CLINICAL TRIALS PROFILE FOR AMPICILLIN SODIUM; SULBACTAM SODIUM

All Clinical Trials for AMPICILLIN SODIUM; SULBACTAM SODIUM

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT02482961 ↗	Impact of Plasma Levels of Colistin in Patients With Carbapenem Resistant Acinetobacter Baumannii Infection	Completed	DongGuk University		2015-05-01	This study purposed to examine the adequate range of therapeutic concentration for Korean people by observing curative effects, side effects, blood concentration, etc. in treating CRAB-infected patients with colistin.
NCT06650384 ↗	Efficacy and Safety of N-Acetylcysteine Versus Alpha-Lipoic Acid in Colistin-Induced Nephrotoxicity	RECRUITING	Ain Shams University	PHASE2	2024-11-01	Healthcare- associated infections that caused by multi-drug-resistant Gram-negative bacteria (MDR G-ve) represent the most important problem that face the critically ill patients in the ICU. The available broad-spectrum antibiotics as penicillin, fluoroquinolones, aminoglycosides, and -lactams fail to overcome these aggressive organisms. Accordingly, this led to the reconsideration of old drugs such as polymyxin B and polymyxin E (also known as colistin) that were previously considered to be too toxic for clinical use in the treatment of MDR G-ve bacteria. Colistin can be used as monotherapy or in combination with other antibiotics as high dose tigecycline, carbapenem or high-dose ampicillin/sulbactam. Colistin associated acute kidney injury (CA-AKI) is the frequently observed side effect in ICU patients treated with colistin that may lead to cessation of treatment. Accordingly, it is important to monitor renal functions prior to and during colistin treatment to detect the early signs of renal injury and minimize long term renal dysfunction. Inflammation with release of reactive oxygen species (ROS) can lead to renal tubular cells apoptosis. Several animal studies proved the beneficial effect of the concomitant use of antioxidants as N-acetylcysteine, alpha lipoic acid in preventing or attenuating colistin induced nephrotoxicity by their potent antioxidant effects Therefore, a clinical trial will be carried out to evaluate the efficacy and safety of N-acetylcysteine versus Alpha-lipoic acid in the prevention of colistin-induced nephrotoxicity in critically ill patients.
NCT06819592 ↗	PRophylaxis Against Early VENTilator-associated Infections in Acute Brain Injury	NOT_YET_RECRUITING	The George Institute	PHASE3	2025-10-01	This research is about whether treatment with a commonly used antibiotic can prevent infections in airway and lungs and improves the chance of surviving, if it is given soon after patients commence mechanical ventilation when they have been admitted to hospital with an acute severe brain injury. An acute severe brain injury can occur as a result of a stroke, a traumatic injury or due to lack of oxygen to the brain that happens as a result of a cardiac arrest. Patients who are unconscious after an acute severe brain injury often need assistance to breath adequately, and this assistance is given by a breathing tube, connected to a mechanical ventilator. This treatment is an emergency medical treatment. The breathing tube is inserted into the patients' airway by either their mouth or neck. For patients who need assistance with their breathing from a mechanical ventilator, infections in the airways and lungs, known as pneumonia, are a common complication. Everyone naturally has bacteria in their mouth, esophagus and stomach. Clinicians think that during the process of inserting the breathing tube, small amounts of these bacteria can be introduced into the airways and lung when people are unconscious following an acute severe brain injury, or during the process of placing the breathing tube into the airways. These bacteria are now in a place they aren't meant to be and can cause an infections in the airways and lungs known as pneumonia. The purpose of this research is to see if giving one dose of a common antibiotic can prevent patients developing pneumonia, which is associated with having a breathing tube inserted and being on a ventilator, improving the chance of recovery following the acute severe brain injury and ultimately improving the chance of surviving. When patients have a known infection, current guidelines are to treat them with antibiotics. Antibiotics work to kill the bacteria causing the infection. When a patient has an infection in their lungs, they often need to stay on the mechanical ventilator for longer. While current practice is to give patients with a proven infection in their airways and lungs (pneumonia) antibiotics, it is unknown if giving an antibiotic to patients to prevent these infections before they show signs of pneumonia may lead to better outcomes.

Clinical Trial Conditions for AMPICILLIN SODIUM; SULBACTAM SODIUM

Condition Name

Condition Name for AMPICILLIN SODIUM; SULBACTAM SODIUM
Intervention	Trials
Disability, Intellectual	1
Intensive Care Medicine	1
Nephrotoxicity	1
Neurological Disorder	1

Condition MeSH

Condition MeSH for AMPICILLIN SODIUM; SULBACTAM SODIUM
Intervention	Trials
Infections	1
Infection	1
Communicable Diseases	1
Respiratory Aspiration	1

Clinical Trial Locations for AMPICILLIN SODIUM; SULBACTAM SODIUM

Trials by Country

Trials by Country for AMPICILLIN SODIUM; SULBACTAM SODIUM
Location	Trials
Japan	15
Australia	4
Egypt	1
Korea, Republic of	1
New Zealand	1

Clinical Trial Progress for AMPICILLIN SODIUM; SULBACTAM SODIUM

Clinical Trial Phase

Clinical Trial Phase for AMPICILLIN SODIUM; SULBACTAM SODIUM
Clinical Trial Phase	Trials
PHASE3	1
PHASE2	1
Phase 3	1

Clinical Trial Status

Clinical Trial Status for AMPICILLIN SODIUM; SULBACTAM SODIUM
Clinical Trial Phase	Trials
Completed	2
RECRUITING	1
NOT_YET_RECRUITING	1

Clinical Trial Sponsors for AMPICILLIN SODIUM; SULBACTAM SODIUM

Sponsor Name

Sponsor Name for AMPICILLIN SODIUM; SULBACTAM SODIUM
Sponsor	Trials
The George Institute	1
Pfizer	1
DongGuk University	1

Sponsor Type

Sponsor Type for AMPICILLIN SODIUM; SULBACTAM SODIUM
Sponsor	Trials
Other	3
Industry	1

Last updated: April 25, 2026

Ampicillin Sodium + Sulbactam Sodium: Clinical Trials Update, Market Analysis, and Projection

What is the current clinical development and trial activity for ampicillin sodium + sulbactam sodium?

Ampicillin sodium/sulbactam sodium is a well-established combination (a beta-lactam/ beta-lactamase inhibitor). Public-facing clinical development is typically limited because many products are approved via established regulatory pathways and focus shifts to new formulations, new geographies, or labeling expansions rather than broad new phase programs.

Global public clinical-trial registrations (signal-level) A search of major public registries shows activity concentrated in:

• Infectious disease use cases (acute bacterial infections where sulbactam’s beta-lactamase inhibition is relevant)
• Comparative or observational studies (effectiveness and safety in routine practice)
• Special populations (pediatrics and adult subgroups), and
• Formulation-driven programs (pharmacokinetic or bioequivalence studies rather than standalone efficacy phase trials)

Practical implication for R&D and investment For this combination, clinical-trial “updates” in the open literature are less about new MOA breakthroughs and more about:

• local comparative effectiveness,
• regimen optimization (dose interval and infusion vs. bolus),
• and switching or reformulation in target markets.

Clinical-trial monitoring checklist (what to track in future updates)

• Any new phase 3 registrations for novel indication expansion
• Any bioequivalence / bridging programs tied to regulatory transitions (new NDA/MAA filings, line extensions)
• Any antimicrobial resistance–driven studies that define microbiologic endpoints (susceptibility breakpoints, beta-lactamase prevalence)

Evidence base Public trial visibility is constrained by geography and proprietary sponsors; the most consistent cross-market signals come from clinical registries such as ClinicalTrials.gov and WHO ICTRP. Trial records for this combination tend to be sporadic and indication-specific. (Source: ClinicalTrials.gov; WHO ICTRP)

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What does the market look like today for ampicillin sodium + sulbactam sodium?

Market structure Ampicillin/sulbactam is sold as:

• hospital-focused IV products (typical acute-care use),
• short-course regimens for susceptible bacterial infections, and
• institutional supply contracts in markets where local manufacturing and generics dominate.

Demand drivers

• Ongoing need for beta-lactam/beta-lactamase inhibitor options for mixed infections
• Use in intra-abdominal infections, skin and soft tissue infections, and select respiratory or urinary bacterial infections depending on local guidelines
• Stewardship frameworks that preserve the beta-lactam class while emphasizing targeted use

Supply and competition

• Competition is primarily generic and multisource for many geographies.
• The competitive axis is pricing, availability, formulation, and tender access, not differentiation.

Pricing reality Because the molecule is mature and frequently generic, market outcomes often track:

• tender volume,
• government or payer hospital formularies,
• and the ability to maintain consistent supply.

Evidence base Market sizing and growth expectations for mature IV antibiotic combinations are typically derived from:

• pharmacy and hospital procurement data,
• pooled sales models across countries,
• and antimicrobial market forecasts by antimicrobial class.

Because no single authoritative global dataset covers every tender and generic channel uniformly, credible projections should use triangulated sources (IMS/IQVIA-like datasets, national procurement statistics, and market-research aggregates). (Sources: FDA; EMA; WHO; Clinical practice context from WHO antimicrobial guidance)

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How do guidelines and reference standards shape prescribing and utilization?

Prescribing depends on local resistance patterns and guideline placement. Beta-lactam/beta-lactamase inhibitor regimens are used where organisms are likely susceptible and where beta-lactamase production is a known risk.

Key framework signals:

• WHO antimicrobial stewardship and resistance guidance emphasizes appropriate use and local susceptibility testing. (Source: WHO)
• National and regional formularies generally reserve certain antibiotic combinations for specific infection syndromes and known susceptibilities.

For investors and R&D teams, the key is not generic “antibiotic growth” but:

• whether the combination remains on hospital formularies, and
• whether its use expands or contracts relative to alternatives (e.g., other beta-lactam/beta-lactamase inhibitors, cephalosporin-based regimens, carbapenems in more severe or resistant settings).

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Where is the profit and volume potential in this molecule category?

In mature antibiotic combinations, the commercial opportunity usually comes from:

1. Formulation and access (IV pack format, stability, infusion protocols, ready-to-use hospital workflows)
2. Regulatory strategy (launch timing in tender cycles, line extensions, labeling optimization)
3. Geographic focus (markets with tender-driven volume where the combination is guideline-aligned and competitively priced)
4. Supply reliability (capacity and supply continuity often decide contract awards more than marginal clinical differentiation)

This makes “clinical development” less of a differentiator than:

• dossier readiness for approvals in priority countries,
• manufacturing scale,
• and tender conversion.

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Market Projection: base-case outlook and drivers

Core market math for mature IV antibiotics For mature and largely generic antibiotics, forecasts typically use:

• hospital inpatient growth,
• antibiotic mix shifts within infection classes,
• and resistance-driven impacts on regimen choice.

Projection ranges by scenario (directional) A defensible forward view is framed as three scenarios for 2026-2035 (directional, since country-level tender data is not uniformly available through open sources):

Scenario	Growth basis	Expected trajectory for ampicillin/sulbactam
Bear	Formularies shift to newer or broader agents; pricing pressure persists	Low single-digit CAGR or flat volumes
Base	Stable guideline role and hospital tender replacement; stewardship limits indiscriminate use	Low single-digit CAGR driven by volume replenishment
Bull	Competitive wins in tender regions; resistance patterns preserve need for beta-lactam/beta-lactamase inhibition	Moderate single-digit CAGR with incremental share gains

Primary bull-case lever Share gain via:

• institutional tender awards,
• stable supply,
• and packaging/form factor aligned with ward procurement.

Primary bear-case lever Shift away due to:

• preferential use of alternative inhibitor combinations,
• tighter antibiotic stewardship limiting broad empiric use without rapid susceptibility confirmation.

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Regulatory and evidence expectations (what matters for filings and launches)

For mature combinations, regulatory focus usually centers on:

• product quality and stability (sterility assurance for IV),
• bioequivalence (if applicable),
• and labeling consistency with existing reference standards.

Regulatory frameworks:

• FDA guidance and approval pathways for antibiotics and generics depend on product type and whether a reference is required. (Source: FDA)
• EMA authorization and quality requirements apply at launch and lifecycle. (Source: EMA)
• WHO antimicrobial guidance shapes how countries educate and govern antibiotic use. (Source: WHO)

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Actionable intelligence: how to use this for R&D, business development, and investment

What should an R&D pipeline prioritize for this combination?

Given the mature status, the highest probability programs typically are:

• formulation improvements (stability, dilution requirements, packaging),
• pharmacokinetic and bridging work for specific populations or local labeling,
• and comparative effectiveness studies aligned to guideline syndromes and microbiology endpoints.

What should BD teams prioritize?

• Contract conversion in hospital networks where beta-lactam/beta-lactamase inhibition remains guideline-consistent.
• Supply chain reliability and lead times for tenders.
• Pricing strategy by country tender cycles and reimbursement.

What should investors underwrite?

• Manufacturing capacity and sterility assurance capability.
• Tender contract backlog and renewal rates.
• Exposure to markets with aggressive generic pricing dynamics.
• Margin sustainability versus multi-supplier competition.

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Key Takeaways

• Ampicillin sodium/sulbactam sodium is a mature beta-lactam/beta-lactamase inhibitor combination with clinical activity that is usually indication- or formulation-driven, not dominated by major new phase breakthroughs.
• Market growth is shaped mainly by hospital tender dynamics, formulary inclusion, and antimicrobial stewardship, with limited scope for differentiation.
• Forward projections are most realistic as low single-digit growth or flat-to-moderate upside scenarios, driven by share gains via supply reliability and tender execution rather than clinical novelty.
• The highest-value operational work is regulatory dossier readiness, manufacturing scale, and packaging/form factor alignment with institutional procurement workflows.

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FAQs

1) Is ampicillin sodium + sulbactam sodium still a standard-of-care option?

In many guideline structures, it remains an option for susceptible bacterial syndromes where beta-lactamase inhibition is relevant, with use governed by local susceptibility patterns and stewardship. (Source: WHO)

2) Are there likely new blockbuster clinical outcomes for this combination?

Open clinical signals generally point to localized comparative or formulation-oriented studies rather than large, differentiating phase programs because the regimen is already established. (Sources: ClinicalTrials.gov; WHO ICTRP)

3) What determines whether the market grows in a given country?

Hospital formularies, tender awards, reimbursement/pricing frameworks, and resistance pattern shifts that influence empiric and targeted regimen selection. (Source: WHO)

4) Where can manufacturers differentiate commercially?

Supply continuity, packaging and stability for IV workflows, and consistent tender execution against multisource generic competition. (Sources: FDA; EMA)

5) How should projections be modeled for investment decisions?

Use scenario-based models tied to procurement volume, market share changes in target tenders, and competitive pricing dynamics rather than expecting innovation-led expansion. (Sources: WHO; FDA; EMA)

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References (APA)

[1] U.S. Food and Drug Administration. (n.d.). Guidance and resources on antibiotics and generic drug development. FDA. https://www.fda.gov
[2] European Medicines Agency. (n.d.). Medicines and guidance for approval and quality requirements. EMA. https://www.ema.europa.eu
[3] World Health Organization. (n.d.). Antimicrobial resistance and antimicrobial stewardship guidance. WHO. https://www.who.int
[4] U.S. National Library of Medicine. (n.d.). ClinicalTrials.gov. https://clinicaltrials.gov
[5] World Health Organization. (n.d.). WHO International Clinical Trials Registry Platform (ICTRP). https://trialsearch.who.int