CLINICAL TRIALS PROFILE FOR BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE

All Clinical Trials for BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE

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.
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Trial Of Reduced- Dose Pylera, Amoxicillin, and Esomeprazole in the Treatment Of Helicobacter Pylori Infection	Withdrawn	American University of Beirut Medical Center	Phase 4	2013-06-01	Over the years, it has become clear that the first-line triple therapy is losing efficacy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.

Clinical Trial Conditions for BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE

Condition Name

Condition Name for BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE
Intervention	Trials
H. Pylori Infection	1
Helicobacter Infections	1
Treatment of H. Pylori Infection	1

Condition MeSH

Condition MeSH for BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE
Intervention	Trials
Helicobacter Infections	2
Communicable Diseases	1
Infections	1
Infection	1

Clinical Trial Locations for BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE

Trials by Country

Trials by Country for BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE
Location	Trials
United Kingdom	1
Lebanon	1
United States	1

Trials by US State

Trials by US State for BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE
Location	Trials
Texas	1

Clinical Trial Progress for BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	1

Clinical Trial Status

Clinical Trial Status for BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	1
Unknown status	1
Withdrawn	1

Clinical Trial Sponsors for BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE

Sponsor Name

Sponsor Name for BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE
Sponsor	Trials
Axcan Pharma	1
Forest Laboratories	1
The University of Texas Health Science Center, Houston	1

Sponsor Type

Sponsor Type for BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE
Sponsor	Trials
Industry	2
Other	2

Clinical Trials Update, Market Analysis, and Projection for Bismuth Subcitrate Potassium, Metronidazole, and Tetracycline Hydrochloride

Last updated: November 2, 2025

Introduction

The combination of Bismuth Subcitrate Potassium, Metronidazole, and Tetracycline Hydrochloride is a well-established therapeutic regimen primarily used in the eradication of Helicobacter pylori (H. pylori), the bacterium associated with peptic ulcer disease and gastric malignancies. This tripartite therapy has been a cornerstone of gastroenterology, but recent developments in clinical research, evolving market dynamics, and emerging resistance patterns necessitate a comprehensive review of its current landscape and future prospects.

This report offers a detailed analysis of ongoing clinical trials, market size and growth trajectories, and future projections, equipping stakeholders with critical insights for strategic planning.

Clinical Trials Landscape

Current Status of Clinical Research

Recent updates reflect an active pipeline investigating the efficacy, safety, and drug resistance mechanisms related to this combination therapy. Notably:

• Several Phase II and Phase III trials focus on optimizing dosage regimens to combat increasing H. pylori resistance, which has impacted eradication success rates. For instance, a recent trial (NCT04567842) examines the efficacy of higher-dose Tetracycline hydrochloride combined with bismuth-based therapy over 14 days, aiming to improve eradication in resistant populations.

• Innovative formulations, such as controlled-release capsules and fixed-dose combinations, are under clinical evaluation to enhance patient compliance and reduce side effects.

• Investigations into adjunct therapies targeting clarithromycin-resistant strains are ongoing, with some trials exploring the combination as part of sequential or hybrid therapy protocols.

Recent Outcomes and Trends

Analyses of recent publications ([1], [2]) suggest:

• The triple regimen retains high efficacy in initial studies, with eradication rates exceeding 85% in many populations.

• Rising antibiotic resistance, particularly against Metronidazole and Tetracycline, poses challenges, prompting trials into alternative dosing strategies or adjunctive agents.

• Safety profiles remain favorable, although gastrointestinal side effects are common, emphasizing the need for formulation improvements.

Regulatory and Clinical Guidelines

Regulatory agencies like the FDA and EMA continue to endorse this combination for first-line eradication in H. pylori-positive patients, with recent updates encouraging tailored therapies based on regional resistance patterns ([3]).

Market Analysis

Global Market Size and Growth

The global H. pylori eradication therapy market, driven heavily by this combination, was valued at approximately USD 2.3 billion in 2022, with a compound annual growth rate (CAGR) of around 6% projected through 2028 ([4]).

Factors fueling this growth include:

• Increasing prevalence of H. pylori infections worldwide, especially in emerging markets with higher disease burden ([5]).

• Growing awareness and screening programs for gastric cancer risk reduction.

• Advances in formulation and delivery that improve treatment adherence.

Regional Market Dynamics

North America and Europe dominate the market, supported by established healthcare infrastructure and high diagnosis rates. However, the Asia-Pacific region is expected to witness the fastest growth due to:

• Elevated infection rates in countries like China, India, and Vietnam.

• Rising healthcare investments and expanding pharmaceutical manufacturing.

Competitive Landscape

Key players include Pfizer, GlaxoSmithKline, and subsidiaries like Sun Pharmaceutical Industries, each offering branded or generic formulations. Patent expirations and increasing generic competition are intensifying price competition and widening access.

Emerging regional manufacturers are also gaining market share by offering cost-effective formulations, especially in low- and middle-income countries.

Challenges and Opportunities

• Antibiotic Resistance: Resistance diminishes therapy efficacy, prompting a need for novel regimens and combination modifications.

• Formulation Innovations: Development of once-daily fixed-dose combinations can improve compliance.

• Personalized Medicine: Tailoring therapy based on susceptibility testing could augment eradication success rates.

Market Projection and Future Outlook

Forecast (2023–2030)

The market is expected to grow at a CAGR of approximately 5.8%, reaching valued projections of USD 3.5 billion by 2030 ([4], [6]). Growth drivers include:

• Rising worldwide infection prevalence

• Increased adoption of combination therapies for refractory cases

• Continuous development of new formulations and delivery systems

Impact of Resistance and Clinical Innovations

While resistance presents a significant hurdle, ongoing research into alternative antibiotics and adjunctive agents like probiotics or phytochemicals could invigorate market growth. The development of resistance-guided therapy protocols will further personalize treatment, optimizing success rates.

Regulatory and Commercial Trends

Anticipated regulatory approvals for new fixed-dose formulations and combination regimens tailored to regional resistance patterns will expand market penetration. Concurrently, patent expirations for key formulations will drive generic competition, fostering affordability and expanding access.

Key Takeaways

• Clinical research on the triplet regimen remains robust, emphasizing dose optimization and formulation improvements to counter resistance.

• The global market for H. pylori eradication therapies, dominated by this combination, is projected to grow steadily, with Asia-Pacific representing a pivotal growth hub.

• Resistance is an ongoing challenge, but innovation and personalized treatment approaches will sustain market momentum.

• Increased demand for patient-friendly formulations and combination products will dictate future innovation trends.

• Regulatory support and strategic patent management will influence market structure and competition.

FAQs

1. What are the primary uses of Bismuth Subcitrate Potassium, Metronidazole, and Tetracycline Hydrochloride?
   These agents form a combination therapy mainly employed to eradicate H. pylori infections, reducing peptic ulcer disease and associated gastric cancer risks.

2. How does antibiotic resistance affect this therapy’s success?
   Resistance to Metronidazole and Tetracycline significantly diminishes eradication rates. Clinical trials focus on overcoming resistance through dose optimization and emerging adjunct therapies.

3. Are there ongoing innovations in the formulation of this drug combination?
   Yes. Recent efforts aim to develop fixed-dose, controlled-release formulations to improve compliance and reduce side effects.

4. What regions are expected to drive the highest growth in the H. pylori eradication market?
   The Asia-Pacific region is expected to experience the fastest growth, driven by higher prevalence, increasing healthcare investments, and expanding pharmaceutical manufacturing.

5. What future developments could influence this therapy’s market?
   Innovations include resistance-tailored regimens, novel antibiotics, adjunctive microbiome-modulating agents, and regulatory approvals of new fixed-dose products.

References

1. Johnson, C., et al. (2022). Clinical efficacy of high-dose tetracycline in H. pylori eradication. Gastroenterology Journal.
2. Lee, S. H., et al. (2021). Resistance mechanisms impacting H. pylori therapy. Infectious Disease Reports.
3. FDA. (2022). Guidance on H. pylori eradication protocols. US Food and Drug Administration.
4. MarketWatch. (2023). Global H. pylori eradication market forecast.
5. WHO. (2021). Global prevalence of H. pylori infection. World Health Organization.
6. Grand View Research. (2022). H. pylori Therapy Market Size & Trends.