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.

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.

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

Omeprazole: Clinical Trials Update and Market Projection

Last updated: April 28, 2026

Omeprazole is a widely marketed proton pump inhibitor (PPI) used for acid-related gastrointestinal disorders. It is no longer under active new-drug “phase-to-approval” dynamics because it is an established, off-patent small molecule across major markets. The current market is shaped by generic entry, label expansions, safety-led prescribing patterns, and substitution between PPIs based on price, formulary access, and dosing convenience.

Where is omeprazole in the clinical-trials pipeline?

Omeprazole’s global development activity is dominated by formulation, regimen, pharmacokinetic (PK), and real-world effectiveness studies rather than first-in-class mechanism trials. Across recent years, the clinical trial landscape consists mainly of:

• PK/bioequivalence and formulation (delayed-release stability, new generics, and alternative dosing formats such as dispersible tablets in some jurisdictions)
• Therapeutic equivalence and outcomes in GERD and peptic ulcer disease (PUD)
• Adverse event and drug-drug interaction evaluation (notably long-term PPI-associated risks and interactions with acid-dependent therapies)

Implication for investors and R&D planners: The meaningful “clinical” differentiation opportunities for omeprazole are usually product-line (formulation, dosing regimen, combination pill strategies) and access (formulary and price positioning), not new clinical endpoints that require full de novo regulatory packages.

What does the trial activity imply for product differentiation?

Given the molecule’s maturity, clinical differentiation tends to occur through these levers:

1. Formulation and patient usability

   • Delayed-release performance and gastric acid suppression consistency
   • Alternative dosage presentations that support adherence

2. Dosing regimen strategy

   • Once-daily versus split dosing in specific clinical pathways
   • Optimizing step-down therapy for GERD/PUD maintenance

3. Combination positioning

   • Co-therapy pathways where PPIs are prescribed alongside antibiotics or mucosal agents in H. pylori and ulcer indications (often governed by local guidelines and bundled reimbursement)

What is the market structure for omeprazole?

Omeprazole is an “always-on” chronic and recurrent-use therapy. The market is structurally split between:

• Generic omeprazole (dominant share in most countries after patent expiry)
• Branded remnants or locally branded versions (where brand loyalty persists)
• Therapeutic class competition from other PPIs (esomeprazole, lansoprazole, pantoprazole, rabeprazole) and from H2 blockers where payers negotiate

Core demand drivers

• Chronic GERD prevalence and long-term symptom recurrence
• PUD management and relapse prevention
• H. pylori eradication regimens that require acid suppression
• Peri-NSAID prophylaxis and stress-ulcer prophylaxis pathways in some healthcare settings

How big is the omeprazole market and where is growth coming from?

Public market data for “omeprazole market” is often estimated at the molecule level and can vary due to methodology (global vs. major geography coverage, inclusion of combinations, and allocation of class revenues). The direction is consistent across market reports: value growth lags volume growth because generics compress pricing.

Market dynamics that shape projections

• Price compression after generic entry lowers revenue growth rates versus unit growth.
• Regulatory and safety labeling influences prescriber comfort, especially for long-term continuous use.
• Switching within PPIs occurs based on payer tiering, originator versus generic availability, and pharmacy supply.

What projection model fits omeprazole today?

For an off-patent, commoditized molecule, the most decision-relevant projection is not a “clinical success” forecast but a unit-share and price forecast. The projection mechanics typically use:

• Units: driven by GERD and PUD incidence, persistence of therapy, and substitution patterns within PPIs
• Net price: driven by generic competition intensity, tender outcomes, and formulary restrictions
• Mix: shifts across:
  • once-daily versus higher-frequency regimens (where clinically required)
  • higher-cost presentations vs standard tablets/capsules (formulation mix)
  • geography mix (emerging-market penetration vs mature-market substitution)

Business conclusion: Omeprazole’s near- and mid-term growth is most likely modest in revenue and supported mainly by volume stability plus occasional pricing stabilization in certain markets after generic consolidation.

Competitive landscape: what could take share from omeprazole?

Omeprazole faces persistent class competition. Key share threats include:

• Esomeprazole and other PPIs with stronger brand cachet in some geographies
• Formulary tiering that favors one PPI per hospital or payer contract
• Patient adherence and dosing tolerance decisions by prescribers, where certain PPIs win on perceived effectiveness or side effect experience

Counterbalancing forces:

• Deep generic pricing keeps omeprazole a default option when payers minimize pharmacy spend
• Long-standing guideline familiarity in GERD and PUD pathways

What recent clinical themes drive label and prescribing behavior?

Regulatory and guideline attention has focused on two categories of evidence used in prescribing decisions:

1. Appropriate duration

   • Step-down strategies where possible for GERD maintenance to reduce prolonged exposure when symptoms permit.

2. Drug-drug interactions and safety

   • Monitoring and clinical review when PPIs are co-prescribed with therapies where acid environment matters.
   • Risk awareness for long-term use scenarios, influencing deprescribing in some patients and reinforcing short-course or lowest-effective-dose strategies.

These themes do not require new omeprazole trials to be impactful; they alter utilization patterns, which then affect market share and revenue.

What are the highest-value R&D targets for omeprazole-related programs?

For teams building around omeprazole rather than re-inventing it, the highest-value work is usually constrained to:

• Next-generation formulations that improve adherence or stability (especially in settings where delayed-release reliability matters)
• Fixed-dose or regimen combinations aligned with locally standard-of-care (cost offsets through reduced pill burden and adherence improvements)
• Regimen-specific outcome studies in populations where clinicians already use PPIs but require better evidence for duration or switching

Geographic projection outlook

A credible projection range across geographies typically follows this pattern:

• Mature markets: revenue growth stays low due to entrenched generics, substitution within the class, and tighter deprescribing or guideline constraints.
• Emerging markets: unit growth is healthier due to rising diagnosis and access expansion, but revenue growth is moderated by lower price levels and rapid generic adoption cycles.

Key adoption drivers by indication

GERD

• Chronic symptoms and recurrence drive repeat use.
• Payer policies often keep PPIs on formulary; the main variable is which PPI is preferred.

PUD and maintenance

• Relapse prevention supports maintenance prescribing when indicated.
• Acid suppression is standard-of-care; omeprazole competes primarily on price and availability.

H. pylori regimens

• Acid suppression is mandatory in standard eradication therapy pathways; selection depends on local prescribing norms and bundled costs.

Peri-NSAID prophylaxis

• Ongoing guideline-based use tied to risk stratification.
• Market share depends on hospital formularies and prescribing habits.

What does the omeprazole clinical update mean for investors now?

Clinical trial updates for omeprazole are not signaling a molecule-level breakthrough. The market is still liquid, but it is liquid through:

• Generic and formulation wins
• Contracting and tender outcomes
• Class substitution dynamics
• Utilization management (dose optimization and duration constraints)

If you are underwriting a program linked to omeprazole, the primary “risk factor” is not failure in phase trials; it is commercial execution: manufacturing reliability, regulatory launch speed in key markets, pricing strategy against competitors, and formulary access.

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Key Takeaways

• Omeprazole’s clinical activity is dominated by formulation, PK/bioequivalence, and regimen/outcomes studies rather than de novo efficacy breakthroughs.
• Market growth is driven mainly by volume stability across GERD/PUD and H. pylori pathways, while revenue growth remains modest due to persistent generic price pressure.
• Competitive dynamics are class-based substitution within PPIs and formulary contracting, not molecule-level innovation.
• The most viable R&D directions are product-line improvements (formulation, adherence, dosing convenience) and combination/regimen strategies aligned with local standard-of-care.

FAQs

1) Is omeprazole currently in late-stage clinical development for a new indication?
No consistent pattern of late-stage, de novo indication development drives the current omeprazole pipeline; clinical activity is largely formulation/biopharm and utilization/outcomes-focused.

2) What most affects omeprazole revenue growth in mature markets?
Generic pricing intensity, payer formularies, and class substitution between PPIs.

3) What indications sustain omeprazole demand?
GERD, PUD maintenance/relapse prevention, and PPIs used as components of H. pylori eradication regimens.

4) What R&D approaches have the highest commercial relevance for omeprazole?
Formulation improvements, adherence-focused dosage options, and combination or regimen strategies that align with clinical pathways and reimbursement.

5) Does safety evidence materially change omeprazole prescribing behavior?
It influences duration, dose optimization, and deprescribing decisions in some patient groups, shaping utilization patterns and net demand.

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References

[1] U.S. Food and Drug Administration. Drug Safety Communication and labeling information related to proton pump inhibitors (PPIs). FDA website.
[2] European Medicines Agency (EMA). Public assessment reports and product information for omeprazole-containing medicines. EMA website.
[3] National Institute for Health and Care Excellence (NICE). Guidance on GERD and PUD management with acid suppression therapies. NICE website.
[4] World Health Organization. Guidelines and background materials on acid-related gastrointestinal disorders and PPI use. WHO website.