CLINICAL TRIALS PROFILE FOR NEXIUM IV

505(b)(2) Clinical Trials for NEXIUM IV

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT00443963 ↗	Total Antioxidant Effects of Esomeprazole in Dyspeptic Patients Receiving Non-steroidal Anti-inflammatory Drugs	Withdrawn	AstraZeneca	Phase 4	2006-12-01	The principal investigator hypothesizes that participants receiving NSAID drugs with dyspeptic symptoms have increased production of gastric levels of free radicals. The primary objective of the study is to determine if Esomeprazole Magnesium increases gastric total antioxidant capacity and decreases gastric free radical production in humans. Participants (age 18 years and older) with no history of upper GI bleeding who are receiving non-steroidal anti-inflammatory drugs and then develop dyspepsia will be recruited from our primary care clinic in Washington, DC. All eligible participants will undergo biopsies of antrum and corpus. The participants will be randomized to receive either Zantac OTC or Nexium for 15 days. On day 15, all participants will undergo repeat upper endoscopy to obtain biopsies of antrum and corpus. Tissue samples will then be extracted to determine total antioxidant capacity and lipid peroxide levels (as an indirect marker of free radical production).
OTC	NCT00443963 ↗	Total Antioxidant Effects of Esomeprazole in Dyspeptic Patients Receiving Non-steroidal Anti-inflammatory Drugs	Withdrawn	Medstar Health Research Institute	Phase 4	2006-12-01	The principal investigator hypothesizes that participants receiving NSAID drugs with dyspeptic symptoms have increased production of gastric levels of free radicals. The primary objective of the study is to determine if Esomeprazole Magnesium increases gastric total antioxidant capacity and decreases gastric free radical production in humans. Participants (age 18 years and older) with no history of upper GI bleeding who are receiving non-steroidal anti-inflammatory drugs and then develop dyspepsia will be recruited from our primary care clinic in Washington, DC. All eligible participants will undergo biopsies of antrum and corpus. The participants will be randomized to receive either Zantac OTC or Nexium for 15 days. On day 15, all participants will undergo repeat upper endoscopy to obtain biopsies of antrum and corpus. Tissue samples will then be extracted to determine total antioxidant capacity and lipid peroxide levels (as an indirect marker of free radical production).

All Clinical Trials for NEXIUM IV

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00123656 ↗	Comparison of Esomeprazole to Aerosolized, Swallowed Fluticasone for Eosinophilic Esophagitis	Completed	American Society for Gastrointestinal Endoscopy	Phase 2	2004-08-01	Eosinophilic esophagitis (EE) is a recently recognized entity. It has been thought to be related to both allergies and acid reflux. There have been reports that both swallowed, aerosolized steroids and proton pump inhibitors have been effective treatments. The researchers propose to directly compare the efficacy of aerosolized fluticasone to esomeprazole in the treatment of eosinophilic esophagitis. The hypothesis is that aerosolized fluticasone (Flovent) will be more effective in relieving symptoms of EE than esomeprazole (Nexium) treatment. Patients will undergo endoscopy, pH monitoring and manometry for diagnosis. Following diagnosis of EE by pathology (biopsy of esophagus), patients will be randomized to esomeprazole or swallowed fluticasone for 8 weeks. At the end of 8 weeks, subjects will be asked to repeat upper endoscopy with biopsies. Three questionnaires (dysphagia, gastroesophageal reflux disease [GERD], and allergy) will be completed by the patient at the first endoscopy and at the end endoscopy. The primary objective is to measure change in eosinophil infiltration of the esophagus in response to treatment of allergy (swallowed fluticasone) versus treatment for reflux (esomeprazole) in EE patients.
NCT00069823 ↗	Study of Acid Reflux in Asthma	Completed	American Lung Association Asthma Clinical Research Centers	Phase 3	2003-09-01	The purpose of this study is to determine if subjects with symptomatic asthma who are assigned to treatment with a proton pump inhibitor (PPI) drug such as Nexium have fewer asthma attacks than similar subjects assigned to placebo treatment.
NCT00069823 ↗	Study of Acid Reflux in Asthma	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	2003-09-01	The purpose of this study is to determine if subjects with symptomatic asthma who are assigned to treatment with a proton pump inhibitor (PPI) drug such as Nexium have fewer asthma attacks than similar subjects assigned to placebo treatment.
NCT00069823 ↗	Study of Acid Reflux in Asthma	Completed	Johns Hopkins Bloomberg School of Public Health	Phase 3	2003-09-01	The purpose of this study is to determine if subjects with symptomatic asthma who are assigned to treatment with a proton pump inhibitor (PPI) drug such as Nexium have fewer asthma attacks than similar subjects assigned to placebo treatment.

Clinical Trial Conditions for NEXIUM IV

Condition Name

Condition Name for NEXIUM IV
Intervention	Trials
GERD	16
Healthy	15
Gastroesophageal Reflux Disease	15
Helicobacter Pylori Infection	13

Condition MeSH

Condition MeSH for NEXIUM IV
Intervention	Trials
Gastroesophageal Reflux	47
Esophagitis, Peptic	18
Dyspepsia	14
Peptic Ulcer	13

Clinical Trial Locations for NEXIUM IV

Trials by Country

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−

Trials by Country for NEXIUM IV
Location	Trials
United States	163
Japan	57
Canada	41
Italy	29
Germany	24

Trials by US State

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−

Trials by US State for NEXIUM IV
Location	Trials
California	11
Texas	11
Florida	8
Pennsylvania	8
New York	8

Clinical Trial Progress for NEXIUM IV

Clinical Trial Phase

Clinical Trial Phase for NEXIUM IV
Clinical Trial Phase	Trials
Phase 4	61
Phase 3	34
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for NEXIUM IV
Clinical Trial Phase	Trials
Completed	118
Unknown status	14
Terminated	8

Clinical Trial Sponsors for NEXIUM IV

Sponsor Name

Sponsor Name for NEXIUM IV
Sponsor	Trials
AstraZeneca	65
Xijing Hospital of Digestive Diseases	5
Chinese University of Hong Kong	5

Sponsor Type

Sponsor Type for NEXIUM IV
Sponsor	Trials
Industry	115
Other	106
U.S. Fed	4

Nexium IV: Clinical Trials, Market Analysis, and Projections

Introduction to Nexium IV

Nexium IV, also known as esomeprazole sodium, is a proton pump inhibitor (PPI) used to treat various conditions related to excessive stomach acid, including gastroesophageal reflux disease (GERD), gastric ulcers, and other acid-related disorders. Here, we will delve into the clinical trials, market analysis, and future projections for Nexium IV.

Clinical Trials Overview

Phase I Clinical Trials

AstraZeneca conducted randomized, open-label, and international Phase I clinical trials on Nexium IV between October 2007 and October 2009. These trials involved 42 patients up to 17 years old with GERD across several countries, including the US, Australia, Belgium, Sweden, and Hungary. The primary objective was to assess the pharmacokinetics of Nexium IV once-daily in pediatric patients[1].

Phase II Clinical Trials

The RELAX study, a Phase II multicenter, randomized, double-blind, parallel-group, and placebo-controlled trial, was conducted between April 2006 and April 2008. This study enrolled 1,100 patients in 134 centers and aimed to compare Nexium IV with a placebo in evaluating the anti-asthmatic effect in asthmatics with GERD. Secondary outcomes included assessing GERD symptoms and the safety and tolerability of Nexium IV[1].

Phase III Clinical Trials

AstraZeneca conducted a randomized, double-blind, multicenter Phase III study between February 2004 and April 2005, enrolling 140 patients aged 12 to 17 years old across 40 locations in the US. The primary goal was to evaluate the safety and tolerability of Nexium IV. Another Phase III trial from April 2007 to June 2008 focused on infants from one month to 11 months old, assessing the drug's effectiveness in reducing GERD signs and symptoms[1].

Other Notable Trials

An open-label, randomized, two-way crossover study was conducted between August 2002 and October 2002, involving 60 GERD patients. This study aimed to determine the maximal acid output after ten days of Nexium 40mg administration and compare the effects of oral and intravenous Nexium doses[1].

Current and Ongoing Trials

A recent open-label, exploratory trial (D9612L00107) is assessing gastric acid control in critically ill, mechanically ventilated patients receiving Nexium IV 40mg twice daily for up to 72 hours. This Phase 4 study is focused on pharmacodynamics and is part of AstraZeneca's ongoing research efforts[4].

Market Analysis

Market Size and Growth

The proton pump inhibitors (PPIs) market, which includes Nexium IV, is expected to reach USD 13.35 billion by 2025 and grow at a CAGR of 5.14% to reach USD 17.16 billion by 2030. The esomeprazole segment, specifically, is anticipated to achieve high growth rates due to various strategic initiatives by market players[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 over the forecast period (2025-2030)[2].

Key Players

Major companies operating in the PPIs market include Bayer AG, Pfizer Inc., Takeda Pharmaceuticals, Cadila Pharmaceuticals, and AstraZeneca. These companies are driving market growth through innovative products and strategic partnerships. For instance, in March 2021, Daiichi Sankyo Co., Ltd. transferred the marketing and distribution rights for Nexium capsules and granules to AstraZeneca in Japan[2].

Market Projections

Esomeprazole Market Growth

The esomeprazole market, which includes Nexium IV, is anticipated to grow from USD 1,904.40 million in 2024 to USD 2,872.07 million by 2032, exhibiting a CAGR of 5.3% during the forecast period. This growth is driven by factors such as an increasing aging population and changing lifestyles that lead to digestive health issues[5].

Factors Influencing Growth

The demand for esomeprazole is influenced by the rising incidence of digestive system disorders due to hectic lifestyles and poor dietary habits. Additionally, ongoing research studies exploring the health effects of esomeprazole are expected to provide new growth opportunities in the coming years[5].

Safety and Efficacy

Clinical Trial Outcomes

Clinical trials have shown that both intravenous and oral administration of Nexium are similarly effective in suppressing acid effects. The studies have also evaluated the safety and tolerability of Nexium IV, particularly in pediatric and infant populations, indicating its efficacy and safety profile[1].

Regulatory Approvals

The FDA approval for Nexium IV was based on several studies, including period-crossover and open-label studies. The biopharmaceutics review by the FDA supported the bioequivalence of the proposed OTC Nexium 24HR DR 20 mg capsules, ensuring that the drug meets the necessary standards for safety and efficacy[3].

Key Takeaways

• Clinical Trials: Nexium IV has undergone extensive clinical trials across various age groups and patient populations, demonstrating its safety and efficacy.
• Market Size: The PPIs market, including Nexium IV, is projected to reach USD 13.35 billion by 2025 and USD 17.16 billion by 2030.
• Regional Growth: North America holds the largest market share, while the Asia Pacific region is expected to be the fastest-growing.
• Market Players: Major companies like AstraZeneca, Bayer AG, and Pfizer Inc. are driving market growth through strategic initiatives.
• Growth Factors: Increasing aging population, changing lifestyles, and ongoing research studies are key factors driving the growth of the esomeprazole market.

FAQs

What is the current market size of the Proton Pump Inhibitors (PPIs) market?

The PPIs market size is expected to reach USD 13.35 billion in 2025[2].

Who are the key players in the PPIs market?

Key players include Bayer AG, Pfizer Inc., Takeda Pharmaceuticals, Cadila Pharmaceuticals, and AstraZeneca[2].

Which region is expected to grow the fastest in the PPIs market?

The Asia Pacific region is estimated to grow at the highest CAGR over the forecast period (2025-2030)[2].

What is the projected growth rate of the esomeprazole market?

The esomeprazole market is anticipated to grow at a CAGR of 5.3% from 2024 to 2032[5].

What are the primary factors driving the growth of the esomeprazole market?

The growth is driven by an increasing aging population, changing lifestyles leading to digestive health issues, and ongoing research studies exploring the health effects of esomeprazole[5].

Sources

1. ClinicalTrialsArena: Nexium I.V.- Treatment of Gastroesophageal Reflux Disease
2. Mordor Intelligence: Proton Pump Inhibitors Market Size & Share Analysis
3. FDA: 204655Orig1s000 - accessdata.fda.gov
4. AstraZeneca Clinical Trials: An Open-label, Exploratory Trial to assess Gastric Acid ...
5. Polaris Market Research: Esomeprazole Market Size, Share, Global Analysis Report ...