CLINICAL TRIALS PROFILE FOR ZANTAC 75

505(b)(2) Clinical Trials for ZANTAC 75

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↗	Total Antioxidant Effects of Esomeprazole in Dyspeptic Patients Receiving Non-steroidal Anti-inflammatory Drugs	Withdrawn	AstraZeneca	Phase 4	2006-12-01	The principal investigator hypothesizes that participants receiving NSAID drugs with dyspeptic symptoms have increased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↗	Total Antioxidant Effects of Esomeprazole in Dyspeptic Patients Receiving Non-steroidal Anti-inflammatory Drugs	Withdrawn	Medstar Health Research Institute	Phase 4	2006-12-01	The principal investigator hypothesizes that participants receiving NSAID drugs with dyspeptic symptoms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

All Clinical Trials for ZANTAC 75

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.

Clinical Trial Conditions for ZANTAC 75

Condition Name

Condition Name for ZANTAC 75
Intervention	Trials
NSAID Associated Gastric Ulcers	2
Healthy	2
Heart Failure	1
Pharmacokinetics	1

Condition MeSH

Condition MeSH for ZANTAC 75
Intervention	Trials
Ulcer	3
Stomach Ulcer	2
Hypotension	2
Bronchial Hyperreactivity	1

Clinical Trial Locations for ZANTAC 75

Trials by Country

Trials by Country for ZANTAC 75
Location	Trials
United States	12
Pakistan	2
Canada	2
United Kingdom	1
Egypt	1

Trials by US State

Trials by US State for ZANTAC 75
Location	Trials
Maryland	3
Texas	2
Wisconsin	1
Utah	1
California	1

Clinical Trial Progress for ZANTAC 75

Clinical Trial Phase

Clinical Trial Phase for ZANTAC 75
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	3
Phase 2	6

Clinical Trial Status

Clinical Trial Status for ZANTAC 75
Clinical Trial Phase	Trials
Completed	13
Withdrawn	4
Terminated	2

Clinical Trial Sponsors for ZANTAC 75

Sponsor Name

Sponsor Name for ZANTAC 75
Sponsor	Trials
AstraZeneca	3
National Cancer Institute (NCI)	3
Benazir Bhutto Hospital, Rawalpindi	2

Sponsor Type

Sponsor Type for ZANTAC 75
Sponsor	Trials
Other	18
Industry	7
NIH	4

ZANTAC 75 Market Analysis and Financial Projection

Last updated: April 28, 2026

Zantac 75 (Ranitidine 75 mg): Clinical Trial Status, Market Update, and Forward Projections

What is Zantac 75 and what is its clinical trial reality?

Zantac 75 is the 75 mg ranitidine dosage form. Ranitidine has been withdrawn from many markets and is effectively discontinued globally as a commercial therapy. The clinical trial landscape for ranitidine is also constrained by that market exit and regulator actions.

Core facts that define the trial picture

• Ranitidine is an H2-receptor antagonist.
• Ranitidine marketing authorization status has been widely affected by regulatory actions tied to NDMA contamination concerns (carcinogenic impurity risk), which led to market withdrawals in multiple jurisdictions. FDA-requested withdrawals and NDMA findings sharply reduced ongoing development and enrollment for new pivotal studies. [1], [2]
• Because the drug’s commercial and regulatory pathway is disrupted, the remaining clinical activity is largely limited to secondary analyses, pharmacovigilance, legacy datasets, or alternative formulations not marketed under “Zantac 75.” [1], [2]

Implication for investors and R&D

• There is no active path that resembles a “normal” late-stage development sprint for ranitidine products at the 75 mg dose level in major regulators’ current frameworks. The dominant “clinical trial update” for ranitidine is regulatory closure rather than clinical innovation.

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What do regulators’ actions imply for clinical development timelines?

Regulatory anchor events

• FDA requested the withdrawal of all ranitidine products from the market in April 2020, citing NDMA impurity formation concerns. [1]
• Health authorities and other regulators issued corresponding actions and guidance, with NDMA impurity concerns also driving widespread market removals. [2]

Net effect on clinical trials

• Withdrawal decisions reduce sponsor willingness to run new interventional trials for the same active ingredient and dose form due to:
  • inability to source compliant market product for studies at scale,
  • limited regulator appetite for new ranitidine submissions,
  • reduced commercial reimbursement momentum.
• Clinical activity shifts away from “new efficacy” trials to safety monitoring and retrospective analyses. [1], [2]

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How big is the ranitidine market today versus Zantac 75 specifically?

Zantac is historically a major acid-suppression brand. But post-withdrawal, ranitidine’s addressable market has collapsed to near-zero for mainstream purchasing channels in jurisdictions where it was withdrawn, with only residual, non-standard supply or local stock in limited settings.

Market reality drivers

• Market withdrawal removes ranitidine from pharmacy channels, strongly constraining volume.
• Patient switching to alternatives (PPIs and other H2 blockers) reallocates demand away from ranitidine.
• Competitive substitution is rapid because H2 antagonism and acid control are class-well-covered by:
  • PPIs for long-term control,
  • other H2 antagonists where allowed.

Dose-level specificity

• “Zantac 75” is a brand/dose representation of ranitidine 75 mg. After ranitidine withdrawal, that dose-level line item does not sustain independent demand forecasting; it collapses with the active ingredient.

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What does the market projection look like post-withdrawal?

Given FDA’s 2020 withdrawal request and parallel international actions, the forecast for ranitidine products is dominated by:

• continued absence from mainstream markets,
• minimal legal commercial pipeline,
• limited remaining sales from residual channels in jurisdictions with delayed implementation or incomplete removal.

Projection model (directional, not price-led)

• 2026–2028: Near-zero active ingredient commercial penetration in major regulated markets; any remaining volume is residual and not modeled as a growth engine.
• 2029–2031: Continued low or declining residual supply impact. Any new development would require a renewed, regulator-ready pathway, which is not consistent with ranitidine’s current regulatory posture tied to NDMA concerns. [1], [2]

Practical conclusion for forward projections

• For “Zantac 75,” the appropriate projection is not a growth curve but a closure curve: volume trends toward baseline residuals and then to minimal presence as stocks exhaust and enforcement tightens.

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Where does substitution demand go (and what does that mean for revenues)?

When ranitidine exits, acid-suppression demand migrates to:

• PPIs (primary)
• alternative H2 antagonists (where permitted)

This substitution reshapes market share away from H2 antagonists generally and especially away from ranitidine brands.

Business consequence

• Any revenue forecast for Zantac 75 post-2020 is constrained by:
  • absence from standard distribution,
  • competitor capture,
  • and the lack of new ranitidine brand re-launch pathways tied to regulatory clearance. [1], [2]

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Competitive landscape: what replaces ranitidine in practice?

Primary therapeutic substitutes

• PPIs: omeprazole, esomeprazole, pantoprazole (typical class behavior)
• Other H2 antagonists: famotidine (typical in markets where available)

Brand economics

• Post-withdrawal, brand differentiation becomes irrelevant for Zantac 75; switching behavior follows class efficacy and safety, not brand.

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Are there any meaningful ongoing trials that sustain “Zantac 75” prospects?

No. The regulatory withdrawals and NDMA impurity concerns are the gating factor that prevents ranitidine from functioning as a continuing late-stage development asset in major markets.

What remains

• Legacy trial analysis and safety surveillance activity occurs as part of pharmacovigilance and retrospective study work, not as a pathway to re-approval for Zantac 75 as a marketed product. [1], [2]

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Actionable investor take: how to interpret “clinical trial updates” for Zantac 75

A “clinical trial update” for Zantac 75 should be treated as:

• a regulatory and safety status update, not a clinical efficacy pipeline update.

If you track it like an active development program, you will overestimate future optionality.

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Key Takeaways

• Zantac 75 (ranitidine 75 mg) is commercially shut down in major markets following NDMA impurity concerns and regulatory withdrawal actions.
• The “clinical trial update” is effectively dominated by regulatory closure since April 2020, shifting activity away from new efficacy trials. [1], [2]
• Market projection for Zantac 75 is a residual-stock decline, not a growth trajectory, because substitution to other acid-suppression therapies absorbs demand.
• Competitive substitution to PPIs and other H2 antagonists limits any remaining upside for ranitidine branding.

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FAQs

1) Is Zantac 75 currently marketed in the US?

FDA requested withdrawal of all ranitidine products from the market in April 2020, which removed Zantac ranitidine products from standard US distribution. [1]

2) Why did regulators act against ranitidine?

Regulators acted on NDMA impurity formation concerns linked to ranitidine quality and impurity risk. [1], [2]

3) Will new ranitidine (Zantac 75) trials restart development?

Regulatory withdrawal actions make re-initiation of mainstream late-stage ranitidine programs highly constrained, with ongoing work largely limited to safety monitoring and retrospective review rather than new approval-seeking efficacy trials. [1], [2]

4) Where did acid control demand go after ranitidine withdrawal?

Patients and prescribers shifted to alternative acid-suppression therapies, primarily PPIs and other H2 antagonists where available. This reduces ranitidine brand demand. [1], [2]

5) What is the correct forecasting posture for Zantac 75?

Forecast as residual presence that trends down toward minimal volume as stock depletes and enforcement tightens, not as a routine dose-line growth model. [1], [2]

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References

[1] U.S. Food and Drug Administration. (2020). FDA requests removal of all ranitidine products (Zantac) from the market. https://www.fda.gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market
[2] World Health Organization. (2020). WHO statements and updates on ranitidine and NDMA impurity-related actions. https://www.who.int/news-room (search: ranitidine NDMA)