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↗	Hypo-Hyperfractionated Chest Radiation for Non Small Cell Lung Cancer With Taxotere/Xeloda Combination Chemotherapy	Withdrawn	Clinical Oncology Research Associates	Phase 1/Phase 2	2005-09-01	The study is designed for patients with non small cell lung cancer whose cancer is too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.

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 Infection	3

Condition MeSH

Condition MeSH for PEPCID AC
Intervention	Trials
COVID-19	7
Virus Diseases	3
Respiratory Tract Diseases	3
Respiration Disorders	3

Clinical Trial Locations for PEPCID AC

Trials by Country

Trials by Country for PEPCID AC
Location	Trials
United States	42
India	2
Canada	1
Australia	1
Jordan	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 (famotidine): Clinical Trials Update and Market Outlook

Last updated: April 27, 2026

What is PEPCID AC and how is it positioned in the market?

PEPCID AC is the OTC brand of famotidine (a histamine H2-receptor antagonist) used for reduction of heartburn and acid indigestion. It is generally sold as oral tablets (commonly 10 mg or 20 mg OTC strengths in the US market, with branded packaging and dosage variations by channel).

Famotidine is a mature, off-patent molecule with multiple manufacturers and widespread generic availability. Commercial differentiation is largely channel and brand-driven (OTC shelf access, pricing, and pack architecture), not clinical innovation.

What is the clinical trials update for famotidine (PEPCID AC)?

Famotidine has no clear, active late-stage clinical development pathway tied to PEPCID AC branding. The drug is established, and recent clinical research is mostly centered on:

• formulation work (new dosage forms, dissolution/PK comparisons)
• retrospective real-world evidence
• special populations and dosing optimization in specific clinical settings

A trial-driven, PEPCID AC-specific pipeline (new Phase 3 efficacy/safety readouts that would move the brand) is not evident in the public record for famotidine as a brand-linked product. The clinical evidence base is dominated by older regulatory-era studies and post-marketing literature rather than brand-new pivotal programs.

Why does the absence of brand-linked late-stage trials matter for PEPCID AC?

OTC H2 blockers do not typically require new pivotal trials for label maintenance when the active ingredient is established and widely generic. As a result, market performance is driven by:

• OTC category growth and consumer behavior
• competitive intensity (PPIs, other H2 blockers, antacids)
• pricing, promotions, and retailer execution
• safety perceptions (frequency of use, tolerability)

How do alternative acid products shape the competitive landscape?

PEPCID AC competes across a cluster of OTC products used for heartburn:

• PPIs (omeprazole, esomeprazole) for longer-lasting acid suppression
• H2 blockers (famotidine generics and other branded H2 products)
• antacids (calcium carbonate, magnesium/aluminum hydroxide)
• combination “acid relief” formats

Given the maturity of H2 blockers and generic penetration, PEPCID AC’s value proposition is typically framed around:

• fast-onset symptom relief relative to some slower-onset regimens
• long-standing safety and tolerability profile
• OTC convenience and lower price tiers than branded PPIs

How is famotidine regulated and what does that imply for new clinical development?

Famotidine is an approved active ingredient with OTC use. For an OTC brand like PEPCID AC, product-level improvements (new packs, dose strengths, or formulation refinements) generally do not require the same development intensity as new chemical entities.

In practice, this means PEPCID AC is more exposed to OTC lifecycle dynamics than to clinical readout catalysts.

What is the market analysis for PEPCID AC (US OTC famotidine category)?

1) Demand drivers

The OTC heartburn population remains structurally large due to:

• high prevalence of GERD-like symptoms
• self-medication behavior
• repeat purchase cycles for chronic or recurrent heartburn

2) Supply and competitive intensity

• Generic famotidine availability is widespread.
• Brand differentiation is mainly marketing and distribution.
• Large OTC manufacturers can pressure pricing through scale and retailer contracts.

3) Channel dynamics

OTC GERD/heartburn is heavily shaped by:

• big-box retail and pharmacy chains
• club stores and value channels
• e-commerce search visibility and promo pricing

4) Therapeutic switching risk

Key switching is between:

• H2 blockers to PPIs for stronger symptom control
• PPIs to H2 blockers for intermittent or milder symptoms and for cost control

Market projection: How will PEPCID AC likely perform over the next 3 to 5 years?

With limited evidence of PEPCID AC-specific late-stage clinical catalysts, projections should be framed around OTC category mechanics: pricing, share shifts, and promotional cycles.

Base-case projection (category-normalized)

• Unit growth: modest, primarily driven by category demand and incremental conversions rather than new clinical breakthroughs.
• Value growth: more sensitive to pricing and promotion, with brand share gains or losses depending on retailer contract dynamics.
• Share trajectory: likely stable-to-slightly pressured unless brand promotion offsets generic pricing.

Bull-case projection

• sustained or increased brand share through stronger retailer placements and promo strategy
• conversion from antacids for longer relief windows
• incremental dose/pack optimization that improves adherence

Bear-case projection

• continued migration to PPIs for customers seeking stronger control
• aggressive generic pricing and retailer delisting pressure on brands
• increased competitive intensity from other OTC acid relief categories

Commercial implications for R&D and investment

Because famotidine is mature:

• Clinical development is unlikely to be the main driver for PEPCID AC growth.
• The more investable levers tend to be product and commercial:
  • formulation changes that improve consumer experience (if feasible within OTC regulatory pathways)
  • pack architecture and dosage convenience
  • marketplace merchandising and retailer strategy

Key metrics to monitor (actionable scoreboard)

Metric	Why it matters	What to watch
OTC heartburn category share by active class	Indicates switching between H2 and PPI	Share drift from H2 to PPI or antacid resurgence
Retail price index for OTC famotidine	Captures promo intensity	Downward pricing pressure vs brand-stable pricing
Brand versus generic shelf presence	Drives conversion	Listing depth and planogram quality at major chains
Prescription-to-OTC conversion trends (if tracked)	Shows symptom management shifts	Refill-to-self-medication behavior proxies
e-commerce search share for “famotidine heartburn relief”	Captures demand capture	Organic visibility and promoted listing dominance

Key Takeaways

• PEPCID AC is an OTC famotidine brand with market power driven by brand distribution and consumer habit rather than clinical innovation.
• Publicly visible, brand-linked late-stage clinical trial activity is not evident; the clinical evidence base is mature.
• Market outcomes depend on OTC category switching, especially between H2 blockers and PPIs, and on retailer pricing and promotions.
• Over the next 3 to 5 years, PEPCID AC’s likely trajectory is stable to modestly pressured on value with the direction of unit growth tied to category expansion and execution.

FAQs

1) What clinical evidence supports famotidine for OTC heartburn?

The efficacy and safety support is built on the long-standing regulatory evidence base for famotidine as an H2 antagonist, plus ongoing post-marketing and real-world literature rather than new pivotal brand-linked trials.

2) Does PEPCID AC have an active late-stage pipeline?

A brand-linked late-stage pipeline is not clearly visible in the public record; famotidine’s development posture is generally mature and focused on incremental work rather than pivotal innovation.

3) What are PEPCID AC’s biggest OTC competitors?

PPIs (for stronger relief), antacids (for quick, episodic relief), and generics and alternative H2 blockers (for price-led switching).

4) How should investors interpret the lack of new pivotal trials?

For a mature OTC active ingredient, it signals the growth model is driven more by commercial execution and consumer switching than by clinical catalysts.

5) What is the most important driver of future sales?

Retail pricing and promotional intensity, plus category-level share shifts between H2 blockers and PPIs.

---

References (APA)

[1] U.S. Food and Drug Administration. (n.d.). Drugs@FDA: FDA Approved Drug Products. https://www.accessdata.fda.gov/scripts/cder/daf/
[2] National Library of Medicine. (n.d.). ClinicalTrials.gov. https://clinicaltrials.gov/
[3] U.S. National Library of Medicine. (n.d.). DailyMed: Famotidine (OTC). https://dailymed.nlm.nih.gov/