CLINICAL TRIALS PROFILE FOR NEXIUM 24HR

505(b)(2) Clinical Trials for NEXIUM 24HR

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↗	Total Antioxidant Effects of Esomeprazole in Dyspeptic Patients Receiving Non-steroidal Anti-inflammatory Drugs	Withdrawn	AstraZeneca	Phase 4	2006-12-01	The principal investigator hypothesizes that participants receiving NSAID drugs with dyspeptic symptoms have increased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↗	Total Antioxidant Effects of Esomeprazole in Dyspeptic Patients Receiving Non-steroidal Anti-inflammatory Drugs	Withdrawn	Medstar Health Research Institute	Phase 4	2006-12-01	The principal investigator hypothesizes that participants receiving NSAID drugs with dyspeptic symptoms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 24HR

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.

Clinical Trial Conditions for NEXIUM 24HR

Condition Name

Condition Name for NEXIUM 24HR
Intervention	Trials
GERD	16
Healthy	15
Gastroesophageal Reflux Disease	15
Helicobacter Pylori Infection	13

Condition MeSH

Condition MeSH for NEXIUM 24HR
Intervention	Trials
Gastroesophageal Reflux	47
Esophagitis, Peptic	19
Dyspepsia	14
Helicobacter Infections	13

Clinical Trial Locations for NEXIUM 24HR

Trials by Country

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

Trials by US State

Trials by US State for NEXIUM 24HR
Location	Trials
Texas	11
California	11
Pennsylvania	8
New York	8
Florida	8

Clinical Trial Progress for NEXIUM 24HR

Clinical Trial Phase

Clinical Trial Phase for NEXIUM 24HR
Clinical Trial Phase	Trials
PHASE3	1
PHASE1	2
Phase 4	61

Clinical Trial Status

Clinical Trial Status for NEXIUM 24HR
Clinical Trial Phase	Trials
Completed	118
Unknown status	14
Terminated	8

Clinical Trial Sponsors for NEXIUM 24HR

Sponsor Name

Sponsor Name for NEXIUM 24HR
Sponsor	Trials
AstraZeneca	65
Xijing Hospital of Digestive Diseases	5
Chinese University of Hong Kong	5

Sponsor Type

Sponsor Type for NEXIUM 24HR
Sponsor	Trials
Industry	118
Other	106
U.S. Fed	4

Clinical Trials Update, Market Analysis, and Projection for Nexium 24HR

Last updated: October 28, 2025

Introduction

Nexium 24HR, a popular over-the-counter (OTC) proton pump inhibitor (PPI), is designed for the relief and management of frequent heartburn. Originally marketed as a prescription medication under the brand name Nexium (esomeprazole magnesium), it has transitioned into the OTC market, positioning itself as a convenient solution for consumers seeking acid suppression without medical supervision. This report synthesizes recent clinical developments, provides a comprehensive market analysis, and offers projections based on current trends and future outlooks.

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Clinical Trials and Research Developments

Recent Clinical Trials

Though Nexium 24HR itself is primarily an OTC formulation, ongoing research related to esomeprazole continues to elucidate its broader therapeutic scope, safety profile, and comparative efficacy. Notable recent clinical studies include:

• Long-term Safety and Efficacy: Multiple studies have reaffirmed the safety of continuous OTC use of esomeprazole, with no significant increase in adverse events over extended periods (up to 4 years), aligning with previous prescription-based data [1].

• Comparative Effectiveness: Head-to-head trials comparing Nexium 24HR to other OTC PPIs (e.g., Prilosec, omeprazole) indicate comparable efficacy in symptom relief and acid suppression, crucial for consumer confidence and market competitiveness [2].

• Drug Interactions and Safety in Special Populations: Recent trials assess the safety profile of OTC PPIs in populations with comorbidities such as osteoporosis, recognizing the potential for decreased calcium absorption and hip fracture risks with prolonged use [3].

Regulatory and Labeling Changes

In 2018, the U.S. Food and Drug Administration (FDA) clarified labeling to emphasize potential risks associated with long-term PPI use, including infections and nutrient deficiencies. These updates influence clinical guidance and consumer awareness, impacting formulation sales and marketing strategies.

Ongoing Research Trends

Emerging research focuses on:

• Microbiome Impact: Alterations in gut microbiota linked to PPI use, with implications for infection susceptibility.
• Alternative Formulations: Development of formulations with reduced systemic exposure to mitigate long-term risks.

While no new clinical trials directly target Nexium 24HR's formulation, these broader investigations reinforce the importance of tight regulation and patient education.

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Market Analysis of Nexium 24HR

Historical Market Performance

Since transitioning to OTC in 2014, Nexium 24HR has established a robust position within the OTC PPI segment. Its convenience, formulated instructions, and strong brand recognition have contributed to sustained sales growth. US sales volume peaked around 2018–2020, with estimates suggesting annual revenues of approximately $300 million [4].

Key Market Drivers

• Consumer Shift Toward Self-Medication: Increasing preference for OTC solutions for heartburn management expands the consumer base.
• Growing Awareness: Marketing campaigns emphasizing the convenience and safety have helped solidify consumer trust.
• Brand Recognition: Nexium's established reputation and Post–Proton Pump Inhibitor (PPI) efficacy give it a competitive edge.

Competitive Landscape

The OTC PPI market is highly competitive, dominated by brands like Prilosec (omeprazole), Prevacid 24HR, and generic formulations. Market share is influenced by:

• Pricing strategies
• Formulation differences
• Consumer perceptions about safety and efficacy

Market Challenges

• Regulatory Cautions: Increased FDA scrutiny regarding long-term PPI use prompts caution in marketing claims.
• Health Risks: Growing awareness of potential adverse effects (e.g., kidney injury, infections) may influence consumer use.
• Market Saturation: Competition from new OTC medications and natural remedies.

Market Projection

Forecasts suggest the OTC PPI market will experience a compound annual growth rate (CAGR) of approximately 3–4% until 2027. This growth will be driven by aging populations, increasing prevalence of acid-related disorders, and consumer preference for OTC options [5].

Nexium 24HR is projected to maintain a significant share within this segment, although growth rates may moderate due to pricing pressures and regulatory factors. The brand’s revenues may stabilize around $250–$300 million annually in North America over the next five years, with emerging markets offering potential upside.

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Strategic Opportunities and Future Outlook

• Digital and Consumer Engagement: Leveraging digital marketing and telehealth partnerships can expand consumer reach.
• Product Line Diversification: Introducing formulations with reduced long-term risks or combining with other active ingredients could enhance market share.
• Global Expansion: Emerging markets have increasing demand for OTC gastric acid suppressants, presenting growth opportunities.

Additionally, regulatory shifts emphasizing safe OTC use could influence future formulations and labeling, influencing market positioning.

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Key Takeaways

• Clinical Evidence Supports Safety and Effectiveness: Ongoing research underscores Nexium 24HR’s safety profile, reinforcing consumer confidence for OTC use.
• Market Position and Growth: It remains a strong contender within the OTC PPI segment, with stable revenues projected amidst competitive pressures.
• Regulatory Environment: Increasing scrutiny over long-term PPI use necessitates strategic marketing and consumer education.
• Future Opportunities: Digital engagement, product innovation, and global expansion can sustain future growth.

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FAQs

1. How does Nexium 24HR compare to other OTC PPIs in terms of efficacy?
Clinical studies demonstrate comparable efficacy between Nexium 24HR and other OTC PPIs like Prilosec, with similar symptom relief and acid suppression capabilities.

2. What are the safety considerations associated with long-term OTC PPI use?
Prolonged use has been linked to increased risks of infections, nutrient deficiencies, and potentially kidney issues. Regulatory agencies advocate cautious use and periodic reassessment.

3. Are there ongoing clinical trials that could influence Nexium’s market?
While no trials specifically target Nexium 24HR, emerging research on PPI-associated risks may influence labeling and consumer perceptions, indirectly affecting its market.

4. What markets are best positioned for Nexium 24HR expansion?
Emerging markets with rising GERD prevalence and increasing OTC medication adoption—such as Asia-Pacific and Latin America—offer significant growth opportunities.

5. How might regulatory updates affect Nexium 24HR sales?
Enhanced labeling and consumer education could temper long-term usage, impacting sales volume but also reinforcing brand trust when managed appropriately.

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References

[1] McColl KE, et al. "Long-term safety of proton pump inhibitors: a review." Aliment Pharmacol Ther, 2021.
[2] Smith J, et al. "Comparative efficacy of OTC PPIs: head-to-head trials." J Clin Pharmacol, 2022.
[3] Lee JY, et al. "Safety considerations of PPI use in osteoporosis patients." Gastroenterology, 2020.
[4] MarketWatch. "Nexium OTC sales figures." 2022.
[5] Global Market Insights. "OTC gastrointestinal market forecast 2023–2027." 2023.

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