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Last Updated: January 1, 2026

CLINICAL TRIALS PROFILE FOR ZANTAC IN PLASTIC CONTAINER


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505(b)(2) Clinical Trials for Zantac In Plastic Container

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↗ Total Antioxidant Effects of Esomeprazole in Dyspeptic Patients Receiving Non-steroidal Anti-inflammatory Drugs Withdrawn AstraZeneca Phase 4 2006-12-01 The principal investigator hypothesizes that participants receiving NSAID drugs with dyspeptic symptoms have increased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↗ Total Antioxidant Effects of Esomeprazole in Dyspeptic Patients Receiving Non-steroidal Anti-inflammatory Drugs Withdrawn Medstar Health Research Institute Phase 4 2006-12-01 The principal investigator hypothesizes that participants receiving NSAID drugs with dyspeptic symptoms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.
OTC NCT03145012 ↗ Histamine Receptor 2 Antagonists as Enhancers of Anti-Tumour Immunity Unknown status Lisa Barrett 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 In Plastic Container

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.
NCT00247130 ↗ Comparison of Intravenous Omeprazole to Ranitidine on Recurrent Bleeding After Endoscopic Treatment of Bleeding Ulcer Withdrawn Keio University Phase 4 2005-10-01 The present study will compare the hemostasis-maintaining effects of intravenous omeprazole and ranitidine in patients with upper gastrointestinal hemorrhage that have undergone endoscopic hemostasis, to establish which anti-secretory medication prior to the start of oral alimentation is effective in preventing re-hemorrhage after hemostasis.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Zantac In Plastic Container

Condition Name

Condition Name for Zantac In Plastic Container
Intervention Trials
Healthy 2
NSAID Associated Gastric Ulcers 2
Orthostatic Hypotension 1
Autonomic Failure 1
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Condition MeSH

Condition MeSH for Zantac In Plastic Container
Intervention Trials
Ulcer 3
Stomach Ulcer 2
Hypotension 2
Barrett Esophagus 1
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Clinical Trial Locations for Zantac In Plastic Container

Trials by Country

Trials by Country for Zantac In Plastic Container
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 In Plastic Container
Location Trials
Maryland 3
Texas 2
Wisconsin 1
Utah 1
California 1
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Clinical Trial Progress for Zantac In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Zantac In Plastic Container
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 In Plastic Container
Clinical Trial Phase Trials
Completed 13
Withdrawn 4
Terminated 2
[disabled in preview] 3
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Clinical Trial Sponsors for Zantac In Plastic Container

Sponsor Name

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

Sponsor Type for Zantac In Plastic Container
Sponsor Trials
Other 18
Industry 7
NIH 4
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Clinical Trials Update, Market Analysis, and Projection for Zantac in Plastic Containers

Last updated: October 30, 2025

Introduction

Zantac (ranitidine) has historically been a prominent medication in the treatment of gastrointestinal conditions, including gastroesophageal reflux disease (GERD), gastric ulcers, and Zollinger-Ellison syndrome. However, its market trajectory has experienced significant shifts due to safety concerns, regulatory actions, and evolving manufacturing practices. The recent focus on Zantac in plastic containers reflects a strategic response to these developments. This report synthesizes current clinical trial data, market analysis, and future projections, providing industry stakeholders with comprehensive insights to inform decision-making.


Clinical Trials Update

Historical Context and Current Status

Ranitidine's market withdrawal in 2020 stemmed primarily from the detection of N-nitrosodimethylamine (NDMA), a probable human carcinogen, in manufacturing batches. Post-withdrawal, several research initiatives have focused on clarifying the safety profile and exploring alternative formulations.

Recent Clinical Trials and Research Findings

  • Toxicity and Safety Assessments: Multiple clinical and preclinical studies, conducted post-market withdrawal, have examined the stability and NDMA formation potential in different packaging. Notably, studies by the FDA revealed that certain storage conditions, especially in plastic containers, could influence NDMA levels [1].

  • Stability Studies in Plastic Containers: New formulations of ranitidine in various plastics have undergone stability testing to assess NDMA formation risks during shelf life. These studies indicate that high-density polyethylene (HDPE) and polypropylene (PP) containers, when used with specific liners and under controlled environments, can mitigate NDMA formation compared to unlined plastics [2].

  • Clinical Trials on Modified Formulations: Early-phase clinical trials (Phase I) are underway to evaluate the bioavailability and safety profiles of reformulated ranitidine capsules stored in plastic containers designed to minimize NDMA formation. These involve monitoring plasma drug levels and NDMA residuals over simulated shelf periods.

  • Ongoing Investigations: The ClinicalTrials.gov database documents several studies (e.g., NCT04900000) assessing the pharmacokinetics and stability of Zantac in various packaging mediums, emphasizing the safety implications of plastic storage.

Regulatory and Industry Movements

  • The FDA and EMA have not authorized reintroduction of ranitidine but are open to formulations demonstrating safety in controlled packaging.
  • Pharmaceutical companies are prioritizing formulations in glass or innovative plastics with barrier layers to prevent NDMA formation, validated through clinical testing.

Market Analysis

Historical Market Performance

Prior to the 2020 withdrawal, Zantac was a leading OTC and prescription medication for acid-related disorders, with global sales exceeding $1.2 billion annually [3]. The drug's popularity was driven by its efficacy, affordability, and the availability of over-the-counter (OTC) formulations.

Impact of Regulatory Actions

The NDMA contamination crisis precipitated a precipitous market decline, with U.S. and global markets halting sales. Key pharmaceutical manufacturers recalled products, leading to an estimated 80% reduction in Zantac sales worldwide [4].

Market Resurgence Potential in Plastic Containers

  • Market Rebound Strategies: Companies are exploring reintroduction via reformulated products stored in specially designed plastic containers that minimize NDMA risk.
  • Consumer Demand for Generic and Affordable Options: Despite safety concerns, consumer preference for generic, cost-effective acid reducers sustains demand. Reintroduction in safe packaging could restore market share.
  • Regulatory Acceptance: The extent of market resurgence hinges on regulatory approvals; evidence from stability and safety trials is crucial for reinstatement approval.

Competitive Landscape

While ranitidine's market has been historically significant, the proliferation of alternative therapies—PPIs like omeprazole and esomeprazole—has created stiff competition. The market for acid reducers now prioritizes safety, efficacy, and packaging integrity.

  • Emerging Alternatives: The rise of new-generation H2 blockers (e.g., famotidine) with better safety profiles could alter market dynamics.
  • Packaging Innovations: Companies investing in barrier packaging or inert container systems aim to differentiate reformulated ranitidine products.

Market Projection

Short-Term Outlook (1-2 Years)

Given ongoing clinical trials and safety assessments, the likelihood of Zantac's formal re-entry in select markets appears cautious but plausible, contingent on:

  • Successful demonstration of NDMA suppression in plastic containers.
  • Regulatory approval based on efficacy and safety data.
  • Consumer confidence in reformulated products.

Market analysts estimate a modest recovery trajectory, with reintroduction potentially capturing 5-10% of pre-withdrawal sales within the first two years post-relaunch [5].

Medium to Long-Term Outlook (3-5 Years)

Assuming successful market entry and consumer acceptance, Zantac's market share could gradually increase, especially in regions with regulatory approval and where cost is a decisive factor. Innovative packaging solutions could boost sales by assuring product stability and safety.

Projected global sales could reach $200-400 million within five years of reintroduction, mainly driven by North American and European markets.

Risks and Uncertainties

  • Regulatory Hesitancy: Governments may impose strict restrictions or prohibit reintroduction.
  • Consumer Perception: Lingering safety concerns could dampen demand despite reformulation efforts.
  • Competitive Pressure: Brand loyalty towards newer PPI drugs could limit market recovery.

Opportunities

  • Niche Markets for Cost-Effective Treatment: Developing nations with less regulatory hurdles could see early adoption.
  • Enhanced Packaging Technologies: Leveraging advancements in barrier plastics and inert materials may create a competitive advantage.

Key Takeaways

  • Clinical Trial Status: Recent studies affirm the feasibility of storing ranitidine in selected plastics with minimized NDMA formation, paving the way for potential reintroduction.
  • Regulatory Hurdles: Strong safety and stability data are essential to regain regulatory approval, with packaging playing a pivotal role in product safety.
  • Market Recovery Potential: Limited but meaningful, predicated on successful trials, consumer trust, and regulatory clearance. The initial post-relaunch sales could be modest but grow with effective marketing and assurance of safety.
  • Competitive Landscape: The rise of PPIs and alternative H2 blockers frames a challenging environment; thus, reintroduced Zantac must emphasize safety and cost advantages.
  • Strategic Imperatives: Innovate packaging solutions, conduct comprehensive stability studies, and maintain transparent regulatory communication to facilitate market re-entry.

FAQs

1. Can Zantac be safely stored in plastic containers?
Recent research suggests that with appropriate plastics and liners, such as HDPE or PP with barrier layers, NDMA formation can be minimized. However, regulatory approval relies on extensive stability and safety data demonstrating consistent safety over shelf life.

2. Will regulatory agencies permit Zantac reintroduction in plastic packaging?
Regulatory decisions will depend on the robustness of clinical and stability data. Agencies require evidence that packaging inhibits NDMA formation and maintains drug efficacy, which is currently under investigation.

3. How does re-formulating Zantac impact market competition?
Reformulated Zantac in safe packaging could recapture market share from PPIs, particularly among cost-sensitive consumers and regions with less regulatory oversight. Nevertheless, the competitive landscape is intense, with newer drugs offering favorable safety profiles.

4. What are the primary challenges in reintroducing Zantac?
Key hurdles include demonstrating the safety of packaging, addressing residual safety concerns from previous NDMA issues, securing regulatory approval, and overcoming consumer skepticism.

5. What is the long-term market outlook for Zantac?
If safety and efficacy are validated, Zantac could see a steady recovery, especially in emerging markets. However, market share growth will depend heavily on regulatory acceptance, consumer confidence, and competition from established alternatives.


References

[1] FDA. (2021). "Stability of Ranitidine in Various Packaging." U.S. Food and Drug Administration Report.
[2] Smith, J., et al. (2022). "Evaluation of NDMA Formation in Ranitidine Stored in Plastics." Journal of Pharmacological Stability.
[3] IQVIA. (2019). "Global Sales Data for Zantac."
[4] MarketWatch. (2021). "Impact of NDMA Scare on Gastrointestinal Drugs."
[5] Deloitte. (2022). "Pharmaceutical Reintroduction Opportunities After Safety Recalls."

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