CLINICAL TRIALS PROFILE FOR ZANTAC

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↗	Total Antioxidant Effects of Esomeprazole in Dyspeptic Patients Receiving Non-steroidal Anti-inflammatory Drugs	Withdrawn	AstraZeneca	Phase 4	2006-12-01	The principal investigator hypothesizes that participants receiving NSAID drugs with dyspeptic symptoms have increased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↗	Total Antioxidant Effects of Esomeprazole in Dyspeptic Patients Receiving Non-steroidal Anti-inflammatory Drugs	Withdrawn	Medstar Health Research Institute	Phase 4	2006-12-01	The principal investigator hypothesizes that participants receiving NSAID drugs with dyspeptic symptoms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

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.

Clinical Trial Conditions for ZANTAC

Condition Name

Condition Name for ZANTAC
Intervention	Trials
Healthy	2
NSAID Associated Gastric Ulcers	2
Orthostatic Hypotension	1

Condition MeSH

Condition MeSH for ZANTAC
Intervention	Trials
Ulcer	3
Stomach Ulcer	2
Hypotension	2

Clinical Trial Locations for ZANTAC

Trials by Country

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

Trials by US State

Trials by US State for ZANTAC
Location	Trials
Maryland	3
Texas	2
New York	1
Tennessee	1
Wisconsin	1

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

Clinical Trial Status

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Withdrawn	4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

Clinical Trial Sponsors for ZANTAC

Sponsor Name

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

Sponsor Type

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

Last updated: April 28, 2026

What is the current clinical and market outlook for Zantac (ranitidine) and what projections are available?

Zantac (ranitidine) is not a commercially active, ongoing-launch oncology-style asset with an expanding late-stage pipeline. It is a withdrawn gastrointestinal (GI) product whose market access collapsed after regulatory action tied to NDMA (N-nitrosodimethylamine) contamination concerns. As a result, there are no credible, forward-looking clinical-trial “updates” that materially change its marketed status, and any market “projection” function is effectively a historical reversion-to-zero exercise rather than a growth forecast.

The actionable decision frame for investors and R&D planners is therefore: (1) regulatory status and discontinuation; (2) what remains in development (if any) that is still “Zantac-branded”; (3) competitive substitution by other H2 blockers and PPIs; (4) residual markets such as generics in jurisdictions with differential enforcement; and (5) expected valuation path tied to legacy supply, not new clinical expansion.

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Is Zantac still approved and sold in major markets?

No in practice. Zantac’s commercial status collapsed in major jurisdictions following NDMA concerns.

• U.S. (FDA): The FDA requested removal of all ranitidine products from the U.S. market and issued communications that ranitidine could have unacceptable NDMA levels under certain conditions. The FDA’s action effectively ended routine sales of ranitidine products in the U.S. (see FDA safety communications).
  Source: FDA announcements on ranitidine NDMA risk and market removal. [1–3]
• Europe (EMA and national agencies): EMA and national regulators also moved to suspend marketing authorization for ranitidine-containing products in the EU in response to NDMA concerns.
  Source: EMA and national regulator actions referencing NDMA risk. [4]
• Global pattern: The NDMA-linked withdrawal drove multi-country discontinuation or suspension, with remaining supply shifting to other acid-suppression classes (PPIs) and non-ranitidine H2 blockers where available.
  Source: FDA and EMA documentation on NDMA risk and product removal/suspension. [1–4]

Implication for “clinical trials update”: There is no ongoing, regulator-driven late-stage program intended to restore ranitidine’s marketed status. New pivotal trials would not be expected to overcome a post-marketing contamination finding that already triggered removal/suspension in major markets.

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What do current clinical-trial records show for “Zantac” (ranitidine) right now?

A “Zantac” clinical update is only meaningful if there are active or recently completed interventional studies intended to re-establish efficacy and safety under contemporary standards. Under the NDMA-driven withdrawal context, the clinical record does not function like a continuing development program.

Observed clinical-trial reality under withdrawal:

• The major driver is regulatory discontinuation, not recruitment of new pivotal evidence.
• Any remaining ranitidine studies are typically academic, pharmacology, or formulation-scoped rather than late-stage registration-enabling trials.

Implication: For market-facing projections, ranitidine is treated as a discontinued asset class. Clinical development timelines do not “turn back on” because the bottleneck is not efficacy proof. It is product safety and NDMA risk management in the manufacturing chain.

Primary records used for these conclusions: FDA and EMA safety actions based on NDMA contamination and market removal/suspension. Trial registries are not the controlling factor in the decision; the regulators’ product-status actions are.

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What happened to the ranitidine market after NDMA actions?

Zantac’s market collapse followed a regulatory sequence centered on NDMA risk.

Regulatory timeline that drove market withdrawal

Date	Jurisdiction	Action	Business impact
2019-09	U.S.	FDA requested withdrawal/removal of ranitidine from the market (NDMA risk communications)	Sales effectively stopped; inventory clearance and replacement by alternative therapies
2020 and after	U.S.	Continued FDA updates on NDMA risk, including removal and discouraging use	Residual supply shrank; prescriber switch accelerated
2019–2020	EU / Member states	Suspension/withdrawal actions for ranitidine products across Europe	EU access sharply reduced; generics also affected where authorizations were suspended
2020+	Global	Multi-country discontinuation pattern	Reallocation to PPIs and other H2 antagonists

Sources: FDA NDMA safety communications and actions; EMA coordination and member-state measures. [1–4]

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What is the competitive landscape after Zantac withdrawal?

Zantac’s place in therapy is acid suppression. Its substitution is therefore structurally predictable:

• PPIs (e.g., omeprazole, esomeprazole, pantoprazole, lansoprazole) capture much of the displaced demand because of stronger acid suppression.
• Other H2 blockers (e.g., famotidine) capture part of the residual H2 demand where tolerated and where payers prefer lower-cost alternatives.

Implication for projection logic: Market share is reallocated to other molecules and formulations, not to a returning ranitidine product. Any “ranitidine market projection” is essentially a residual, jurisdiction-dependent clearance and substitution effect.

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Market analysis: how should Zantac’s demand be modeled going forward?

Best-fit projection approach for a withdrawn product

For Zantac/ranitidine, forward projections should be modeled as:

1. No re-expansion scenario (base case): demand trends continue down because the product remains removed/suspended in major markets.
2. Residual-availability scenario (downside or limited upside depending on enforcement): small volumes persist only where supply chains or local authorization status allows continued sales, often through remaining inventories or jurisdictions with different enforcement.

Scenario table (qualitative, decision-grade)

Metric	Base case (no return)	Residual case (localized availability)
Patient access	Near-zero in major markets	Low, patchy, jurisdiction-specific
Prescribing	Sustained substitution to PPIs and other H2 blockers	Minimal incremental use
Pricing	Not a growth market; any pricing is clearance-driven	Temporary pricing volatility tied to supply
Volume trajectory	Structural decline to zero	Declines, then flattens at low residual
Regulatory risk	Permanent-policy state post-NDMA	Continued exposure to further actions

This aligns with the regulator-driven withdrawal/suspension facts. [1–4]

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Does Zantac still have an active IP or patent-driven commercial runway?

Zantac is not an active “runway” story in the sense of a molecule returning to broad, sponsor-led commercialization. IP effects may matter for generics and local authorizations historically, but the NDMA-triggered withdrawal is the dominant determinant of market access.

Implication: R&D investment appraisal should treat Zantac as a discontinued product whose value, if any, is limited to:

• historical manufacturing/supply contracts,
• legacy data value (mechanism of H2 antagonism, formulation learnings),
• and possibly generic residual markets where authorization and enforcement allow.

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Investment-grade bottom line: clinical and market outlook

Clinical outlook

• No meaningful, regulator-restoring late-stage development path is implied by the NDMA-driven discontinuation posture. [1–4]
• Clinical trial “updates” do not drive commercialization because product status is the binding constraint.

Market outlook

• Near-term and long-term growth is not a credible expectation for Zantac as a branded therapy in major markets, given withdrawal/suspension actions. [1–4]
• Future activity is substitution-led toward PPIs and other H2 blockers, not ranitidine re-entry.

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Key Takeaways

• Zantac (ranitidine) is effectively discontinued in major markets due to NDMA contamination concerns, with FDA-requested removal in the U.S. and EMA/national actions across Europe. [1–4]
• A “clinical trials update” for Zantac does not map to a re-launch or approval restoration strategy; the commercial limiter is safety-linked withdrawal, not lack of efficacy evidence.
• Market demand should be modeled as a structural decline with substitution to PPIs and other H2 blockers, not as a growth forecast.
• Any remaining ranitidine sales are residual, jurisdiction-dependent, and clearance-driven rather than a new commercial cycle.

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FAQs

1) Why did Zantac disappear from major markets?
Regulators linked ranitidine products to NDMA risk, triggering FDA market removal requests in the U.S. and suspension actions coordinated across Europe. [1–4]

2) Are there current late-stage trials that will bring Zantac back?
No. The controlling factor is NDMA safety and product status, which has already driven withdrawal/suspension across major jurisdictions. [1–4]

3) What replaces Zantac for acid-related indications?
PPIs capture much of the displaced demand, with other H2 blockers (such as famotidine) taking remaining H2-appropriate use. [1–4]

4) Can ranitidine still be sold somewhere?
In limited, jurisdiction-specific cases, residual availability can persist depending on local authorization and enforcement after NDMA actions. [1–4]

5) Does IP analysis change the outlook for Zantac?
IP may matter historically for generic competition, but NDMA-linked regulatory withdrawal is the dominant driver of market access, overriding typical IP-driven commercialization dynamics. [1–4]

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References (APA)

1. U.S. Food & Drug Administration. (2019). FDA requests removal of certain ranitidine products (Zantac) from the market. FDA. https://www.fda.gov/news-events/press-announcements/fda-requests-removal-certain-ranitidine-products-zantac-market
2. U.S. Food & Drug Administration. (2020). FDA updates and safety communications on ranitidine. FDA. https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-safety-information-ranitidine
3. U.S. Food & Drug Administration. (2020). NDMA in ranitidine drug substance and drug product. FDA. https://www.fda.gov/drugs/drug-safety-and-availability/ndma-ranitidine-drug-substance-and-drug-product
4. European Medicines Agency. (2019–2020). EMA and national measures on ranitidine-containing medicines due to NDMA. EMA. https://www.ema.europa.eu/en/medicines/safety/urgent-safety-communications/ranitidine-ndma-related-urgent-safety-communication