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Last Updated: June 20, 2025

CLINICAL TRIALS PROFILE FOR ZANTAC 25


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505(b)(2) Clinical Trials for Zantac 25

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 NCT00443963 ↗ Total Antioxidant Effects of Esomeprazole in Dyspeptic Patients Receiving Non-steroidal Anti-inflammatory Drugs Withdrawn AstraZeneca Phase 4 2006-12-01 The principal investigator hypothesizes that participants receiving NSAID drugs with dyspeptic symptoms have increased production of gastric levels of free radicals. The primary objective of the study is to determine if Esomeprazole Magnesium increases gastric total antioxidant capacity and decreases gastric free radical production in humans. Participants (age 18 years and older) with no history of upper GI bleeding who are receiving non-steroidal anti-inflammatory drugs and then develop dyspepsia will be recruited from our primary care clinic in Washington, DC. All eligible participants will undergo biopsies of antrum and corpus. The participants will be randomized to receive either Zantac OTC or Nexium for 15 days. On day 15, all participants will undergo repeat upper endoscopy to obtain biopsies of antrum and corpus. Tissue samples will then be extracted to determine total antioxidant capacity and lipid peroxide levels (as an indirect marker of free radical production).
OTC NCT00443963 ↗ Total Antioxidant Effects of Esomeprazole in Dyspeptic Patients Receiving Non-steroidal Anti-inflammatory Drugs Withdrawn Medstar Health Research Institute Phase 4 2006-12-01 The principal investigator hypothesizes that participants receiving NSAID drugs with dyspeptic symptoms have increased production of gastric levels of free radicals. The primary objective of the study is to determine if Esomeprazole Magnesium increases gastric total antioxidant capacity and decreases gastric free radical production in humans. Participants (age 18 years and older) with no history of upper GI bleeding who are receiving non-steroidal anti-inflammatory drugs and then develop dyspepsia will be recruited from our primary care clinic in Washington, DC. All eligible participants will undergo biopsies of antrum and corpus. The participants will be randomized to receive either Zantac OTC or Nexium for 15 days. On day 15, all participants will undergo repeat upper endoscopy to obtain biopsies of antrum and corpus. Tissue samples will then be extracted to determine total antioxidant capacity and lipid peroxide levels (as an indirect marker of free radical production).
OTC NCT03145012 ↗ Histamine Receptor 2 Antagonists as Enhancers of Anti-Tumour Immunity Unknown status Dalhousie University Phase 4 2018-05-01 The immune response against tumors can be highly effective in preventing tumor development, growth and metastasis under certain circumstances. However, tumor associated immune suppression can profoundly limit the impact of natural tumor immunity and also reduce the effectiveness of tumor immunotherapy strategies. A major component of tumor associated immune suppression is mediated by myeloid cells, especially the monocytic subset of myeloid derived suppressor cells (MDSC). In recent studies that were conducted through a CCSRI Innovation grant, the investigators discovered that oral treatment of mice with the commonly used histamine receptor 2 (H2) antagonists ranitidine or famotidine inhibits both primary breast tumor development and metastasis, in three distinct mouse tumor models and reduces the numbers of monocytic MDSC. These findings have enormous potential to aid in effective cancer immunotherapy and may have immediate implications for cancer patients. The objective of this investigation is to determine whether treatment with the H2 receptor antagonist ranitidine alters immune suppression, through modulation of immune cell populations. The investigators will examine peripheral blood monocyte, neutrophil and NK cell numbers, subsets and activation status from healthy volunteers treated for 6 weeks with daily oral ranitidine. Ranitidine is widely available and used over the counter in Canada. These drugs are widely recognized as safe, well tolerated and have very few side effects. It has been suggested that among the general population, over 10% of those over the age of 65 take such medications on a regular basis for relief against gastrointestinal discomfort. The outcome of pre-clinical studies in mice warrant further investigation into transferability to humans. If the outcome of the current proposal proves to be viable, then these drugs could provide a safe method to reduce tumor associated immunosuppression with broad implications, both for current cancer patients and for those at high risk of developing cancer. Further to this, the outcome of our proposal may provide a new strategy for improving the effectiveness of T-cell mediated immunotherapy.
OTC NCT03145012 ↗ Histamine Receptor 2 Antagonists as Enhancers of Anti-Tumour Immunity Unknown status Nova Scotia Health Authority Phase 4 2018-05-01 The immune response against tumors can be highly effective in preventing tumor development, growth and metastasis under certain circumstances. However, tumor associated immune suppression can profoundly limit the impact of natural tumor immunity and also reduce the effectiveness of tumor immunotherapy strategies. A major component of tumor associated immune suppression is mediated by myeloid cells, especially the monocytic subset of myeloid derived suppressor cells (MDSC). In recent studies that were conducted through a CCSRI Innovation grant, the investigators discovered that oral treatment of mice with the commonly used histamine receptor 2 (H2) antagonists ranitidine or famotidine inhibits both primary breast tumor development and metastasis, in three distinct mouse tumor models and reduces the numbers of monocytic MDSC. These findings have enormous potential to aid in effective cancer immunotherapy and may have immediate implications for cancer patients. The objective of this investigation is to determine whether treatment with the H2 receptor antagonist ranitidine alters immune suppression, through modulation of immune cell populations. The investigators will examine peripheral blood monocyte, neutrophil and NK cell numbers, subsets and activation status from healthy volunteers treated for 6 weeks with daily oral ranitidine. Ranitidine is widely available and used over the counter in Canada. These drugs are widely recognized as safe, well tolerated and have very few side effects. It has been suggested that among the general population, over 10% of those over the age of 65 take such medications on a regular basis for relief against gastrointestinal discomfort. The outcome of pre-clinical studies in mice warrant further investigation into transferability to humans. If the outcome of the current proposal proves to be viable, then these drugs could provide a safe method to reduce tumor associated immunosuppression with broad implications, both for current cancer patients and for those at high risk of developing cancer. Further to this, the outcome of our proposal may provide a new strategy for improving the effectiveness of T-cell mediated immunotherapy.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Zantac 25

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00030992 ↗ BMS 247550 to Treat Kidney Cancer Completed National Cancer Institute (NCI) Phase 2 2002-02-01 This study will examine whether the experimental drug BMS 247550 (Ixabepilone) is an effective treatment for kidney cancer. BMS 247550 belongs to a class of drugs called epothilones that interfere with the ability of cancer cells to divide. In the way they kill cells, they are very similar to a class of compounds known as the taxanes, which include the drug Taxol. Other characteristics of the epothilones, however, enable them to work in cells that are resistant to Taxol. Patients 18 years of age or older with kidney cancer that has not spread to the central nervous system (unless the brain tumor has remained stable for at least six months after surgical or radiation treatment) may be eligible for this study. Pregnant or nursing women may not participate. Candidates are screened with various tests that may include blood and urine tests, electrocardiogram (EKG), and chest x-ray. Computerized tomography (CT) scans or X-rays, and possibly nuclear medicine studies may be done to determine the extent of disease. Participants receive BMS 247550 by a 1-hour infusion into a vein for 5 consecutive days (days 1, 2, 3, 4 and 5) of each 21-day treatment cycle. Patients must stay in the National Institutes of Health (NIH) area near Bethesda, Maryland, for 7 to 8 days during the first treatment cycle and for the 5 days of treatment in subsequent cycles. The total number of cycles will vary among patients, depending on their individual clinical situation. The drug dose may be increased gradually in subsequent cycles in patients who can tolerate such increases. In addition, participants undergo the following tests and procedures: - Periodic physical examinations and frequent blood tests - X-ray and other imaging studies to determine if the tumor is responding to the treatment. - Tumor biopsies to confirm the diagnosis or spread of tumor and to examine the reaction of certain proteins in cancer cells to BMS 247550. Two biopsies will be done. For this procedure, a small piece of tumor tissue is withdrawn through a needle under local anesthetic. Treatment will be stopped in patients whose tumor grows while receiving BMS 247550. Patients whose tumor disappears completely will be followed at NIH periodically for examinations and tests. Patients whose disease does not completely resolve or whose disease recurs may be advised of other appropriate research protocols at NIH or, if none are available, will be returned to the care of their local doctor.
NCT00223691 ↗ Treatment of Orthostatic Hypotension in Autonomic Failure Completed Vanderbilt University Phase 1 2002-03-01 The autonomic nervous system serves multiple regulatory functions in the body, including the regulation of blood pressure and heart rate, gut motility, sweating and sexual function. There are several diseases characterized by abnormal function of the autonomic nervous system. Medications can also alter autonomic function. Impairment of the autonomic nervous system by diseases or drugs may lead to several symptoms, including blood pressure problems (e.g., high blood pressure lying down and low blood pressure on standing), sweating abnormalities, constipation or diarrhea and sexual dysfunction. Because treatment options for these patients are limited. We propose to study patients autonomic failure and low blood pressure upon standing and determine the cause of their disease by history and examination and their response to autonomic testing which have already been standardized in our laboratory. Based on their possible cause, we will tests different medications that may alleviate their symptoms.
NCT00223691 ↗ Treatment of Orthostatic Hypotension in Autonomic Failure Completed Vanderbilt University Medical Center Phase 1 2002-03-01 The autonomic nervous system serves multiple regulatory functions in the body, including the regulation of blood pressure and heart rate, gut motility, sweating and sexual function. There are several diseases characterized by abnormal function of the autonomic nervous system. Medications can also alter autonomic function. Impairment of the autonomic nervous system by diseases or drugs may lead to several symptoms, including blood pressure problems (e.g., high blood pressure lying down and low blood pressure on standing), sweating abnormalities, constipation or diarrhea and sexual dysfunction. Because treatment options for these patients are limited. We propose to study patients autonomic failure and low blood pressure upon standing and determine the cause of their disease by history and examination and their response to autonomic testing which have already been standardized in our laboratory. Based on their possible cause, we will tests different medications that may alleviate their symptoms.
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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Zantac 25

Condition Name

Condition Name for Zantac 25
Intervention Trials
Healthy 2
NSAID Associated Gastric Ulcers 2
Barrett Esophagus 1
Peptic Ulcers 1
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Condition MeSH

Condition MeSH for Zantac 25
Intervention Trials
Ulcer 3
Hypotension 2
Stomach Ulcer 2
Communicable Diseases 1
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Clinical Trial Locations for Zantac 25

Trials by Country

Trials by Country for Zantac 25
Location Trials
United States 12
Pakistan 2
Canada 2
Japan 1
United Kingdom 1
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Trials by US State

Trials by US State for Zantac 25
Location Trials
Maryland 3
Texas 2
Wisconsin 1
Utah 1
California 1
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Clinical Trial Progress for Zantac 25

Clinical Trial Phase

Clinical Trial Phase for Zantac 25
Clinical Trial Phase Trials
Phase 4 5
Phase 3 3
Phase 2 6
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Clinical Trial Status

Clinical Trial Status for Zantac 25
Clinical Trial Phase Trials
Completed 13
Withdrawn 4
Terminated 2
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Clinical Trial Sponsors for Zantac 25

Sponsor Name

Sponsor Name for Zantac 25
Sponsor Trials
National Cancer Institute (NCI) 3
AstraZeneca 3
M.D. Anderson Cancer Center 2
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Sponsor Type

Sponsor Type for Zantac 25
Sponsor Trials
Other 18
Industry 7
NIH 4
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Zantac: Updates, Market Analysis, and Projections

Introduction

Zantac, a well-known antacid medication developed by GlaxoSmithKline (GSK) and later marketed by various companies including Sanofi and Boehringer Ingelheim, has been at the center of significant legal and medical scrutiny. Here, we will delve into the latest updates on clinical trials, market analysis, and projections for Zantac.

Clinical Trials and Litigation Updates

Ongoing Trials and Settlements

As of late 2024, several Zantac trials have been underway, with mixed outcomes. The first California Zantac trial, Russell v. Boehringer Ingelheim, ended with a hung jury in November 2024. The jury agreed that Zantac was dangerous and that Boehringer Ingelheim failed to warn consumers about its risks, but they were split on whether Zantac directly caused the plaintiff's cancer[1].

Other trials, such as Joiner v. GlaxoSmithKline and Gross v. Boehringer Ingelheim, have also been in progress. These cases involve allegations that Zantac caused various types of cancer, including colorectal and prostate cancer[4].

Settlements

Sanofi has recently settled Zantac lawsuits to the tune of $100 million, which translates to approximately $25,000 per claimant for around 4,000 claimants. This settlement aims to resolve most of the claims in U.S. states, excluding those consolidated in Delaware[3].

Legal Challenges

Despite these settlements, the companies involved continue to face significant litigation. In Delaware, approximately 75,000 Zantac cases have been consolidated, with about 20,000 against Sanofi. The legal landscape is further complicated by the federal court's ruling in 2022 that rejected the science backing the claims that Zantac can cause cancer, freeing the drugmakers from about 50,000 federal cases[3].

Market Analysis

Current Market Status

The global ranitidine (Zantac) market has seen significant disruptions due to the ongoing litigation and regulatory actions. In 2019, the FDA instructed all companies to take Zantac off the market after confirming that ranitidine, the main ingredient, can transform into a possible carcinogen over time or when exposed to high temperatures[3].

Market Dynamics

Despite the challenges, the market for ranitidine and its alternatives is still being analyzed for future projections. A comprehensive market research report forecasts the global ranitidine market from 2025 to 2030, covering manufacturers, regions, types, and applications. This report highlights the ongoing market dynamics, including the impact of regulatory changes and litigation on the pharmaceutical industry[2].

Impact on Pharmaceutical Companies

The litigation and settlements have had varying impacts on the companies involved. Sanofi's share price increased by 1.7% following the announcement of the settlement figure, while GSK's share price rose by 2.3%. These reactions reflect investor optimism that the companies may not have to pay much larger sums to resolve the cases[3].

Projections and Future Outlook

Regulatory Changes

Zantac has returned to the market with a new formulation that does not include ranitidine, addressing the FDA's concerns about the potential carcinogenic effects of the original ingredient. This change is expected to stabilize the market and restore consumer confidence in the product[3].

Market Growth

The global ranitidine market report suggests that despite current challenges, the market is expected to grow over the next few years. The report provides detailed forecasts and analyses of market trends, which will be crucial for manufacturers and investors looking to navigate this complex landscape[2].

Competitive Landscape

GSK, Sanofi, and Boehringer Ingelheim continue to face significant competition and legal hurdles. However, their strong defenses and the recent settlements suggest that they are taking steps to mitigate the financial and reputational impacts of the litigation. The competitive landscape is likely to evolve as new formulations and alternative treatments emerge[3].

Key Takeaways

  • Litigation and Trials: Ongoing trials and settlements highlight the legal challenges faced by Zantac manufacturers, with mixed outcomes and ongoing appeals.
  • Market Dynamics: The global ranitidine market is impacted by regulatory changes and litigation, but is expected to grow with new formulations and market strategies.
  • Regulatory Changes: Zantac has been reformulated to address FDA concerns, and this change is expected to stabilize the market.
  • Financial Impact: Settlements and legal costs are significant, but companies are taking steps to manage these impacts.

FAQs

What is the current status of Zantac trials?

As of late 2024, several Zantac trials are ongoing, with one trial in California ending in a hung jury and other trials involving various types of cancer allegations.

How much did Sanofi settle Zantac lawsuits for?

Sanofi settled Zantac lawsuits for $100 million, which translates to approximately $25,000 per claimant for around 4,000 claimants.

Why was Zantac taken off the market?

Zantac was taken off the market in 2019 after the FDA confirmed that ranitidine, its main ingredient, can transform into a possible carcinogen over time or when exposed to high temperatures.

What is the future outlook for the ranitidine market?

The global ranitidine market is expected to grow over the next few years despite current challenges, driven by new formulations and market strategies.

Which companies are most affected by Zantac litigation?

GSK, Sanofi, and Boehringer Ingelheim are the most affected companies, with GSK facing the most claims due to its role in developing and initially marketing Zantac.

Sources

  1. Wisner Baum: Zantac Trial Schedule | Wisner Baum
  2. Market Research Reports: Global Ranitidine (Zantac) Market 2024 by Manufacturers, Regions, Type and Application, Forecast to 2030
  3. FiercePharma: Sanofi's Zantac settlement is worth $100M, or $25K per claimant
  4. Lawsuit Information Center: Zantac Cancer Lawsuit | January 2025 Settlement Update
Last updated: 2025-01-02

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