-lactamase inhibitor combinations (e.g., piperacillin-tazobactam, ticarcillin-clavulanate).

Pfizer’s extensive distribution network and established clinician relationships support Unasyn’s market position, particularly in North America and Europe. However, emerging markets present growth opportunities due to increasing infectious disease burdens.

Regulatory and Reimbursement Environment

Unasyn benefits from broad regulatory approval, including FDA and EMA, with reimbursement largely aligned with hospital formularies. The ongoing threat of antimicrobial resistance may influence formulary preferences, emphasizing the need for stewardship programs to optimize Unasyn's utilization.

Pricing Trends and Impact on Market Penetration

Pricing remains competitive: in the United States, the average wholesale price (AWP) for Unasyn is approximately USD 20-$50 per vial, depending on dosage. Cost considerations, especially compared to newer agents, influence prescribing patterns, with stewardship programs emphasizing judicious use.

Market Challenges

Key challenges include:

• Antimicrobial resistance diminishing efficacy.
• Limited innovation in formulations or indications.
• Potential shifts toward oral alternatives.
• Global antimicrobial stewardship policies restricting broad-spectrum antibiotic use.

Market Projection and Future Outlook

Growth Drivers

• Rising incidence of HAIs and resistant bacterial strains.
• Increased use of IV antibiotics in hospitals.
• Expanding healthcare infrastructure in emerging markets.

Potential Market Opportunities

• Expanded use in multidrug-resistant infections where Unasyn’s efficacy remains viable.
• Development of novel formulations to enhance efficacy or administration convenience.
• Inclusion in combination regimens for complex infections.

Forecast Summary (2023–2030)

Based on current trends, the Unasyn market is projected to grow at a compound annual growth rate (CAGR) of approximately 2.5% to 3.0%. Growth is expected to be more significant in emerging markets with expanding healthcare systems, despite competition from newer agents.

Risks to Growth

• Evolving antibiotic resistance may limit Unasyn's utility.
• Trend toward oral antibiotics for mild infections.
• Regulatory restrictions on broad-spectrum antibiotic use.
• Market saturation in saturated healthcare markets.

Strategic Recommendations

• Invest in clinical research exploring Unasyn’s role in resistant infections.
• Enhance stewardship and awareness programs to optimize utilization.
• Develop targeted formulations for specific infections or patient populations.
• Explore geographic expansion into underpenetrated markets.

Key Takeaways

• While Unasyn’s core clinical indications are well-established, ongoing trials focus primarily on resistance management and novel formulations, with limited large-scale studies.
• The global antibacterial market offers steady growth prospects; however, Unasyn faces intense competition from newer combination agents and formulary preferences shifting toward oral or targeted therapies.
• Market expansion in emerging economies remains promising, driven by rising infectious disease burdens and expanding healthcare infrastructure.
• Resistance trends pose a critical challenge, emphasizing the need for strategic stewardship, research, and formulation innovation.
• Overall, the Unasyn market is expected to sustain moderate growth, driven by hospital and complex infection demands, although it must navigate the hurdles posed by resistance and evolving therapeutic paradigms.

FAQs

1. What are the recent clinical trials involving Unasyn?
Recent trials are limited but focus on its efficacy against multidrug-resistant infections, pediatric use, and formulation improvements. No significant large-scale phase III trials are currently ongoing [2].

2. How does antimicrobial resistance impact Unasyn’s market?
Rising β-lactamase producing bacteria threaten Unasyn’s efficacy, prompting cautious use and limiting its application in resistant infections. Surveillance data reinforce the need for stewardship to preserve its utility [3].

3. What are the competitive advantages of Unasyn?
Its broad-spectrum activity, safety profile, and established clinical use provide stability. Its intravenous administration makes it suitable for hospital settings and severe infections.

4. Which markets are the most promising for Unasyn’s growth?
Emerging markets in Asia-Pacific and Latin America offer growth due to expanding healthcare infrastructure and infectious disease prevalence. North America and Europe remain mature but stable markets.

5. What future innovations could influence Unasyn’s market?
Development of extended-release formulations, novel combination regimens, and targeted indications for resistant infections could extend its market relevance, alongside updated stewardship practices.

References

[1] Grand View Research. "Antibacterial Drugs Market Size, Share & Trends Analysis" (2023).
[2] ClinicalTrials.gov. Trials involving Unasyn.
[3] Centers for Disease Control and Prevention. Antibiotic Resistance Threats Report (2022).