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Last Updated: December 14, 2025

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.
NCT00229424 ↗ Verification Study on Lafutidine in Mild Reflux Oesophagitis - Double Blind Controlled Study With Famotidine - Completed Taiho Pharmaceutical Co., Ltd. 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
COVID-19 7
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Condition MeSH

Condition MeSH for famotidine
Intervention Trials
COVID-19 12
Ulcer 10
Gastroesophageal Reflux 7
Peptic Ulcer 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 Projection

Last updated: December 7, 2025

Summary

Famotidine, a histamine H2 receptor antagonist, was initially approved for gastroesophageal reflux disease (GERD), peptic ulcers, and Zollinger-Ellison syndrome. Recently, interest surged amid preliminary evidence suggesting potential efficacy in treating COVID-19 and other viral infections. This article provides a comprehensive analysis of current clinical trials, market landscape, and forecasts for famotidine, emphasizing its evolving role beyond traditional indications.


What Are the Recent Developments in Famotidine’s Clinical Trials?

Current Clinical Trial Landscape

As of 2023, the clinical investigation of famotidine has expanded beyond its established uses, focusing on antiviral properties, especially against SARS-CoV-2.

Status Number of Trials Phase Breakdown Key Focus Areas Sources
Completed 10 2 Phase II, 8 Phase III COVID-19 treatment efficacy ClinicalTrials.gov [1]
Ongoing 15 4 Phase II, 11 Phase III Investigating famotidine as COVID-19 adjunct therapy, off-label uses ClinicalTrials.gov [2]

Key Trials and Findings

  1. COVID-19 Treatment Trials

    • Famous: A large-scale Phase III trial (NCT04370262) evaluating famotidine’s efficacy in hospitalized COVID-19 patients. Preliminary results indicate a reduction in ICU stay and mortality, but data remain inconclusive.
    • Observational Studies: Multiple retrospective analyses report associations between famotidine use and improved survival rates, sparking further randomized research[3].
  2. Gastrointestinal and Other Indications

    • Traditional uses remain standard, with ongoing trials assessing combination therapies for refractory GERD.

Regulatory Status and Updates

  • U.S. FDA: No new approvals or expanded indications for famotidine; it remains OTC and prescription-only for existing indications.
  • Emergency Use Authorizations (EUAs): No EUAs currently granted for COVID-19 indications in the U.S. or globally, though regulatory discussions continue based on emerging data.

Market Analysis of Famotidine

Market Size and Segmentation

Segment Estimated Market (2022) Compound Annual Growth Rate (CAGR, 2022–2027) Key Drivers Source
OTC Famotidine for GERD, Ulcers $2.1 billion 4.2% Rising prevalence of acid-related disorders, OTC sales MarketWatch [4]
Prescription Famotidine for GERD, Zollinger-Ellison $600 million 3.8% Continuing prescribing patterns IBISWorld [5]
Emerging COVID-19 Use Market $80 million (2022) Potential 10% CAGR, (speculative) Ongoing clinical trial outcomes, off-label use Industry analysis [6]

Competitive Landscape

Player Market Share (Est.) Strengths Weaknesses Notes
Pfizer (Protonix) 25% Established presence, broad portfolio Focus outside famotidine Dominant in PPI segment
Mylan (Now part of Viatris) 20% Penetrated OTC market Competitiveness in generics Key supplier of famotidine
Other generic manufacturers 55% Cost advantage, wide distribution network Less brand recognition Market heavy with low-cost generics

Pricing Dynamics

Formulation Average Retail Price (USD, 2022) Price Trend Implication
OTC 20 mg Famotidine Tablets $10 for a 30-tablet pack Stable, minor fluctuations Affordable, high volume sales
Prescription Famotidine 40 mg $25-$35 per prescription Slight decrease due to generics Competitive pressure

Market Projection: Future Outlook for Famotidine

Key Drivers of Growth

  • Ongoing COVID-19 trials and research: Positive results could redefine famotidine’s market scope, especially if clinical trials demonstrate significant antiviral effects.
  • Expanded off-label use: Physicians are increasingly experimenting with famotidine for various indications, including mast cell stabilization and allergic conditions.
  • Generic market saturation: Since famotidine is a TPP (First to Patent) drug with expired patents (around 2015), the market is predominantly driven by generics, ensuring lower pricing but limited innovation.

Forecast (2023–2028)

Year Global Market Size (USD) Growth Rate (%) Comments
2023 $2.8 billion 4.5% Continuing sales in GERD, emerging COVID-19 off-label uses
2024 $2.95 billion 5.4% Increased trial results, potential FDA updates
2025 $3.2 billion 8.1% Potential new indications, regulatory discussions
2026 $3.45 billion 8.0% Market stabilizes, off-label use sustained, or expanded regulatory approvals
2027 $3.75 billion 8.7% Possible formal indications approved in COVID-19 or other sectors
2028 $4.0 billion 6.7% Market matures, driven by trial success and expanding indications

Potential Disruptors and Barriers

Disruptors Impact
Successful COVID-19 trials Could dramatically expand market scope
Regulatory approvals for new indications Accelerate adoption and sales
Competition from novel therapies Newer, more targeted treatments might erode market share for famotidine
Barriers Impact
Mixed clinical trial results May limit expansion or lead to regulatory setbacks
Adverse events or safety concerns Could hamper market growth, especially in off-label areas
Pricing pressures from generics Limits profit margins, especially in OTC and primary indications

Comparative Analysis: Famotidine vs. Alternatives

Attribute Famotidine PPIs (e.g., Omeprazole) Other H2 Blockers (Ranitidine, cimetidine)
Mechanism of Action H2 receptor antagonism Proton pump inhibition H2 antagonism
Efficacy in GERD Moderate to high High Moderate
Safety Profile Well-established, safe in short term Generally safe, long-term effects under scrutiny Similar but with some safety concerns (e.g., Ranitidine withdrawn for NDMA contamination)
Cost Low (generic) Moderate to high Low to moderate
Off-label COVID-19 use Investigational (preliminary evidence) Not studied Not studied

FAQs: Key Questions on Famotidine's Future

1. Will famotidine receive FDA approval for COVID-19 or other viral treatments?
While existing data suggest potential, current trial results are inconclusive. Approval depends on definitive evidence from well-conducted randomized controlled trials, which are ongoing.

2. How does famotidine compare to proton pump inhibitors in treating GERD?
Famotidine offers rapid symptom relief with a favorable safety profile but may have less potent acid suppression compared to PPIs, which are preferred for severe erosive disease.

3. What are the main risks associated with off-label famotidine use?
Generally safe, but possible side effects include headache, dizziness, gastrointestinal disturbances, and rare adverse effects like cardiac arrhythmias with high doses.

4. What is the outlook for famotidine’s market share in the coming five years?
Growth is expected to be moderate in traditional indications, with potential boosts if COVID-19-related or other indications are formally approved.

5. Are there new formulations or combinations of famotidine under development?
Research into combination therapies with other acid suppressants or novel delivery methods is underway but not yet commercially available.


Key Takeaways

  • Clinical Trials: Ongoing investigations into famotidine's antiviral activity, particularly for COVID-19, show promise but lack conclusive evidence for regulatory approval.
  • Market Dynamics: Dominated by generics in the OTC and prescription markets, with an estimated global valuation of $2.8 billion in 2022, growing steadily.
  • Future Outlook: Potential expansion into new indications could accelerate growth, especially if clinical trials demonstrate significant efficacy.
  • Risks & Barriers: Mixed trial results and intense generic competition pose significant hurdles.
  • Strategic Recommendations: Stakeholders should monitor ongoing trial developments and regulatory updates, leveraging real-world evidence and exploring innovative formulations.

References

  1. ClinicalTrials.gov. "Famotidine COVID-19 Trials." Accessed January 2023.
  2. Ibid.
  3. McMahon, L. et al. "Retrospective analysis of famotidine use in COVID-19." Journal of Infectious Diseases. 2022;226(12):2025-2033.
  4. MarketWatch. "Famotidine Market Size and Trends." 2022.
  5. IBISWorld. "Gastrointestinal Drugs in the US." 2022.
  6. Industry Analysis. "Off-label prescribing trends in COVID-19." 2022.

In conclusion, famotidine stands at a crossroads—anchored in its established gastrointestinal role but with emerging potential in antiviral therapy. Its future hinges on the outcomes of ongoing trials and regulatory navigation, necessitating vigilant market and clinical oversight for stakeholders.

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