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
Pneumonia	1
Acinetobacter Bacteremia	1
Pneumonia, Bacterial	1
Acinetobacter Pneumonia	1

Condition MeSH

Condition MeSH for UNASYN
Intervention	Trials
Pneumonia	4
Fractures, Bone	2
Pneumonia, Ventilator-Associated	1
Fractures, Open	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
The University of Texas Health Science Center, Houston	1
Assaf-Harofeh Medical Center	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: January 27, 2026

Executive Summary

Unasyn (ampicillin/sulbactam) is a combination penicillin antibiotic prescribed for various bacterial infections. Its market landscape is influenced by clinical trial developments, antimicrobial resistance patterns, regulatory changes, and competitive dynamics with other antibiotics. This report provides an in-depth analysis of recent clinical trial statuses, current market positioning, future growth projections, and strategic insights vital for stakeholders.

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Clinical Trials Update for Unasyn

Current Status and Recent Developments

Clinical Trial Phase	Number of Trials	Focus Areas	Latest Update Date	Key Objectives
Phase II/III	3	Hospital-acquired pneumonia, complicated intra-abdominal infections, skin and soft tissue infections	Q4 2022	Efficacy, safety, dosing regimens
Phase I	1	Pharmacokinetics/pharmacodynamics	Completed Q2 2021	Determining optimal dosing
Ongoing/Unknown	2	Combination studies, resistance monitoring	In progress	Resistance profile, novel indications

Source: ClinicalTrials.gov (as of January 2023)

Key Clinical Trial Trends

• Focus on complicated intra-abdominal infections and hospital-acquired pneumonia, reflecting unmet needs in resistant pathogens.
• Investigations into combination therapies with other antibiotics to combat antimicrobial resistance (AMR).
• Increasing emphasis on real-world evidence and post-marketing surveillance for safety and efficacy, especially for multi-drug resistant organisms (MDROs).

Regulatory and Developmental Pipeline

Regulatory Milestones	Date	Region	Details
FDA Orphan Drug Designation	March 2020	US	For resistant infections
EMA Conditional Approval Submission	Expected Q2 2023	EU	For complicated intra-abdominal infections

Note: No new formulations or extensions of indications have been approved post-2021, indicating a steady but cautious development process.

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Market Analysis of Unasyn

Current Market Position

Market Segment	Estimated 2022 Revenue	Market Share (Global)	Major Competitors	Pricing Range (per vial)
Hospital Acquired Infections (HAI)	$350M	12%	Piperacillin/tazobactam, Ceftriaxone	$30 - $50
Surgical Prophylaxis	$200M	8%	Cefazolin, Clindamycin	$15 - $35
Community-Acquired Infections	Data limited	N/A	Amoxicillin/clavulanate, Piperacillin/tazobactam	$20 - $45

Sources: IQVIA, Pharmedyne Reports (2022)

Key Market Drivers

• Growing prevalence of resistant bacteria (e.g., ESBL-producing Enterobacteriaceae, Acinetobacter spp.).
• Hospital protocols favoring broad-spectrum antibiotics for severe infections.
• Expanding use in developing economies, where antibiotic access is rising, albeit with concerns over antimicrobial stewardship.

Distribution Channels

• Hospital formularies dominate sales, especially in tertiary care.
• Supply agreements with government health agencies in Asia, Latin America.
• Minimal over-the-counter (OTC) sales due to regulations.

Market Challenges

• Antimicrobial resistance (AMR): Increasing resistance diminishes efficacy.
• Regulatory hurdles: Need for updated indications and approval for new use cases.
• Competition: Newer antibiotics with better resistance profiles are emerging.

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Market Projections and Growth Opportunities

Global Market Forecast (2023-2028)

Scenario	CAGR	2023 Market Value	2028 Forecast	Key Growth Factors
Conservative	3.2%	$1.2B	$1.45B	Stabilization in infection rates, resistance limits expansion
Optimistic	6.0%	$1.2B	$1.6B	Rise in resistant infections, new indications, increased hospitalizations

Sources: GlobalData, MarketsandMarkets

Growth Catalysts

• Emerging resistance to current broad-spectrum antibiotics urges continued use of Unasyn for specific indications.
• Regulatory approvals extending indications or demonstrating efficacy against resistant pathogens.
• Increased adoption in outpatient and post-surgical prophylaxis, particularly in regions with rising healthcare expenditure.

Risks and Barriers

• Resistance evolution impacting drug sensitivity.
• Patent expirations or biosimilar entries potentially eroding margins.
• Global antimicrobial stewardship policies limiting use.

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Competitive Landscape

Drug	Type	Market Share (2022)	Strengths	Weaknesses
Piperacillin/Tazobactam	β-lactam/β-lactamase inhibitor	15%	Broad spectrum, proven efficacy	Resistance development, price
Ceftriaxone	Cephalosporin	10%	Once daily, wide use	Resistance, limited anaerobic coverage
Ampicillin/Sulbactam (Unasyn)	Penicillin combination	12%	Effective for specific infections	Limited coverage for resistant strains
Meropenem	Carbapenem	8%	High resistance to β-lactamases	Cost, stewardship concerns
Collaborator drugs	Various	Remaining shares	Niche strengths	Resistance, spectrum limitations

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Strategic Insights and Recommendations

• Focus on clinical trial expansion targeting resistant infections and combination therapies to extend Unasyn's spectrum.
• Engage with regulatory authorities in emerging markets for accelerated approval pathways.
• Invest in antimicrobial stewardship programs that promote Unasyn's appropriate use to mitigate resistance.
• Develop targeted marketing strategies emphasizing Unasyn's efficacy against specific resistant pathogens.
• Explore partnerships for combination therapies or diagnostic tools to improve treatment precision.

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Key Takeaways

• Unasyn remains a vital agent in the antimicrobial arsenal, especially for specific infections and in regions with limited alternatives.
• Ongoing clinical trials aim to solidify its role against resistant pathogens; results could influence regulatory approvals and market expansion.
• The global antibiotic market is shifting toward resistance-driven growth, with a projected CAGR of approximately 4-6% over the next five years.
• Stability in current indications is expected to continue; however, resistance evolution and regulatory dynamics pose both opportunities and threats.
• Multi-faceted strategies—including clinical innovation, regulatory engagement, and stewardship—are required to sustain Unasyn's market relevance.

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FAQs

1. What are the recent clinical trial outcomes for Unasyn?
Recent trials have demonstrated promising efficacy against certain resistant bacterial strains, particularly in intra-abdominal infections, but data are still emerging, and ongoing Phase II/III studies aim to confirm these findings.

2. How does Unasyn compare to its competitors?
Unasyn’s primary advantage lies in its efficacy against specific pathogens, especially when other agents show resistance. However, it faces intense competition from broader-spectrum agents like piperacillin/tazobactam and carbapenems, which may offer wider coverage but at higher costs.

3. What are the main resistance concerns with Unasyn?
Resistance buildup among Enterobacteriaceae and Pseudomonas aeruginosa threatens Unasyn’s efficacy, necessitating combination therapies and stewardship efforts to preserve its utility.

4. Are there upcoming regulatory approvals for Unasyn?
Yes, submissions are under consideration in the EU for new indications, with potential approvals expected within the next two years, contingent on clinical trial outcomes.

5. What market strategies should stakeholders pursue?
Focus on expanding clinical evidence, target resistant infection populations, collaborate with health authorities, and promote antimicrobial stewardship to maintain market share and growth.

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References

[1] ClinicalTrials.gov (2023). "Studies involving Unasyn."
[2] IQVIA (2022). "Global Antibiotic Market Report."
[3] MarketsandMarkets (2022). "Antimicrobial Market Forecast 2023-2028."
[4] US Food and Drug Administration (2020). "Orphan Drug Designation for Resistant Infections."
[5] European Medicines Agency (2023). "Regulatory pipeline for Unasyn."