CLINICAL TRIALS PROFILE FOR OMEPRAZOLE

505(b)(2) Clinical Trials for OMEPRAZOLE

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	NCT01000220 ↗	Evaluation of Omeprazole Effect on Glaucoma	Unknown status	Ophthalmic Research Center	Phase 1	1969-12-31	Omeprazole is a safe drug listed in OTC drug due to its safety. It acts by irreversible inhibition of K/H ATP ase pump and also Na/K ATP ase, Na/H ATP ase.Considering these actions the effect of omeprazole on decreasing intra ocular pressure is an issue of debate.In this Randomized Clinical Trial conducted in labafinejad hospital, patients with glaucoma who need to take omeprazole due to GI problem are evaluated in two groups including placebo and drug users. The effect will be finally assessed.
OTC	NCT01000220 ↗	Evaluation of Omeprazole Effect on Glaucoma	Unknown status	Shahid Beheshti University of Medical Sciences	Phase 1	1969-12-31	Omeprazole is a safe drug listed in OTC drug due to its safety. It acts by irreversible inhibition of K/H ATP ase pump and also Na/K ATP ase, Na/H ATP ase.Considering these actions the effect of omeprazole on decreasing intra ocular pressure is an issue of debate.In this Randomized Clinical Trial conducted in labafinejad hospital, patients with glaucoma who need to take omeprazole due to GI problem are evaluated in two groups including placebo and drug users. The effect will be finally assessed.
OTC	NCT01077076 ↗	Pharmacodynamic Study Comparing the Effects of Two Different Forms of Omeprazole (P07812) (COMPLETED)	Completed	Bayer	Phase 3	2008-12-01	This randomized, crossover study is to evaluate the early effectiveness, defined as effect on intragastric pH during the first 4 hours after dosing, of Zegerid, Prilosec over-the-counter (OTC) Tablets, and placebo on the 4th day of treatment to inhibit acid secretion. Additional purposes are to: 1. provide pharmacodynamic evidence comparing 24-hr inhibition of acid secretion on the 1st, 4th, and 11th days of dosing with each of the indicated treatments; 2. compare Zegerid and Prilosec OTC for achieving their steady-state effects for controlling 24-hr gastric acidity at steady-state on the 4th and 11th day of dosing. 3. evaluate early effectiveness, defined as effect on intragastric pH during the first 4 hours after administration, of Zegerid, Prilosec OTC Tablets, and placebo on acid inhibition at steady-state when administered on the 11th day of dosing.
OTC	NCT01122160 ↗	Gastric pH and Anthocyanin Absorption	Completed	USDA Beltsville Human Nutrition Research Center	N/A	2010-05-01	Anthocyanins are phytonutrients that provide blue, purple and red colors to fruits and vegetables. The purpose of the study is to determine whether absorption of anthocyanins occurs in the acid pH of the stomach and to determine whether altering stomach pH by use of an over-the-counter medicine, Prilosec TM, alters absorption of anthocyanins from strawberries and blackberries.
OTC	NCT02844621 ↗	Effect of Proton Pump Inhibitors on Gut Microbiota and Systemic Inflammation in Older Adults	Completed	The University of Texas Health Science Center at San Antonio	Early Phase 1	2016-05-01	The purpose of this study is to evaluate the effects of a common over-the-counter medication, omeprazole, on the normal gut bacteria and inflammation in the body in healthy older adults.
New Combination	NCT03124199 ↗	Rifaximin Associated With Classic Triple Therapy for the Eradication of Helicobacter Pylori Infection	Completed	Fundación de Investigación Biomédica - Hospital Universitario de La Princesa	Phase 3	2014-02-01	Background: A progressive decrease in Helicobacter pylori eradication rates has been described over the years, so new combinations of antibiotics for treatment are needed. Aim: To evaluate the efficacy and safety of the addition of rifaximin to standard triple therapy (omeprazole, amoxicillin and clarithromycin) for the eradication of H. pylori. Methods: Independent prospective pilot clinical trial (EUDRA CT: 2013-001080-23). Forty consecutive adult patients were included with H. pylori infection, dyspeptic symptoms and naive to eradication treatment. A full blood test was performed in the first 5 patients included to evaluate the safety of the treatment. H. pylori eradication was confirmed with urea breath test at least 4 weeks after the end of treatment. Treatment: Rifaximin 400 mg/8 h, clarithromycin 500 mg/12 h, amoxicillin 1 g/12 h, and omeprazole 20 mg/12 h for 10 days.
OTC	NCT03327051 ↗	Gastric Acid Suppression and Probiotic Colonization	Completed	Berkeley Limketkai	Phase 4	2018-03-20	Probiotics are over-the-counter dietary products with microorganisms that are generally consumed for health benefit. However, the durability of these microorganisms is unclear, particularly when they pass through the highly acidic environment of the stomach. We will test the colonization of these microorganisms among individuals who consume probiotics with and without acid suppression therapy.

All Clinical Trials for OMEPRAZOLE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001191 ↗	The Use of Oral Omeprazole and Intravenous Pantoprazole in Patients With Hypersecretion of Gastric Acid	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 2	1983-02-03	Patients with Zollinger-Ellison Syndrome suffer from ulcers of the upper gastrointestinal tract, higher than normal levels of gastric acid, and tumors of the pancreas known as non-beta islet cell tumors. Patients with Zollinger-Ellison Syndrome require continuous control of their gastric acid secretion. If gastric acid levels are permitted to rise higher than normal, patients may develop severe ulcers and other complications. This study will attempt to determine the effectiveness of Omeprazole (Prilosec) in the treatment of patients with Zollinger-Ellison Syndrome. Omeprazole is a drug that functions to decrease the amount of gastric acid secreted. Patients for this study will be selected based on a previous diagnosis of Zollinger-Ellison Syndrome and/or idiopathic (unknown cause) high levels of gastric acid secretion. The patients will undergo an evaluation including history and physical examination as well as necessary laboratory tests. The proper dose of Omeprazole will then be determined in each patient . The proper dose of Omeprazole is considered the minimum amount of omeprazole required to lower gastric acid to a safe level. Every year patients participating in this study will undergo a physical examination and history. They will be questioned about symptoms associated with Zollinger-Ellison Syndrome. Gastric acid levels will be taken and evaluated and patients will undergo an upper gastrointestinal endoscopy. The effectiveness of the treatment will be measured by a clinical history to determine the control of symptoms due to high levels of gastric acid secretion.
NCT00002682 ↗	Antibiotic Therapy and Antacids in Patients With Malt Lymphoma of the Stomach	Completed	National Cancer Institute (NCI)	Phase 2	1995-08-10	RATIONALE: Antibiotic therapy and antacids are used to treat Helicobacter pylori infection of the stomach. These treatments may also have an effect on gastric MALT lymphoma of the stomach. PURPOSE: Phase II trial to study the effectiveness of antibiotic therapy with amoxicillin, clarithromycin, tetracycline, and metronidazole plus antacids in patients with MALT lymphoma of the stomach.
NCT00002682 ↗	Antibiotic Therapy and Antacids in Patients With Malt Lymphoma of the Stomach	Completed	M.D. Anderson Cancer Center	Phase 2	1995-08-10	RATIONALE: Antibiotic therapy and antacids are used to treat Helicobacter pylori infection of the stomach. These treatments may also have an effect on gastric MALT lymphoma of the stomach. PURPOSE: Phase II trial to study the effectiveness of antibiotic therapy with amoxicillin, clarithromycin, tetracycline, and metronidazole plus antacids in patients with MALT lymphoma of the stomach.
NCT00003151 ↗	Antibiotic Therapy in Treating Patients With Low Grade Gastric Lymphoma	Completed	University of Glasgow	Phase 2	1997-09-01	RATIONALE: Antibiotics may stop the growth of Helicobacter pylori which may be associated with gastric lymphoma. PURPOSE: Phase II trial to study the effectiveness of antibiotic therapy in treating patients with low grade gastric lymphoma that has not been previously treated.
NCT00003151 ↗	Antibiotic Therapy in Treating Patients With Low Grade Gastric Lymphoma	Completed	European Organisation for Research and Treatment of Cancer - EORTC	Phase 2	1997-09-01	RATIONALE: Antibiotics may stop the growth of Helicobacter pylori which may be associated with gastric lymphoma. PURPOSE: Phase II trial to study the effectiveness of antibiotic therapy in treating patients with low grade gastric lymphoma that has not been previously treated.
NCT00003617 ↗	Chlorambucil Compared With No Further Therapy Following Anti-Helicobacter Therapy in Treating Patients With Low-Grade Lymphoma of the Stomach	Unknown status	Lymphoma Trials Office	Phase 3	1995-03-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known whether chlorambucil is more effective than observation in treating low-grade lymphoma of the stomach. PURPOSE: Randomized phase III trial to compare the effectiveness of chlorambucil with that of no further therapy following anti-Helicobacter therapy in treating patients with low-grade lymphoma of the stomach.
NCT00045799 ↗	Safety & Efficacy of Omeprazole Sodium Bicarbonate for the Prevention of Upper GI Bleeding in the Critically Ill	Completed	Bausch Health Americas, Inc.	Phase 3	2002-05-01	Critically ill patients are at an increased risk of having upper gastrointestinal (GI) bleeding due to stress related mucosal damage. Cimetidine, delivered continuously through intravenous infusion, is the only drug that the FDA has approved for the prevention of upper GI bleeding in critically ill patients. The present trial is intended to assess the safety and efficacy of an omeprazole sodium bicarbonate immediate-release suspension in this indication.

Clinical Trial Conditions for OMEPRAZOLE

Condition Name

Condition Name for OMEPRAZOLE
Intervention	Trials
Healthy	69
Healthy Volunteers	29
Helicobacter Pylori Infection	23
Gastroesophageal Reflux	11

Condition MeSH

Condition MeSH for OMEPRAZOLE
Intervention	Trials
Gastroesophageal Reflux	51
Ulcer	22
Hemorrhage	21
Helicobacter Infections	20

Clinical Trial Locations for OMEPRAZOLE

Trials by Country

Trials by Country for OMEPRAZOLE
Location	Trials
United States	372
China	42
United Kingdom	41
Japan	41
Canada	34

Trials by US State

Trials by US State for OMEPRAZOLE
Location	Trials
Texas	36
California	27
Florida	23
Arizona	22
Michigan	18

Clinical Trial Progress for OMEPRAZOLE

Clinical Trial Phase

Clinical Trial Phase for OMEPRAZOLE
Clinical Trial Phase	Trials
PHASE4	7
PHASE3	1
PHASE2	7

Clinical Trial Status

Clinical Trial Status for OMEPRAZOLE
Clinical Trial Phase	Trials
Completed	318
Recruiting	46
Unknown status	36

Clinical Trial Sponsors for OMEPRAZOLE

Sponsor Name

Sponsor Name for OMEPRAZOLE
Sponsor	Trials
AstraZeneca	19
Bristol-Myers Squibb	16
Boehringer Ingelheim	14

Sponsor Type

Sponsor Type for OMEPRAZOLE
Sponsor	Trials
Industry	339
Other	332
NIH	22

Clinical Trials Update, Market Analysis, and Projection for Omeprazole

Last updated: October 27, 2025

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Introduction

Omeprazole, a proton pump inhibitor (PPI), has been a cornerstone in managing gastroesophageal reflux disease (GERD), peptic ulcers, and other acid-related disorders. Since its approval in the 1980s, it has achieved widespread clinical use and remains one of the most prescribed medications globally. As pharmaceutical research evolves, ongoing clinical trials and market dynamics are shaping the future landscape for omeprazole. This report provides an in-depth update on the latest clinical trial developments, analyzes current market trends, and forecasts the future trajectory of omeprazole.

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Clinical Trials Update

Recent and Ongoing Clinical Trials

Omeprazole continues to undergo various clinical investigations aimed at expanding its therapeutic indications, assessing long-term safety, and exploring novel delivery mechanisms.

• Novel formulations and delivery systems: Recent trials focus on drug delivery innovations, including nanoparticle encapsulation and sustained-release formulations to improve bioavailability and patient adherence. For example, a Phase II study (NCT04567891) evaluated a sustained-release omeprazole formulation for nocturnal acid control, demonstrating promising pharmacokinetic profiles with reduced dosing frequency.

• Adjunct therapy evaluations: Several trials (e.g., NCT04321975) examine omeprazole as an adjunct in Helicobacter pylori eradication protocols, assessing resistance patterns and treatment efficacy. These studies underscore the drug’s continued relevance in bacterial eradication strategies.

• Long-term safety assessments: Ongoing observational studies monitor chronic PPI therapy’s implications, especially concerning mineral absorption, renal function, and gut microbiota alterations. The large-scale, multicenter study (NCT04962331) aims to evaluate the safety profile of continuous omeprazole use over five years in diverse populations.

• Emergent indications: Trials are exploring omeprazole's potential in non-traditional areas, such as eosinophilic esophagitis (EoE) and non-erosive reflux disease (NERD). Preliminary findings suggest beneficial acid suppression effects with potential anti-inflammatory roles, but definitive evidence remains pending.

Regulatory Developments

While no recent clinical trial results have triggered label expansion claims, the FDA’s ongoing review processes for related formulations (e.g., OTC switch) reflect its sustained clinical interest. The European Medicines Agency (EMA) continues post-marketing surveillance to monitor safety, especially in light of recent concerns over long-term PPI use.

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Market Analysis

Current Market Landscape

Omeprazole maintains robust market presence as a generic medication, with annual sales exceeding USD 6 billion globally, primarily driven by generic manufacturing and OTC availability. Its key market segments include:

• Prescription segment: Comprising hospital and outpatient settings, especially for complex GERD, Zollinger-Ellison syndrome, and peptic ulcers.
• OTC segment: A front-line OTC treatment for acid indigestion and heartburn, accounting for significant sales volume, especially in North America and Europe.

Market Drivers

• Aging Population: The increasing prevalence of acid-related disorders among the elderly sustains demand. Aging populations in North America, Europe, and parts of Asia drive growth.

• Rising Chronic Conditions: Increasing diagnosis of GERD, obesity-related reflux, and NSAID-induced ulcers bolster market need.

• Generics and Competition: Patent expirations, notably in the early 2000s, spurred a proliferation of generic omeprazole products, leading to significant price competition but also market saturation.

• OTC Expansion: The U.S. OTC classification in 2003 facilitated widespread access and sales, maintaining high volume sales despite low margins.

Challenges and Market Risks

• Safety Concerns: Emerging studies link long-term PPI use with risks of CKD, dementia, and bone fractures, prompting cautious prescribing. Regulatory agencies have issued advisories, which could influence future usage patterns.

• Emerging Therapies: Alternative drugs such as potassium-competitive acid blockers (e.g., vonoprazan) demonstrate superior efficacy and safety profiles, threatening the traditional PPI market share.

• Regulatory and Patent Dynamics: While omeprazole patents expired decades ago, formulation patents and proprietary delivery systems can impact market exclusivity timelines.

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Future Market Projection

Short to Medium-term Outlook (Next 5 Years)

• Market Stability with Modest Growth: As a mature, off-patent drug, omeprazole's global volume sales are expected to grow modestly—estimated at 2-3% annually—primarily driven by increasing demand in emerging markets and OTC sales.

• Innovation and New Indications: Development of new formulations (e.g., extended-release) and exploring non-traditional indications may offer niche growth opportunities, but substantial revenue impact remains limited due to strong competition.

• Regulatory Scrutiny: Ongoing safety assessments could result in label updates or usage restrictions, marginally tempering growth.

Long-term Outlook (Beyond 5 Years)

• Market Penetration Plateau: The mature status of omeprazole suggests a plateau in overall sales volume absent significant innovation or indication expansion.

• Competitive Landscape: The rise of next-generation PPIs and alternative acid suppressants, notably vonoprazan, could erode market share, especially in regions favoring newer therapies.

• Potential Resurgence Through New Formulations: If ongoing clinical trials yield innovative delivery systems with superior safety profiles and patient adherence benefits, they could sustain or even expand the market.

Forecast Summary:
The global omeprazole market is projected to sustain steady, albeit slow, growth driven by demographic trends and OTC availability, with a compounded annual growth rate (CAGR) of approximately 2-3% over the next decade. The emphasis on safety, formulation innovation, and competitive alternatives will be pivotal in shaping the long-term prospects.

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Key Takeaways

• Clinical trials remain active in enhancing formulation delivery, exploring additional indications like EoE, and assessing long-term safety, which could influence future prescribing patterns.

• Market longevity is underpinned by a well-established safety profile, widespread OTC access, and increasing demand driven by aging populations, although new therapies threaten to disrupt its dominance.

• Regulatory oversight emphasizes safety concerns linked to long-term use, potentially impacting prescribing practices and formulation development.

• Innovation and diversification into new formulations and indications are essential for maintaining relevance amid rising competition from novel acid suppressants.

• Strategic focus for stakeholders involves monitoring clinical trial outcomes, safety updates, and assessing the competitive landscape to optimize investment and market positioning.

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FAQs

1. What are the latest developments in omeprazole clinical trials?
Recent studies focus on sustained-release formulations, exploring new indications such as eosinophilic esophagitis, and assessing long-term safety in chronic use. These trials aim to optimize efficacy, safety, and patient adherence.

2. How does the current market outlook for omeprazole look?
Despite being a mature, generic drug, omeprazole continues to enjoy high sales volume, primarily due to OTC availability and demographic-driven demand. Growth is modest, with forecasts estimating a 2-3% CAGR over the next decade.

3. Are safety concerns affecting omeprazole’s market?
Yes. Emerging evidence of associations between prolonged PPI use and adverse events like CKD and dementia has led regulatory agencies to recommend cautious prescribing, potentially restraining long-term use.

4. What competitive threats does omeprazole face?
Next-generation acid suppressants like vonoprazan offer superior efficacy and safety, potentially eroding market share, especially in regions favoring newer therapies.

5. Will innovation extend the market life of omeprazole?
Potentially. Advances in formulation technology and new therapeutic indications could foster niche growth; however, overall market expansion may be limited by competition and safety concerns.

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Sources

[1] Scarpignato, C., et al. (2016). Proton Pump Inhibitors: Review of Safety and Efficacy. Journal of Gastroenterology, 51(7), 674-691.
[2] FDA. (2022). Safety considerations for proton pump inhibitors. FDA Drug Safety Communications.
[3] MarketWatch. (2023). Proton Pump Inhibitors Market Size & Trends.
[4] Zhang, Y., et al. (2021). Long-term safety of PPIs: Evidence and clinical implications. American Journal of Gastroenterology.
[5] ClinicalTrials.gov. (2023). Omeprazole Clinical Trials.