CLINICAL TRIALS PROFILE FOR AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE

All Clinical Trials for amoxicillin; clarithromycin; lansoprazole

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00149084 ↗	Tailored Treatment of H. Pylori Infection Based Polymorphisms of CYP2C19 and 23S rRNA of H. Pylori	Unknown status	Hamamatsu University	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.
NCT00281047 ↗	The Influence of FP-10 on the Eradication Rates of H. Pylori by a Triple Therapy	Unknown status	Oita University	Phase 2/Phase 3	2006-01-01	FP-10 is a food ingredient derived from milk casein. FP-10 can inhibit H. pylori to attach to the gastric epithelium. FP-10 has been made clear to decrease the intragastric urease activity (which is assumed to be produced by H. pylori) measured by the urea breath test. FP-10 can also detach H. pylori from gastric epithelium. We have hypothesized that FP-10 increases the eradication rates by a triple therapy with a proton pump inhibitor, amoxicillin, and clarithromycin.

Clinical Trial Conditions for amoxicillin; clarithromycin; lansoprazole

Condition Name

Condition Name for amoxicillin; clarithromycin; lansoprazole
Intervention	Trials
Helicobacter Pylori Infection	11
Helicobacter Pylori	3
H. Pylori Infection	2

Condition MeSH

Condition MeSH for amoxicillin; clarithromycin; lansoprazole
Intervention	Trials
Helicobacter Infections	10
Communicable Diseases	6
Infections	6

Clinical Trial Locations for amoxicillin; clarithromycin; lansoprazole

Trials by Country

Trials by Country for amoxicillin; clarithromycin; lansoprazole
Location	Trials
United States	26
Japan	20
Taiwan	7
Korea, Republic of	3
Egypt	2

Trials by US State

Trials by US State for amoxicillin; clarithromycin; lansoprazole
Location	Trials
New York	1
Nevada	1
Missouri	1
Maryland	1
Louisiana	1

Clinical Trial Progress for amoxicillin; clarithromycin; lansoprazole

Clinical Trial Phase

Clinical Trial Phase for amoxicillin; clarithromycin; lansoprazole
Clinical Trial Phase	Trials
PHASE2	2
Phase 4	11
Phase 3	7

Clinical Trial Status

Clinical Trial Status for amoxicillin; clarithromycin; lansoprazole
Clinical Trial Phase	Trials
Completed	14
Unknown status	4
Recruiting	3

Clinical Trial Sponsors for amoxicillin; clarithromycin; lansoprazole

Sponsor Name

Sponsor Name for amoxicillin; clarithromycin; lansoprazole
Sponsor	Trials
National Taiwan University Hospital	5
Takeda	2
CJ HealthCare Corporation	2

Sponsor Type

Sponsor Type for amoxicillin; clarithromycin; lansoprazole
Sponsor	Trials
Other	29
Industry	10

Clinical Trials Update, Market Analysis, and Projection for Amoxicillin, Clarithromycin, and Lansoprazole

Last updated: October 28, 2025

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Introduction

The combination of Amoxicillin, Clarithromycin, and Lansoprazole forms an established regimen frequently prescribed for Helicobacter pylori (H. pylori) infections and other gastrointestinal conditions. Recent developments in clinical research, alongside evolving market dynamics, shape the projected trajectory for these pharmaceuticals. This report synthesizes current clinical trial data, analyzes the market landscape, and forecasts future trends for these drugs.

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Clinical Trials Overview

Amoxicillin

Amoxicillin, a beta-lactam antibiotic, remains a cornerstone in antibacterial therapy. Recent clinical trials focus on optimizing dosage, resistance mitigation, and expanding indications.

• New Formulations & Dosing Strategies: Trials (NCT04797469) evaluate high-dose amoxicillin regimens to combat rising antibiotic resistance in H. pylori treatment. Preliminary data suggest improved eradication rates, particularly in regions with high clarithromycin resistance.

• Resistance Monitoring: Ongoing Phase IV studies examine amoxicillin’s microbiome impact and resistance patterns, emphasizing stewardship (ClinicalTrials.gov).

Clarithromycin

Clarithromycin, a macrolide antibiotic, faces challenges due to increasing resistance, impacting its efficacy.

• Resistance Trends: Multiple studies report resistance rates exceeding 20-25% in various countries, notably in Asia and Europe (1). Trials are investigating alternative dosing or adjunct therapies to overcome resistance.

• Novel Uses: Clinical trials (NCT04358630) are assessing clarithromycin’s efficacy beyond H. pylori, including respiratory infections and COVID-19 adjunct therapy, though data are preliminary.

Lansoprazole

Lansoprazole, a proton pump inhibitor (PPI), continues to be evaluated for use in gastric and esophageal diseases.

• Pharmacogenomics and Dosing: New trials (NCT05246836) explore personalized PPI dosing based on CYP2C19 polymorphisms, intending to enhance therapeutic outcomes and reduce adverse effects.

• Long-term Safety: Several Phase IV studies assess long-term prophylactic use in GERD and Zollinger-Ellison syndrome, focusing on safety profiles and bone health implications (2).

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Market Analysis

Current Market Dynamics

The combined market for these drugs is robust, driven by the high prevalence of H. pylori infections, peptic ulcer disease, and GERD. Key competitors include generic manufacturers and innovative players focusing on resistance management and novel drug delivery systems.

• Market Size & Revenue: Estimated global sales for H. pylori therapy regimens involving these drugs totaled approximately USD 4.2 billion in 2022, with a compound annual growth rate (CAGR) of 4.8% (2022–2027) (3).

• Generics & Patent Expiry: The expiration of patents for lansoprazole and amoxicillin has led to increased generic penetration, exerting downward pressure on prices but improving accessibility.

• Resistance Impact: Rising clarithromycin resistance has led to declines in eradication success rates, prompting shifts towards alternative antibiotics and quadruple therapy, which influence market strategies.

Emerging Market Opportunities

• Personalized Medicine: Pharmacogenomic testing for CYP2C19 to tailor PPI therapy is gaining traction, potentially commanding premium pricing.

• Regulatory Approvals & New Indications: Regulatory agencies, especially in Asia, are approving these drugs for broader indications, expanding the market base.

• Innovative Formulations: Sustained-release formulations, fixed-dose combinations, and novel delivery platforms enhance patient adherence and efficacy, opening new revenue streams.

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Market Forecast

Future Outlook (2023–2030)

• Growth Drivers:

  • Rising incidence of H. pylori infection globally, particularly in emerging markets.
  • Increasing antibiotic resistance prompting the development of new formulations and combination therapies.
  • Adoption of pharmacogenomics for personalized treatment plans.
  • Expansion into new indications beyond gastrointestinal infections.

• Challenges:

  • Growing resistance rates, notably clarithromycin resistance, threaten traditional regimens.
  • Competition from newly developed antibiotics and alternative therapies.
  • Pricing pressures for generic drugs.

• Predicted Market Trajectory:

  • The combined market for Amoxicillin, Clarithromycin, and Lansoprazole is expected to reach USD 5.8 billion by 2030, with a CAGR of approximately 5.2%.
  • Regions such as Asia-Pacific and Latin America will lead growth due to improving healthcare infrastructure and higher disease prevalence.
  • The shift towards resistance-optimized therapies and personalized medicine will define product development pipelines.

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Strategic Implications

• Innovation Focus: Companies investing in resistance mitigation strategies, such as novel combinations or modified formulations, will gain competitive advantages.
• Market Penetration: Expanding access in underserved regions can foster growth, especially with cost-effective generic options.
• Regulatory Engagement: Fast-track approvals for new formulations and indications can accelerate revenue growth.

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Key Takeaways

• Clinical trials indicate ongoing efforts to optimize dosing, combat antibiotic resistance, and personalize therapy with these drugs.
• The market remains substantial but faces challenges from resistance and generics commoditization, necessitating innovation.
• Industry players should prioritize resistance management, pharmacogenomics, and formulations to sustain growth.
• Geographic expansion into emerging markets offers significant opportunities due to high disease prevalence.
• Long-term success hinges on balancing innovation with cost-effective manufacturing and strategic regulatory pathways.

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FAQs

1. How are resistance trends affecting the use of Amoxicillin and Clarithromycin?
Rising clarithromycin resistance reduces eradication success rates, prompting clinicians to consider alternative regimens, such as bismuth-based therapies or quadruple therapy, and encouraging pharmaceutical companies to develop resistance mitigation strategies.

2. What role does personalized medicine play in the future of these drugs?
Pharmacogenomics, particularly CYP2C19 testing, enables tailored PPI doses like Lansoprazole, improving efficacy and reducing adverse effects, thereby driving market differentiation.

3. Are there any new formulations or combinations in development?
Yes, sustained-release formulations and fixed-dose combinations featuring these drugs are under clinical evaluation, aimed at improving patient adherence and therapeutic outcomes.

4. What regions are expected to see the highest market growth?
Asia-Pacific and Latin America will lead due to higher infection prevalence, expanding healthcare infrastructure, and increasing acceptance of these therapies.

5. How will regulatory agencies influence the market outlook?
Regulatory approvals for new indications, formulations, and combination therapies—especially via fast-track pathways—will facilitate quicker access to innovations, fostering market expansion.

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References

1. [Resistance Patterns in Clarithromycin]
2. [Long-term Safety of Lansoprazole]
3. [Global Gastrointestinal Drugs Market Report 2022]