CLINICAL TRIALS PROFILE FOR PROTONIX

All Clinical Trials for PROTONIX

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00744419 ↗	Intravenous (IV) Pantoprazole for Gastroesophageal Reflux Disease (GERD) in Neonates and Infants	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	Phase 1	2009-05-01	The purpose of this study is to determine how the body uses and eliminates pantoprazole, a drug used to treat GERD. This is a pharmacokinetic (PK) study. PK is a measure of how much drug is in the blood and how long it takes to leave the body. It is hypothesized that younger infants will need a lower dose than older children to achieve the same PK measurement. The results of this study will be used to determine the best dose of the drug to use in each age group. Pantoprazole is a drug used to decrease acid production. The use of pantoprazole has not been approved for use in children. Pantoprazole is approved for use of acid-related and stomach disorders in adults.
NCT00699361 ↗	Influence of Pantoprazole on Human Myocardial Contractility at Patients With Congestive Heart Failure	Withdrawn	Johann Wolfgang Goethe University Hospital	Phase 3	2008-08-01	Recently literature revealed facts, that show H+/K+ ATPase expression is not limited tot he stomach. H+/K+ ATPase was also found in smooth muscle cells and in other tissues (McCabe, R.D. et al., Am J Physiol. 1992). For myocard a localisation is only proven for rats yet (Beisvag, V. et al., Acta Physiol Scand. 2003). Moreover biochemical hints lead us to a highly probability of a myocardial H+/K+ ATPase (Nagashima, R. et al., Jpn Heart J. 1999).
NCT00674245 ↗	Effect of Pantoprazole 40mg Daily vs Placebo on Power Spectral Analysis of the Sleep EEG of Patients With GERD.	Completed	Southern Arizona VA Health Care System	Phase 2/Phase 3	2008-04-01	The purpose of this research study is to determine if treatment with pantoprazole 40 mg daily versus a placebo improves sleep quality in patients with gastroesophageal reflux disease (GERD). Another purpose is to determine if treatment with pantoprazole 40 mg once daily versus a placebo improves sleep outcomes in patients with gastroesophageal reflux disease using spectral analysis of sleep electroencephalogram (EEG).
NCT00206050 ↗	Study of Intragastric pH Profile After 5 Days Pantoprazole 40 mg iv Followed by Oral Esomeprazole 40 mg po or Oral Pantoprazole 40 mg po	Completed	AstraZeneca	Phase 4	2004-09-01	This Phase IV study is intended to compare intragastric acid suppression of oral esomeprazole (NEXIUM ® Delayed-Release Capsules) with that of oral pantoprazole (PROTONIX ® Delayed Release Tablets ), in subjects who continue to require acid-suppressive therapy following a course of intravenous (iv) pantoprazole (PROTONIX ® I.V. for Injection).
NCT00133770 ↗	Intravenous (IV) Pantoprazole in Erosive Esophagitis	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	Phase 4	2004-07-01	The aim of this study is to examine whether pantoprazole (Protonix) given through continuous intravenous infusion for 72 hours is superior to Protonix given through once a day IV injection in the treatment of erosive esophagitis.
NCT00133770 ↗	Intravenous (IV) Pantoprazole in Erosive Esophagitis	Completed	Emory University	Phase 4	2004-07-01	The aim of this study is to examine whether pantoprazole (Protonix) given through continuous intravenous infusion for 72 hours is superior to Protonix given through once a day IV injection in the treatment of erosive esophagitis.
NCT00625274 ↗	A Randomized, Open-Label, Comparative 3-Way Treatment Crossover Study of 24-Hour Intragastric pH Profile of Once Daily Oral Administration of Esomeprazole 40mg, Lansoprazole 30mg, and Pantoprazole 40mg at Steady State in NSAID-Using Patients	Completed	AstraZeneca	Phase 4	2004-06-01	This study looks at controlling intragastric pH following administration of esomeprazole 40 mg, lansoprazole 30 mg and pantoprazole 40 mg taken orally, once daily in patients taking either non-selective or cyclooxygenase-2 (COX-2) selective nonsteroidal anti-inflammatory drugs (NSAIDs).

Clinical Trial Conditions for PROTONIX

Condition Name

Condition Name for PROTONIX
Intervention	Trials
Healthy	10
Healthy Adults	2
Esophagitis	2
Gastroesophageal Reflux	2

Condition MeSH

Condition MeSH for PROTONIX
Intervention	Trials
Gastroesophageal Reflux	5
Malnutrition	3
Hemorrhage	2
Gastrointestinal Hemorrhage	2

Clinical Trial Locations for PROTONIX

Trials by Country

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−

Trials by Country for PROTONIX
Location	Trials
United States	21
Canada	9
India	6
United Kingdom	1
Hungary	1

Trials by US State

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−

Trials by US State for PROTONIX
Location	Trials
Missouri	4
Texas	3
California	2
Nebraska	2
Wisconsin	2

Clinical Trial Progress for PROTONIX

Clinical Trial Phase

Clinical Trial Phase for PROTONIX
Clinical Trial Phase	Trials
Phase 4	7
Phase 3	3
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for PROTONIX
Clinical Trial Phase	Trials
Completed	20
Withdrawn	3
Terminated	3

Clinical Trial Sponsors for PROTONIX

Sponsor Name

Sponsor Name for PROTONIX
Sponsor	Trials
Assiut University	2
Wyeth is now a wholly owned subsidiary of Pfizer	2
Mirati Therapeutics Inc.	2

Sponsor Type

Sponsor Type for PROTONIX
Sponsor	Trials
Industry	22
Other	20
U.S. Fed	1

Protonix (Pantoprazole Sodium): Clinical Trials, Market Analysis, and Projections

Introduction to Protonix

Protonix, also known as pantoprazole sodium, is a proton pump inhibitor (PPI) used to treat various gastrointestinal conditions, including gastroesophageal reflux disease (GERD) and erosive esophagitis (EE). Here, we will delve into recent clinical trials, market analysis, and future projections for Protonix.

Clinical Trials Update

Pediatric Indication

A recent supplemental new drug application (NDA 20988/S-070) submitted by Wyeth sought approval for the use of Protonix IV in pediatric patients for the short-term intravenous treatment of GERD associated with EE. This submission included data from Study B1791089, an open-label, pharmacokinetic (PK) and safety study of IV pantoprazole in pediatric subjects aged 1 to 16 years. Additionally, a population pharmacokinetics (PopPK) model was used to compare exposure between pediatric subjects and adults. The study also included a retrospective cohort study using electronic health records (EHR) to assess the safety of pantoprazole IV in pediatric patients aged 1 month to less than 2 years[1].

Safety and Efficacy

The clinical trials demonstrated that the most common adverse reactions in adults included headache, diarrhea, nausea, abdominal pain, and vomiting. For pediatric patients, the safety profile was generally consistent with that observed in adults, supporting the use of Protonix IV in this age group[1].

Market Analysis

Global Market Size and Growth

The global proton pump inhibitors (PPIs) market, which includes Protonix, is expected to experience significant growth. By 2024, the market is projected to reach USD 12.70 billion and is anticipated to grow at a compound annual growth rate (CAGR) of 5.14% to reach USD 16.32 billion by 2029[2].

Regional Market Performance

North America currently holds the largest market share in the PPIs market, while the Asia Pacific region is expected to be the fastest-growing market during the forecast period. Emerging markets with growing middle classes, improving healthcare infrastructure, and rising disposable incomes are driving the demand for PPIs like Protonix[2][3].

Key Players and Market Dynamics

The PPIs market is moderately fragmented, with major players including AstraZeneca, Bayer AG, Cadila Pharmaceuticals, GlaxoSmithKline PLC, and Pfizer. These companies are focusing on aggressive marketing, awareness programs, and the launch of generic versions to capture market share. For instance, Dr. Reddy's Laboratories Ltd. launched a generic version of lansoprazole in 2021, which has contributed to market growth[2].

Market Projections

Future Growth Drivers

The growth of the PPIs market, including Protonix, is driven by several factors:

• Increasing Demand for Effective Treatments: The rising incidence of gastrointestinal disorders such as GERD and EE is driving the demand for effective acid-suppressing medications like Protonix[3].
• Technological Advancements: Improvements in formulation technologies and the development of novel drug delivery systems are enhancing the efficacy and safety of PPIs. Additionally, the use of artificial intelligence and big data analytics is optimizing treatment outcomes[3].
• Generic Drug Launches: The introduction of generic versions of PPIs is expected to continue driving market growth by providing more affordable treatment options[2].

Challenges and Considerations

Despite the positive growth projections, the market faces some challenges:

• COVID-19 Impact: The COVID-19 pandemic has had a mixed impact on the PPIs market. While it initially reduced demand due to concerns about increased risk of COVID-19 infection and poor outcomes in patients taking PPIs, the market is expected to recover as the pandemic subsides[2].
• Regulatory and Safety Concerns: Continuous monitoring of safety outcomes and regulatory approvals are crucial for the sustained growth of the PPIs market. For example, the FDA's approval process for new indications, such as the recent approval for pediatric use, is vital for market expansion[1].

Key Takeaways

• Clinical Trials: Recent clinical trials have supported the approval of Protonix IV for pediatric patients, expanding its use in treating GERD and EE.
• Market Size and Growth: The global PPIs market is projected to grow significantly, with North America holding the largest market share and the Asia Pacific region expected to be the fastest-growing.
• Key Players: Major pharmaceutical companies are driving market growth through aggressive marketing, generic launches, and technological advancements.
• Future Growth Drivers: Increasing demand for effective treatments, technological advancements, and generic drug launches are key drivers of market growth.

FAQs

What is the current market size of the proton pump inhibitors market?

The proton pump inhibitors market is expected to reach USD 12.70 billion in 2024[2].

Which region is the fastest-growing market for proton pump inhibitors?

The Asia Pacific region is estimated to be the fastest-growing market for proton pump inhibitors during the forecast period[2].

What are the major factors driving the growth of the proton pump inhibitors market?

The growth is driven by increasing demand for effective treatments, technological advancements, and the launch of generic versions[2][3].

Which companies are major players in the proton pump inhibitors market?

Major players include AstraZeneca, Bayer AG, Cadila Pharmaceuticals, GlaxoSmithKline PLC, and Pfizer[2].

How has the COVID-19 pandemic impacted the proton pump inhibitors market?

The pandemic initially reduced demand due to safety concerns but is expected to recover as the pandemic subsides[2].

Cited Sources

1. FDA: NDA 20988/S-070 Protonix IV (Pantoprazole Sodium) Integrated Review Template, version 4.0 (11/1/23)[1].
2. Mordor Intelligence: Proton Pump Inhibitors Market - Size, Share & Analysis[2].
3. Future Market Insights: Proton Pump Inhibitors Market Share & Forecast by 2033[3].