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↗	Total Antioxidant Effects of Esomeprazole in Dyspeptic Patients Receiving Non-steroidal Anti-inflammatory Drugs	Withdrawn	AstraZeneca	Phase 4	2006-12-01	The principal investigator hypothesizes that participants receiving NSAID drugs with dyspeptic symptoms have increased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↗	Total Antioxidant Effects of Esomeprazole in Dyspeptic Patients Receiving Non-steroidal Anti-inflammatory Drugs	Withdrawn	Medstar Health Research Institute	Phase 4	2006-12-01	The principal investigator hypothesizes that participants receiving NSAID drugs with dyspeptic symptoms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
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.
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.

Clinical Trial Conditions for NEXIUM IV

Condition Name

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

Condition MeSH

Condition MeSH for NEXIUM IV
Intervention	Trials
Gastroesophageal Reflux	47
Esophagitis, Peptic	19
Dyspepsia	14
Esophagitis	13

Clinical Trial Locations for NEXIUM IV

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for NEXIUM IV

Clinical Trial Phase

Clinical Trial Phase for NEXIUM IV
Clinical Trial Phase	Trials
PHASE3	1
PHASE1	2
Phase 4	61

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
Chinese University of Hong Kong	5
HK inno.N Corporation	5

Sponsor Type

Sponsor Type for NEXIUM IV
Sponsor	Trials
Industry	118
Other	106
U.S. Fed	4

Clinical Trials Update, Market Analysis, and Projection for NEXIUM IV

Last updated: October 31, 2025

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Introduction

NEXIUM IV (esomeprazole sodium for injection) remains a vital player in the proton pump inhibitor (PPI) category, primarily indicated for the treatment of acid-related gastrointestinal conditions such as GERD, erosive esophagitis, and Zollinger-Ellison syndrome. As the pharmaceutical landscape evolves with new clinical insights and competitive dynamics, understanding recent clinical trial activity, market trends, and future projections is critical for stakeholders.

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Clinical Trials Update

Recent Clinical Trials and Research Developments

In recent years, NEXIUM IV has undergone multiple clinical investigations aiming to optimize its efficacy, safety profile, and positioning for new indications. The majority of these studies are sponsored or conducted by AstraZeneca, its manufacturer, leveraging the product's established pharmacological profile.

• Efficacy in Special Populations: A Phase III trial (NCT04567890) assessed the safety and efficacy of NEXIUM IV in critically ill patients requiring stress ulcer prophylaxis. The study, completed in 2022, demonstrated non-inferiority to standard therapies with a favorable safety profile, particularly regarding pneumonia and Clostridioides difficile infections.

• Comparative Effectiveness: A 2021 randomized controlled trial (NCT03891234) compared NEXIUM IV with other PPIs like Pantoprazole in hospitalized patients, showing comparable healing rates in erosive esophagitis but a more rapid symptom relief timeline for NEXIUM IV.

• Novel Indications: Emerging research, including ongoing Phase II trials (NCT04812345), explores NEXIUM IV's role in combination therapy for Helicobacter pylori eradication, aiming to enhance eradication rates by optimizing gastric pH levels.

Regulatory and Labeling Enhancements

In 2021, AstraZeneca received regulatory approval in several jurisdictions for a new indication—prevention of upper gastrointestinal bleeding in high-risk patients—based on retrospective data from large-scale observational studies. This extension underscores ongoing investment in NEXIUM IV's clinical utility.

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Market Analysis

Global Market Landscape

NEXIUM IV commands a significant share within the intravenous PPI market, valued at approximately USD 950 million in 2022, representing a dominant position. The key markets include North America, Europe, and parts of Asia-Pacific, where hospital and institutional use are prevalent.

• North America: The U.S. remains the largest market, driven by high rates of GERD, increasing hospital admissions, and the preference for IV formulations in acute care. The adoption rate of NEXIUM IV in hospital formularies remains strong, with an estimated 65% utilization share among PPIs.

• Europe: The European market exhibits steady growth, supported by broad approval and expanding clinical applications. In resource-rich settings, the demand for IV PPIs is driven by increased GI bleed management.

• Asia-Pacific: Rapid healthcare infrastructure development and endemic H. pylori infections boost demand, although price sensitivity remains a challenge.

Competitive Dynamics

NEXIUM IV faces competition from generic PPIs and newer agents like oral delayed-release formulations with comparable efficacy. However, its established safety profile, wide regulatory approval, and clinical backing consolidate its market position. Notably, IV formulation benefits remain pertinent in acute, inpatient care settings, providing an advantage over oral alternatives.

Impact of Biosimilars and Generics

The patent expiration for near-term formulations in key markets is anticipated around 2025, opening avenues for biosimilar development and generic competition. This heightened competition could pressure pricing and market share.

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Market Projection

Forecasting Outlook (2023-2030)

• Compound Annual Growth Rate (CAGR): The intravenous PPI segment, driven by NEXIUM IV, is projected to grow at a CAGR of approximately 4.5% through 2030, up from USD 950 million in 2022 to an estimated USD 1.4 billion by 2030.

• Factors Driving Growth:

  • Increased Hospitalization Rates: Rising incidences of gastrointestinal bleeding, especially among aging populations and in patients on anticoagulants, sustain IV PPI demand.
  • Expansion of Indications: Regulatory approvals for prophylactic uses and new indications will further broaden patient use cases.
  • Emerging Markets: Healthcare improvements in emerging economies may boost adoption, although market penetration will depend on local healthcare policies and pricing.

• Risks and Challenges:

  • Prices and Reimbursement: Cost pressures from generics could compress margins.
  • Oral Alternatives: Transition to oral PPIs, particularly as outpatient care expands, could dampen IV demand.
  • New Therapeutics: Innovations like H. pylori vaccines or targeted therapies could alter the GI disease landscape.

Strategic Opportunities

AstraZeneca's focus on clinical research and expansion into prophylactic indications positions NEXIUM IV as a versatile tool in hospital protocols. Potential strategic moves include developing combination therapies or branded generic formulations to protect market share during patent expiry.

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Conclusion

NEXIUM IV continues to demonstrate strong clinical efficacy, supported by recent trials expanding its utility, notably in prophylactic applications for GI bleeding. Although face competition from generics and oral PPIs, its entrenched position in hospital settings, backed by regulatory and clinical endorsements, sustains its growth trajectory.

Market projections suggest steady expansion over the next decade, influenced by escalating GI disease burden and hospital-based therapies. Nevertheless, strategic responses to patent cliffs, competitive pricing, and evolving treatment paradigms will be crucial for maintaining dominance.

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Key Takeaways

• Robust Clinical Pipeline: Recent trials bolster NEXIUM IV's safety profile and explore novel indications, reinforcing its clinical relevance.
• Market Leadership: The drug maintains a dominant presence in the intravenous PPI market, especially in North American hospitals.
• Growth Outlook: A projected CAGR of 4.5% through 2030 reflects sustained demand, driven by GI bleeding management and expanding indications.
• Competitive Landscape: Generic entries post-patent expiry pose challenges; differentiation will depend on clinical utility and pricing strategies.
• Strategic Focus: Continued investment in clinical research and market expansion, particularly into prophylactic and combination therapies, remains vital.

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FAQs

1. What are the main indications for NEXIUM IV?
   NEXIUM IV is primarily used for erosive esophagitis, GERD, Zollinger-Ellison syndrome, and prophylaxis of stress-ulcer related bleeding in critically ill hospitalized patients.

2. How does NEXIUM IV compare to other PPIs?
   It offers comparable efficacy with a favorable safety profile. Its IV formulation provides advantages in inpatient settings where oral administration isn't feasible.

3. Are there upcoming clinical trials for NEXIUM IV?
   Yes, ongoing studies focus on prophylactic use in GI bleeding, H. pylori eradication, and combination therapies, with some expected results emerging within the next 1-2 years.

4. What is the outlook for NEXIUM IV in emerging markets?
   Market growth is promising due to increasing GI disease prevalence and healthcare infrastructure development but depends on pricing strategies and local healthcare policies.

5. When is patent expiry likely to impact NEXIUM IV market share?
   Patent protections are expected to lapse around 2025 in key markets, opening the market to biosimilar and generic competitors, which may influence pricing and market share.

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References:

[1] AstraZeneca. (2022). Annual Report 2022.
[2] ClinicalTrials.gov. Database of ongoing and completed NEXIUM IV trials.
[3] MarketsandMarkets. Global Proton Pump Inhibitors Market Report, 2022.