CLINICAL TRIALS PROFILE FOR PRILOSEC

505(b)(2) Clinical Trials for Prilosec

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	NCT00746733 ↗	Vyvanse and Adderall XR Given Alone and in Combination With Prilosec OTC	Completed	Shire	Phase 1	2008-09-08	The purpose of this study is to determine if taking Vyvanse with Prilosec OTC or Adderall XR with Prilosec OTC changes how quickly the drug is absorbed into the body and/or changes how much of the drug is absorbed into the body.
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 Prilosec

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.
NCT00210470 ↗	A Phase 2 Clinical Trial of the Safety and Effects of IRX-2 in Treating Patients With Operable Head and Neck Cancer	Completed	Brooklyn ImmunoTherapeutics, LLC	Phase 2	2005-07-01	This was a Phase 2a trial to investigate the safety and biological activity of the RIX-2 Regimen in patients with untreated, resectable squamous cell cancer of the head and neck (HNSCC).
NCT00210470 ↗	A Phase 2 Clinical Trial of the Safety and Effects of IRX-2 in Treating Patients With Operable Head and Neck Cancer	Completed	IRX Therapeutics	Phase 2	2005-07-01	This was a Phase 2a trial to investigate the safety and biological activity of the RIX-2 Regimen in patients with untreated, resectable squamous cell cancer of the head and neck (HNSCC).
NCT00233935 ↗	Defined Green Tea Catechin Extract in Preventing Esophageal Cancer in Patients With Barrett's Esophagus	Completed	National Cancer Institute (NCI)	Phase 1	2005-11-01	The goal of this clinical research study is to test the safety of defined green tea catechin extract at different dose levels. Researchers also want to find out what effects, good and bad, it may have on individual and their risk for esophagus cancer. Esophagus cancer is an increased risk associated with Barrett's esophagus. Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of defined green tea catechin extract may prevent esophageal cancer.
NCT00446004 ↗	Effect of a Proton Pump Inhibitor on Gleevec® in Healthy Volunteers	Completed	Novartis	Phase 1	2007-04-01	This is a research study that will investigate the effects of proton pump inhibitors (often used to treat stomach upset) on Gleevec® (a drug that is FDA-approved to treat some types of cancer) in healthy volunteers. Twelve healthy volunteers (six men and six women) will be recruited to complete the study. This research study will compare Gleevec® in the body when taken with and without proton pump inhibitors (PPI). Each volunteer will receive a 400 mg pill of Gleevec® on two occasions. On one occasion they will take the dose of Gleevec® alone (without PPI). On another occasion, they will take the Gleevec® after taking 40 mg of PPI daily by mouth for six days. Several blood samples will be drawn to measure the concentrations of Gleevec® and its breakdown products in the blood, with and without the influence of PPI.

Clinical Trial Conditions for Prilosec

Condition Name

Condition Name for Prilosec
Intervention	Trials
Healthy	12
Healthy Volunteers	4
Laryngopharyngeal Reflux	2
Chronic Low Back Pain	2

Condition MeSH

Condition MeSH for Prilosec
Intervention	Trials
Gastroesophageal Reflux	7
Esophagitis	4
Ulcer	3
Malnutrition	2

Clinical Trial Locations for Prilosec

Trials by Country

Trials by Country for Prilosec
Location	Trials
United States	83
Japan	36
India	7
Canada	5
Brazil	4

Trials by US State

Trials by US State for Prilosec
Location	Trials
Arizona	7
Pennsylvania	7
California	6
Texas	5
New York	5

Clinical Trial Progress for Prilosec

Clinical Trial Phase

Clinical Trial Phase for Prilosec
Clinical Trial Phase	Trials
Phase 4	12
Phase 3	7
Phase 2	3

Clinical Trial Status

Clinical Trial Status for Prilosec
Clinical Trial Phase	Trials
Completed	42
Withdrawn	3
Unknown status	2

Clinical Trial Sponsors for Prilosec

Sponsor Name

Sponsor Name for Prilosec
Sponsor	Trials
Bayer	4
Dr. Reddy's Laboratories Limited	4
Brooklyn ImmunoTherapeutics, LLC	3

Sponsor Type

Sponsor Type for Prilosec
Sponsor	Trials
Industry	44
Other	23
NIH	10

Prilosec: Clinical Trials, Market Analysis, and Projections

Introduction to Prilosec

Prilosec, known generically as omeprazole, is a proton pump inhibitor (PPI) widely used to treat conditions such as gastroesophageal reflux disease (GERD), duodenal and gastric ulcers, and other acid-related gastrointestinal disorders. Here, we will delve into the current status of clinical trials, market analysis, and future projections for Prilosec.

Clinical Trials and Safety Concerns

Ongoing Litigation and Safety Issues

Prilosec has been at the center of several lawsuits due to allegations that the drug causes kidney injuries and chronic kidney disease. As of January 2025, there were 11,975 lawsuits pending against AstraZeneca, the manufacturer of Prilosec and Nexium, another popular PPI. In October 2023, AstraZeneca agreed to a $425 million settlement for these cases, although the multidistrict litigation (MDL) remains active[1].

FDA Warnings and Investigations

The FDA has issued several safety warnings regarding Prilosec and other PPIs, including potential risks of erectile dysfunction, acute generalized exanthematous pustulosis, and rhabdomyolysis. Despite these warnings, Prilosec has not been recalled, unlike the acid-reducing drug Zantac, which was recalled in 2019 due to contamination concerns[1].

Clinical Trial Outcomes

Clinical trials have shown the efficacy of omeprazole in treating various gastrointestinal conditions. For example, the ERADICATE Hp2 study demonstrated the effectiveness of Talicia, a capsule combining antibiotics and omeprazole, in treating Helicobacter pylori infections. This combination therapy has been shown to be highly effective, which is expected to boost the demand for omeprazole in the future[3].

Market Analysis

Global Market Size and Growth

The global omeprazole market is projected to grow significantly due to the increasing prevalence of GERD and other acid-related disorders. By 2033, the omeprazole API market is expected to reach a substantial value, driven by a compound annual growth rate (CAGR) of several percent during the forecast period (2025-2033)[2].

Regional Market Dynamics

North America and Europe currently hold the largest share of the omeprazole market, primarily due to the high prevalence of GERD and well-established healthcare systems. However, the Asia-Pacific region is expected to witness significant growth due to increasing healthcare expenditure and a growing population[2][5].

Key Market Trends

Several trends are driving the growth of the omeprazole market:

• Increasing Demand for Liquid and Powder Formulations: There is a growing demand for liquid and powder formulations of omeprazole, which is expected to expand market opportunities.
• Adoption of Biosimilars and Generic Drugs: The approval and launch of inexpensive generic drugs and biosimilars are key drivers of market growth.
• Research and Development: Continuous investment in research and development by major players is expected to introduce novel medications and bolster market expansion[2][3].

Market Projections

Proton Pump Inhibitors Market

The broader proton pump inhibitors (PPIs) market, which includes Prilosec, is projected to reach USD 13.35 billion by 2025 and grow at a CAGR of 5.14% to reach USD 17.16 billion by 2030. This growth is driven by the increasing number of people suffering from GERD and other acid-related disorders[5].

Omeprazole Market Specifics

The global omeprazole market was valued at USD 2,668.4 million in 2017 and is expected to exhibit a CAGR of 5.2% during the forecast period (2018-2026). This growth is attributed to the increasing adoption of omeprazole in combination with antibiotics to treat ulcers associated with H.pylori bacteria and the launch of generic and biosimilar versions of the drug[3].

Major Players in the Market

The omeprazole market is fragmented, with both established and emerging companies playing significant roles. Major players include:

• AstraZeneca Plc.
• Sandoz, Inc.
• Dr. Reddy’s Laboratories, Inc.
• Mylan N.V.
• Apotex, Inc.
• Impax Laboratories, Inc.
• Perrigo Company Plc
• Lek Pharmaceuticals d.d.[2][3].

Regulatory Environment

FDA Oversight

Despite the FDA's safety warnings and ongoing investigations into potential side effects, Prilosec remains a widely prescribed medication. The FDA has not added any new warnings to the drug's label, but it continues to monitor reports of adverse effects associated with PPIs[1].

Consumer Compliance and Understanding

Studies have shown that consumers generally comply with the label directions for Prilosec OTC. Label-comprehension studies and actual-use trials have established that consumers understand the proper use of the medication, including when to take it and when to contact a healthcare professional[4].

Key Takeaways

• Litigation and Safety: Prilosec is involved in ongoing litigation related to kidney injuries, with a significant settlement agreed upon in 2023.
• Clinical Trials: Omeprazole has shown efficacy in treating various gastrointestinal conditions, including H.pylori infections.
• Market Growth: The global omeprazole market is projected to grow significantly, driven by increasing prevalence of GERD and other acid-related disorders.
• Regional Dynamics: North America and Europe are the largest markets, but the Asia-Pacific region is expected to grow rapidly.
• Market Trends: Increasing demand for liquid and powder formulations, adoption of biosimilars, and continuous R&D are key market drivers.

FAQs

What is the current status of Prilosec lawsuits?

As of January 2025, there were 11,975 lawsuits pending against AstraZeneca, with a $425 million settlement agreed upon in October 2023 for Prilosec and Nexium cases[1].

How is the omeprazole market expected to grow?

The global omeprazole market is projected to grow at a CAGR of several percent during the forecast period (2025-2033), driven by increasing prevalence of GERD and other acid-related disorders[2].

Which regions are expected to see significant growth in the omeprazole market?

North America and Europe currently hold the largest share, but the Asia-Pacific region is expected to witness notable growth due to increasing healthcare expenditure and a growing population[2][5].

What are the key trends driving the omeprazole market?

Key trends include the increasing demand for liquid and powder formulations, the adoption of biosimilars and generic drugs, and continuous investment in research and development[2][3].

Who are the major players in the omeprazole market?

Major players include AstraZeneca Plc., Sandoz, Inc., Dr. Reddy’s Laboratories, Inc., Mylan N.V., Apotex, Inc., and Lek Pharmaceuticals d.d.[2][3].

Sources

1. DrugWatch: Prilosec Lawsuit | Kidney Damage Settlements & Updates
2. Data Insights Market: Omeprazole API Strategic Dynamics: Competitor Analysis 2025-2033
3. GlobeNewswire: Global Omeprazole Market to Surpass US$ 4.1 Billion by 2026
4. Prilosec OTC: Prilosec OTC Product Monograph
5. Mordor Intelligence: Proton Pump Inhibitors Market - PPIS - Size, Share & Analysis

Last updated: 2025-01-07