You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: February 10, 2025

CLINICAL TRIALS PROFILE FOR NEXIUM


✉ Email this page to a colleague

« Back to Dashboard


505(b)(2) Clinical Trials for NEXIUM

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↗ Total Antioxidant Effects of Esomeprazole in Dyspeptic Patients Receiving Non-steroidal Anti-inflammatory Drugs Withdrawn AstraZeneca Phase 4 2006-12-01 The principal investigator hypothesizes that participants receiving NSAID drugs with dyspeptic symptoms have increased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↗ Total Antioxidant Effects of Esomeprazole in Dyspeptic Patients Receiving Non-steroidal Anti-inflammatory Drugs Withdrawn Medstar Health Research Institute Phase 4 2006-12-01 The principal investigator hypothesizes that participants receiving NSAID drugs with dyspeptic symptoms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

All Clinical Trials for NEXIUM

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.
NCT00123656 ↗ Comparison of Esomeprazole to Aerosolized, Swallowed Fluticasone for Eosinophilic Esophagitis Completed University of Utah 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.
NCT00170001 ↗ Which Supraesophageal Reflux Symptoms Reliably Respond to Proton-Pump-Inhibitor (PPI) Therapy Completed AstraZeneca N/A 2005-04-01 The investigators hypothesize that persons with the particular cluster of symptoms that are due to supraesophageal reflux (SER) will have complete resolution of those symptoms with adequate acid suppression when a PPI is administered for 6 months.
NCT00170001 ↗ Which Supraesophageal Reflux Symptoms Reliably Respond to Proton-Pump-Inhibitor (PPI) Therapy Completed Mayo Clinic N/A 2005-04-01 The investigators hypothesize that persons with the particular cluster of symptoms that are due to supraesophageal reflux (SER) will have complete resolution of those symptoms with adequate acid suppression when a PPI is administered for 6 months.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for NEXIUM

Condition Name

Condition Name for NEXIUM
Intervention Trials
GERD 16
Healthy 15
Gastroesophageal Reflux Disease 15
Helicobacter Pylori Infection 13
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for NEXIUM
Intervention Trials
Gastroesophageal Reflux 47
Esophagitis, Peptic 18
Dyspepsia 14
Peptic Ulcer 13
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for NEXIUM

Trials by Country

Trials by Country for NEXIUM
Location Trials
United States 163
Japan 57
Canada 41
Italy 29
Germany 24
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for NEXIUM
Location Trials
California 11
Texas 11
Florida 8
Pennsylvania 8
New York 8
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for NEXIUM

Clinical Trial Phase

Clinical Trial Phase for NEXIUM
Clinical Trial Phase Trials
Phase 4 61
Phase 3 34
Phase 2/Phase 3 3
[disabled in preview] 63
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for NEXIUM
Clinical Trial Phase Trials
Completed 118
Unknown status 14
Terminated 8
[disabled in preview] 21
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for NEXIUM

Sponsor Name

Sponsor Name for NEXIUM
Sponsor Trials
AstraZeneca 65
Chinese University of Hong Kong 5
HK inno.N Corporation 5
[disabled in preview] 16
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for NEXIUM
Sponsor Trials
Industry 115
Other 106
U.S. Fed 4
[disabled in preview] 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

NEXIUM: Clinical Trials, Market Analysis, and Projections

Introduction to NEXIUM

NEXIUM, also known as esomeprazole, is a proton pump inhibitor (PPI) widely used for the treatment of various acid-related diseases, including gastroesophageal reflux disease (GERD), erosive esophagitis, and other conditions such as gastric ulcers and Zollinger-Ellison syndrome[3][4].

Clinical Trials Overview

Phase I Clinical Trials

AstraZeneca conducted randomized, open-label, and international Phase I clinical trials on NEXIUM I.V. between October 2007 and October 2009. These trials enrolled 42 patients up to 17 years old with GERD across several countries, aiming to assess the pharmacokinetics of NEXIUM I.V. in pediatric patients[1].

Phase II Clinical Trials

The RELAX study, a Phase II multicentre, 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 to evaluate the anti-asthmatic effect in asthmatics with GERD and to assess the symptoms of GERD, as well as the safety and tolerability of NEXIUM I.V.[1].

Phase III Clinical Trials

AstraZeneca conducted a randomized, double-blind, multicentre 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 objective was to evaluate the safety and tolerability of NEXIUM I.V. in this age group. Another Phase III study 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].

Additional Studies

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

FDA Approval and Clinical Studies

The FDA approval for NEXIUM I.V. was based on several clinical studies, including period-crossover and open-label studies. These studies demonstrated that both intravenous and oral administration of NEXIUM were similarly effective in suppressing acid effects[1].

Market Analysis

Current Market Size and Growth

The esomeprazole market, which includes NEXIUM, is expected to register a Compound Annual Growth Rate (CAGR) of 5.2% during the forecast period from 2025 to 2030. The market was adversely impacted by the COVID-19 pandemic but has shown recovery driven by increased product sales, new product launches, and strategic developments[2].

Regional Market Performance

North America holds the largest share in the esomeprazole market, driven by factors such as the rising geriatric population, the surge in patients with GERD, and the increasing adoption of novel drug delivery systems. The Asia Pacific region is expected to be the fastest-growing market during the forecast period[2].

Key Players

Major players in the esomeprazole market include Teva Pharmaceutical Industries Ltd., Amneal Pharmaceuticals LLC, Viatris Inc., Daiichi Sankyo Company, Limited, and Sun Pharmaceutical Industries Ltd. AstraZeneca's Nexium generated significant revenues, with $1.33 billion in 2021, particularly in emerging markets[2].

Market Projections

Impact of GERD Prevalence

The increasing prevalence of GERD, a chronic and highly prevalent disorder, especially among the middle-aged and older population, is a significant driving factor for the market growth. GERD affects approximately 20% of adults in Western cultures and has a substantial negative impact on well-being and quality of life[2].

Strategic Developments and Product Launches

The market is expected to grow due to new product launches, strategic developments, and increased product sales. For instance, AstraZeneca entered into an agreement to out-license the rights to Nexium-authorized generics in Japan, contributing to market growth[2].

Regional Growth

North America is projected to continue its dominance in the esomeprazole market, driven by the growing adoption of novel drug delivery systems and the increasing prevalence of gastrointestinal diseases. The aging population in the US, expected to reach 80.8 million by 2040, will further drive the demand for esomeprazole[2].

Financial Performance of NEXIUM

Global Sales

The global sales of NEXIUM stood at $945 million in 2023, although the sales have recorded a historical decline of 25% between 2020 and 2023. This decline is expected to stabilize as the market recovers from the pandemic's impact[3].

Revenue Contributions

NEXIUM remains a significant contributor to AstraZeneca's revenue, despite facing generic competition in some markets. The company's overall product sales increased by 17% in FY 2023, reflecting new launches and expanded reimbursement across key brands[5].

Key Takeaways

  • Clinical Trials: NEXIUM has undergone extensive clinical trials to evaluate its safety, tolerability, and efficacy across various age groups and conditions.
  • Market Growth: The esomeprazole market is expected to grow at a CAGR of 5.2% from 2025 to 2030, driven by increasing GERD prevalence and strategic developments.
  • Regional Dominance: North America holds the largest market share, with the Asia Pacific region expected to be the fastest-growing.
  • Financial Performance: Despite a historical decline, NEXIUM's sales are expected to stabilize and grow as the market recovers from the pandemic.

FAQs

What is the current market size of the esomeprazole market?

The esomeprazole market is projected to register a CAGR of 5.2% during the forecast period (2025-2030), with North America holding the largest market share[2].

Who are the key players in the esomeprazole market?

Key players include Teva Pharmaceutical Industries Ltd., Amneal Pharmaceuticals LLC, Viatris Inc., Daiichi Sankyo Company, Limited, and Sun Pharmaceutical Industries Ltd.[2].

Which region is the fastest-growing in the esomeprazole market?

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

What are the primary indications for NEXIUM?

NEXIUM is indicated for the treatment of GERD, risk reduction of NSAID-associated gastric ulcers, H. pylori eradication, and pathological hypersecretory conditions, including Zollinger-Ellison syndrome[4].

How has COVID-19 impacted the esomeprazole market?

COVID-19 adversely impacted the market initially due to access issues and medicine shortages, but the market has recovered with increased product sales and strategic developments[2].

Sources

  1. Clinical Trials Arena: Nexium I.V.- Treatment of Gastroesophageal Reflux Disease[1]
  2. Mordor Intelligence: Esomeprazole Market - Size, Share & Brands[2]
  3. GlobalData: The Global Drug sales of Nexium[3]
  4. FDA Label: NEXIUM (esomeprazole magnesium) Label[4]
  5. AstraZeneca: Full-year and Q4 2023 results announcement[5]

More… ↓

⤷  Free Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.