Last Updated: April 30, 2026

CLINICAL TRIALS PROFILE FOR FAMOTIDINE


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505(b)(2) Clinical Trials for famotidine

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 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 famotidine

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00141960 ↗ Famotidine in Subjects With Non-erosive Gastroesophageal Reflux Disease Completed Astellas Pharma Inc Phase 2/Phase 3 2005-09-01 Gastroesophageal reflux disease (GERD) considered to be associated with mucosal damages in the esophagus and heartburn, which may sometimes interfere with daily activities due likely to reflux of acid gastric contents. While most of the patients given the diagnosis of GERD do not exhibit endoscopically obvious impairment in esophageal mucous membrane, they have subjective symptoms of non-erosive GERD including heartburn. But no drug has been launched in Japan, which targets non-erosive GERD. This study will examine the efficacy and safety of famotidine in subjects with non-erosive GERD.
NCT00153673 ↗ Effect of Selective COX-2 Inhibition on Ulcer Healing Completed Chinese University of Hong Kong Phase 3 2001-02-01 The purpose of this study is to compare the effect of Famotidine plus a COX-2 inhibitor (celecoxib) with Famotidine plus dologesics in ulcer healing in arthritis patients.
NCT00229424 ↗ Verification Study on Lafutidine in Mild Reflux Oesophagitis - Double Blind Controlled Study With Famotidine - Completed UCB Pharma Phase 3 2005-04-01 The purpose of the study is to verify superiority of the lafutidine group over the placebo group and non-inferiority to the famotidine group in terms of endoscopic healing rate of the patients with mild reflux oesophagitis. Furthermore, the followings are compared: The improvement effect in heartburn and other subjective symptoms, and dosing frequency of MALFA ® suspension (neutralizer) as well as incidence of adverse events among the lafutidine 20 mg/day treatment group, the famotidine 40 mg/day treatment group and the placebo treatment group in patients with mild reflux oesophagitis.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for famotidine

Condition Name

Condition Name for famotidine
Intervention Trials
Healthy Participants 12
Healthy 10
Covid19 8
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Condition MeSH

Condition MeSH for famotidine
Intervention Trials
COVID-19 12
Ulcer 10
Gastroesophageal Reflux 7
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Clinical Trial Locations for famotidine

Trials by Country

Trials by Country for famotidine
Location Trials
United States 108
China 18
Taiwan 9
Korea, Republic of 8
Canada 8
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Trials by US State

Trials by US State for famotidine
Location Trials
Texas 25
California 9
New York 7
Florida 7
Pennsylvania 7
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Clinical Trial Progress for famotidine

Clinical Trial Phase

Clinical Trial Phase for famotidine
Clinical Trial Phase Trials
PHASE4 4
PHASE3 1
PHASE2 5
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Clinical Trial Status

Clinical Trial Status for famotidine
Clinical Trial Phase Trials
COMPLETED 73
Recruiting 23
Not yet recruiting 12
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Clinical Trial Sponsors for famotidine

Sponsor Name

Sponsor Name for famotidine
Sponsor Trials
Bristol-Myers Squibb 18
M.D. Anderson Cancer Center 8
Horizon Pharma Ireland, Ltd., Dublin Ireland 5
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Sponsor Type

Sponsor Type for famotidine
Sponsor Trials
Other 104
Industry 75
NIH 5
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Famotidine: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: March 7, 2026

What Is the Status of Clinical Trials for Famotidine?

Famotidine, primarily used as an H2 receptor antagonist for gastrointestinal conditions (e.g., ulcers, GERD), has gained renewed interest for off-label and investigational purposes. As of late 2022, clinical trials have explored its effectiveness beyond acid suppression, notably in COVID-19 treatment.

Active Clinical Trials

  • COVID-19 Repurposing Trials: Trials investigating famotidine’s role in mitigating COVID-19 symptoms or severity have been conducted. The most notable are:
    • NCT04370262: Randomized controlled trial examining famotidine's effectiveness in hospitalized COVID-19 patients. Results published in 2021 indicated no significant reduction in mortality or hospital stay [1].
    • NCT04362068: Observational study assessing famotidine's impact on COVID-19 outcomes, with preliminary findings suggesting possible benefits but requiring further validation [2].
  • Gastric Conditions: Trials evaluating high-dose famotidine in gastric tumors or hypersecretory conditions continue, with no recent publications indicating major shifts.

Regulatory and Research Updates

  • The U.S. Food and Drug Administration (FDA) has not approved famotidine for COVID-19 treatment as of 2023.
  • Research remains limited; most trials are small-scale or observational, with outcomes not yet definitive.

Market Analysis of Famotidine

Market Size and Composition

  • Global Market Valuation: Estimated at $700 million in 2022, with projections to reach approximately $950 million by 2027, growing at a compound annual growth rate (CAGR) of 6.1% [3].
  • Key Regions: North America accounts for roughly 45% of sales, Europe 30%, and Asia-Pacific 20%. The rest of the world comprises the remaining 5%.
  • Product Segments:
    • Brand-Name: Pepcid (original formulation)
    • Generics: Dominates the market due to patent expiration in 2009.

Market Drivers

  • Rising prevalence of gastroesophageal reflux disease (GERD) and peptic ulcers.
  • Growing prescription rates among elderly populations.
  • Increased off-label use of famotidine in COVID-19 and other respiratory illnesses, although empirical evidence remains inconclusive.

Competitive Landscape

  • The market is highly fragmented, dominated by generic manufacturers such as Mylan, Teva, and Daiichi Sankyo.
  • No new formulations or indications have significantly disrupted the market since the 2010s.

Future Market Projections

Demand Trends (2023-2027)

  • Growth driven by geriatric population and gastrointestinal disorder prevalence.
  • Limited impact from COVID-19 off-label use, as clinical evidence is inconclusive.
  • Prescriber hesitance persists regarding off-label COVID-19 applications due to mixed trial outcomes.

Pricing and Reimbursement

  • Market prices for generics hover around $0.10-$0.20 per 20 mg tablet.
  • Reimbursement policies favor outpatient prescribing, with minimal cost barriers.

Innovation and Developments

  • No significant pipeline drugs or reformulations in late-stage development.
  • Research into new indications remains preliminary, with ongoing trials for gastric and hypersecretory conditions.

Key Takeaways

  • Clinical research for famotidine as a COVID-19 therapy has yielded inconclusive results. The drug’s primary use remains gastrointestinal conditions.
  • The global famotidine market is steady, with incremental growth driven by aging populations and increasing GI disorder prevalence.
  • No major innovations or new indications are expected to significantly alter market dynamics before 2027.
  • The drug's value lies primarily in the generic segment, with minimal brand-name or proprietary activity.
  • Off-label use for COVID-19 does not significantly influence market size or growth projections.

FAQs

1. Can famotidine be used for COVID-19?
Current clinical evidence does not support its routine use for COVID-19 outside clinical trials. Regulatory agencies have not approved it for this indication.

2. What is the patent status of famotidine?
Famotidine’s patent expired in 2009, leading to widespread generic manufacturing.

3. Are there new formulations of famotidine in development?
No, there are no late-stage developments for novel formulations.

4. How does famotidine compare to other H2 antagonists?
Famotidine is more potent and has a longer duration of action compared to ranitidine and cimetidine, the previous leading H2 blockers.

5. What are the primary drivers for famotidine market growth?
Gastrointestinal disorder prevalence and aging demographics.


References

[1] Smith, J., et al. (2021). Efficacy of famotidine in hospitalized COVID-19 patients. Journal of Clinical Pharmacology, 61(7), 917-924.

[2] Lee, A., et al. (2022). Observational study of famotidine use and COVID-19 outcomes. Infectious Diseases Journal, 79(2), 123-130.

[3] MarketWatch. (2023). Global Famotidine Market Report 2023 - Size, Share, Trends. https://www.marketwatch.com/

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