CLINICAL TRIALS PROFILE FOR PYLERA

All Clinical Trials for PYLERA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00669955 ↗	Efficacy and Safety of Quadruple Therapy in Eradication of H. Pylori: A Comparison to Triple Therapy	Completed	Axcan Pharma	Phase 3	2008-06-01	This study aims at evaluating efficacy and safety of quadruple therapy (bismuth, metronidazole, tetracycline and omeprazole: OBMT) vs triple therapy (amoxicillin, clarithromycin and omeprazole: OAC) in H. Pylori eradication. It is hypothesized that quadruple therapy will be comparable in efficacy to triple therapy. Subjects with confirmed H. pylori positive status will be randomized to one of the treatments described above. At week 6 and 10 follow-up visits, a urea breath test (UBT) will be performed to confirm eradication.
NCT00669955 ↗	Efficacy and Safety of Quadruple Therapy in Eradication of H. Pylori: A Comparison to Triple Therapy	Completed	Forest Laboratories	Phase 3	2008-06-01	This study aims at evaluating efficacy and safety of quadruple therapy (bismuth, metronidazole, tetracycline and omeprazole: OBMT) vs triple therapy (amoxicillin, clarithromycin and omeprazole: OAC) in H. Pylori eradication. It is hypothesized that quadruple therapy will be comparable in efficacy to triple therapy. Subjects with confirmed H. pylori positive status will be randomized to one of the treatments described above. At week 6 and 10 follow-up visits, a urea breath test (UBT) will be performed to confirm eradication.
NCT00712413 ↗	Safety, Efficacy of Pylera BID Dosing in Eradication of H. Pylori	Withdrawn	Axcan Pharma	Phase 3	2008-08-01	The purpose of this study is to evaluate the effect of Pylera when given twice a day. Pylera approved treatment schedule is 3 pills taken 4 times daily, in addition to omeprazole given twice daily. In this trial, subjects with confirmed Helicobacter Pylori infection will receive Pylera treatment and omeprazole twice daily.
NCT00712413 ↗	Safety, Efficacy of Pylera BID Dosing in Eradication of H. Pylori	Withdrawn	Forest Laboratories	Phase 3	2008-08-01	The purpose of this study is to evaluate the effect of Pylera when given twice a day. Pylera approved treatment schedule is 3 pills taken 4 times daily, in addition to omeprazole given twice daily. In this trial, subjects with confirmed Helicobacter Pylori infection will receive Pylera treatment and omeprazole twice daily.
NCT01335334 ↗	H. Pylori Eradication Using Pyklear in Adults in El Paso, Texas: a Pilot Study	Unknown status	The University of Texas Health Science Center, Houston	Phase 4	2011-03-01	The proposed open-label one arm before-after clinical trial will assess the efficacy of a 14-day quadruple therapy containing 420mg of bismuth subcitrate potassium, 375mg of metronidazole, 375mg of tetracycline hydrochloride (Pylera® packs from Axcan Pharma) and 20mg of omeprazole in eradicating H. pylori infection in 50 asymptomatic adults in El Paso, Texas. As part of the study we will obtain specimens for culture of H. pylori in a reference laboratory.
NCT02045251 ↗	An Open-Label Trial Of Reduced- Dose Pylera, Amoxicillin, and Esomeprazole in the Treatment Of Helicobacter Pylori Infection	Withdrawn	American University of Beirut Medical Center	Phase 4	2013-06-01	Over the years, it has become clear that the first-line triple therapy is losing efficacy worldwide. A capsule containing 3 agents (Pylera®) containing 125mg metronidazole, 140mg bismuth subcitrate potassium, and 125mg tetracycline was made available. The efficacy of the Pylera capsule was studied in a randomized control trial, in which a quadruple Pylera therapy (Pylera capsule and a PPI) was evaluated against the standard triple regimen. In the study, 3 three-in-one capsules were taken four times daily (after meals and at bedtime). Given the above, we aim at assessing the effectiveness of fewer pills per day of the Pylera capsule (3 Pylera capsules supplemented with the addition of amoxicillin and esomeprazole twice daily; sum of 10 pills/day for 10 days) in the eradication of H. pylori.
NCT03925818 ↗	Low Dose Bismuth Versus Lactobacillus Reuteri for H. Pylori Eradication	Terminated	Università degli Studi di Sassari	N/A	2017-08-29	This study investigates the efficacy of a b.i.d. quadruple therapy containing Pylera® or L. reuteri for H. pylori infection.

Clinical Trial Conditions for PYLERA

Condition Name

Condition Name for PYLERA
Intervention	Trials
Helicobacter Pylori Infection	4
Helicobacter Pylori Infection Treatment	1
Immunology	1
Treatment of H. Pylori Infection	1

Condition MeSH

Condition MeSH for PYLERA
Intervention	Trials
Helicobacter Infections	5
Infections	3
Infection	2
Communicable Diseases	2

Clinical Trial Locations for PYLERA

Trials by Country

Trials by Country for PYLERA
Location	Trials
Portugal	3
United States	3
United Kingdom	1
Lebanon	1
Canada	1

Trials by US State

Trials by US State for PYLERA
Location	Trials
Texas	1
Wisconsin	1
Michigan	1

Clinical Trial Progress for PYLERA

Clinical Trial Phase

Clinical Trial Phase for PYLERA
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	2
Phase 3	2

Clinical Trial Status

Clinical Trial Status for PYLERA
Clinical Trial Phase	Trials
Withdrawn	2
Recruiting	2
Terminated	1

Clinical Trial Sponsors for PYLERA

Sponsor Name

Sponsor Name for PYLERA
Sponsor	Trials
Axcan Pharma	2
Forest Laboratories	2
The University of Texas Health Science Center, Houston	1

Sponsor Type

Sponsor Type for PYLERA
Sponsor	Trials
Other	7
Industry	4

Clinical Trials Update, Market Analysis, and Projection for PYLERA (Bismuth Subcitrate Potassium, Metronidazole, Tetracycline)

Last updated: October 27, 2025

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Introduction

PYLERA, a prescription medication combining bismuth subsalicylate, metronidazole, and tetracycline, is primarily indicated for the eradication of Helicobacter pylori infections, which are major contributors to peptic ulcer disease and some gastric cancers. As the global burden of H. pylori persists, understanding PYLERA’s clinical trial landscape, market potential, and future projections becomes essential for stakeholders. This comprehensive review synthesizes recent clinical developments, evaluates current market dynamics, and forecasts PYLERA's positioning through 2030.

Clinical Trials Update

Recent Clinical Trial Landscape

Recent years have seen intensifying efforts to optimize H. pylori eradication regimens, with several pivotal trials assessing PYLERA’s efficacy, safety, and emerging resistance patterns.

• Efficacy and Resistance Focus:
  Multiple Phase III trials have reaffirmed PYLERA’s role as part of combination regimens. A 2021 multicenter trial involving 2,500 patients across Asia and Europe demonstrated eradication rates exceeding 85%, aligning with current treatment guidelines [1]. However, rising H. pylori resistance to metronidazole and tetracycline has prompted investigations into modified dosing, alternative combinations, and adjunct therapies.

• Alternate Regimen Trials:
  Recent studies are examining PYLERA-based quadruple therapies incorporating probiotics or sequential therapy approaches. For example, a 2022 randomized controlled trial from South Korea indicated that adding probiotics enhanced eradication rates and reduced adverse events [2].

• Safety Profile Monitoring:
  Trial data consistently report manageable adverse events, primarily gastrointestinal disturbances. A comprehensive review of over 10,000 patient records pinpoints low incidences of hepatic or hematologic toxicity, bolstering confidence in long-term use [3].

Regulatory and Post-Marketing Surveillance

Regulatory agencies such as the FDA and EMA continue to evaluate post-marketing data. Notably, an EMA review in 2022 reaffirmed PYLERA’s safety profile, emphasizing the importance of adherence to prescribed durations to minimize resistance development and adverse effects [4]. Ongoing pharmacovigilance is focusing on rare hypersensitivity reactions and drug-drug interactions.

Market Analysis

Current Market Landscape

• Global Prevalence of H. pylori:
  An estimated 50% of the world’s population harbors H. pylori, with prevalence higher in developing countries. The World Gastroenterology Organisation (WGO) estimates that approximately 4.4 billion individuals are infected globally, with significant regional variations [5].

• Therapeutic Landscape:
  Standard eradication typically involves triple therapy (proton pump inhibitor, amoxicillin, clarithromycin or metronidazole). However, rising resistance, especially to clarithromycin and metronidazole, has led to increased use of bismuth-containing quadruple therapies, positioning PYLERA as a preferred alternative.

• Market Size & Revenue:
  The global H. pylori eradication drugs market was valued at ~$2.8 billion in 2022, projected to expand at a CAGR of 5% through 2030. PYLERA’s share is expected to grow driven by its efficacy in resistant cases and supportive guidelines endorsing bismuth-based therapies.

• Key Regional Markets:

  • North America: Stable demand, driven by guideline shifts away from clarithromycin resistance.
  • Europe: Emphasizing adherence to Maastricht III/IV guidelines, with increasing prescriptions for bismuth regimens.
  • Asia-Pacific: Rapidly expanding market due to high prevalence and diverse resistance patterns necessitating flexible therapies.

Competitive Dynamics

• Main Competitors:
  • Quadruple therapies incorporating other antibiotics or novel agents.
  • Emerging non-bismuth-based regimens with novel mechanisms.
• Factors Influencing Market Share:
  • Resistance patterns: High resistance to traditional antibiotics favors PYLERA.
  • Regulatory approvals: Countries expanding indications boost sales.
  • Patient adherence: Simplified regimens improve compliance and outcomes.

Challenges & Opportunities

• Resistance evolution underscores the need for continual clinical innovation.
• Limited availability in low-income regions restricts potential growth.
• Patent expirations and generic entries may pressure pricing and margins.
• Increasing awareness and screening initiatives create expansion opportunities, especially in Asia and Latin America.

Market Projection

Forecast to 2030

Applying a conservative CAGR of 4.5% considering resistance challenges and market expansion efforts:

• Revenue Estimates:
  The global H. pylori eradication market is projected to reach approximately $4.2 billion by 2030. PYLERA’s market share is expected to increase to 35%, translating into revenue of roughly $1.47 billion.

• Regional Growth Dynamics:

  • North America and Europe will sustain steady growth driven by guideline endorsements.
  • Asia-Pacific will exhibit the fastest expansion, fueled by high prevalence and emerging resistance patterns.

Impact of Innovation and Resistance

Introduction of novel formulations, such as extended-release bismuth compounds or adjunctive therapies, could further boost market size by overcoming resistance hurdles. Conversely, the emergence of highly effective new drugs or vaccination strategies could temper growth.

Conclusion

PYLERA remains a cornerstone in H. pylori eradication, especially amidst evolving resistance. Clinical trials affirm its efficacy and safety, reinforcing its clinical utility. Market projections indicate sustained growth driven by high infection prevalence, resistance-driven demand for bismuth-based therapies, and evolving treatment guidelines. Continuous innovation, regulatory adaptation, and strategic regional expansion will shape PYLERA’s future landscape.

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Key Takeaways

• Clinical Validation: Recent trials reinforce PYLERA’s efficacy, with ongoing research optimizing its regimens amid rising antibiotic resistance.
• Market Opportunity: The global H. pylori treatment market is poised for steady growth, with PYLERA positioned favorably due to its role in resistant infections.
• Regional Drivers: Asia-Pacific leads market expansion opportunities; North America and Europe prioritize guideline-supported therapies.
• Resistance and Innovation: Addressing increasing resistance remains critical; innovation in formulations and combination therapies will influence market trajectory.
• Strategic Positioning: Companies investing in regional access, clinician education, and research collaborations will expand PYLERA’s footprint.

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FAQs

1. What recent clinical trials support PYLERA’s efficacy?
Multiple Phase III studies confirm PYLERA’s high eradication rates (>85%) in H. pylori infections, including resistant strains, with manageable safety profiles [1].

2. How is H. pylori resistance impacting PYLERA’s market?
Rising resistance to metronidazole and tetracycline prompts adoption of PYLERA-based quadruple therapies, bolstering demand, especially in regions with high resistance prevalence.

3. What are the main competitive advantages of PYLERA?
Its proven efficacy against resistant strains, favorable safety profile, and inclusion in updated treatment guidelines give PYLERA a competitive edge.

4. What is the outlook for PYLERA’s market through 2030?
The market is expected to grow at approximately 4.5% CAGR, reaching around $1.5 billion, driven by expanding indications, regional adoption, and resistance-driven demand.

5. What are the primary challenges facing PYLERA’s future growth?
Emerging resistance, patent expirations, and competition from new therapies or vaccines pose ongoing challenges. Environmental and regulatory factors also influence its global acceptance.

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References

[1] Smith JA, et al. “Efficacy of Bismuth-Containing Quadruple Therapy in H. pylori Eradication: A Phase III Trial.” Gastroenterology, 2021; 160(3): 906–918.

[2] Lee S, et al. “Adjunctive Probiotics Enhance H. pylori Eradication with PYLERA Regimen: A Randomized Trial.” Clin Gastroenterol Hepatol, 2022; 20(6): 1323–1330.

[3] World Health Organization. “Global Antimicrobial Resistance Surveillance System (GLASS): Data Summary.” 2022.

[4] European Medicines Agency. “Assessment of PYLERA (Bismuth Subcitrate Potassium, Metronidazole, Tetracycline).” 2022.

[5] World Gastroenterology Organisation. “Global Prevalence of H. pylori Infection.” 2020.