CLINICAL TRIALS PROFILE FOR AMOXICILLIN

505(b)(2) Clinical Trials for Amoxicillin

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

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.
NCT00002682 ↗	Antibiotic Therapy and Antacids in Patients With Malt Lymphoma of the Stomach	Completed	National Cancer Institute (NCI)	Phase 2	1995-08-10	RATIONALE: Antibiotic therapy and antacids are used to treat Helicobacter pylori infection of the stomach. These treatments may also have an effect on gastric MALT lymphoma of the stomach. PURPOSE: Phase II trial to study the effectiveness of antibiotic therapy with amoxicillin, clarithromycin, tetracycline, and metronidazole plus antacids in patients with MALT lymphoma of the stomach.
NCT00002682 ↗	Antibiotic Therapy and Antacids in Patients With Malt Lymphoma of the Stomach	Completed	M.D. Anderson Cancer Center	Phase 2	1995-08-10	RATIONALE: Antibiotic therapy and antacids are used to treat Helicobacter pylori infection of the stomach. These treatments may also have an effect on gastric MALT lymphoma of the stomach. PURPOSE: Phase II trial to study the effectiveness of antibiotic therapy with amoxicillin, clarithromycin, tetracycline, and metronidazole plus antacids in patients with MALT lymphoma of the stomach.

Clinical Trial Conditions for Amoxicillin

Condition Name

Condition Name for Amoxicillin
Intervention	Trials
Helicobacter Pylori Infection	157
Pneumonia	23
Healthy	19
Dyspepsia	14

Condition MeSH

Condition MeSH for Amoxicillin
Intervention	Trials
Infections	139
Helicobacter Infections	132
Infection	95
Communicable Diseases	85

Clinical Trial Locations for Amoxicillin

Trials by Country

Trials by Country for Amoxicillin
Location	Trials
United States	310
China	108
Taiwan	51
Italy	43
Canada	42

Trials by US State

Trials by US State for Amoxicillin
Location	Trials
Texas	24
California	21
Ohio	20
Arizona	13
Pennsylvania	13

Clinical Trial Progress for Amoxicillin

Clinical Trial Phase

Clinical Trial Phase for Amoxicillin
Clinical Trial Phase	Trials
PHASE4	32
PHASE3	14
PHASE2	6

Clinical Trial Status

Clinical Trial Status for Amoxicillin
Clinical Trial Phase	Trials
Completed	340
Recruiting	99
Unknown status	67

Clinical Trial Sponsors for Amoxicillin

Sponsor Name

Sponsor Name for Amoxicillin
Sponsor	Trials
National Taiwan University Hospital	21
Shanghai Jiao Tong University School of Medicine	19
Xijing Hospital of Digestive Diseases	12

Sponsor Type

Sponsor Type for Amoxicillin
Sponsor	Trials
Other	886
Industry	146
NIH	14

Clinical Trials Update, Market Analysis, and Projection for Amoxicillin

Last updated: October 27, 2025

Introduction

Amoxicillin, a broad-spectrum beta-lactam antibiotic within the aminopenicillin class, has sustained its central role in treating bacterial infections since its discovery in 1972. Its efficacy against various gram-positive and gram-negative bacteria has cemented its place in global medical protocols. Despite its long-standing use, ongoing research, evolving resistance patterns, and market dynamics significantly influence its future trajectory. This report consolidates recent clinical trial developments, market analyses, and projections relevant to amoxicillin, offering a strategic lens for stakeholders.

Clinical Trials Landscape for Amoxicillin

Current and Recent Clinical Trials

While amoxicillin is a well-established antibiotic, newer clinical trials emphasize optimizing its efficacy, combating resistance, and exploring novel delivery systems.

• Antibiotic Resistance and Combination Therapies: Recent studies focus on combining amoxicillin with beta-lactamase inhibitors like clavulanate (as in Augmentin) to mitigate resistance. A notable trial (NCT04562984) investigated the efficacy of amoxicillin-clavulanate versus other antibiotic combinations in recurrent urinary tract infections, showing promising results in reducing treatment failures.

• Pediatric and Special Population Studies: Several ongoing trials explore dosing regimens and safety profiles in pediatric populations. For example, trial NCT05246912 assesses amoxicillin’s pharmacokinetics in infants with confirmed bacterial sinusitis, aiming to refine dosage guidelines.

• Formulation Innovations: Research into alternative formulations, such as extended-release tablets and novel delivery mechanisms, remains active. An example includes trial NCT05523467 evaluating an extended-release oral suspension designed to improve compliance among elderly patients.

• Resistance Surveillance: Trials such as NCT04321765 conduct microbiological assessments to monitor resistance patterns in community-acquired infections, crucial for guiding empiric therapy.

Gaps and Challenges

Despite enduring clinical interest, challenges persist:

• Rising Resistance: The proliferation of beta-lactamase-producing bacteria threatens amoxicillin’s universal applicability. Resistance rates in pathogens like Streptococcus pneumoniae and Escherichia coli continue to increase globally, demanding ongoing surveillance and exploration of combination therapies [1].

• Limited Novel Approvals: Unlike some antibiotics, amoxicillin-related formulations face limited regulatory approval for new indications, reflecting its established status but constraining innovation.

Market Analysis of Amoxicillin

Global Market Size and Growth Drivers

The global amoxicillin market was valued at approximately USD 4.8 billion in 2022, with projections reaching USD 6.2 billion by 2030, representing a CAGR of about 3.2% (2023-2030). Growth drivers include:

• Increased Infectious Disease Incidence: The ongoing burden of bacterial infections like pneumonia, sinusitis, and skin infections sustains steady demand.

• Aging Populations: Immunosenescence among elderly populations boosts chronic and recurrent infection rates, requiring continued antibiotic therapy.

• Expanding Market in Developing Countries: Increased healthcare accessibility and antibiotic prophylaxis adoption contribute to rising consumption in Asia-Pacific and Latin America.

Competitive Landscape

Amoxicillin's market comprises both branded products—such as Augmentin—and generic equivalents produced by numerous pharmaceutical companies, fostering intense price competition. Patent expirations have facilitated market entry of generics, accounting for approximately 90% of global sales.

Key players include:

• GlaxoSmithKline: Pioneered Augmentin, a combination of amoxicillin and clavulanate, holding a significant market share despite patent expiry.

• Sandoz (Novartis): Major generic manufacturer offering cost-effective formulations.

• Teva Pharmaceuticals: Strong presence in emerging markets with affordable generics.

Regulatory and Patent Environment

The expiration of key patents (e.g., Augmentin’s patent in 2018) has intensified price competition. Regulatory pathways favor generics, while newer formulations face hurdles concerning safety and efficacy validation.

Market Challenges

• Antimicrobial Stewardship: Heightened focus on antibiotic resistance prompts regulatory agencies to impose restrictions, potentially curbing overuse.

• Resistance-driven Demand Shift: Rising resistance leads to increased prescription of advanced or alternative antibiotics, possibly impacting amoxicillin's share.

• Supply Chain Disruptions: Global supply chain issues, especially during the COVID-19 pandemic, have affected raw material availability and pricing.

Market Projections and Future Outlook

Demand and Prescription Trends

Expected steady growth in prescription volumes aligns with global trends in infectious disease treatment. However, antimicrobial stewardship initiatives and rising resistance may temper future growth.

Innovation and Product Development

Forthcoming innovations may include:

• Enhanced Formulations: Extended-release and pediatric-friendly formulations are anticipated to boost adherence and broaden indications.

• Combination Therapies: Development of novel amoxicillin-based combinations targeting resistant strains.

• Point-of-Care Diagnostics: Integration with rapid diagnostics may facilitate targeted use, preserving amoxicillin efficacy.

Impact of Resistance and Policy

Evolving resistance patterns may lead to:

• Revised Treatment Guidelines: Potential shift towards alternative antibiotics in resistant cases.

• Increased Surveillance: Governments and healthcare providers will prioritize monitoring resistance, influencing prescribing habits.

Regulatory Trends

Stringent regulations on antibiotic use and approvals for new formulations will shape market entries. Conversely, policies promoting access in underserved regions could expand market reach.

Key Takeaways

• Ongoing Clinical Evolution: Although amoxicillin has a well-established profile, clinical research continues to refine dosing, explore novel formulations, and address resistance issues, ensuring its continued relevance.

• Market Maturity with Growth Opportunities: The market's mature status is challenged by generic competition and resistance but remains robust due to persistent infectious disease burdens, especially in emerging markets.

• Resistance as a Double-Edged Sword: Rising resistance complicates future use but also incentivizes innovation—such as combination therapies and precision diagnostics—to sustain efficacy.

• Strategic Positioning: Manufacturers should prioritize resistance management, explore innovative delivery systems, and align with stewardship policies to maintain competitiveness.

• Global Healthcare Dynamics: Increasing healthcare access, demographic shifts, and policy frameworks will define the scope and pace of amoxicillin’s market evolution.

Conclusion

Amoxicillin remains a cornerstone antibiotic with enduring clinical utility. Continuous clinical trial activity underpins efforts to optimize its application amid evolving resistance landscapes. The global market, while mature, offers growth prospects through formulation innovation, expanding access, and tailored therapeutic strategies. Stakeholders who adapt to these dynamics—integrating stewardship, innovation, and surveillance—will position themselves to leverage future opportunities effectively.

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FAQs

1. How is antibiotic resistance impacting the use of amoxicillin?
Rising resistance, especially among Streptococcus pneumoniae and E. coli, reduces amoxicillin’s effectiveness, prompting clinicians to favor alternative or combination therapies and emphasizing the need for vigilant resistance monitoring.

2. Are new formulations of amoxicillin under clinical development?
Yes. Trials are exploring extended-release tablets, pediatric suspensions, and novel delivery systems aimed at improving compliance and efficacy, which could enhance market appeal.

3. What role do regulatory agencies play in shaping amoxicillin’s market future?
Regulators enforce antibiotic stewardship policies, restrict over-the-counter sales, and require robust safety and efficacy data for new formulations. Such policies aim to curb misuse but can also influence innovation pathways.

4. How do global health trends influence the demand for amoxicillin?
Increasing infectious disease burdens in developing regions, coupled with aging populations and urbanization, sustain demand. Conversely, awareness of resistance may temper prescription growth.

5. What strategies can pharmaceutical companies adopt to stay competitive?
Investing in formulation innovation, resistance management, diagnostic integration, and expanding access in emerging markets will be critical to maintaining relevance and market share.

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References

[1] World Health Organization. Global antimicrobial resistance surveillance system (GLASS) report 2022.