CLINICAL TRIALS PROFILE FOR OMEPRAZOLE MAGNESIUM

All Clinical Trials for Omeprazole Magnesium

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00206440 ↗	Nexium Study To Suppress Nausea During Chemotherapy	Terminated	AstraZeneca	Phase 3	2005-08-01	This study will look at a drug called esomeprazole, the newest PPI, as a way to further reduce the amount of nausea and vomiting seen in breast cancer patients receiving adriamycin or epirubicin chemotherapy. Esomeprazole may help protect the gut lining from the stomach acid and thus lessen the nausea and vomiting. If patients have less stomach sickness, they may be able to enjoy their daily routines much more while they are getting chemotherapy.
NCT00206440 ↗	Nexium Study To Suppress Nausea During Chemotherapy	Terminated	Baylor Breast Care Center	Phase 3	2005-08-01	This study will look at a drug called esomeprazole, the newest PPI, as a way to further reduce the amount of nausea and vomiting seen in breast cancer patients receiving adriamycin or epirubicin chemotherapy. Esomeprazole may help protect the gut lining from the stomach acid and thus lessen the nausea and vomiting. If patients have less stomach sickness, they may be able to enjoy their daily routines much more while they are getting chemotherapy.
NCT00674115 ↗	A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (CL2007-17 )(P07813)(COMPLETED)	Completed	Bausch Health Americas, Inc.	Phase 3	2008-04-01	Open-label randomized crossover design studies. 60 participants will be evaluated on Day 1 to compare effects on stomach acid; 30 participants will continue treatment for 7 days and will have repeat evaluations at Day 7. The other 30 participants will receive a single administration of sodium bicarbonate.
NCT00674115 ↗	A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (CL2007-17 )(P07813)(COMPLETED)	Completed	Valeant Pharmaceuticals International, Inc.	Phase 3	2008-04-01	Open-label randomized crossover design studies. 60 participants will be evaluated on Day 1 to compare effects on stomach acid; 30 participants will continue treatment for 7 days and will have repeat evaluations at Day 7. The other 30 participants will receive a single administration of sodium bicarbonate.
NCT00674115 ↗	A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (CL2007-17 )(P07813)(COMPLETED)	Completed	Bayer	Phase 3	2008-04-01	Open-label randomized crossover design studies. 60 participants will be evaluated on Day 1 to compare effects on stomach acid; 30 participants will continue treatment for 7 days and will have repeat evaluations at Day 7. The other 30 participants will receive a single administration of sodium bicarbonate.
NCT00693225 ↗	Impact of Timing on the Efficacy of Zegerid 40 mg in Healing Reflux Esophagitis: A Pilot Study	Completed	Bausch Health Americas, Inc.	Phase 4	2008-01-01	The purpose of this study was to determine the effect of morning versus bedtime administration of omeprazole/sodium bicarbonate (Zegerid) on endoscopic healing for patients with moderate or severe reflux esophagitis. Our hypothesis was that bedtime administration of Zegerid would be superior in healing esophagitis compared to morning administration prior to a meal.
NCT00693225 ↗	Impact of Timing on the Efficacy of Zegerid 40 mg in Healing Reflux Esophagitis: A Pilot Study	Completed	Valeant Pharmaceuticals International, Inc.	Phase 4	2008-01-01	The purpose of this study was to determine the effect of morning versus bedtime administration of omeprazole/sodium bicarbonate (Zegerid) on endoscopic healing for patients with moderate or severe reflux esophagitis. Our hypothesis was that bedtime administration of Zegerid would be superior in healing esophagitis compared to morning administration prior to a meal.

Clinical Trial Conditions for Omeprazole Magnesium

Condition Name

Condition Name for Omeprazole Magnesium
Intervention	Trials
Healthy	2
HIV	2
Human Experimentation	1
Magnesium Sulfate	1

Condition MeSH

Condition MeSH for Omeprazole Magnesium
Intervention	Trials
Crush Injuries	2
Esophagitis, Peptic	2
Heartburn	1
Eczema	1

Clinical Trial Locations for Omeprazole Magnesium

Trials by Country

Trials by Country for Omeprazole Magnesium
Location	Trials
United States	3
India	2
China	2
Netherlands	2
Romania	2

Trials by US State

Trials by US State for Omeprazole Magnesium
Location	Trials
Arizona	1
Minnesota	1
Texas	1

Clinical Trial Progress for Omeprazole Magnesium

Clinical Trial Phase

Clinical Trial Phase for Omeprazole Magnesium
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	2
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Omeprazole Magnesium
Clinical Trial Phase	Trials
Completed	8
Not yet recruiting	3
Terminated	1

Clinical Trial Sponsors for Omeprazole Magnesium

Sponsor Name

Sponsor Name for Omeprazole Magnesium
Sponsor	Trials
Bausch Health Americas, Inc.	2
Valeant Pharmaceuticals International, Inc.	2
Bayer	2

Sponsor Type

Sponsor Type for Omeprazole Magnesium
Sponsor	Trials
Industry	13
Other	8

Omeprazole Magnesium: Clinical Trials, Market Analysis, and Projections

Introduction to Omeprazole Magnesium

Omeprazole magnesium, a proton pump inhibitor (PPI), is widely used to treat various gastrointestinal disorders, including gastroesophageal reflux disease (GERD), duodenal ulcers, gastric ulcers, and erosive esophagitis. This article delves into the recent clinical trials, market analysis, and future projections for omeprazole magnesium.

Clinical Trials and Bioequivalence Studies

Recent clinical trials have focused on developing bioequivalent formulations of omeprazole magnesium. A study published in Medicina in 2024 detailed the development of a new bioequivalent delayed-release omeprazole product. This study involved a bioequivalence study comparing the test drug to a reference drug, where the pharmacokinetic parameters such as Cmax (maximum concentration) and AUC (area under the curve) were analyzed. The results showed no statistically significant differences between the test and reference drugs, indicating that the new formulation is bioequivalent[1].

Pharmacokinetic Parameters

The study highlighted that the average Cmax values for the test and reference drugs were 1321 ± 249.0 ng/mL and 1274 ± 233 ng/mL, respectively. The AUC 0-t and AUC 0-∞ values also showed insignificant variability, with the test drug having values of 4521 ± 841 ng/mL·h and 4636 ± 814 ng/mL·h, respectively, compared to the reference drug's values of 4371 ± 695 ng/mL·h and 4502 ± 640 ng/mL·h. These findings confirmed that the new formulation meets the bioequivalence criteria[1].

Market Analysis

Global Market Size and Forecast

The omeprazole magnesium market is experiencing significant growth. As of 2024, the market size was valued at USD 1.13 billion and is projected to exceed USD 2.56 billion by 2037, growing at a CAGR of over 6.5% during the forecast period of 2025-2037[5].

Geographical Segmentation

North America is expected to dominate the market, holding a majority revenue share of 59% by 2037. This is driven by the high prevalence of H. pylori infections and peptic ulcers in the region. The Asia Pacific region is also expected to contribute substantially, with a projected market share of 28.6% by 2037, driven by increasing awareness and growing incidences of gastrointestinal diseases[5].

Dosage Forms and Indications

The capsule segment is anticipated to propel the omeprazole market growth, expected to occupy 52% of the market share by 2037. Tablets, while easy to handle and inexpensive, also play a significant role. The primary indications for omeprazole include duodenal ulcers, gastric ulcers, gastroesophageal reflux disease, and erosive esophagitis[5].

Market Drivers

Increasing Chronic Diseases

The global rise in chronic diseases such as cancer, diabetes, and respiratory ailments is a significant driver for the omeprazole market. According to the World Health Organization (WHO), chronic diseases will account for 90% of all global fatalities by 2050, increasing the demand for treatments like omeprazole[5].

Clinical Trial Successes

Positive results from clinical trials, such as those involving the Talicia capsule by RedHill Biopharma, which combines antibiotics and a PPI for H. pylori elimination therapy, are expected to boost the global demand for omeprazole[5].

Market Expansion and R&D

Major market players are focusing on research and development and market expansion activities. For instance, the transfer of marketing and distribution rights for esomeprazole products by Daiichi Sankyo Co., Ltd. to AstraZeneca in Japan highlights the strategic initiatives driving market growth[3].

Challenges and Considerations

Drug Interactions

Proton pump inhibitors, including omeprazole, can interact with other drugs, potentially leading to adverse effects. For example, PPIs can impair magnesium absorption, which, when combined with other medications like loop and thiazide diuretics, can increase the risk of hypomagnesemia[4].

COVID-19 Impact

The COVID-19 pandemic had a temporary impact on the PPI market, including omeprazole, due to associations between PPI use and increased risk of COVID-19 infection and poor outcomes. However, as the pandemic subsides, the market is expected to recover and grow favorably[3].

Future Projections

Market Growth

The omeprazole magnesium market is poised for significant growth, driven by increasing demand for gastrointestinal disease treatments, successful clinical trials, and strategic market expansion by key players. The market is expected to expand across various regions, with North America and the Asia Pacific being key contributors[5].

New Formulations and Products

The development of new formulations, such as the bioequivalent delayed-release omeprazole product, and products like vonoprazan, which is FDA-cleared for the treatment of GERD, will further drive market growth. These innovations are expected to enhance patient compliance and treatment outcomes[1][5].

Key Takeaways

• Bioequivalence: Recent clinical trials have successfully developed bioequivalent formulations of omeprazole magnesium, ensuring equivalent pharmacokinetic profiles to existing reference drugs.
• Market Growth: The omeprazole magnesium market is projected to grow significantly, reaching USD 2.56 billion by 2037, driven by increasing chronic diseases and successful clinical trials.
• Geographical Segmentation: North America and the Asia Pacific are expected to be major contributors to the market growth.
• Dosage Forms: Capsules are expected to dominate the market, while tablets remain a viable option.
• Challenges: Drug interactions and the impact of the COVID-19 pandemic are key considerations, but the market is expected to recover and grow favorably.

FAQs

What is the current market size of omeprazole magnesium?

The current market size of omeprazole magnesium was valued at USD 1.13 billion in 2024[5].

What is the projected growth rate of the omeprazole magnesium market?

The omeprazole magnesium market is expected to grow at a CAGR of over 6.5% from 2025 to 2037[5].

Which regions are expected to dominate the omeprazole magnesium market?

North America and the Asia Pacific are expected to be the major contributors to the market growth, with North America holding a 59% revenue share by 2037[5].

What are the primary indications for omeprazole magnesium?

The primary indications include duodenal ulcers, gastric ulcers, gastroesophageal reflux disease, and erosive esophagitis[5].

How do proton pump inhibitors like omeprazole interact with other drugs?

Proton pump inhibitors can interact with other drugs, potentially impairing magnesium absorption and increasing the risk of hypomagnesemia when combined with certain medications[4].

Sources

1. Development of a New Bioequivalent Omeprazole Product - Medicina, 2024.
2. Global Omeprazole Magnesium (Cas 95382-33-5) Market Size And Forecast - Market Research Intellect, December 2024.
3. Proton Pump Inhibitors Market - Mordor Intelligence.
4. Navigating Drug Interactions with Proton Pump Inhibitors - JAMA Network Open, 2024.
5. Omeprazole Market Size & Share | Growth Forecasts 2037 - Research Nester, December 2024.