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.
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.
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

Condition Name

Condition Name for AMOXICILLIN
Intervention	Trials
Helicobacter Pylori Infection	137
Pneumonia	22
Healthy	18
Helicobacter Infections	13

Condition MeSH

Condition MeSH for AMOXICILLIN
Intervention	Trials
Infections	139
Helicobacter Infections	131
Infection	95
Communicable Diseases	84

Clinical Trial Locations for AMOXICILLIN

Trials by Country

+

−

Trials by Country for AMOXICILLIN
Location	Trials
United States	303
China	91
Taiwan	46
Italy	42
Canada	41

Trials by US State

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−

Trials by US State for AMOXICILLIN
Location	Trials
Texas	21
California	21
Ohio	19
Florida	13
Arizona	13

Clinical Trial Progress for AMOXICILLIN

Clinical Trial Phase

Clinical Trial Phase for AMOXICILLIN
Clinical Trial Phase	Trials
Phase 4	245
Phase 3	96
Phase 2/Phase 3	14

Clinical Trial Status

Clinical Trial Status for AMOXICILLIN
Clinical Trial Phase	Trials
Completed	324
Recruiting	77
Unknown status	67

Clinical Trial Sponsors for AMOXICILLIN

Sponsor Name

Sponsor Name for AMOXICILLIN
Sponsor	Trials
National Taiwan University Hospital	20
Shanghai Jiao Tong University School of Medicine	18
GlaxoSmithKline	12

Sponsor Type

Sponsor Type for AMOXICILLIN
Sponsor	Trials
Other	786
Industry	144
NIH	14

Clinical Trials, Market Analysis, and Projections for Amoxicillin

Introduction

Amoxicillin, a widely used antibiotic, has been a cornerstone in the treatment of various bacterial infections for decades. This article will delve into recent clinical trials, market analysis, and projections for amoxicillin, providing a comprehensive overview of its current and future standing in the pharmaceutical market.

Recent Clinical Trials

Antibiotic-Associated Diarrhea Trial

A recent Phase 4 clinical trial, conducted by Rockefeller University, focuses on the effects of amoxicillin on gut health in healthy individuals. This study aims to understand how short-term use of amoxicillin impacts gut nerve and support cells, potentially leading to conditions like irritable bowel syndrome. The trial involves a screening period of up to 3 weeks, variable treatment duration, and a follow-up period of up to 1 year[4].

Key Objectives and Findings

• Primary Objectives: To determine the number of colonic submucosal glia and neurons in the colon.
• Secondary Objectives: To analyze changes in gene expression in submucosal glia and neurons.
• Significance: This trial, although not directly related to the therapeutic use of amoxicillin, provides valuable insights into its effects on gut health, which is crucial for understanding potential long-term side effects.

Market Analysis

Global Market Size and Growth

The global amoxicillin market is expected to grow steadily over the forecast period. Here are some key points:

• Current Market Size: The global amoxicillin market was valued at USD 4.7 billion in 2021[3].
• Projected Growth: It is anticipated to reach USD 5.51 billion by 2029, growing at a Compound Annual Growth Rate (CAGR) of approximately 2% during the forecast period of 2022-2029[3].
• Regional Dominance: North America dominates the market due to the high prevalence of respiratory infections and advanced healthcare facilities. The Asia-Pacific region is also witnessing significant growth due to an increase in cardiovascular diseases and an aging population[3].

Market Drivers

Several factors are driving the growth of the amoxicillin market:

• Increased Understanding of Antibiotics: The rising awareness of the common harms and benefits of antibiotics is shaping demand. Approved indications by regulatory bodies, such as the U.S. FDA, for conditions like Helicobacter pylori eradication and lower respiratory tract infections, are boosting market growth[3].
• Growing Impaired Renal Function: The increasing number of patients with impaired renal function, particularly in aging populations, is creating more opportunities for amoxicillin use[3].
• Prevalence of Lower Respiratory Infections: The high incidence of respiratory infections globally is another significant driver[3].

Market Segments

The amoxicillin market is segmented based on several criteria:

• Therapy Type: Monotherapy and combinational therapy.
• Indication: Respiratory tract infections, skin infections, chest infections, ear infections, urinary tract infections, and others.
• Distribution Channel: Hospital pharmacy, online pharmacy, retail pharmacy.
• End-Users: Hospitals, homecare, specialty clinics[3].

Projections and Future Outlook

Market Growth Projections

The global antibiotics market, which includes amoxicillin, is projected to continue growing:

• Global Antibiotics Market: Expected to reach nearly $44.7 billion by 2020 from $40.6 billion in 2015, growing at a CAGR of 2.0% from 2015 to 2020[5].
• Beta Lactam & Beta Lactamase Inhibitors: This segment, which includes amoxicillin, is expected to grow at over 2.7% and reach over $20.5 billion by 2025[2].

Emerging Trends and Challenges

• Antibiotic Resistance: The rising issue of antibiotic resistance is a significant challenge. New antibiotics and innovative formulations are needed to combat resistant strains[5].
• Regulatory Framework: Regulatory agencies are continually updating guidelines based on emerging evidence, which can impact market growth and product development[3].

Competition and Alternatives

Oral Sulopenem as an Alternative

Recent clinical trials have shown that oral sulopenem could be a superior alternative to amoxicillin/clavulanate for treating uncomplicated urinary tract infections (uUTIs). The REASSURE trial demonstrated statistical superiority of oral sulopenem over amoxicillin/clavulanate, with a better safety profile and fewer serious adverse events[1].

Key Takeaways

• Clinical Trials: Ongoing trials are focusing on the effects of amoxicillin on gut health and its potential long-term side effects.
• Market Growth: The global amoxicillin market is expected to grow at a CAGR of approximately 2% from 2022 to 2029.
• Market Drivers: Increased understanding of antibiotics, growing impaired renal function, and prevalence of lower respiratory infections are key drivers.
• Future Outlook: The market is expected to continue growing, but challenges such as antibiotic resistance and regulatory updates must be addressed.
• Alternatives: New antibiotics like oral sulopenem are emerging as potential alternatives with superior efficacy and safety profiles.

FAQs

What is the current market size of the global amoxicillin market?

The global amoxicillin market was valued at USD 4.7 billion in 2021[3].

What is the projected growth rate of the global amoxicillin market?

The market is expected to grow at a CAGR of approximately 2% from 2022 to 2029[3].

What are the main drivers of the amoxicillin market?

The main drivers include increased understanding of antibiotics, growing impaired renal function, and the prevalence of lower respiratory infections[3].

Are there any new antibiotics emerging as alternatives to amoxicillin?

Yes, oral sulopenem has shown superiority to amoxicillin/clavulanate in treating uUTIs and is being considered for other indications[1].

How does antibiotic resistance impact the amoxicillin market?

Antibiotic resistance is a significant challenge, necessitating the development of new antibiotics and innovative formulations to combat resistant strains[5].

References

1. Urology Times: "Oral sulopenem shows superiority to amoxicillin/clavulanate for uUTIs"[1].
2. Business Wire: "Antibiotics Market Analysis, Trends, and Forecasts, 2025"[2].
3. Data Bridge Market Research: "Global Amoxicillin Market – Industry Trends and Forecast to 2029"[3].
4. WithPower: "Amoxicillin for Antibiotic-Associated Diarrhea - Clinical Trials"[4].
5. BCC Research: "Global Antibiotics Market Size, Share & Industry Growth Analysis"[5].