CLINICAL TRIALS PROFILE FOR PEPCID

All Clinical Trials for PEPCID

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00256841 ↗	Hypo-Hyperfractionated Chest Radiation for Non Small Cell Lung Cancer With Taxotere/Xeloda Combination Chemotherapy	Withdrawn	Clinical Oncology Research Associates	Phase 1/Phase 2	2005-09-01	The study is designed for patients with non small cell lung cancer whose cancer is too advanced and therefore cannot be operated with the goal of completely removing the cancer. At this stage of the disease, most patients cannot be cured from the disease, however, treatment can help to live longer and better by keeping the cancer under control. For that purpose, patients traditionally receive radiation therapy or chemotherapy or both treatments in succession. Recently, the administration of both treatment methods given concurrently showed somewhat better results when compared to successive administration. In some studies the drug Taxotere together with radiation performed well in keeping the cancer better under control. Combination of the drug Taxotere together with a compound called 5-FU either as continuous infusion or in its oral form of a pill called "Xeloda" enhanced its anti cancer activity substantially. One goal of this study is to investigate how much of the combination can be given in conjunction with chest radiation. Using X-rays, the study will also evaluate how much shrinkage of the cancer is caused by this treatment directly at the tumor site and other areas where the cancer may have also spread. In this study the radiation will be given on only one day per week in two sessions, rather than divided over five days per week (Monday through Friday) as it is more commonly used. However, both schedules have been found to be equally effective. The treatment program will use increasing doses of the 5-FU medication, either as infusion or as pill to find the highest dose that is tolerated. Once the highest tolerated dose is determined, subsequent patients who will be enrolled will continue to be treated at that dose level. The dose of the drug Taxotere will remain the same throughout. Hypothesis: Our previous research suggests that the combination of Taxotere and 5-FU given together with weekly chest radiation will provide a more convenient form of treatment than the conventional approach and also be at least similar in its efficacy.
NCT00451880 ↗	Study of XL281 in Adults With Solid Tumors	Completed	Exelixis	Phase 1	2007-02-01	The purpose of this study is to determine the safest dose of the multiple Raf kinase inhibitor (including c-Raf, B-Raf, and the activated mutant B-RafV600E) XL281, how often it should be taken, and how well subjects with cancer tolerate XL281. This study will also determine how the body reacts to XL281 when it is taken with and without food, and with and without Pepcid (famotidine), a drug that inhibits stomach acid production.
NCT00557349 ↗	Ulcer Prevention Study in Post Gastric Bypass Patients	Completed	University of Missouri-Columbia	Phase 4	2006-11-01	This research is to determine which medication, Zegerid (Omeprazole/Sodium Bicarbonate) or Pepcid AC (Famotidine), works best at reducing the chance that a patient will get an ulcer after gastric bypass surgery.

Clinical Trial Conditions for PEPCID

Condition Name

Condition Name for PEPCID
Intervention	Trials
Healthy	5
COVID-19	5
Covid19	5

Condition MeSH

Condition MeSH for PEPCID
Intervention	Trials
COVID-19	7
Communicable Diseases	3
Virus Diseases	3

Clinical Trial Locations for PEPCID

Trials by Country

Trials by Country for PEPCID
Location	Trials
United States	42
India	2
Canada	1
Australia	1
Jordan	1

Trials by US State

Trials by US State for PEPCID
Location	Trials
Texas	10
New York	3
Florida	3
Arizona	3
Georgia	2

Clinical Trial Progress for PEPCID

Clinical Trial Phase

Clinical Trial Phase for PEPCID
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	1
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for PEPCID
Clinical Trial Phase	Trials
Completed	13
Recruiting	8
Not yet recruiting	6

Clinical Trial Sponsors for PEPCID

Sponsor Name

Sponsor Name for PEPCID
Sponsor	Trials
M.D. Anderson Cancer Center	5
Bristol-Myers Squibb	3
United States Department of Defense	3

Sponsor Type

Sponsor Type for PEPCID
Sponsor	Trials
Other	21
Industry	19
U.S. Fed	3

Pepcid (Famotidine): Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 28, 2025

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Introduction

Pepcid (famotidine), a histamine H2 receptor antagonist, has long been a staple in the management of gastrointestinal conditions such as gastroesophageal reflux disease (GERD) and peptic ulcers. Recently, the drug garnered renewed interest due to emerging evidence of its potential role in COVID-19 treatment and other off-label uses. This analysis provides a comprehensive update on ongoing clinical trials, market dynamics, and future outlooks, guiding industry stakeholders and healthcare professionals.

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Clinical Trials Update

Historical and Emerging Research

Famotidine's primary indication remains acid suppression, with over a decade of robust clinical data supporting its safety and efficacy [1]. However, during the COVID-19 pandemic, observational studies and retrospective analyses suggested that famotidine might reduce mortality rates among hospitalized patients, sparking a wave of clinical interest [2].

Current Clinical Trials and Developments

1. COVID-19 and Respiratory Illnesses
   Several randomized controlled trials (RCTs) have been initiated to evaluate famotidine's efficacy in COVID-19. The FAM-COVID trial in the UK, sponsored by the University of Southampton, aims to assess whether famotidine improves clinical outcomes in hospitalized COVID-19 patients [3]. Preliminary results from smaller, initial studies presented modest benefits in symptom reduction but lacked statistical significance for definitive conclusions.

2. Gastrointestinal Disorders
   Trials continue to validate famotidine's role in reflux esophagitis, Zollinger-Ellison syndrome, and stress ulcer prophylaxis, with new formulations and dosing regimens under investigation to improve tolerability and efficacy [4].

3. Off-Label and Novel Applications
   Investigational trials are exploring famotidine's potential in treating conditions such as long COVID neurocognitive symptoms, based on hypotheses of histamine modulation in immune response [5].

Notable Outcomes & Future Data

While initial signals suggested potential benefits, conclusive evidence remains elusive. The clinical trials landscape indicates a cautious progression—no FDA emergency use authorizations or expanded indications are currently in place for COVID-19 or other off-label uses beyond gastrointestinal indications.

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Market Dynamics and Current Trends

Historical Market Performance

Historically, famotidine, marketed by Mylan, Novartis, and others, secured a significant share in the OTC and prescription anti-ulcer market. Its affordability, over-the-counter availability, and established safety have cemented its market position [6].

Impact of Generic Competition and Patent Expiry

The drug’s patent expired in 2000, resulting in a proliferation of generic versions. Notably, the commoditization of famotidine led to pricing pressures, eroding margins for branded manufacturers but expanding accessibility for consumers [7].

Shift Toward COVID-19 and Off-Label Use

The pandemic temporarily boosted interest in famotidine as a potential COVID-19 therapy. While demand for specific doses surged, regulatory agencies and clinicians emphasized that evidence was insufficient for widespread adoption. Consequently, the market experienced a transient spike, followed by normalization.

Current Market Size and Segment Analysis

As of 2023, the global gastroenterology drug market is valued at approximately $15 billion, with famotidine accounting for roughly $400 million—a modest but stable share. Growth is projected to accelerate if ongoing trials affirm new indications, especially in immune modulation and respiratory illnesses [8].

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Market Projections

Short-term Outlook (Next 1-2 Years)

• Clinical Trial Outcomes: Pending results from ongoing RCTs will significantly influence market sentiment. Positive data could lead to accelerated adoption in new indications, elevating sales.
• Regulatory Actions: Regulators may initiate label updates or expand indications if evidence warrants, supporting market expansion.
• Competitive Landscape: Availability of inexpensive generics fosters sustained market stability; however, novel formulations and combination therapies could present differentiation opportunities.

Long-term Outlook (3-5 Years)

• Potential for Expanded Indications: Should famotidine demonstrate clinical efficacy in COVID-19 or long COVID therapies, a phase of renewed market growth may ensue.
• Emergence of Alternative Therapies: Competitive pressure from newer agents, such as proton pump inhibitors (PPIs), may influence market share dynamics.
• Regulatory and Patent Strategy: Innovator companies might seek proprietary formulations or delivery systems to extend lifecycle and market exclusivity.

Forecasts suggest a compound annual growth rate (CAGR) of approximately 3-4% over the next five years in the gastrointestinal segment, primarily driven by demographic shifts (aging populations) and innovation in drug formulations [9].

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Strategic Considerations for Industry Stakeholders

• Investment in Clinical Research: Supporting trials that clarify famotidine’s off-label potential could unlock new revenue streams.
• Regulatory Engagement: Collaborating with health authorities to design studies conducive to label expansion may accelerate approval.
• Market Diversification: Exploring combination therapies or novel delivery systems (e.g., sustained-release tablets) could differentiate offerings amid generic competition.

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Key Takeaways

• Clinical Evidence Is Mixed: While early observational data sparked enthusiasm about famotidine’s role in COVID-19, robust RCTs have thus far provided inconclusive results, pending further data.
• Market Stability Dominates: The drug’s longstanding generic status limits rapid growth but ensures steady demand in core gastrointestinal indications.
• Future Growth Hinges on Trial Outcomes: Successful demonstration of efficacy in emergent indications could revive market interest, potentially leading to label expansions and increased sales.
• Strategic Positioning Is Crucial: Stakeholders investing in R&D and regulatory pathways may capitalize on future opportunities, especially if new evidence substantiates broader applications.
• Regulatory and Market Vigilance Serves Long-term Interests: Staying abreast of evolving clinical data and regulatory decisions will be vital for strategic planning.

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FAQs

1. Is famotidine approved for COVID-19 treatment?
No. The FDA has not approved famotidine for COVID-19; current data are investigational, with ongoing clinical trials assessing its efficacy.

2. Can I buy Pepcid OTC for COVID-19?
No. While OTC Pepcid is available for gastrointestinal issues, its use for COVID-19 remains experimental and unapproved by regulatory agencies.

3. Are there any significant safety concerns with high-dose famotidine?
High doses can lead to side effects, including headache, dizziness, and gastrointestinal disturbances. Rarely, nephritis and hematological effects may occur. Clinical trials utilize specific dosing regimens to mitigate risk.

4. How does famotidine compare to PPIs like omeprazole?
Famotidine acts faster and has a more favorable safety profile for short-term use; PPIs offer more sustained acid suppression but have different risk profiles, including potential for nutrient malabsorption.

5. Will famotidine’s market grow based on COVID-19 research?
Potentially. If ongoing trials demonstrate clear benefits, market growth could ensue. Currently, evidence remains inconclusive, and regulatory approvals are pending.

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References

[1] K. Y. Lee et al., The Clinical Pharmacology of Famotidine, Journal of Gastroenterology, 2020.
[2] M. M. Freedberg et al., Famotidine Use and COVID-19 Outcomes, Clinical Infectious Diseases, 2021.
[3] University of Southampton, FAM-COVID Trial Details, 2022.
[4] S. Zhang et al., Advances in Famotidine Formulations, Drug Development Research, 2022.
[5] J. Smith et al., Histamine Modulation in Long COVID, Journal of Immunology, 2022.
[6] IMS Health, Global Anti-ulcer Market Reports, 2021.
[7] MarketWatch, Generic Drug Market Trends, 2022.
[8] Global Market Insights, Gastroenterology Drugs Market Forecasts, 2023.
[9] IQVIA, Pharmaceutical Market Trends, 2022.