CLINICAL TRIALS PROFILE FOR AMOXICILLIN PEDIATRIC

505(b)(2) Clinical Trials for AMOXICILLIN PEDIATRIC

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 Combination	NCT03124199 ↗	Rifaximin Associated With Classic Triple Therapy for the Eradication of Helicobacter Pylori Infection	Completed	Fundación de Investigación Biomédica - Hospital Universitario de La Princesa	Phase 3	2014-02-01	Background: A progressive decrease in Helicobacter pylori eradication rates has been described over the years, so new combinations of antibiotics for treatment are needed. Aim: To evaluate the efficacy and safety of the addition of rifaximin to standard triple therapy (omeprazole, amoxicillin and clarithromycin) for the eradication of H. pylori. Methods: Independent prospective pilot clinical trial (EUDRA CT: 2013-001080-23). Forty consecutive adult patients were included with H. pylori infection, dyspeptic symptoms and naive to eradication treatment. A full blood test was performed in the first 5 patients included to evaluate the safety of the treatment. H. pylori eradication was confirmed with urea breath test at least 4 weeks after the end of treatment. Treatment: Rifaximin 400 mg/8 h, clarithromycin 500 mg/12 h, amoxicillin 1 g/12 h, and omeprazole 20 mg/12 h for 10 days.

All Clinical Trials for AMOXICILLIN PEDIATRIC

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001658 ↗	Amoxicillin for the Treatment of Pediatric Autoimmune Disorders Associated With Streptococcal Infections	Completed	National Institute of Mental Health (NIMH)	Phase 4	1997-07-01	Bacteria carry substances on their surface called antigens. When antigens come into contact with the right kinds of cells in the body an immune reaction is caused. This reaction is often the symptoms of sickness that a patient feels. In order for the body to fight off the attack of antigens, it creates substances called antibodies. Antibodies counter the action of antigens and make the bacteria harmless. However, the immune system must learn how to make the right antibodies for the right antigens. Sometimes the body creates antibodies that confuse normal tissues as foreign and attack them. This is called an autoimmune reaction and sometimes occurs when the body is exposed to certain bacteria. One bacteria known for causing autoimmune reactions is Group A beta-hemolytic Streptococcus (GABHS). This bacteria often causes throat infections commonly known as "strep throat". Some researchers believe that the autoimmune reaction associated with strep throat infections may cause neuropsychiatric disorders, like obsessive-compulsive disorder and/or tic disorder in children. As a result, each time a child with one of these disorders experiences an infection with GABHS his/her symptoms can reoccur or worsen. Researchers believe that by giving patients a certain antibiotic, they can prevent GABHS infection and thus prevent the return of symptoms. This study is designed to test the effectiveness of the antibiotic Amoxicillin for the treatment of Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal infections (PANDAS). Patients will receive Amoxicillin for six weeks and placebos "inactive sugar pills" for six weeks in order to see if the medication is truly working. Effectiveness of the treatment will be based on the presence or absence of symptoms. If at the end of the study Amoxicillin is proven to be effective treatment for PANDAS patients may be offered the opportunity to continue taking the medication for an additional six months.
NCT00002052 ↗	Prospective Comparison of Ampicillin / Amoxicillin Versus Ceftriaxone for the Treatment of Salmonella Infections in AIDS Patients	Completed	University of Southern California	N/A	1969-12-31	To compare the effectiveness of standard treatment with parenteral ampicillin and oral amoxicillin compared to initial daily therapy with ceftriaxone followed by 3 times weekly suppressive treatment for salmonella infections in AIDS patients.
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.

Clinical Trial Conditions for AMOXICILLIN PEDIATRIC

Condition Name

Condition Name for AMOXICILLIN PEDIATRIC
Intervention	Trials
Helicobacter Pylori Infection	158
Pneumonia	23
Healthy	19

Condition MeSH

Condition MeSH for AMOXICILLIN PEDIATRIC
Intervention	Trials
Infections	139
Helicobacter Infections	132
Infection	95

Clinical Trial Locations for AMOXICILLIN PEDIATRIC

Trials by Country

Trials by Country for AMOXICILLIN PEDIATRIC
Location	Trials
United States	310
China	111
Taiwan	51
Italy	43
Canada	42

Trials by US State

Trials by US State for AMOXICILLIN PEDIATRIC
Location	Trials
Texas	24
California	21
Ohio	20
Florida	13
Arizona	13

Clinical Trial Progress for AMOXICILLIN PEDIATRIC

Clinical Trial Phase

Clinical Trial Phase for AMOXICILLIN PEDIATRIC
Clinical Trial Phase	Trials
PHASE4	35
PHASE3	14
PHASE2	7

Clinical Trial Status

Clinical Trial Status for AMOXICILLIN PEDIATRIC
Clinical Trial Phase	Trials
Completed	340
Recruiting	100
Unknown status	67

Clinical Trial Sponsors for AMOXICILLIN PEDIATRIC

Sponsor Name

Sponsor Name for AMOXICILLIN PEDIATRIC
Sponsor	Trials
National Taiwan University Hospital	21
Shanghai Jiao Tong University School of Medicine	19
GlaxoSmithKline	12

Sponsor Type

Sponsor Type for AMOXICILLIN PEDIATRIC
Sponsor	Trials
Other	890
Industry	146
NIH	14

Clinical Trials Update, Market Analysis, and Projection for Amoxicillin Pediatric

Last updated: October 28, 2025

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Introduction

Amoxicillin Pediatric remains a cornerstone in pediatric infectious disease management, primarily for bacterial respiratory tract infections, otitis media, and urinary tract infections. As antibiotic resistance patterns evolve and regulatory landscapes adapt, understanding current clinical trial developments, market dynamics, and future projections is essential for stakeholders across pharmaceutical, healthcare, and investment sectors.

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Clinical Trials Update

Recent Clinical Trials and Regulatory Developments

Over the past two years, several pivotal clinical trials have reinforced the efficacy and safety profile of Amoxicillin Pediatric. The focus has shifted toward optimizing dosage, minimizing resistance, and evaluating alternative formulations.

• Formulation Innovation: Trials explore concentrated drops and dispersible tablets to enhance adherence among infants and young children. For example, a recent multicenter study published in Pediatric Infectious Disease Journal ([1]) demonstrated comparable pharmacokinetics and improved compliance with dispersible formulations in children aged 6 months to 5 years.

• Resistance Monitoring: Ongoing post-marketing surveillance and clinical studies are evaluating the emergence of β-lactamase-producing bacteria. The NICE guidelines incorporate data suggesting that high-dose amoxicillin (up to 90 mg/kg/day) remains effective against resistant strains in middle-income countries ([2]).

• Safety Profiles: Recent Phase IV studies reaffirm the benign safety profile, emphasizing minimal gastrointestinal disturbance and allergic reactions in pediatric populations, consistent with prior evidence.

• Novel Delivery Platforms: Investigations into prolonged-release formulations aim to reduce dosing frequency and improve compliance. Preliminary data from a 2022 trial indicated sustained plasma concentrations over 24 hours with a fixed-dose combination, although regulatory approval remains pending ([3]).

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Market Analysis

Current Market Landscape

The global pediatric antibiotics market, driven by rising pediatric infectious disease prevalence, is valued at approximately USD 8 billion as of 2022, with Amoxicillin Pediatric constituting a major share owing to its broad-spectrum activity and cost-effectiveness.

Key market contributors include Pfizer, GlaxoSmithKline, and Teva Pharmaceuticals. Pfizer's Amoxicillin products account for nearly 35% of the pediatric antibiotic prescription volume in North America, reflecting established prescribing habits and broad healthcare coverage.

Competitive Dynamics

• Generic Competition: The high patent expirations for Amoxicillin formulations have led to a surge in generic manufacturers. This intensifies price competition and constrains profit margins but broadens access in low- and middle-income regions.

• Emergent Resistance: Increasing amoxicillin resistance, particularly in Streptococcus pneumoniae and Haemophilus influenzae, prompts the development of combination therapies, such as amoxicillin-clavulanate, and encourages innovation in extended-spectrum formulations.

• Regulatory and Policy Impacts: Governments are emphasizing antimicrobial stewardship, leading to stricter prescribing guidelines and potential restrictions, which may influence market volume growth.

Market Forecasts (2023-2030)

Analysts project a CAGR of 4.2% for the pediatric antibiotics segment, reaching USD 11.4 billion by 2030 ([4]). The growth drivers include:

• Increasing Pediatric Population: Projected to grow at a 1.2% annual rate globally, particularly in Africa and Asia-Pacific regions.

• Improved Access and Awareness: Initiatives by WHO and UNICEF aim to improve antibiotic access, especially in low-resource settings, potentially expanding market penetration.

• Innovation in Formulations: Demand for user-friendly formulations (e.g., dispersible tablets) forecasts a compound annual growth of approximately 6%, driven by pediatric compliance needs.

• Resistance-Driven Market Shifts: Rising resistance may eventually diminish demand unless accompanied by new formulations or combination therapies.

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Future Projections and Opportunities

Emerging Trends

• Personalized Dosing: Pharmacogenomics could enable tailored dosages, reducing side effects and resistance, albeit requiring significant R&D investment.

• Digital Health Integration: Digital adherence monitoring tools complement pharmacotherapy, improving treatment outcomes and reducing misuse.

• Combination Strategies: Development of fixed-dose combinations incorporating β-lactamases inhibitors could expand the utility of Amoxicillin Pediatric in resistant cases.

Challenges

• Antibiotic Stewardship: Regulations aimed at curbing unnecessary antibiotic use may suppress sales growth but ensure sustainable market development.

• Resistance Escalation: Resistance patterns could necessitate formulations beyond amoxicillin’s spectrum, requiring innovation and diversification.

• Regulatory Barriers: Approvals of new formulations or indications may face delays, impacting timelines for market entry.

Opportunities

• Developing Regions: Expanding manufacturing and distribution in Africa and Southeast Asia to cater to growing pediatric populations.

• Formulation Diversification: Creating palatable, stable, and easy-to-administer forms enhances compliance and captures market share.

• Biomarker-Guided Therapy: Implementation of rapid diagnostics to identify bacterial pathogens and resistance profiles may refine prescribing and foster premium pricing.

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Key Takeaways

1. Clinical Affirmation: The clinical efficacy and safety of Amoxicillin Pediatric are reinforced by recent studies, supporting its continued role in pediatric infectious disease management.

2. Market Expansion: Despite intense competition from generics, strategic investments in formulation innovation and regional expansion underpin growth prospects.

3. Resistance Management: Addressing rising bacterial resistance remains paramount, prompting product innovation such as extended-spectrum formulations and combination therapies.

4. Projected Growth: The pediatric antibiotics market, with Amoxicillin at its core, is expected to grow steadily, reaching USD 11.4 billion by 2030, driven by demographic shifts, policy changes, and product development.

5. Regulatory & Stewardship Dynamics: Navigating evolving regulatory landscapes and antimicrobial stewardship initiatives presents both challenges and opportunities, emphasizing the need for developing adaptive strategies.

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FAQs

1. How is antimicrobial resistance affecting Amoxicillin Pediatric formulations?
Resistance via β-lactamase-producing bacteria diminishes amoxicillin’s effectiveness; thus, formulations with β-lactamase inhibitors (e.g., amoxicillin-clavulanate) are increasingly adopted, and high-dose regimens are evaluated to overcome resistance.

2. Are new formulations of Amoxicillin Pediatric under clinical development?
Yes, extended-release and dispersible formulations are active in clinical trials, aiming to improve adherence and spectrum, with some nearing regulatory approval.

3. How does global regulation impact the market for pediatric antibiotics?
Regulatory agencies emphasize antimicrobial stewardship, which may restrict broad-use prescriptions but encourages the development of targeted, safe, and effective formulations, shaping future product pipelines.

4. What regional variations influence the Amoxicillin Pediatric market?
Developing nations with high pediatric infection burdens and lower antibiotic access present opportunities, while high-income countries focus on resistance management and formulation innovation.

5. What are the prospects for Amoxicillin Pediatric in the next decade?
The drug’s market will likely sustain growth through formulation improvements, regional expansion, and integration into comprehensive infection management strategies, despite resistance and regulatory challenges.

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References

[1] Pediatric Infectious Disease Journal, 2021. Efficacy of Dispersible Amoxicillin Formulations in Infants.
[2] NICE Guidelines, 2022. Managing Antibiotic Resistance in Respiratory Infections.
[3] ClinicalTrials.gov, 2022. Extended-Release Amoxicillin Formulation in Pediatric Population.
[4] Market Research Future, 2023. Global Pediatric Antibiotics Market Forecast.