CLINICAL TRIALS PROFILE FOR ESOMEPRAZOLE MAGNESIUM

505(b)(2) Clinical Trials for ESOMEPRAZOLE MAGNESIUM

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↗	Total Antioxidant Effects of Esomeprazole in Dyspeptic Patients Receiving Non-steroidal Anti-inflammatory Drugs	Withdrawn	AstraZeneca	Phase 4	2006-12-01	The principal investigator hypothesizes that participants receiving NSAID drugs with dyspeptic symptoms have increased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↗	Total Antioxidant Effects of Esomeprazole in Dyspeptic Patients Receiving Non-steroidal Anti-inflammatory Drugs	Withdrawn	Medstar Health Research Institute	Phase 4	2006-12-01	The principal investigator hypothesizes that participants receiving NSAID drugs with dyspeptic symptoms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

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00206440 ↗	Nexium Study To Suppress Nausea During Chemotherapy	Terminated	AstraZeneca	Phase 3	2005-08-01	This study will look at a drug called esomeprazole, the newest PPI, as a way to further reduce the amount of nausea and vomiting seen in breast cancer patients receiving adriamycin or epirubicin chemotherapy. Esomeprazole may help protect the gut lining from the stomach acid and thus lessen the nausea and vomiting. If patients have less stomach sickness, they may be able to enjoy their daily routines much more while they are getting chemotherapy.
NCT00206440 ↗	Nexium Study To Suppress Nausea During Chemotherapy	Terminated	Baylor Breast Care Center	Phase 3	2005-08-01	This study will look at a drug called esomeprazole, the newest PPI, as a way to further reduce the amount of nausea and vomiting seen in breast cancer patients receiving adriamycin or epirubicin chemotherapy. Esomeprazole may help protect the gut lining from the stomach acid and thus lessen the nausea and vomiting. If patients have less stomach sickness, they may be able to enjoy their daily routines much more while they are getting chemotherapy.
NCT00206024 ↗	Acid-Associated Heartburn Symptoms and Dose of Esomeprazole	Completed	AstraZeneca	Phase 4	2004-11-01	This is a multi-center, double-blind, parallel-group, randomized, proof of concept trial to investigate the relationship between dose of esomeprazole magnesium and acid-associated heartburn symptoms during 4 weeks of treatment. The safety and tolerability of esomeprazole magnesium in doses up to 40 mg BID will also be assessed.
NCT00206180 ↗	NEXIUM® in the Treatment of Moderate and Severe Erosive Esophagitis	Completed	AstraZeneca	Phase 4	2004-06-01	The purpose of this study is to decide if controlling stomach acid is related to healing of erosive esophagitis after treatment with esomeprazole magnesium (NEXIUM®) 10 mg and 40 mg once daily.

Clinical Trial Conditions for ESOMEPRAZOLE MAGNESIUM

Condition Name

Condition Name for ESOMEPRAZOLE MAGNESIUM
Intervention	Trials
GERD	3
Erosive Esophagitis	2
Reflux Esophagitis	2
Gastroesophageal Reflux Disease	2

Condition MeSH

Condition MeSH for ESOMEPRAZOLE MAGNESIUM
Intervention	Trials
Gastroesophageal Reflux	6
Esophagitis	4
Esophagitis, Peptic	3
Barrett Esophagus	2

Clinical Trial Locations for ESOMEPRAZOLE MAGNESIUM

Trials by Country

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Trials by Country for ESOMEPRAZOLE MAGNESIUM
Location	Trials
United States	62
Italy	9
Canada	5
Argentina	4
Mexico	4

Trials by US State

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−

Trials by US State for ESOMEPRAZOLE MAGNESIUM
Location	Trials
Texas	4
California	4
Pennsylvania	3
North Carolina	3
New York	3

Clinical Trial Progress for ESOMEPRAZOLE MAGNESIUM

Clinical Trial Phase

Clinical Trial Phase for ESOMEPRAZOLE MAGNESIUM
Clinical Trial Phase	Trials
Phase 4	6
Phase 3	6
Phase 2	3

Clinical Trial Status

Clinical Trial Status for ESOMEPRAZOLE MAGNESIUM
Clinical Trial Phase	Trials
Completed	15
Withdrawn	2
Active, not recruiting	1

Clinical Trial Sponsors for ESOMEPRAZOLE MAGNESIUM

Sponsor Name

Sponsor Name for ESOMEPRAZOLE MAGNESIUM
Sponsor	Trials
AstraZeneca	11
Torrent Pharmaceuticals Limited	2
Icahn School of Medicine at Mount Sinai	1

Sponsor Type

Sponsor Type for ESOMEPRAZOLE MAGNESIUM
Sponsor	Trials
Industry	15
Other	5
NIH	1

Esomeprazole Magnesium: Clinical Trials, Market Analysis, and Projections

Clinical Trials and Safety Profile

Esomeprazole magnesium, a proton pump inhibitor (PPI), has been extensively evaluated in clinical trials to assess its safety and efficacy.

Patient Population and Trial Outcomes

The safety of esomeprazole magnesium was evaluated in over 15,000 patients aged 18 to 84 years in various clinical trials. These trials focused on the healing and maintenance of erosive esophagitis (EE), treatment of symptomatic gastroesophageal reflux disease (GERD), and other indications such as the risk reduction of NSAID-associated gastric ulcers and H. pylori eradication[1].

Indications and Dosage

Esomeprazole magnesium is indicated for the short-term treatment (4 to 8 weeks) of EE in adults and pediatric patients. For adults, the recommended dosage is 20 mg or 40 mg once daily, while pediatric dosages vary based on age and weight. For example, pediatric patients aged 12 to 17 years may receive 20 mg or 40 mg once daily, and those aged 1 to 11 years may receive 10 mg or 20 mg once daily, depending on their weight[1].

Safety Considerations

Long-term use of esomeprazole magnesium has been associated with several safety concerns. These include the potential for cyanocobalamin (Vitamin B-12) deficiency with daily long-term use, hypomagnesemia and other mineral metabolism disorders, and interactions with other medications such as clopidogrel, St. John's Wort, and rifampin. Additionally, esomeprazole can interfere with diagnostic investigations for neuroendocrine tumors by increasing chromogranin A (CgA) levels, necessitating a temporary cessation of the medication before such tests[1].

Market Analysis

The esomeprazole market has shown significant growth and is expected to continue this trend in the coming years.

Market Size and Growth

As of 2023, the esomeprazole market was valued at USD 1,810.61 million and is anticipated to grow to USD 2,872.07 million by 2032, exhibiting a Compound Annual Growth Rate (CAGR) of 5.3% during the forecast period. This growth is driven by factors such as the increasing prevalence of GERD, the rising aging population, and the adoption of novel drug delivery systems[5].

Regional Market Dynamics

North America is expected to hold a significant share in the esomeprazole market due to the high prevalence of GERD among adults, strategic developments, and the increasing number of product approvals. The United States is a major contributor to this regional growth, with a growing geriatric population and an upsurge in gastrointestinal diseases[2].

Impact of COVID-19

The COVID-19 pandemic initially adversely impacted the esomeprazole market due to reduced access to pharmacies and medicine shortages. However, the market has since recovered, driven by increased product sales, new product launches, and strategic developments. For instance, AstraZeneca's Nexium generated significant revenues in 2021, and the company entered into agreements to out-license authorized generics, contributing to market growth[2].

Market Trends

Several trends are influencing the growth and direction of the esomeprazole market.

Increasing Prevalence of GERD

GERD is one of the most common gastrointestinal disorders, with a prevalence of approximately 20% in adults in Western cultures. This chronic condition is more prevalent in the middle-aged and older population, driving the demand for esomeprazole and other PPIs[2].

Novel Drug Delivery Systems

The adoption of novel drug delivery systems is a significant factor contributing to the market's growth. These systems enhance patient compliance and efficacy, making esomeprazole more appealing to both patients and healthcare providers[5].

Strategic Developments and Approvals

Key players in the market are receiving approvals and engaging in strategic developments, such as out-licensing agreements and new product launches. For example, Indchemie Health received FDA approval to manufacture and market esomeprazole magnesium capsules in 2021, which has boosted market competition and growth[2].

Projections and Future Outlook

The esomeprazole market is projected to continue its growth trajectory driven by several key factors.

Aging Population

The increasing aging population, particularly in regions like North America, is expected to drive the demand for esomeprazole. The older population is projected to reach 80.8 million by 2040 and 94.7 million by 2060 in the United States, contributing to the market's growth[2].

Lifestyle Factors

The hectic lifestyles of many individuals, leading to poor dietary habits and increased incidence of digestive system disorders, are creating a critical need for medications like esomeprazole. This trend is expected to continue, supporting market growth[5].

Research and Development

Ongoing research studies exploring the health effects of esomeprazole are expected to provide new growth opportunities. These studies may uncover additional indications or improve the safety profile of the drug, further enhancing its market position[5].

Key Takeaways

• Clinical Trials: Esomeprazole magnesium has been evaluated in over 15,000 patients, showing efficacy in treating EE, GERD, and other conditions.
• Safety Profile: Long-term use is associated with risks such as Vitamin B-12 deficiency, hypomagnesemia, and drug interactions.
• Market Size and Growth: The market is valued at USD 1,810.61 million in 2023 and is expected to grow to USD 2,872.07 million by 2032 with a CAGR of 5.3%.
• Regional Dynamics: North America, particularly the United States, is a dominant region due to the high prevalence of GERD and the aging population.
• Market Trends: Increasing GERD prevalence, adoption of novel drug delivery systems, and strategic developments are key drivers.
• Future Outlook: The market is expected to grow driven by the aging population, lifestyle factors, and ongoing research.

FAQs

Q: What are the primary indications for esomeprazole magnesium? A: Esomeprazole magnesium is primarily indicated for the healing and maintenance of erosive esophagitis (EE), treatment of symptomatic gastroesophageal reflux disease (GERD), and risk reduction of NSAID-associated gastric ulcers[1].

Q: What are the potential long-term safety concerns associated with esomeprazole magnesium? A: Long-term use can lead to cyanocobalamin (Vitamin B-12) deficiency, hypomagnesemia, and other mineral metabolism disorders. It also interacts with several medications and can interfere with diagnostic tests for neuroendocrine tumors[1].

Q: How has the COVID-19 pandemic impacted the esomeprazole market? A: The pandemic initially reduced access to pharmacies and caused medicine shortages, but the market has since recovered due to increased product sales, new product launches, and strategic developments[2].

Q: What role do novel drug delivery systems play in the esomeprazole market? A: Novel drug delivery systems enhance patient compliance and efficacy, making esomeprazole more appealing and contributing to market growth[5].

Q: What are the key drivers of the esomeprazole market growth? A: The increasing prevalence of GERD, the rising aging population, and the adoption of novel drug delivery systems are significant drivers of the esomeprazole market growth[2][5].

Sources

1. Drugs.com: Esomeprazole Oral Suspension: Package Insert / Prescribing Info.
2. Mordor Intelligence: Esomeprazole Market Size | Mordor Intelligence.
3. Mordor Intelligence: Esomeprazole Market Trends - Mordor Intelligence.
4. EMPR: Naproxen/Esomeprazole Magnesium Prescription & Dosage.
5. Polaris Market Research: Esomeprazole Market Size, Share, Global Analysis Report 2024-2032.