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Last Updated: May 22, 2025

CLINICAL TRIALS PROFILE FOR ZANTAC


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505(b)(2) Clinical Trials for Zantac

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↗ Total Antioxidant Effects of Esomeprazole in Dyspeptic Patients Receiving Non-steroidal Anti-inflammatory Drugs Withdrawn AstraZeneca Phase 4 2006-12-01 The principal investigator hypothesizes that participants receiving NSAID drugs with dyspeptic symptoms have increased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↗ Total Antioxidant Effects of Esomeprazole in Dyspeptic Patients Receiving Non-steroidal Anti-inflammatory Drugs Withdrawn Medstar Health Research Institute Phase 4 2006-12-01 The principal investigator hypothesizes that participants receiving NSAID drugs with dyspeptic symptoms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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Zantac

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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Zantac

Condition Name

Condition Name for Zantac
Intervention Trials
Healthy 2
NSAID Associated Gastric Ulcers 2
Spinal-induced Hypotension 1
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Condition MeSH

Condition MeSH for Zantac
Intervention Trials
Ulcer 3
Stomach Ulcer 2
Hypotension 2
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Clinical Trial Locations for Zantac

Trials by Country

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

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

Clinical Trial Phase

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Withdrawn 4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

Sponsor Name

Sponsor Name for Zantac
Sponsor Trials
AstraZeneca 3
National Cancer Institute (NCI) 3
Benazir Bhutto Hospital, Rawalpindi 2
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Sponsor Type

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

Introduction to Zantac and Its Controversies

Zantac, a popular heartburn medication containing the active ingredient ranitidine, has been at the center of significant controversy due to its association with various types of cancer. Here, we will delve into the current status of clinical trials, market analysis, and future projections for Zantac.

Clinical Trials and Lawsuits Update

Ongoing Trials and Recent Developments

As of December 2024, several Zantac trials are underway or have recently concluded. In California, the first Zantac trial began in September 2024, involving a colorectal cancer lawsuit against GlaxoSmithKline and Boehringer Ingelheim. Another trial, Russell v. Boehringer Ingelheim, concluded with a hung jury in November 2024, with the plaintiff alleging that Zantac caused his bladder cancer[3].

In Illinois, the third Zantac trial is ongoing, with the plaintiff claiming that long-term use of Zantac OTC led to prostate cancer. This trial is crucial as it could influence the outcome of thousands of pending cases in Illinois and over 70,000 cases in Delaware[5].

Bellwether Trials and Settlements

Bellwether trials, which are test cases designed to predict the outcome of similar lawsuits, have been significant in the Zantac litigation. In Philadelphia, four bellwether trials were initially scheduled but have been postponed due to an appellate review of a recusal motion against the presiding judge[1].

GlaxoSmithKline has settled several Zantac lawsuits before they went to trial, including cases in California state court. However, other defendants like Boehringer Ingelheim have not settled, leading to ongoing trials[1][3].

Market Analysis of Zantac

Global Market Size and Growth

The global Ranitidine (Zantac) market was valued at approximately $1.3 billion in 2022, with a compound annual growth rate (CAGR) of around 4.5% from 2018 to 2022. Despite this growth, the market has faced volatility due to regulatory issues and the increasing availability of alternative treatments[2].

Regional Market Trends

North America, particularly the United States, remains a pivotal region for the Zantac market. The market in this region is expected to grow significantly, driven by the adoption of advanced technology and the presence of major industry players. Europe is also anticipated to experience significant growth during the forecast period from 2024 to 2031[2][4].

Impact of AI and Automation

AI and automation are transforming the Zantac market by enhancing data analysis, forecasting, and operational efficiencies. Advanced algorithms and machine learning are used to analyze market data, enabling more accurate predictions of market trends and consumer behavior. Automation is streamlining production and distribution processes, potentially reducing costs and improving supply chain management[2].

Market Outlook and Projections

Drivers and Restraints

The Zantac market is driven by the high demand for gastrointestinal treatments and the ongoing need for heartburn medications. However, the market is restrained by regulatory issues, particularly the discovery of NDMA (a carcinogenic chemical) in ranitidine, which has led to numerous lawsuits and recalls[2][4].

Future Growth Prospects

Despite the current challenges, the global Ranitidine (Zantac) market is expected to continue growing, albeit at a slower pace. The market is projected to grow from 2025 to 2031, with North America and Europe being key regions. New investments and technological advancements are expected to support this growth[2][4].

Competitive Landscape

The Zantac market is highly competitive, with major players including GlaxoSmithKline, Boehringer Ingelheim, and Sanofi-Aventis U.S. LLC. These companies are facing significant legal challenges but continue to innovate and adapt to market demands. The competitive landscape is also influenced by the emergence of generic versions of ranitidine and alternative treatments[2][4].

Legal and Regulatory Environment

The legal environment for Zantac has been tumultuous, with thousands of lawsuits filed alleging that the drug caused various types of cancer. A significant ruling in June 2024 by a Delaware state court judge allowed Zantac lawsuits to proceed to jury trials, giving new hope to plaintiffs[5].

Consumer Behavior and Market Trends

Consumer behavior has been significantly impacted by the safety concerns surrounding Zantac. Many consumers are opting for alternative heartburn medications, which has affected the market share of Zantac. However, the ongoing demand for gastrointestinal treatments ensures that the market remains viable, albeit with a shift towards safer alternatives[2][4].

Technological Trends and Innovations

Technological advancements, such as AI and automation, are crucial in the Zantac market. These technologies help in data analysis, forecasting, and operational efficiencies, which are essential for market stability and growth. The integration of advanced algorithms and machine learning is expected to continue shaping the market strategies and adapting to evolving industry demands[2].

Key Takeaways

  • Clinical Trials: Ongoing trials are critical in determining the liability of Zantac manufacturers and the compensation for plaintiffs.
  • Market Size: The global Zantac market was valued at $1.3 billion in 2022, with a projected growth from 2025 to 2031.
  • Regional Trends: North America and Europe are key regions driving market growth.
  • Legal Challenges: Thousands of lawsuits are pending, with significant rulings allowing cases to proceed to jury trials.
  • Technological Impact: AI and automation are enhancing market operations and forecasting.

Frequently Asked Questions (FAQs)

1. What is the current status of Zantac trials?

As of December 2024, several Zantac trials are underway, including cases in California and Illinois, with some trials resulting in settlements or hung juries.

2. How has the discovery of NDMA affected the Zantac market?

The discovery of NDMA in ranitidine has led to numerous lawsuits, recalls, and a significant decline in consumer trust, impacting the market's growth and stability.

3. Which regions are leading the Zantac market?

North America, particularly the United States, and Europe are the leading regions in the Zantac market, driven by advanced technology and the presence of major industry players.

4. How are AI and automation impacting the Zantac market?

AI and automation are enhancing data analysis, forecasting, and operational efficiencies, helping to optimize market strategies and adapt to evolving industry demands.

5. What are the future growth prospects for the Zantac market?

Despite current challenges, the market is expected to grow from 2025 to 2031, driven by new investments and technological advancements, although at a slower pace due to regulatory and legal issues.

Cited Sources

  1. Lawsuit Information Center: Zantac Cancer Lawsuit | January 2025 Settlement Update
  2. GitHub: Market-Report/20/Ranitidine-Zantac-Market.md
  3. Wisner Baum: Zantac Lawsuit Update December 2024
  4. Cognitive Market Research: Global Ranitidine Zantac Market Report 2024 Edition
  5. Lawsuit Legal News: Zantac Lawsuit: Settlement Updates (November 2024)
Last updated: 2024-12-31

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