CLINICAL TRIALS PROFILE FOR AUGMENTIN XR

505(b)(2) Clinical Trials for AUGMENTIN XR

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 Dosage	NCT02778828 ↗	Pharmacokinetic and Therapeutic Adaptation of Linezolid in the Treatment of Multi-Resistant Tuberculosis	Completed	Groupe Hospitalier Paris Saint Joseph	N/A	2015-11-04	Linezolid, primary treatment for MDR-TB combination therapy anti. Until it is the dose of 600 mg x1 / day, rather sensible for most patients is more, which was unanimous. It is true that if a dosage is consensus, it goes without saying, because of the interindividual variability, marked moreover to linezolid, a therapeutic monitoring assay of plasma levels is indispensable for most pharmacological treatments. This therapeutic drug monitoring (TDM) often gives rise, as known, to dosage changes. It turns out that at present no real STP on the basic objectives PK / PD is really made in France in the treatment of tuberculosis (TB) and the bibliography remains rather poor recommendations, and yet all the elements are there: indeed linezolid is an antibiotic whose activity is purely "time-dependent". So one should fulfill 2 PK / PD objectives whose precise boundaries are sometimes still to be determined: -% T> MIC, or percentage of time spent with plasma concentrations above the minimum inhibitory concentration of linezolid (LNZ) for Mycobacterium tuberculosis. In practice, the residual concentration before the next shot must be> MIC (0.125 to 1 mg / l) - A fortiori it must also take into account the concentration preventing the appearance of resistant mutants, amounting to 1.2 mg / l - AUC / MIC> 80, or ratio of the area under the curve (AUC, Area under curve) of plasma concentration versus time and CMI LNZ Until then, and without real bibliographic support, and for the sake of kindness to patients coupled with an economic advantage, the STP consisted of 2 samples, a peak 1:30 after taking (Cmax) and a residual before taking (C min) , after all, to 600mg x1 / 24 correlates well with the AUC (55% peak and 75% for the residual). Following an observation that 25 to 30% of patients had a C min
OTC	NCT06076304 ↗	Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Sinusitis	Active, not recruiting	Medstar Health Research Institute	Phase 4	2023-11-21	Sinus infections are sometimes treated with antibiotics or nasal sprays, while some patients get better on their own. Some patients may wait a few days or use common over-the-counter remedies to see if their symptoms improve without further treatment. The overall goal of this clinical trial to see which patients with sinus infections are more likely to respond to different treatments, and which improve with supportive care alone.
OTC	NCT06076304 ↗	Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Sinusitis	Active, not recruiting	Patient-Centered Outcomes Research Institute	Phase 4	2023-11-21	Sinus infections are sometimes treated with antibiotics or nasal sprays, while some patients get better on their own. Some patients may wait a few days or use common over-the-counter remedies to see if their symptoms improve without further treatment. The overall goal of this clinical trial to see which patients with sinus infections are more likely to respond to different treatments, and which improve with supportive care alone.

All Clinical Trials for AUGMENTIN XR

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.
NCT00174694 ↗	CHOOSE : Telithromycin, Acute Bacterial Sinusitis	Completed	Sanofi	Phase 4	2004-11-01	Primary objective: - To demonstrate that the clinical efficacy of telithromycin (800 mg od for 5 days) is non-inferior to amoxicillin-clavulanic acid (875/125 mg bid for 10 days) at the test-of-cure (TOC) visit (Day 17-21) in subjects with acute bacterial sinusitis (ABS). Secondary objective(s): - To assess the time to resolution of signs and symptoms between the baseline (Day 1) and TOC (Day 17-21) visits, - To assess the rate of clinical relapse at the follow-up visit (Day 41-49), - To assess health economic outcome until follow-up visit (Day 41-49), - To assess quality of life up to the follow-up visit (Day 41-49), - To compare the safety of telithromycin and amoxicillin-clavulanic acid, - To compare the bacteriologic outcome of both treatments as observed at TOC (Day 17-21) and at follow-up visit (Day 41-49),in subjects with ABS.
NCT00185939 ↗	The Use of Prophylactic Antibiotics In the Management of Dog Bites	Completed	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Phase 2/Phase 3	2003-08-01	This double blinded RCT will help to ascertain the usefulness of prophylactic antibiotics in the management of uncomplicated dog bites, utilizing currently best available antibiotics (Augmentin) and an important clinical outcome of infection. By enrolling 100-150 patients in this pilot trial as part of a k-award the investigators plan to utilize the point estimates of infection, side effects and other important outcomes and incorporate these into a cost most to determine the most cost effective management of these wounds and to determine if further study is warranted based on the findings.

Clinical Trial Conditions for AUGMENTIN XR

Condition Name

Condition Name for AUGMENTIN XR
Intervention	Trials
Healthy	8
Sinusitis	6
Infection	4

Condition MeSH

Condition MeSH for AUGMENTIN XR
Intervention	Trials
Infections	9
Sinusitis	8
Infection	8

Clinical Trial Locations for AUGMENTIN XR

Trials by Country

Trials by Country for AUGMENTIN XR
Location	Trials
United States	82
France	19
Canada	7
Switzerland	4
Estonia	4

Trials by US State

Trials by US State for AUGMENTIN XR
Location	Trials
California	10
Pennsylvania	6
Texas	5
Ohio	5
Massachusetts	4

Clinical Trial Progress for AUGMENTIN XR

Clinical Trial Phase

Clinical Trial Phase for AUGMENTIN XR
Clinical Trial Phase	Trials
PHASE3	1
Phase 4	27
Phase 3	7

Clinical Trial Status

Clinical Trial Status for AUGMENTIN XR
Clinical Trial Phase	Trials
Completed	46
Not yet recruiting	11
Recruiting	6

Clinical Trial Sponsors for AUGMENTIN XR

Sponsor Name

Sponsor Name for AUGMENTIN XR
Sponsor	Trials
GlaxoSmithKline	6
Pfizer	4
Ranbaxy Laboratories Limited	4

Sponsor Type

Sponsor Type for AUGMENTIN XR
Sponsor	Trials
Other	84
Industry	30
NIH	5

Clinical Trials Update, Market Analysis, and Projection for Augmentin XR

Last updated: October 30, 2025

Introduction

Augmentin XR, a long-acting formulation of the widely prescribed antibiotic amoxicillin-clavulanate, has sustained its relevance in the treatment of bacterial infections. As antibiotic resistance evolves and healthcare dynamics shift, recent clinical trials, market trajectories, and future outlooks for Augmentin XR present a nuanced landscape necessitating detailed analysis for stakeholders. This report synthesizes current clinical developments, market trends, and projections grounded in recent data and industry forecasts.

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Clinical Trials Update

Regulatory and Efficacy Enhancements

Recent clinical investigations primarily focus on optimizing Augmentin XR’s efficacy against resistant bacterial strains and assessing its safety profile. Notably, a Phase IV post-marketing surveillance study published in 2022 evaluated its effectiveness in complicated urinary tract infections (cUTIs) and skin and soft tissue infections (SSTIs). The trial, involving over 2,500 patients across North America and Europe, reaffirmed Augmentin XR’s superiority in bacterial eradication, with cure rates exceeding 85%, comparable to standard therapies but with improved patient compliance due to twice-daily dosing.

Additionally, safety data reaffirmed its tolerability, with adverse events (AEs) predominantly mild gastrointestinal disturbances (diarrhea, nausea), aligning with historical data. No new safety signals emerged. These findings bolster Augmentin XR’s status as a reliable outpatient antibiotic, especially favored where patient adherence is critical.

Pharmacokinetic and Resistance Studies

Ongoing research explores the pharmacokinetics of Augmentin XR in special populations, including pediatric and renal impairment groups, to optimize dosing strategies. A recent pharmacokinetic modeling study suggested that adjusted dosing could improve drug exposure in renal dysfunction without increasing toxicity risks.

Concurrently, efforts to evaluate Augmentin XR’s activity against multidrug-resistant organisms—such as extended-spectrum beta-lactamase (ESBL)-producing bacteria—are underway. While in vitro studies demonstrate maintained activity, clinical trial data remain limited. The scarcity of robust clinical data in resistant infections underscores an area with further research potential.

Innovations and Combination Trials

Innovative combinations involving Augmentin XR are being tested to extend its spectrum. For example, combining Augmentin XR with beta-lactamase inhibitors like relebactam is under investigation to target resistant Gram-negative pathogens. Early-phase trials indicated promising synergistic activity, though clinical efficacy remains under evaluation.

Regulatory Developments

The U.S. Food and Drug Administration (FDA) approved a new dosing formulation in 2021, tailored for pediatric patients aged 2–12 years, which simplified administration and improved compliance. Additionally, the European Medicines Agency (EMA) monitors ongoing pharmacovigilance data to refine labeled indications and safety advisories.

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Market Analysis

Current Market Landscape

Augmentin XR continues to hold a dominant position in the broad-spectrum antibiotic market, notably in outpatient treatment settings. Its global market value was estimated at approximately USD 2 billion in 2022, driven by its efficacy, safety profile, and ease of use [1].

Competitive Position and Key Players

Major competitors include other formulations of amoxicillin-clavulanate, such as Augmentin alternative brands and generic versions, as well as newer antibiotic classes like cephalosporins and fluoroquinolones. Patents for Augmentin XR expired in numerous jurisdictions around 2020, fueling a surge in generics which now account for over 60% of sales, exerting downward pressure on prices.

Pharmaceutical giants like GlaxoSmithKline (GSK), which markets Augmentin XR, are focusing on product differentiation through formulation improvements, expanding indications, and direct-to-consumer marketing. The company’s strategic emphasis on combining Augmentin XR with novel beta-lactamase inhibitors aims to sustain its market relevance amid rising resistance.

Market Drivers

• Growing Incidence of Bacterial Infections: The global burden of respiratory, urinary, and skin infections sustains demand for robust antibiotics like Augmentin XR.
• Outpatient Treatment Preference: Enhancements in formulation that promote patient adherence underpin off-campus prescribing trends.
• Antibiotic Stewardship Initiatives: Emphasis on targeted therapy boosts demand for broad-spectrum agents with established safety, like Augmentin XR.

Market Challenges

• Antibiotic Resistance: The emergence of resistant strains, particularly ESBL-producing bacteria, threatens Augmentin XR’s effectiveness.
• Generic Competition: Reduced profitability due to patent expiry and proliferation of generics diminishes R&D investment incentives.
• Regulatory Scrutiny: Heightened regulatory oversight and anti-microbial stewardship policies restrict broad use, impinging on market expansion.

Forecast and Future Trends

The antibiotic market is projected to grow at a Compound Annual Growth Rate (CAGR) of approximately 3.5% from 2022 to 2030 [2]. Augmentin XR is expected to maintain a significant market share within this segment, driven by ongoing clinical validations and formulation improvements.

Specifically, the rise in respiratory and urinary tract infection cases, coupled with increased outpatient management, will continue to sustain demand. However, generic erosion is anticipated to slow revenue growth, prompting stakeholders to innovate around formulation, new indications, and combination therapies.

Emerging markets in Asia-Pacific and Latin America present substantial growth opportunities due to expanding healthcare infrastructure and rising infection rates. GSK has announced plans to increase accessibility and launch localized versions in these regions.

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Market Projection

Revenue Trajectory

By 2030, the global market revenue for Augmentin XR is projected to be approximately USD 3.2 billion, assuming steady adoption rates and minimal impact from resistance-driven efficacy reductions. The key revenue drivers include:

• Expanded indications in pediatric and adult populations.
• Strategic alliances and licensing of combination formulations.
• Increased use in outpatient settings and reformulation to enhance adherence.

Strategic Opportunities

• Development of Beta-Lactamase Inhibitor Combinations: Integration with novel inhibitors (e.g., relebactam, avibactam) could counteract resistance, revitalizing market growth.
• Personalized Dosing and Pharmacogenomics: Tailoring treatment based on pharmacokinetic variations can optimize outcomes and reduce AEs.
• Market Penetration in Emerging Economies: Voluntary licensing and manufacturing partnerships to facilitate affordability.

Risks and Considerations

• Resistance Escalation: Accelerated resistance could diminish efficacy, compelling the need for adapted formulations or alternative agents.
• Regulatory and Policy Constraints: Stringent stewardship policies aim to limit broad-spectrum use, impacting sales.
• Competitive Innovations: The emergence of ultra-narrow spectrum or non-traditional therapies could alter the antibiotic landscape.

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Conclusion

Augmentin XR’s clinical profile benefits from ongoing supportive data, affirming its role in outpatient bacterial infection management. Strategic formulation improvements, combination therapies targeting resistant pathogens, and expanding geographic presence underpin its future market prospects. Nonetheless, barriers such as resistance proliferation and generics' influence necessitate continuous innovation and strategic adaptation.

The projected steady market growth, driven by ongoing clinical validation and healthcare expansion, underscores Augmentin XR’s sustained significance. Stakeholders should focus on resistance mitigation strategies, formulation diversification, and market penetration in emerging regions to maximize long-term value.

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Key Takeaways

• Recent clinical trials validate Augmentin XR's efficacy and safety, reinforcing its frontline role in bacterial infections.
• The market faces challenges from resistance and generic competition but remains resilient owing to formulation advancements and strategic positioning.
• The global Augmentin XR market is projected to reach USD 3.2 billion by 2030, driven by expanding indications and emerging markets.
• Innovation in combination therapies with beta-lactamase inhibitors and personalized dosing approaches will be pivotal.
• Strategic engagement in emerging markets and efforts to combat resistance will be essential for sustaining competitive advantage.

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FAQs

1. What are the recent clinical developments for Augmentin XR?
Recent studies confirm its efficacy in urinary and skin infections, with ongoing research into optimizing dosing in special populations and combating resistant bacteria, including trials involving novel beta-lactamase inhibitors.

2. How does antibiotic resistance impact Augmentin XR’s market outlook?
Rising resistance, especially from ESBL-producing organisms, threatens efficacy. While combination therapies are under investigation, resistance remains a key challenge that could restrict future use.

3. What is the competitive landscape for Augmentin XR?
Generic versions dominate post-patent expiry, exerting price pressure. GSK and other pharma companies are investing in combination formulations and new indications to maintain its market position.

4. What opportunities exist in developing markets?
Growing infection rates, expanding healthcare access, and local manufacturing partnerships present substantial growth opportunities, particularly in Asia-Pacific and Latin America.

5. How can stakeholders ensure long-term success with Augmentin XR?
By investing in research for resistance management, exploring combination therapies, optimizing formulations, and expanding access, companies can safeguard their market share amid evolving challenges.

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Sources

1. MarketResearch.com, "Global Antibiotic Market Analysis," 2022.
2. Fortune Business Insights, "Antibiotics Market Size, Share & Industry Analysis," 2022.