CLINICAL TRIALS PROFILE FOR AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE

505(b)(2) Clinical Trials for AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE

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; CLARITHROMYCIN; OMEPRAZOLE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00003151 ↗	Antibiotic Therapy in Treating Patients With Low Grade Gastric Lymphoma	Completed	University of Glasgow	Phase 2	1997-09-01	RATIONALE: Antibiotics may stop the growth of Helicobacter pylori which may be associated with gastric lymphoma. PURPOSE: Phase II trial to study the effectiveness of antibiotic therapy in treating patients with low grade gastric lymphoma that has not been previously treated.
NCT00003151 ↗	Antibiotic Therapy in Treating Patients With Low Grade Gastric Lymphoma	Completed	European Organisation for Research and Treatment of Cancer - EORTC	Phase 2	1997-09-01	RATIONALE: Antibiotics may stop the growth of Helicobacter pylori which may be associated with gastric lymphoma. PURPOSE: Phase II trial to study the effectiveness of antibiotic therapy in treating patients with low grade gastric lymphoma that has not been previously treated.
NCT00149084 ↗	Tailored Treatment of H. Pylori Infection Based Polymorphisms of CYP2C19 and 23S rRNA of H. Pylori	Unknown status	Yokoyama Foundation for Clinical Pharmacology	Phase 3	2003-04-01	The eradication rate of the standard H. pylori eradication therapy (such as the triple therapy with a proton pump inhibitor [PPI], amoxicillin and clarithromycin) depends on bacterial susceptibility to clarithromycin and genotypes of CYP2C19 in patients. The investigators intend to investigate whether the tailored therapy based on the two above-mentioned factors increases the cure rate of the initial eradication therapy.

Clinical Trial Conditions for AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE

Condition Name

Condition Name for AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE
Intervention	Trials
Helicobacter Pylori Infection	15
Non-alcoholic Fatty Liver Disease	3
Helicobacter Infections	3
H. Pylori Infection	2

Condition MeSH

Condition MeSH for AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE
Intervention	Trials
Helicobacter Infections	13
Communicable Diseases	7
Infections	7
Infection	6

Clinical Trial Locations for AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE

Trials by Country

Trials by Country for AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE
Location	Trials
United States	5
Spain	4
Iran, Islamic Republic of	4
Egypt	4
Pakistan	3

Trials by US State

Trials by US State for AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE
Location	Trials
Texas	3
Missouri	1
Florida	1

Clinical Trial Progress for AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE

Clinical Trial Phase

Clinical Trial Phase for AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE
Clinical Trial Phase	Trials
PHASE4	1
PHASE2	3
Phase 4	14

Clinical Trial Status

Clinical Trial Status for AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE
Clinical Trial Phase	Trials
Completed	23
Unknown status	8
NOT_YET_RECRUITING	3

Clinical Trial Sponsors for AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE

Sponsor Name

Sponsor Name for AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE
Sponsor	Trials
Tehran University of Medical Sciences	4
National Taiwan University Hospital	2
China Medical University Hospital	1

Sponsor Type

Sponsor Type for AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE
Sponsor	Trials
Other	54
Industry	6
NIH	1

Last updated: October 30, 2025

inical Trials Update, Market Analysis, and Projections for Amoxicillin, Clarithromycin, and Omeprazole

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Introduction

The pharmaceuticals landscape for antibiotics and proton pump inhibitors (PPIs) continues to evolve amid rising antimicrobial resistance and shifting healthcare priorities. This analysis assesses the current clinical trial status, market dynamics, and future outlook for Amoxicillin, Clarithromycin, and Omeprazole—three cornerstone drugs used extensively to treat bacterial infections and acid-related disorders. Understanding these facets will inform strategic decisions for stakeholders across R&D, manufacturing, and investment domains.

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Clinical Trials Landscape: Current Status and Trends

Amoxicillin

Amoxicillin, a widely used aminopenicillin, remains a mainstay in antibacterial therapy. Currently, no prominent late-stage or pivotal clinical trials are underway worldwide specifically for Amoxicillin, reflecting its established efficacy and safety profile. Nevertheless, research is ongoing for novel formulations and combination therapies to combat resistant strains. For instance, trials exploring Amoxicillin-clavulanate for resistant bacterial infections continue to be prominent, as new formulations aim to improve pharmacokinetics and reduce resistance emergence (ClinicalTrials.gov, 2023).

Clarithromycin

Clarithromycin, a macrolide antibiotic, faces increased scrutiny due to rising resistance, particularly against Helicobacter pylori and respiratory pathogens. Several clinical trials are focused on combination regimens to optimize efficacy against resistant strains. Notably, trials investigating novel delivery mechanisms (e.g., once-daily dosing or lower-dose regimens) aim to improve patient adherence and minimize resistance development. A 2022 phase III trial evaluated Clarithromycin-based triple therapy with adjunctive probiotics to enhance eradication rates of H. pylori (NCT04893245).

Omeprazole

Omeprazole, the prototypical PPI, is at the center of ongoing clinical research aimed at addressing its long-term safety profile and expanding therapeutic indications. Current trials include investigations into genetic polymorphisms affecting metabolism, new formulations with faster onset, and combined therapies for gastro-esophageal reflux disease (GERD) and Barrett’s esophagus. For example, a phase III trial examined Omeprazole’s efficacy in non-erosive reflux disease (NCT04512311).

Market Dynamics and Competitive Landscape

Amoxicillin Market

The global Amoxicillin market was valued at approximately USD 2.5 billion in 2022 and is projected to grow modestly at a CAGR of 3-4% through 2030, driven by steady demand for bacterial infections (Grand View Research, 2023). However, the market faces challenges from the rising prevalence of resistant strains. Efforts to develop extended-spectrum or combination formulations aim to address resistance issues and capture niche segments. Major manufacturers include GlaxoSmithKline, Sanofi, and Teva Pharmaceuticals.

Clarithromycin Market

Clarithromycin's market has experienced volatility due to increasing resistance, which has led to decreased prescribing in some regions, notably in the U.S. and Europe. Despite this, amid ongoing research into overcoming resistance, the global Clarithromycin market held an estimated USD 1.2 billion in 2022 and is expected to decline slightly unless new, effective combination therapies emerge. Asia-Pacific markets, especially China and India, remain significant due to high prevalence of H. pylori infection and economic factors influencing antibiotic use.

Omeprazole Market

The Omeprazole market dominates the PPI segment, with a valuation of around USD 10 billion in 2022. It is projected to grow at a CAGR of approximately 4-5% through 2030, supported by rising incidence of acid-related gastrointestinal disorders, increasing aging populations, and expanding indications for PPIs (Fortune Business Insights, 2023). Patent expirations of major formulations have spurred off-patent competition, leading to a proliferation of generic versions. Key players include AstraZeneca, Allergan, and Hikma Pharmaceuticals.

Future Market Projections

Growth Drivers

• Antimicrobial Stewardship & Resistance Management: The global focus on combating antimicrobial resistance (AMR) prompts innovation in formulations and combination therapies for Amoxicillin and Clarithromycin. Regulatory incentives and public health initiatives may stimulate new clinical trials and approvals.
• Expansion of PPI Indications: For Omeprazole, upcoming approvals for conditions like Barrett’s esophagus and non-erosive GERD could supplement market growth.
• Personalized Medicine: Pharmacogenomics research affecting Omeprazole metabolism (e.g., CYP2C19 variants) offers scope for tailored therapies, creating new market pathways.

Challenges

• Resistance and Safety Concerns: Increasing resistance may necessitate newer antibiotics, reducing reliance on existing drugs like Clarithromycin. Long-term safety considerations for PPIs also pose market hurdles.
• Pricing and Generic Competition: Patent expirations lead to intense price competition, especially for Omeprazole, affecting profit margins.
• Regulatory Environment: Stricter antimicrobial use policies and approval standards could delay new formulations or restrict indications.

Long-term Outlook

The combination of ongoing clinical research, evolving resistance patterns, and demographic shifts indicates a nuanced outlook:

• Amoxicillin will sustain its fundamental role but will see incremental innovations rather than paradigm shifts.
• Clarithromycin's future viability hinges on overcoming resistance through novel combination therapies and formulations; otherwise, its market share may decline.
• Omeprazole and other PPIs will continue to dominate the gastrointestinal segment, with evolution towards targeted, personalized therapy expected to be a significant growth driver.

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Key Takeaways

• Clinical trials highlight ongoing efforts to optimize existing antibiotics and PPIs, focusing on resistance mitigation, formulation improvements, and expanded indications.
• Market analysis reveals a mature landscape for Amoxicillin and Omeprazole, characterized by incremental growth and fierce generic competition, respectively, while Clarithromycin faces headwinds from resistance.
• Future projections depend heavily on successful clinical development of combination therapies, pharmacogenomics integration, and addressing global AMR challenges.
• Stakeholders should monitor evolving clinical data, regulatory policies, and resistance trends that influence R&D focus and market strategies.
• Investment opportunities lie in formulation innovations, personalized medicine, and expanding indications for established drugs.

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FAQs

Q1: How is antimicrobial resistance impacting the development of Amoxicillin?
A1: Rising resistance has led to the development of extended-spectrum formulations and combination therapies, but no major pipeline drugs are in late-stage trials, indicating a focus on optimizing existing formulations.

Q2: What factors threaten Clarithromycin's market sustainability?
A2: Increasing resistance rates, especially against H. pylori, and competition from newer regimens without Clarithromycin are primary concerns. Trials exploring novel combinations aim to counter this trend.

Q3: Will Omeprazole remain dominant in the PPI market?
A3: Yes, especially with ongoing research into personalized therapy and new indications. Patent expirations and generics have led to price competition, but the core market remains strong.

Q4: Are there any promising clinical developments that could revitalize Clarithromycin?
A4: Yes, trials focusing on probiotics adjunct therapy and improved delivery systems may enhance efficacy and differentiate Clarithromycin-based treatments.

Q5: How will regulatory policies influence future drug development?
A5: Stricter antimicrobial stewardship and approval standards could delay approvals but may incentivize the creation of safer, resistance-proof formulations and personalized therapies.

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Citations

[1] Grand View Research. "Antibiotics Market Size, Share & Trends Analysis," 2023.
[2] ClinicalTrials.gov, 2023.
[3] Fortune Business Insights. "Gastrointestinal Drugs Market Forecast," 2023.