CLINICAL TRIALS PROFILE FOR PEPCID AC

All Clinical Trials for PEPCID AC

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↗	Hypo-Hyperfractionated Chest Radiation for Non Small Cell Lung Cancer With Taxotere/Xeloda Combination Chemotherapy	Withdrawn	Clinical Oncology Research Associates	Phase 1/Phase 2	2005-09-01	The study is designed for patients with non small cell lung cancer whose cancer is too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.
NCT01067066 ↗	A Phase I Study of TPI 287 - Temozolomide Combination in Melanoma	Terminated	Cortice Biosciences, Inc.	Phase 1	2010-02-03	The goal of the Phase I portion of this study is to find the highest tolerable dose of TPI 287 that can be given in combination with Temodar (temozolomide) to patients with metastatic melanoma. The goal of the Phase II portion of this study is to learn if TPI 287, given in combination with temozolomide, can control metastatic melanoma. The safety of this combination will also be studied. NOTE: Study stopped before progressing to Phase II portion.
NCT01067066 ↗	A Phase I Study of TPI 287 - Temozolomide Combination in Melanoma	Terminated	M.D. Anderson Cancer Center	Phase 1	2010-02-03	The goal of the Phase I portion of this study is to find the highest tolerable dose of TPI 287 that can be given in combination with Temodar (temozolomide) to patients with metastatic melanoma. The goal of the Phase II portion of this study is to learn if TPI 287, given in combination with temozolomide, can control metastatic melanoma. The safety of this combination will also be studied. NOTE: Study stopped before progressing to Phase II portion.

Clinical Trial Conditions for PEPCID AC

Condition Name

Condition Name for PEPCID AC
Intervention	Trials
Covid19	5
Healthy	5
COVID-19	5
COVID-19 Virus Disease	3

Condition MeSH

Condition MeSH for PEPCID AC
Intervention	Trials
COVID-19	7
Infections	3
Coronavirus Infections	3
Communicable Diseases	3

Clinical Trial Locations for PEPCID AC

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for PEPCID AC

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for PEPCID AC

Sponsor Name

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

Sponsor Type

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

Pepcid AC: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 28, 2025

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Overview of Pepcid AC

Pepcid AC, a widely used over-the-counter medication, contains famotidine, a histamine H2 receptor antagonist primarily prescribed to manage conditions like gastroesophageal reflux disease (GERD), peptic ulcers, and Zollinger-Ellison syndrome. Its established safety profile and efficacy have cemented it as a staple in antacid therapy. Recently, however, the drug's repositioning potential and evolving market dynamics have garnered heightened interest from pharmaceutical stakeholders.

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Clinical Trials Landscape

Recent Trials and Emerging Therapeutic Applications

Over the past two years, clinical research has pivoted to explore famotidine’s repurposing for novel indications. Notably, a series of investigations targeted its utility as a treatment adjunct for COVID-19. Early observational studies suggested that famotidine might mitigate cytokine storm severity, prompting randomized controlled trials (RCTs).

• COVID-19 Related Trials: Multiple RCTs, including trials registered under ClinicalTrials.gov (e.g., NCT04370262), assessed famotidine's effectiveness in reducing hospitalization time and mortality among COVID-19 patients. Preliminary data indicated a potential benefit; however, subsequent larger-scale trials yielded mixed results, with some failing to demonstrate statistically significant improvements over standard care.

• Cancer and Gastrointestinal Disorders: Other ongoing trials examine famotidine’s antitumor properties and prophylactic effects against gastrointestinal bleeding in critically ill patients. These are at early phases, with preliminary safety and pharmacokinetic data being collected.

Regulatory Status and Approvals

Despite widespread off-label and experimental use, famotidine remains approved by the FDA primarily for acid-related disorders. Post-COVID research has not yet translated into formal label expansions, though ongoing studies may influence future regulatory decisions.

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Market Analysis

Current Market Size and Revenue Streams

Pepcid AC holds a dominant position within OTC gastrointestinal therapies, with global revenues estimated at approximately $250 million annually. The US OTC segment accounts for the lion’s share, supported by high consumer familiarity and robust distribution channels.

• Retail and Pharmacy Sales: The drug benefits from high repeat purchase rates, driven by chronic use in GERD management. The COVID-19 pandemic initially boosted sales due to increased health awareness, though recent fluctuations reflect market saturation for traditional indications.

• Prescription Market: While Famotidine is available by prescription, its primary revenue driver remains OTC sales. There is minimal reliance on prescription channels for Pepcid AC, but prescription formulations of famotidine are utilized for more severe gastroenterological conditions.

Competitive Landscape

The H2 receptor antagonist class faces stiff competition from proton pump inhibitors (PPIs), such as omeprazole and esomeprazole, which have overtaken H2 blockers in efficacy for many indications. Nonetheless, famotidine retains advantages like fewer drug interactions and an established safety profile.

Emerging generic manufacturers and retail chains have intensified price competition, exerting downward pressure on revenues. Furthermore, recent patent expirations have facilitated entry of lower-cost generics, expanding accessibility but compressing profit margins.

Market Drivers and Barriers

• Drivers:

  • Increased prevalence of GERD and acid-related ailments, especially among aging populations.
  • Growing consumer preference for OTC solutions, driven by healthcare trends emphasizing self-management.
  • Investigational research potentially expanding use cases.

• Barriers:

  • Market saturation.
  • Competition from more potent PPIs.
  • Limited patent protection, translating into generic proliferation.

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Market Projections

Short to Mid-Term Outlook (Next 3-5 Years)

Analysts project modest growth for Pepcid AC's core market, averaging 2-3% annually, sustained by demographic trends and persistent demand for OTC antacids. The aging population, particularly in North America and Europe, will underpin consistent sales volume.

Ongoing clinical trials exploring famotidine's repositioning for COVID-19, oncology, and other indications could catalyze phase III confirmations, potentially paving the way for label expansion. If approved for new indications, revenue streams could expand significantly, adding 20-30% to market size within 2-3 years post-approval.

Long-Term Perspective (Beyond 5 Years)

Market growth will increasingly depend on:

• Success of clinical trials translating into expanded indications.
• Competitive dynamics, including advancements in alternative therapies.
• Regulatory approval pathways.

Potential development of new formulations—such as targeted delivery systems or combination therapies—could further extend the drug's lifecycle.

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Emerging Opportunities and Challenges

Opportunities:

• Repositioning famotidine as an adjunct in infectious disease protocols.
• Developing combination OTC products targeting multiple gastrointestinal conditions.
• Expansion into emerging markets with rising healthcare access.

Challenges:

• Ensuring robust clinical evidence to support label extensions.
• Managing pricing strategies amidst commoditization.
• Differentiating Pepcid AC in a crowded OTC marketplace.

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Key Takeaways

• The clinical trial landscape for famotidine is shifting from traditional GERD applications toward investigational uses, notably COVID-19 and oncology, though results remain mixed.
• Market-wise, Pepcid AC continues to generate substantial revenue, primarily through OTC retail channels, but faces intensifying competition from PPIs and generics.
• Near-term growth will hinge on the outcomes of ongoing trials and potential regulatory approvals for new indications.
• Strategic expansion into emerging markets, coupled with innovation in formulations, presents avenues for sustained growth.
• The long-term outlook depends heavily on clinical validation of new therapeutic applications and market positioning against evolving competitors.

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Frequently Asked Questions

1. Can Pepcid AC be effectively repurposed for COVID-19 treatments?
Current evidence from clinical trials is inconclusive. While early studies suggested potential benefits, larger, well-controlled studies are required to confirm efficacy before formal approval or widespread adoption.

2. Are there any patents protecting Pepcid AC from generic competition?
Most patents related to famotidine have expired, leading to a highly competitive generic market. This results in lower prices but also reduces profitability for brand owners.

3. Will the market for Pepcid AC grow considering competition from PPIs?
While PPIs have overtaken H2 antagonists for many indications, Pepcid AC maintains a foothold in specific patient populations and OTC sales driven by safety profiles and consumer preference for cost-effective options.

4. What is the potential for label expansion of famotidine?
Pending positive clinical trial outcomes, especially for emergent indications like COVID-19 or certain cancers, regulatory agencies may approve label extensions, unlocking new market segments.

5. How have recent clinical trials impacted Pepcid AC’s market value?
Mixed trial results have limited immediate value impact; however, continued research and eventual approval for new indications could significantly enhance market prospects.

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Sources

[1] ClinicalTrials.gov. List of famotidine-related trials.
[2] Market research reports on OTC gastrointestinal drugs.
[3] FDA approval database for famotidine indications.
[4] Industry analysis on generic drug market trends.
[5] Recent publications on famotidine's investigational uses.