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	70
Healthy Volunteers	29
Helicobacter Pylori Infection	24
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	43
United Kingdom	42
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	8
PHASE3	3
PHASE2	7

Clinical Trial Status

Clinical Trial Status for omeprazole
Clinical Trial Phase	Trials
Completed	319
Recruiting	48
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	342
Other	335
NIH	22

Last updated: June 25, 2026

Omeprazole clinical trials update, market analysis, and market projection (2025–2035)

Omeprazole remains a mature, high-volume proton pump inhibitor (PPI) with an extensive generic base and limited sponsor-led innovation. Clinical trial activity is dominated by formulation, bioequivalence, and lifecycle studies rather than new molecular entities. Market growth is driven by pricing resilience in branded channels, steady demand for GERD and peptic ulcer indications, and geographic expansion of low-cost generics. Near-term upside is constrained by patent/market maturity, but mid-decade demand can still track population growth and background gastrointestinal prescribing.

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What is the current clinical trial landscape for omeprazole (2024–2026)?

Omeprazole is widely available as generics in most jurisdictions, so the dominant “clinical trial” footprint is typically:

• bioequivalence studies for generic oral products (capsules/tablets, delayed-release pellets)
• formulation changes (different enteric coatings, capsule sizes, sprinkle formulations)
• real-world safety or treatment adherence studies tied to label use
• pediatric and special-population studies (where regulatory requirements persist)

Where do omeprazole trials cluster geographically?

Clinical activity generally clusters in countries with:

• high generic manufacturing and compliance infrastructure
• active regulatory harmonization programs (bioequivalence requirements)
• high GERD prevalence

Typical patterns in global trial registries show a mix of North America, Europe, and Asia-Pacific for BE and lifecycle studies, with lower counts of investigator-initiated efficacy trials compared with newer GI drug classes.

What trial types are most common?

1) Bioequivalence and pharmacokinetic studies

• Primary endpoints: Cmax, AUC, Tmax
• Design: crossover or parallel, standardized fed/fasted conditions
• Products: delayed-release capsules/tablets, omeprazole-sodium, enteric-coated granules/sprinkles

2) Formulation and dosing regimen studies

• Enteric coating durability under gastric pH changes
• Stability and dose uniformity studies tied to manufacturing scale-up

3) Safety and tolerability studies

• short- to medium-term monitoring for common PPI class risks
• adherence and switching studies (e.g., from other PPIs)

How does trial intensity compare with newer PPIs?

Compared with esomeprazole, lansoprazole, pantoprazole, vonoprazan, and newer combinations, omeprazole trial activity is lower in terms of novel endpoints but remains steady in BE and formulation compliance categories.

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What do recent omeprazole clinical updates focus on: GERD, ulcer healing, or safety?

Primary therapeutic focus: GERD and acid-related dyspepsia

Most non-BE studies center on:

• symptom control in GERD
• healing rates for erosive esophagitis
• appropriateness of dose, timing before meals, and duration

Ulcer and H. pylori-related use

Omeprazole is commonly used:

• in combination regimens with antibiotics for H. pylori eradication
• with or without other gastroprotective regimens in ulcer risk settings

Because antibiotic combination protocols require coordinated trial design, omeprazole trial papers and registered studies often track established combination frameworks rather than new mechanistic hypotheses.

Safety updates that drive lifecycle studies

Lifecycle and post-marketing surveillance studies frequently examine class-associated risks:

• hypomagnesemia
• vitamin B12 deficiency
• fracture risk signal associations
• enteric infections (class-level concern)
• kidney-related events

In mature PPIs, these studies skew toward observational designs and risk monitoring rather than controlled efficacy trials.

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Which omeprazole clinical trial outcomes are typically measured and how are endpoints structured?

For bioequivalence

• AUC0-inf and AUC0-t
• Cmax
• Tmax
• enteric-coated performance under dissolution tests
• fed versus fasted comparisons (depending on protocol)

Regulatory compliance determines acceptance criteria in most markets, which drives trial design toward narrow endpoints rather than clinical outcomes.

For clinical efficacy studies

When registries capture efficacy trials beyond BE:

• GERD symptom scores
• proportion with symptom resolution
• esophagitis healing (endoscopic grading)
• time-to-relief and maintenance response

In practice, these are less frequent because the drug is mature and standard-of-care evidence is already established.

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What is the current market size for omeprazole and what is the competitive landscape?

Demand drivers

Omeprazole demand is shaped by:

• chronic GERD prevalence and maintenance therapy behavior
• gastric protection in patients requiring NSAIDs or antiplatelet therapy
• H. pylori regimen persistence in combination protocols
• continued inclusion in formularies and treatment pathways

Supply and competitive structure

The competitive landscape is dominated by:

• multi-source generics across North America, Europe, and emerging markets
• branded products in select channels where legacy brand equity remains
• constant substitution dynamics driven by reimbursement and pharmacy purchasing

Market concentration

Because omeprazole is off-patent in most markets, absolute sales are driven more by pricing and distribution than by innovation. Major generic manufacturers and contract packers supply most of the global volume.

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How does generic substitution impact omeprazole pricing and revenue?

Pricing

As generics increase market penetration:

• unit prices fall sharply after entry
• margin compresses for weaker suppliers
• surviving players often rely on scale, distribution contracts, and low-cost manufacturing

Revenue stability

Omeprazole’s volume elasticity is relatively strong:

• GERD and ulcer-related indications are ongoing chronic or recurrent
• many patients remain on long-term PPI therapy
• switching between PPIs occurs but rarely eliminates total PPI category spend

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What market projections apply to omeprazole from 2025 to 2035?

Base-case trajectory

For a mature, multi-source drug:

• growth tracks incremental volume demand and population
• net revenue growth depends on pricing stabilization and mix shifts
• substitution keeps long-term pricing pressure persistent

A typical projection pattern for mature PPIs:

• mid-single-digit CAGR by volume or modest value growth by revenue in some geographies
• flat-to-low value growth in highly competitive markets
• higher relative growth in emerging markets where access expands and generic penetration continues

Upside factors

• expansion of over-the-counter (OTC) channels in additional jurisdictions
• increased GERD awareness and diagnosis rates
• continuing use in gastric protection protocols

Downside factors

• substitution within the class toward newer agents or different PPIs (including therapy refinements)
• stronger stewardship guidelines that reduce long-term maintenance in low-risk patients
• payer restrictions or step-therapy implementations

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What regulatory and reimbursement factors influence omeprazole market growth?

FDA and other regulators

Omeprazole is generally supported by:

• established ANDA pathways for generics
• BE-based approvals for multiple dosage forms
• mature labeling and established dosing regimens

Reimbursement dynamics

Reimbursement typically:

• favors least-cost options
• encourages generic substitution in pharmacy benefit management
• imposes prior authorization in some settings for long-term use

These factors shape market share more than therapeutic breakthrough potential.

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What is the strongest commercial thesis for omeprazole over the next decade?

Omeprazole’s strongest thesis is category durability:

• GERD and acid-related dyspepsia remain common
• PPIs are entrenched in treatment pathways for ulcer prevention and H. pylori combination regimens
• low-cost generics sustain broad access

The commercial center of gravity is manufacturing efficiency and distribution, not differentiation.

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How does omeprazole compare with other PPIs on clinical differentiation and market risk?

Clinical differentiation

Across standard indications (GERD, erosive esophagitis, ulcer protection), clinical differences among PPIs are generally modest in practice for mature products. Differentiation is more about:

• dosing convenience (timing, formulations)
• patient tolerability profiles
• brand or access channel strength

Market risk

Omeprazole faces:

• strong substitution to other low-cost PPIs
• periodic shifts to newer class members depending on reimbursement incentives
• price competition within the generic tier

Competitive mapping

• Pantoprazole: strong generic footprint and payer familiarity
• Esomeprazole: sometimes higher demand due to brand familiarity in select markets
• Lansoprazole: similar access but different channel strength
• Vonoprazan and emerging combinations: more meaningful competitive pressure in certain formularies, though typically not enough to displace all PPI use

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What generic launch and lifecycle risks exist for omeprazole products?

For omeprazole, “launch risk” is mainly operational:

• formulation bioequivalence risk (enteric coat and dissolution profile)
• manufacturing compliance risk (process validation, stability)
• supply chain and raw material sourcing
• labeling and coding transitions

Because the molecule is established and multi-sourced, the market risk is more competitive intensity than IP exclusion.

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What formulation innovations are most likely to move the needle commercially?

Even in a mature molecule, the commercial levers tend to be:

• improved enteric coating durability and capsule/sprinkle stability
• patient-centric delivery formats (smaller capsules, sprinkle formulations)
• pediatric-friendly dosing presentations
• combination products or adherence-optimized regimens (where allowed)

These innovations typically win through access and patient adherence, not via new clinical outcomes.

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Key Takeaways

• Omeprazole clinical trial activity is dominated by bioequivalence and lifecycle studies, with fewer novel efficacy trials given the drug’s maturity.
• Demand is anchored in GERD and acid-related indications and is reinforced by long-term maintenance and ulcer prevention use patterns.
• Market growth is likely to be modest and driven by volume expansion and geographic access rather than price premium or new mechanism differentiation.
• Competitive pressure stays structurally high because multi-source generics and substitution across PPIs keep pricing constrained.
• Commercial strategy for omeprazole centers on cost-effective manufacturing, formulation BE success, distribution reach, and payer channel execution.

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FAQs

1) Are there ongoing bioequivalence studies for omeprazole capsules and tablets?
Yes. Omeprazole typically has continuous BE and formulation-related studies for generic entry and product line expansions across multiple dosage forms.

2) Does omeprazole have meaningful pediatric clinical development activity today?
Pediatric studies persist mainly through formulation suitability and regulatory compliance frameworks rather than breakthrough efficacy.

3) What clinical endpoints are used when omeprazole formulations are compared?
Bioequivalence studies usually focus on Cmax and AUC, supported by enteric-coated performance and dissolution characteristics; efficacy studies (when present) use symptom and healing endpoints.

4) Will omeprazole sales be threatened by newer acid suppressants like vonoprazan?
They may be pressured in specific payer formularies, but the broad generic base and entrenched PPI role generally limit displacement.

5) What market factor matters most for omeprazole revenue in highly generic markets?
Net price and product access under pharmacy and payer contracts, driven by the least-cost competitive set.

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References (APA)

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
2. ClinicalTrials.gov. Omeprazole (search results and study records). U.S. National Library of Medicine. https://clinicaltrials.gov/
3. EMA. European public assessment reports and product information for omeprazole-containing medicines. European Medicines Agency. https://www.ema.europa.eu/
4. WHO. ATC/DDD Index: Omeprazole (ATC code and DDD reference). World Health Organization. https://www.whocc.no/