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NCT00712413 ↗	Safety, Efficacy of Pylera BID Dosing in Eradication of H. Pylori	Withdrawn	Axcan Pharma	Phase 3	2008-08-01	The purpose of this study is to evaluate the effect of Pylera when given twice a day.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NCT00712413 ↗	Safety, Efficacy of Pylera BID Dosing in Eradication of H. Pylori	Withdrawn	Forest Laboratories	Phase 3	2008-08-01	The purpose of this study is to evaluate the effect of Pylera when given twice a day.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	3
Helicobacter Pylori	1
Helicobacter Pylori Infection Treatment	1
Immunology	1

Condition MeSH

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

Clinical Trial Locations for PYLERA

Trials by Country

Trials by Country for PYLERA
Location	Trials
United States	3
Portugal	2
Canada	1
Italy	1
United Kingdom	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
Phase 4	2
Phase 3	2
N/A	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	6
Industry	4

Pylera: Clinical Trials, Market Analysis, and Projections

Introduction to Pylera

Pylera, formerly known as Helizide, is a patented three-in-one capsule triple therapy designed for the eradication of Helicobacter pylori (H. pylori), a bacterium primarily responsible for gastric and duodenal ulcers. This treatment combines bismuth subcitrate potassium, metronidazole, and tetracycline, and is typically used in conjunction with a proton pump inhibitor like omeprazole[4].

Clinical Trials and Efficacy

Eradication Rates and Treatment Regimens

Clinical trials have demonstrated the efficacy of Pylera in eradicating H. pylori infections. A study comparing sequential and bismuth-based quadruple therapies, including Pylera, showed that both regimens achieved high eradication rates. The bismuth-based quadruple therapy, which includes Pylera, resulted in an eradication rate of 91% at intention-to-treat analysis and 97% at per protocol analysis[1].

Adverse Events and Resistance

While Pylera is effective, it is associated with a higher frequency of adverse events compared to sequential therapy. Adverse events occurred in 56.9% of patients receiving the quadruple therapy, significantly more than the 25.8% in the sequential therapy group[1]. Additionally, the presence of clarithromycin and metronidazole dual resistance slightly reduced the success rate of both therapies, though not significantly[1].

Market Analysis

Current Market Position

Pylera is part of the broader H. pylori treatment market, which is expected to grow due to increasing disease prevalence and the introduction of new combination therapies. As of 2022, the total market size for H. pylori infection treatments in the 7 major markets (7MM) was approximately USD 2.6 million, with projections indicating growth during the forecast period (2023-2034)[3].

Pricing and Competition

Pylera is priced slightly below competitor agents, which helps in its market positioning. The marketer has also invested in online presence, such as the website Pylera.com, to enhance awareness and accessibility of the drug[5].

Market Projections

Growth Drivers

The H. pylori treatment market is expected to grow driven by several factors, including the recent approval of combination therapies and increasing disease prevalence. Emerging therapies, such as those from Nexbiome Therapeutics, TrioMedicine, and TenNor Therapeutics, are also anticipated to transform the market landscape in the coming years[3].

Market Size and Forecast

The H. pylori infection market size is projected to increase during the forecast period, driven by the introduction of new and effective treatments. By 2034, the market is expected to see significant growth, largely due to the adoption of novel therapeutic approaches and combination therapies[3].

Emerging Therapies and Impact on Pylera

Novel Therapeutic Targets

Several novel therapies are in various stages of clinical trials, which could potentially impact the market share of Pylera. For example, Ceclazepide, a prodrug developed by Trio Medicines, is undergoing Phase I clinical trials and shows promise as a powerful antagonist for the gastrin/CCK2 receptor[3].

Microbiome-Based Treatments

BGA-1901, a single-strain live biotherapeutic featuring Lactobacillus casei rhamnosus LCR35, is another emerging treatment currently in Phase III clinical trials. This microbiome-based approach could offer an alternative to traditional antibiotic regimens like Pylera[3].

Key Takeaways

• Efficacy: Pylera has demonstrated high eradication rates for H. pylori infections, comparable to other first-line treatments.
• Adverse Events: While effective, Pylera is associated with a higher frequency of adverse events compared to some other treatment regimens.
• Market Growth: The H. pylori treatment market is expected to grow, driven by new combination therapies and increasing disease prevalence.
• Competition: Emerging therapies, including novel antibiotics and microbiome-based treatments, may impact Pylera’s market share in the future.
• Pricing: Pylera is competitively priced, slightly below other similar treatments.

FAQs

What is Pylera used for?

Pylera is used for the eradication of Helicobacter pylori (H. pylori) infections, which are the primary cause of gastric and duodenal ulcers.

How is Pylera administered?

Pylera is administered as three capsules four times a day (after meals and at bedtime) for 10 days, typically in conjunction with a proton pump inhibitor like omeprazole[4].

What are the common adverse events associated with Pylera?

Common adverse events include central and peripheral nervous system effects, photosensitivity, darkening of the tongue and/or black stool, and other gastrointestinal symptoms[4].

How does Pylera compare to other H. pylori treatments in terms of efficacy?

Pylera has been shown to have high eradication rates, similar to other first-line treatments such as sequential therapy, with rates of 91% at intention-to-treat analysis and 97% at per protocol analysis[1].

What are the emerging therapies that could impact Pylera’s market share?

Emerging therapies include Ceclazepide from Trio Medicines, BGA-1901 from Nexbiome Therapeutics, and other microbiome-based treatments currently in various stages of clinical trials[3].

What is the projected market size for H. pylori treatments by 2034?

The H. pylori infection market size is expected to grow significantly by 2034, driven by the introduction of new and effective treatments, although the exact figure is not specified in the available sources.

Sources

1. Pylera and sequential therapy for first-line Helicobacter pylori treatment - PubMed
2. NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025 - Drug Development
3. Helicobacter pylori Infections Treatment: Novel Therapeutic Targets - DelveInsight
4. PYLERA® (bismuth subcitrate potassium, metronidazole, tetracycline) - FDA
5. Pylera - MM+M - Medical Marketing and Media