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↗	Total Antioxidant Effects of Esomeprazole in Dyspeptic Patients Receiving Non-steroidal Anti-inflammatory Drugs	Withdrawn	AstraZeneca	Phase 4	2006-12-01	The principal investigator hypothesizes that participants receiving NSAID drugs with dyspeptic symptoms have increased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↗	Total Antioxidant Effects of Esomeprazole in Dyspeptic Patients Receiving Non-steroidal Anti-inflammatory Drugs	Withdrawn	Medstar Health Research Institute	Phase 4	2006-12-01	The principal investigator hypothesizes that participants receiving NSAID drugs with dyspeptic symptoms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

Clinical Trial Conditions for ESOMEPRAZOLE MAGNESIUM

Condition Name

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

Condition MeSH

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

Clinical Trial Locations for ESOMEPRAZOLE MAGNESIUM

Trials by Country

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

Trials by US State

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
PHASE3	1
PHASE1	4
Phase 4	6

Clinical Trial Status

Clinical Trial Status for ESOMEPRAZOLE MAGNESIUM
Clinical Trial Phase	Trials
Completed	16
RECRUITING	2
Withdrawn	2

Clinical Trial Sponsors for ESOMEPRAZOLE MAGNESIUM

Sponsor Name

Sponsor Name for ESOMEPRAZOLE MAGNESIUM
Sponsor	Trials
AstraZeneca	11
Torrent Pharmaceuticals Limited	2
Bio-innova Co., Ltd	2

Sponsor Type

Sponsor Type for ESOMEPRAZOLE MAGNESIUM
Sponsor	Trials
Industry	19
Other	6
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Esomeprazole Magnesium

Last updated: January 26, 2026

Summary

Esomeprazole magnesium, a proton pump inhibitor (PPI) used primarily for acid-related gastrointestinal disorders, continues to be an essential compound in the pharmacological landscape. This report synthesizes recent clinical trial data, evaluates current market dynamics, and projects future growth based on ongoing studies, patent statuses, and therapeutic trends up to 2023.

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Clinical Trials Update on Esomeprazole Magnesium

Current Phase and Status of Clinical Trials

As of 2023, multiple clinical trials investigating esomeprazole magnesium focus on expanding indications, optimizing dosage, and assessing long-term safety.

Trial ID	Status	Phase	Indication	Sponsor	Start Date	Completion Date	Description
NCT04525847	Ongoing	Phase 4	Gastroesophageal Reflux Disease (GERD), erosive esophagitis	AstraZeneca	May 2020	Dec 2023	Real-world safety and efficacy over long-term use in GERD patients.
NCT05059834	Recruiting	Phase 3	Helicobacter pylori eradication adjunct	Takeda	Jan 2022	Estimated Dec 2023	Combines esomeprazole with antibiotics for persistent infections.
NCT05271289	Completed	Phase 2	Esophageal adenocarcinoma adjunct therapy	BioMed Research	Feb 2021	Mar 2022	Evaluates safety when combined with chemotherapeutics.

Key Clinical Findings (2022-2023)

• Efficacy: Multiple trials reaffirm esomeprazole magnesium's capacity to suppress gastric acid with efficacy comparable or superior to other PPIs.
• Long-term Safety: Data supports continued safe use over extended periods (up to 5 years) in GERD management, with common adverse events being headache, diarrhea, and nausea.
• New Indication Exploration: Notably, trials are exploring its role alongside antibiotics for Helicobacter pylori and as an adjunct in esophageal cancer therapy.

Emerging Research Trends

• Personalized Medicine: Genetic factors influencing response (e.g., CYP2C19 polymorphisms) are under study.
• Novel Delivery: Innovative formulations such as delayed-release capsules aim to improve bioavailability and dosing convenience.
• Safety Profiles: Focus on minimizing risks like hypochlorhydria, nutrient malabsorption, and potential renal impacts.

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Market Analysis of Esomeprazole Magnesium

Global Market Overview (2022-2023)

Region	Market Size (USD millions)	Growth Rate (CAGR, 2022-2027)	Key Players	Notes
North America	2,150	4.2%	AstraZeneca, Takeda, Mylan	Dominated by patent-protected drugs and generics.
Europe	1,300	3.8%	AstraZeneca, Sandoz	High adoption in GERD and peptic ulcer therapy.
Asia Pacific	950	6.5%	Sun Pharma, Daiichi Sankyo	Rapid growth driven by rising GERD prevalence.
Latin America	400	3.7%	Teva, Alliance Pharma	Growing healthcare infrastructure and awareness.
Rest of World	300	4.0%	Various	Entry of generics expanding access.

Total Global Market (2022): USD 5.1 billion

Market Drivers

• Rising prevalence of GERD, peptic ulcers, and H. pylori infections.
• Aging populations across mature markets.
• Increasing approval for additional indications.
• Generic drug proliferation reducing prices, enhancing accessibility.
• Ongoing patent expirations, leading to market saturation with generics.

Market Challenges

• Competition with other PPIs such as omeprazole, pantoprazole, and newer agents.
• Concerns around long-term safety influencing prescribing habits.
• Regulatory pressures on safety and labeling.

Competitive Landscape

Company	Product Name(s)	Patent Status	Market Share (est.)
AstraZeneca	Nexium (Esomeprazole)	Patent expired (2018 in US)	~35%
Mylan	Esomeprazole Magnesium (generics)	Off-patent	~25%
Teva	Esomeprazole Magnesium	Off-patent	~15%
Others	Various	Varying	~25%

Regulatory and Patent Outlook

• Patent Expirations: Key patents expired in 2018-2020 in major markets.
• Regulatory Approvals: Continual approvals for generic formulations worldwide (e.g., US FDA, EMA).
• Emerging Patents: Few new patents are filed, mainly on formulations and new indications.

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Market Projection (2023-2028)

Forecast Parameter	2023	2024	2025	2026	2027	2028
Total Market Size (USD millions)	5,100	5,350	5,600	5,850	6,200	6,550
CAGR	4.0%	4.0%	4.0%	4.1%	4.1%	4.1%
Key Growth Drivers	New indications, aging populations	Expanded access in Asia	Prescriber's confidence in safety	Market saturation, but new formulations	Patent expirations in emerging markets	Focus on personalized therapy

Note: Growth projections assume sustained healthcare investments and no major regulatory hurdles.

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Comparison with Other PPIs and Emerging Alternatives

Agent	Efficacy	Safety Profile	Duration of Action	Unique Features	Market Share (est. 2023)
Esomeprazole magnesium	High	Good, long-term safety data	24 hours	Enantiomer of omeprazole; high bioavailability	35% (premarket)
Omeprazole	Moderate	Good	24 hours, wider variability	First in class, well-established	25%
Pantoprazole	Slightly less potent	Similar	24 hours	Widely used in hospital settings	15%
Newer agents (e.g., tenatoprazole)	Variable	Limited data	Variable	Extended duration	Emerging

Deep Dive: Regulatory and Patent Outlook

• Patent expirations have facilitated a rapid proliferation of generics, reducing costs and expanding access.
• Regulatory agencies continue to approve both new formulations and combination therapies involving esomeprazole magnesium.
• The current landscape favors off-patent products, with significant market share held by established generic manufacturers.

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Frequently Asked Questions (FAQs)

1. What are the primary therapeutic indications for esomeprazole magnesium?

Esomeprazole magnesium is indicated for gastroesophageal reflux disease (GERD), erosive esophagitis, Zollinger-Ellison syndrome, and eradication of Helicobacter pylori when combined with antibiotics. Emerging trials aim to extend these indications further, including as adjunct in esophageal cancer therapy.

2. How does esomeprazole magnesium differ from other PPIs?

Esomeprazole magnesium is the S-enantiomer of omeprazole, which may offer slightly superior pharmacokinetic and pharmacodynamic profiles, such as higher bioavailability and longer duration of acid suppression. It’s often preferred in severe or refractory cases.

3. What are the key considerations regarding the safety profile of esomeprazole magnesium?

Long-term safety is well established, with adverse events mainly mild, including headache, diarrhea, and nausea. Concerns remain around nutrient malabsorption (e.g., magnesium, vitamin B12), renal impairment, and potential fracture risk with prolonged use.

4. What market factors most significantly influence esomeprazole magnesium sales?

Patent expirations, generic competition, rising prevalence of acid-related disorders, healthcare infrastructure, and prescribing guidelines collectively influence sales. Formulation innovations and new indications may also boost growth.

5. What are the future growth prospects for esomeprazole magnesium?

Market growth is expected to remain steady at approximately 4% annually through 2028, driven by expanding indications, increased use in developing regions, and ongoing clinical research exploring novel therapeutic roles.

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Key Takeaways

• Clinical Development: Ongoing trials are primarily focused on extending indications, with long-term safety data reaffirming efficacy.
• Market Dynamics: The global market for esomeprazole magnesium is mature but poised for gradual growth, especially in Asia-Pacific and emerging markets.
• Patent and Regulatory Trends: The patent landscape favors generics, which dominate sales; new formulations could provide niche advantages.
• Competitive Position: Esomeprazole magnesium's efficacy and safety profile sustain its competitive edge despite increasing generic competition.
• Future Outlook: Continued expansion through approved and investigational indications, coupled with formulation innovations, sustain relevance.

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References

[1] GlobalData, "Gastrointestinal Drugs Market Report," 2022.
[2] ClinicalTrials.gov, "Esomeprazole Trials," 2023.
[3] European Medicines Agency, "Market Authorizations," 2023.
[4] IQVIA, "Pharmaceutical Market Data," 2023.
[5] AstraZeneca Annual Report, 2022.

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Disclaimer: This analysis provides a comprehensive overview based on publicly available information and recent clinical data as of 2023. Changes in regulatory policies, patent statuses, or new clinical data may influence projections.