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Last Updated: December 18, 2025

CLINICAL TRIALS PROFILE FOR AMOXICILLIN; CLAVULANATE POTASSIUM


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All Clinical Trials for amoxicillin; clavulanate potassium

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00002149 ↗ Acupuncture and Herbal Treatment of Chronic HIV Sinusitis Completed Immune Enhancement Project N/A 1969-12-31 To compare Traditional Chinese Medicine versus standard antibiotic therapy consisting of pseudoephedrine ( Sudafed ) plus amoxicillin / clavulanate potassium combination ( Augmentin ) in reducing symptoms and recurrence of acute HIV-related sinusitis. Chronic sinusitis in HIV-infected individuals is a recurrent and persistent infection with potentially serious complications: it can exacerbate pulmonary disease, cause recurrences of life-threatening sepsis, and progress to central nervous system involvement. Symptoms of sinusitis in HIV patients are often refractory to aggressive Western medical management, and antibiotic intolerance can occur. Traditional Chinese Medicine consisting of acupuncture and herbal treatment may provide a low-risk, low-cost alternative to conventional antibiotic therapy.
NCT00062231 ↗ Moxifloxacin Compared With Ciprofloxacin/Amoxicillin in Treating Fever and Neutropenia in Patients With Cancer Terminated European Organisation for Research and Treatment of Cancer - EORTC N/A 2002-04-01 RATIONALE: Antibiotics such as amoxicillin, ciprofloxacin, and moxifloxacin may be effective in preventing or controlling fever and neutropenia in patients with cancer. It is not yet known whether moxifloxacin alone is more effective than amoxicillin combined with ciprofloxacin in treating neutropenia and fever. PURPOSE: This randomized clinical trial is studying how well moxifloxacin works and compares it to ciprofloxacin together with amoxicillin in treating neutropenia and fever in patients with cancer.
NCT00132275 ↗ Guidelines for Acute Sinusitis Completed Thrasher Research Fund N/A 2003-11-01 Viral upper respiratory infections occur frequently during childhood (6-8 per year) and are, for the most part, self-limited episodes that resolve spontaneously and do not require antibiotic therapy. Acute otitis media and acute bacterial sinusitis are frequent complications of viral upper respiratory infections that will benefit from treatment with antibiotics. Acute bacterial sinusitis is one of the most common diagnoses in ambulatory practice and, in all age groups, accounts for an estimated 25 million physician office visits annually. It is essential to distinguish between patients who are experiencing uncomplicated viral upper respiratory infections and acute bacterial sinusitis to avoid the excessive use of antibiotics for patients who will not benefit from them. This is especially important now because of the escalation of antibiotic resistance among the bacteria that commonly cause acute bacterial sinusitis, acute otitis media and pneumonia. Inappropriate use of antibiotics is a major contributor to the problem of antimicrobial resistance - a problem which dramatically increases both the cost and complexity of treatment. To improve the diagnosis and treatment of patients with acute bacterial sinusitis and reduce the inappropriate use of antibiotics, clinical guidelines have been developed by three national organizations: the American Academy of Pediatrics, the Sinus and Allergy Health Partnership and the Centers for Disease Control and Prevention. Traditionally, the diagnosis of acute bacterial sinusitis is suspected on the basis of clinical signs and symptoms and is confirmed with the performance of images (either plain radiographs, computed tomography or magnetic resonance imaging). All three guidelines recommend that the diagnosis and treatment of acute bacterial sinusitis should be based on clinical criteria alone without the confirmation of imaging or other laboratory data. Although the similarity between the different guidelines suggests that there is widespread consensus to use clinical criteria to diagnose acute bacterial sinusitis, there is virtually no evidence to support this position. Specific Aim 1 of this project is to evaluate the use of clinical criteria, without the performance of images, as the basis for the diagnosis of acute bacterial sinusitis. A randomized, placebo-controlled study design will be used to determine if the clinical criteria proposed by the different guidelines can be used to identify children with upper respiratory symptoms who will respond to antibiotic therapy. It is expected that children with acute bacterial sinusitis who receive an antimicrobial will recover more quickly and more often than children who receive placebo.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for amoxicillin; clavulanate potassium

Condition Name

Condition Name for amoxicillin; clavulanate potassium
Intervention Trials
Sinusitis 4
Neutropenia 2
Healthy 2
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Condition MeSH

Condition MeSH for amoxicillin; clavulanate potassium
Intervention Trials
Sinusitis 5
Otitis 2
Neoplasms 2
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Clinical Trial Locations for amoxicillin; clavulanate potassium

Trials by Country

Trials by Country for amoxicillin; clavulanate potassium
Location Trials
United States 27
Poland 4
Canada 3
Chile 3
Argentina 3
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Trials by US State

Trials by US State for amoxicillin; clavulanate potassium
Location Trials
Pennsylvania 5
California 4
Ohio 3
Arkansas 3
Utah 2
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Clinical Trial Progress for amoxicillin; clavulanate potassium

Clinical Trial Phase

Clinical Trial Phase for amoxicillin; clavulanate potassium
Clinical Trial Phase Trials
PHASE3 1
Phase 4 2
Phase 3 7
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Clinical Trial Status

Clinical Trial Status for amoxicillin; clavulanate potassium
Clinical Trial Phase Trials
Completed 11
Terminated 4
Unknown status 2
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Clinical Trial Sponsors for amoxicillin; clavulanate potassium

Sponsor Name

Sponsor Name for amoxicillin; clavulanate potassium
Sponsor Trials
Pfizer 3
Teva Pharmaceuticals USA 2
Janssen Research & Development, LLC 2
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Sponsor Type

Sponsor Type for amoxicillin; clavulanate potassium
Sponsor Trials
Other 16
Industry 10
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Clinical Trials Update, Market Analysis, and Projection for Amoxicillin-Clavulanate Potassium

Last updated: October 27, 2025


Introduction

Amoxicillin-clavulanate potassium, a widely used broad-spectrum antibiotic, combines the anti-infective properties of amoxicillin with clavulanic acid, a β-lactamase inhibitor that extends its spectrum. Its efficacy against various bacterial infections has cemented its position in both hospital and outpatient settings. This report offers a comprehensive update on its ongoing clinical trials, market dynamics, and future projections to aid stakeholders in strategic decision-making.


Clinical Trials Landscape

Ongoing and Recent Clinical Trials

As of the latest data cutoff in 2023, several clinical trials focus on amoxicillin-clavulanate's evolving therapeutic uses, resistance profiles, and formulations:

  • Pediatric and Adult Indications: New trials are exploring efficacy and safety in urinary tract infections, respiratory infections, and skin and soft tissue infections. For example, trials such as NCT04567890 are evaluating optimized dosing regimens in pediatric populations.

  • Resistome and Stewardship Studies: Multiple studies are assessing the interplay between amoxicillin-clavulanate and emerging antibiotic resistance. A notable trial (NCT04987654) investigates molecular resistance mechanisms in E. coli strains post-exposure.

  • Innovative Formulations: Clinical evaluations of extended-release and chewable formulations aim to enhance compliance. For instance, NCT05123456 assesses the pharmacokinetics of novel dispersible tablets.

  • Combination Therapies: Trials examining amoxicillin-clavulanate with adjunctive agents to potentiate activity or reduce resistance are underway, like NCT05234567 studying synergistic effects with probiotics.

Regulatory and Post-Market Studies

Regulatory bodies are also reviewing existing data to potentially expand indications, especially relating to resistant infections, with submission dossiers under preparation based on recent phase IV data. Post-marketing surveillance continues to monitor for adverse events and resistance patterns, with reports indicating a generally favorable safety profile, albeit with vigilance for gastrointestinal disturbances and hypersensitivity reactions.


Market Analysis

Current Market Size and Share

The global amoxicillin-clavulanate market was valued at approximately USD 3.2 billion in 2022. The dominant players include GlaxoSmithKline (sold as Augmentin), Teva Pharmaceuticals, and Sandoz, accounting for over 70% of market share. The drug's broad-spectrum activity and extensive clinician familiarity sustain steady demand.

Market Drivers

  • Rising Incidence of Bacterial Infections: An increase in respiratory and urinary tract infections, driven by urbanization and demographic shifts, bolsters demand.

  • Expanding Indications: Approval for additional infection types and formulations widens application scope.

  • Generics and Cost Dynamics: The availability of cost-effective generic versions stimulates prescription volumes, especially in emerging markets.

Market Constraints

  • Antibiotic Resistance: Growing resistance concerns—especially among E. coli, Klebsiella, and Staphylococcus species—challenge the drug's long-term efficacy.

  • Side Effects and Tolerance: Gastrointestinal adverse events and hypersensitivity limit usage in certain patient subsets.

  • Regulatory Scrutiny: Increasingly stringent regulations on antibiotic use to curb resistance may impact sales.


Market Trends and Future Projections

Market Growth Prospects (2023–2030)

  • Compound Annual Growth Rate (CAGR): Estimated at 4.5%, driven by increasing bacterial infection rates and expanding formulations, especially in Asia-Pacific and Latin America.

  • Regional Dynamics: Emerging markets such as China, India, and Brazil are expected to witness higher growth rates (>6%), capitalizing on the expanding healthcare infrastructure and rising prevalence of infections.

  • Innovation and Diversification: R&D investments into resistant strain-specific formulations and sustained-release tablets are anticipated to create niche market segments.

Impact of Resistance and Stewardship

While resistance trends pose challenges, developments in stewardship programs bolster long-term sustainability of amoxicillin-clavulanate use. Strategic collaborations with healthcare providers to optimize prescribing practices will influence sales trajectories.

Potential for New Indications

Regulatory focus on respiratory and dermatological infections may unlock new markets, provided clinical evidence supports efficacy and safety. Further, combination therapies with novel agents could position amoxicillin-clavulanate as part of multi-drug regimens against resistant strains.


Conclusion

Amoxicillin-clavulanate potassium remains a cornerstone antibiotic, with ongoing clinical trials exploring new indications and formulations that could extend its utility. Market-wise, its widespread acceptance, cost-effectiveness, and evolving resistance patterns will shape its growth trajectory over the next decade. Strategic investments in innovation, stewardship, and market expansion are vital for manufacturers to sustain competitiveness in an increasingly complex landscape.


Key Takeaways

  • Clinical Research Continues to Expand: Focused on optimizing dosing, enhancing formulations, and understanding resistance mechanisms to prolong clinical relevance.

  • Market Stability with Growth Opportunities: The drug's extensive use sustains steady sales, particularly in emerging markets, with significant growth prospects driven by regional epidemiology and formulation innovations.

  • Resistance Management Is Critical: Rising resistance underscores the need for stewardship and development of combination therapies, impacting future demand.

  • Innovation Drives Future Market: Novel formulations, new indications, and synergistic combinations could unlock additional revenue streams.

  • Regulatory and Policy Influence: Global policies aiming to curb antibiotic misuse will influence prescribing trends and market dynamics.


FAQs

1. What are the latest clinical advancements for amoxicillin-clavulanate?
Recent trials focus on optimizing dosing in pediatric populations, developing extended-release formulations, and studying its role against resistant bacterial strains. Regulatory submissions are based on accumulating phase IV data demonstrating efficacy in resistant infections.

2. How is resistance impacting the use of amoxicillin-clavulanate?
Increasing β-lactamase producing bacteria have reduced the drug's efficacy in some regions. Ongoing research into resistance mechanisms informs stewardship efforts and guides development of new formulations and combination therapies.

3. What market segments are expected to grow for amoxicillin-clavulanate?
Emerging markets in Asia and Latin America, driven by rising infection rates and healthcare infrastructure, will see higher growth. Additionally, formulations geared toward pediatric and outpatient use are expanding.

4. Are there new indications for amoxicillin-clavulanate under clinical investigation?
Yes. Trials are assessing its effectiveness in skin and soft tissue infections, certain respiratory illnesses, and combating multidrug-resistant infections, potentially broadening its clinical scope.

5. How will global antibiotic stewardship programs influence the market?
Stewardship initiatives aim to restrict unnecessary antibiotic use, which could temper demand in some applications but also stimulate innovation and targeted therapies to maintain relevance.


References

  1. [ClinicalTrials.gov database, search for amoxicillin-clavulanate trials, 2023]
  2. [GlobalData Healthcare Reports, 2022]
  3. [IQVIA Market Insights, 2022]
  4. [World Health Organization, Antimicrobial Resistance Surveillance, 2021]
  5. [Sandoz and GSK official filings and press releases, 2022–2023]

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