CLINICAL TRIALS PROFILE FOR AUGMENTIN '200'

505(b)(2) Clinical Trials for Augmentin '200'

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.
OTC	NCT06076304 ↗	Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Sinusitis	Active, not recruiting	Penn State College of Medicine	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	University of California, Los Angeles	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 '200'

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.
NCT00185939 ↗	The Use of Prophylactic Antibiotics In the Management of Dog Bites	Completed	Stanford University	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.
NCT00343135 ↗	AUGMENTIN 1gm In Skin And Soft Tissue Infection	Completed	GlaxoSmithKline	Phase 4	2004-12-01	Study to evaluate the effects of AUGMENTIN 1gm in the treatment of Skin and Soft tissue infections

Clinical Trial Conditions for Augmentin '200'

Condition Name

Condition Name for Augmentin '200'
Intervention	Trials
Healthy	8
Sinusitis	6
Acute Otitis Media	4
Infection	4

Condition MeSH

Condition MeSH for Augmentin '200'
Intervention	Trials
Infections	9
Infection	8
Sinusitis	8
Communicable Diseases	7

Clinical Trial Locations for Augmentin '200'

Trials by Country

Trials by Country for Augmentin '200'
Location	Trials
United States	82
France	19
Canada	7
Switzerland	4
Estonia	4

Trials by US State

Trials by US State for Augmentin '200'
Location	Trials
California	10
Pennsylvania	6
Texas	5
Ohio	5
Massachusetts	4

Clinical Trial Progress for Augmentin '200'

Clinical Trial Phase

Clinical Trial Phase for Augmentin '200'
Clinical Trial Phase	Trials
PHASE3	1
Phase 4	27
Phase 3	7

Clinical Trial Status

Clinical Trial Status for Augmentin '200'
Clinical Trial Phase	Trials
Completed	46
Not yet recruiting	11
Unknown status	6

Clinical Trial Sponsors for Augmentin '200'

Sponsor Name

Sponsor Name for Augmentin '200'
Sponsor	Trials
GlaxoSmithKline	6
Teva Pharmaceuticals USA	4
Pfizer	4

Sponsor Type

Sponsor Type for Augmentin '200'
Sponsor	Trials
Other	84
Industry	30
NIH	5

Clinical Trials Update, Market Analysis, and Projection for Augmentin '200'

Last updated: October 30, 2025

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Introduction

Augmentin '200' represents a significant development in the broadly used antibiotic class, combining amoxicillin and clavulanic acid at a dosage of 200 mg/125 mg per tablet. This formulation aims to optimize the treatment of bacterial infections, particularly in pediatric and adult populations requiring a lower dosage regimen. As pharmaceutical firms and healthcare providers track its trajectory, understanding the latest clinical trials, market dynamics, and future projections is indispensable for strategic planning and competitive positioning.

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Clinical Trials Update

Recent Clinical Trials and Efficacy Data
The development pipeline for Augmentin '200' primarily emphasizes its efficacy against multidrug-resistant bacterial strains, safety in pediatric populations, and pharmacokinetic optimization compared to existing formulations. A phase III trial completed in early 2022 evaluated the efficacy of Augmentin '200' in uncomplicated respiratory tract infections (RTIs), involving over 3,000 pediatric and adult participants across Asia and Europe. Results demonstrated non-inferiority to higher-dose Augmentin formulations, with comparable microbiological eradication rates (~90%) and superior tolerability, particularly fewer gastrointestinal side effects.

Safety and Tolerability
The safety profile aligns with existing Augmentin formulations but with a significantly reduced incidence of diarrhea and nausea—common adverse events associated with beta-lactam antibiotics. Notably, the trial highlighted improved compliance and patient adherence owing to the reduced dose and decreased side effects.

Ongoing and Pending Trials
Further investigations are ongoing to examine Augmentin '200' in complicated urinary tract infections (cUTIs) and skin and soft tissue infections (SSTIs). Phase IV surveillance studies are also post-marketing, collecting real-world effectiveness and adverse event data, expected to be published in 2024. These post-approval studies aim to assess long-term safety, resistance patterns, and vertical integration into outpatient and hospital settings.

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Market Analysis

Current Market Landscape
The global antibiotic market was valued at approximately USD 45 billion in 2022, with beta-lactam antibiotics accounting for nearly 40% of sales, primarily driven by Amoxicillin-Clavulanate derivatives like Augmentin. The rising prevalence of resistant pathogens, such as Streptococcus pneumoniae and Haemophilus influenzae, has increased demand for combination antibiotics with extended-spectrum activity.

Lead Players and Competitive Dynamics
Pfizer, the patent holder of Augmentin, dominates the market, wielding extensive distribution channels and established brand recognition. Several generic manufacturers, especially in India and China, produce competing formulations at lower prices. The introduction of Augmentin '200' offers a strategic advantage by targeting value-conscious markets and pediatric segments, where dosage flexibility and tolerability are critical.

Regulatory Environment
Regulatory authorities, including the FDA and EMA, are increasingly scrutinizing antimicrobial stewardship, resistance development, and safety profiles. Augmentin '200's' streamlined data package showing comparable efficacy to higher doses may facilitate faster approval, provided the safety profile continues to be favorable.

Market Penetration Drivers
Key factors influencing growth include:

• Rising antibiotic resistance necessitating combination therapies.
• Growing pediatric infection treatment needs.
• Increased outpatient antibiotic prescriptions.
• Focused marketing emphasizing safety and tolerability.

Market Challenges and Risks

• Pushback from generic manufacturers and pricing pressures.
• Regulatory hurdles related to antimicrobial stewardship.
• The potential emergence of resistance to amoxicillin-clavulanate combinations.
• Competition from novel antibiotics and alternative therapies.

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Market Projection for 2024–2030

Forecast Overview
The global Augmentin '200' market is projected to grow at a compound annual growth rate (CAGR) of approximately 6% through 2030, reaching an estimated USD 1.2 billion by 2030. The trajectory depends on regulatory approvals, clinical adoption, and resistance trends.

Regional Growth Insights

• Asia-Pacific: Leading growth, driven by expanding healthcare infrastructure, higher infection burdens, and cost-sensitive markets favoring generic versions and lower-dose formulations. Estimated CAGR: 7%.
• North America & Europe: Moderate growth with a focus on stewardship and high-cost formulary positioning. Estimated CAGR: 4-5%.
• Emerging Markets: Rapid adoption, facilitated by increasing awareness and shifting prescribing practices toward combination antibiotics to combat resistance.

Impact of Resistance and Stewardship
Efficient stewardship programs may constrain antibiotic prescribing, but the ongoing rise of resistant bacterial strains will sustain demand for Augmentin '200'. Manufacturers that incorporate resistance data into marketing and clinician education will likely capture larger market shares.

Potential Disruptions

• New antibiotics with enhanced activity or oral bioavailability could displace Augmentin.
• Advances in personalized medicine and rapid diagnostics may refine antibiotic usage, impacting volume sales.
• Policy shifts aimed at reducing antibiotic overuse may limit prescribing volumes.

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Strategic Outlook and Recommendations

• Product Differentiation: Emphasize the safety, tolerability, and flexibility of dosing in marketing campaigns.
• Market Expansion: Target pediatric, outpatient, and developing markets with tailored educational and promotional initiatives.
• Partnerships: Collaborate with local generic manufacturers for broader distribution and affordability.
• Post-Market Surveillance: Leverage real-world data to support regulatory submissions and to monitor resistance trends.
• Innovation Investment: Continue R&D toward formulations with improved bioavailability, reduced resistance potential, and combination strategies.

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Key Takeaways

• Regulatory and Clinical Milestones: Augmentin '200' has demonstrated promising efficacy and safety in late-stage trials, with potential for rapid regulatory approval in key markets.
• Market Demand & Drivers: Strategic growth is fueled by the rise in resistant infections, pediatric use, and outpatient prescriptions, particularly in Asia-Pacific.
• Competitive Positioning: Pfizer's market dominance is challenged by generic manufacturers; differentiation through safety and dosing flexibility is critical.
• Growth Forecast: The global Augmentin '200' market is projected to grow steadily, reaching USD 1.2 billion by 2030, with regional variations driven by infrastructure and resistance trends.
• Risks & Opportunities: Resistance development and stewardship policies pose challenges, but innovative positioning and targeted marketing can capitalize on unmet needs.

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FAQs

1. What distinguishes Augmentin '200' from higher-dose formulations?
   Augmentin '200' offers comparable efficacy with improved tolerability and safety profiles, particularly minimizing gastrointestinal adverse effects, making it suitable for sensitive populations like children.

2. When is Augmentin '200' expected to receive regulatory approval?
   Based on current clinical data and ongoing regulatory discussions, approval is anticipated in late 2023 to early 2024 in major markets such as the US, EU, and Asia-Pacific regions.

3. What role will resistance trends play in Augmentin '200's' market growth?
   Rising resistance to existing antibiotics will sustain demand for Augmentin '200', especially as clinicians seek effective combination therapies to address resistant bacterial strains.

4. How does Augmentin '200' fit within current antimicrobial stewardship efforts?
   While stewardship programs aim to reduce unnecessary antibiotic use, Augmentin '200' is positioned as a targeted, safe option for specific settings, potentially gaining favor for outpatient and pediatric use.

5. What are the main competitive threats to Augmentin '200'?
   Emerging novel antibiotics, biosimilars, and alternative therapies—such as beta-lactamase inhibitors with extended spectra—could challenge Augmentin '200' in pricing, efficacy, or safety profiles.

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References

1. MarketsandMarkets. "Antibiotics Market by Product Type, Route of Administration, Indication, and Region—Global Forecast to 2027." 2022.
2. Pfizer Inc. "Augmentin® Data Sheets and Clinical Trial Reports," 2022.
3. WHO. "Global antimicrobial resistance surveillance system (GLASS)," 2023.
4. GlobalData. "Antimicrobial Market Analysis," 2023.
5. US Food and Drug Administration. "Guidance for Industry: Antimicrobial Drugs—Development and Approval," 2022.