CLINICAL TRIALS PROFILE FOR TAGAMET

All Clinical Trials for Tagamet

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00038402 ↗	Evaluation of the Addition of Herceptin to Standard Chemotherapy in the Neoadjuvant Setting for Operable Breast Cancer	Completed	Genentech, Inc.	Phase 3	2001-04-01	The purpose of this study is to evaluate the addition of Herceptin to standard chemotherapy treatment of patients newly diagnosed with operable breast cancer. Other objectives: 1) to evaluate the potential of this therapy to reduce the size of the tumor and increase the possibility of breast conservative surgery, 2) evaluate the ability of this regimen to prevent recurrence of breast cancer and impact on survival, 3) determine side effect profile with the addition of Herceptin, and 4) evaluate significance of HER2 expression by two different methods.
NCT00038402 ↗	Evaluation of the Addition of Herceptin to Standard Chemotherapy in the Neoadjuvant Setting for Operable Breast Cancer	Completed	M.D. Anderson Cancer Center	Phase 3	2001-04-01	The purpose of this study is to evaluate the addition of Herceptin to standard chemotherapy treatment of patients newly diagnosed with operable breast cancer. Other objectives: 1) to evaluate the potential of this therapy to reduce the size of the tumor and increase the possibility of breast conservative surgery, 2) evaluate the ability of this regimen to prevent recurrence of breast cancer and impact on survival, 3) determine side effect profile with the addition of Herceptin, and 4) evaluate significance of HER2 expression by two different methods.
NCT00233935 ↗	Defined Green Tea Catechin Extract in Preventing Esophageal Cancer in Patients With Barrett's Esophagus	Completed	National Cancer Institute (NCI)	Phase 1	2005-11-01	The goal of this clinical research study is to test the safety of defined green tea catechin extract at different dose levels. Researchers also want to find out what effects, good and bad, it may have on individual and their risk for esophagus cancer. Esophagus cancer is an increased risk associated with Barrett's esophagus. Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of defined green tea catechin extract may prevent esophageal cancer.
NCT01256879 ↗	Cimetidine Biowaivers	Completed	Food and Drug Administration (FDA)	Phase 4	2011-03-01	The purpose of this research is to see if non-drug ingredients in capsules and oral solutions affect how well drugs are absorbed. This is called "bioequivalence." Medications taken by mouth, such as capsules and solutions, need to be absorbed into the body in order to do any good. Capsules and solutions contain a drug, but also contain non-drug ingredients that are called excipients or fillers. Excipients in the capsules and solutions can impact how much drug is absorbed into the body. This is called "bioINequivalence." Capsules and solutions in this research contain the drug cimetidine. This drug is being used since it has high water solubility (can dissolve in water) and low ability to be absorbed.
NCT01256879 ↗	Cimetidine Biowaivers	Completed	University of Maryland	Phase 4	2011-03-01	The purpose of this research is to see if non-drug ingredients in capsules and oral solutions affect how well drugs are absorbed. This is called "bioequivalence." Medications taken by mouth, such as capsules and solutions, need to be absorbed into the body in order to do any good. Capsules and solutions contain a drug, but also contain non-drug ingredients that are called excipients or fillers. Excipients in the capsules and solutions can impact how much drug is absorbed into the body. This is called "bioINequivalence." Capsules and solutions in this research contain the drug cimetidine. This drug is being used since it has high water solubility (can dissolve in water) and low ability to be absorbed.
NCT01256879 ↗	Cimetidine Biowaivers	Completed	University of Maryland, Baltimore	Phase 4	2011-03-01	The purpose of this research is to see if non-drug ingredients in capsules and oral solutions affect how well drugs are absorbed. This is called "bioequivalence." Medications taken by mouth, such as capsules and solutions, need to be absorbed into the body in order to do any good. Capsules and solutions contain a drug, but also contain non-drug ingredients that are called excipients or fillers. Excipients in the capsules and solutions can impact how much drug is absorbed into the body. This is called "bioINequivalence." Capsules and solutions in this research contain the drug cimetidine. This drug is being used since it has high water solubility (can dissolve in water) and low ability to be absorbed.
NCT02157376 ↗	Stress Ulcer Prophylaxis of Intravenous Esomeprazole in Chinese Seriously Ill Patients	Completed	AstraZeneca	Phase 3	2014-07-01	The efficacy of esomeprazole will be compared versus cimetidine (a drug that previously demonstrated prevention of bleeding events) during treatment period in proportion of patients for the prevention of upper GI bleeding.

Clinical Trial Conditions for Tagamet

Condition Name

Condition Name for Tagamet
Intervention	Trials
Prognostic Stage IIIC Breast Cancer AJCC v8	1
Anatomic Stage IIIA Breast Cancer AJCC v8	1
Prognostic Stage 0 Breast Cancer AJCC v8	1
Prognostic Stage IV Breast Cancer AJCC v8	1

Condition MeSH

Condition MeSH for Tagamet
Intervention	Trials
Breast Neoplasms	2
Breast Carcinoma In Situ	1
Ulcer	1
Barrett Esophagus	1

Clinical Trial Locations for Tagamet

Trials by Country

Trials by Country for Tagamet
Location	Trials
United States	7
China	1

Trials by US State

Trials by US State for Tagamet
Location	Trials
Washington	2
Texas	2
Ohio	1
Maryland	1
New York	1

Clinical Trial Progress for Tagamet

Clinical Trial Phase

Clinical Trial Phase for Tagamet
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	2
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Tagamet
Clinical Trial Phase	Trials
Completed	4
Recruiting	3

Clinical Trial Sponsors for Tagamet

Sponsor Name

Sponsor Name for Tagamet
Sponsor	Trials
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	2
National Cancer Institute (NCI)	1
Food and Drug Administration (FDA)	1

Sponsor Type

Sponsor Type for Tagamet
Sponsor	Trials
Other	6
NIH	4
Industry	2

Last updated: April 27, 2026

TAGAMET (cimetidine): clinical trials update, market analysis, and projection

What is TAGAMET and what is its current clinical footprint?

TAGAMET is cimetidine, a first-generation H2-receptor antagonist used for duodenal and gastric ulcer disease, GERD-related acid symptoms, and related conditions that depend on histamine-driven gastric acid secretion. The drug is widely marketed globally as a mature, off-patent therapy.

Clinical-trials reality check: Cimetidine’s late-stage development era is historical; current evidence is dominated by routine clinical use, guideline references, and comparative or mechanistic studies rather than large, new pivotal Phase 3 programs. Trial activity in recent years is typically smaller, sponsor-driven studies (often in specific indications, populations, or formulations) rather than a repeat of the original efficacy-defining packages.

Implication for a clinical trials update: The practical “update” for TAGAMET is not a stream of late-stage readouts; it is the absence of ongoing, high-impact Phase 3 drug-development timelines that would change the label footprint. Any “newness” is generally incremental and does not alter the market’s fundamental maturity.

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What does the current competitive landscape look like for H2 blockers?

H2 blockers compete on:

• Unit cost per acid-suppression day
• Availability of OTC options
• Formulary positioning in hospital and managed care settings
• Switching dynamics to proton pump inhibitors (PPIs) for refractory GERD or ulcer disease

For cimetidine specifically, the competitive set is:

• OTC and prescription H2 blockers: famotidine, nizatidine (availability varies by region)
• PPIs: omeprazole, esomeprazole, pantoprazole, lansoprazole (dominant in most guideline pathways for GERD and ulcer prophylaxis)
• Alternatives where relevant: antacids, alginates, and combination approaches

Market-positioning consequence: Even where H2 blockers retain a role (nocturnal symptoms, step-down therapy, specific patient tolerability profiles), cimetidine’s clinical adoption has historically been pressured by famotidine’s favorable tolerability profile and by PPI guideline dominance.

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What is the market size and trajectory for cimetidine/TAGAMET?

TAGAMET is best treated as a mature generics market within the broader acid-reducing category (H2 blockers plus adjacent acid suppressants). In this structure, revenue growth is limited by:

• Generic price floors
• Long-term substitution toward PPIs (where appropriate)
• Low clinical differentiation among H2 blockers

Directional market conclusion (projection):

• Peak-to-decline dynamics apply: demand is stable-to-declining in developed markets as PPIs and other agents absorb use cases.
• Volume can persist due to legacy prescribing and OTC availability, but value growth is constrained.

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What drives demand for TAGAMET going forward?

Key demand drivers are administrative and clinical rather than blockbuster innovation:

1. Formulary inertia and legacy utilization

   • Long-established regimens in hospitals and outpatient settings maintain baseline volumes.

2. Patient-level tolerability and cost

   • H2 blockers can remain the choice when PPIs are not preferred or when symptom patterns fit.

3. Regional access and pricing

   • In markets where specific H2 blockers are priced and stocked differently, cimetidine can retain intermittent share.

4. Prescriber familiarity

   • Despite safety and interaction concerns being well documented historically, cimetidine use persists in specific practice patterns.

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Are there new clinical-trial readouts that change the label or commercial prospects?

No. TAGAMET’s commercially relevant clinical narrative in recent years is dominated by mature-drug utilization rather than new pivotal outcomes that would:

• expand indications,
• extend exclusivity,
• or materially improve differentiation versus other acid suppressants.

In practical business terms, this means:

• R&D pipeline catalysts are absent for a material label expansion story.
• Commercial planning rests on generic manufacturing scale, supply continuity, and competitive pricing, not clinical re-positioning.

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How should investors and business planners project TAGAMET revenue?

Because TAGAMET is off-patent and operates in a commodity-like generics segment, the projection should be built on:

• price erosion rate
• volume retention
• share movement within H2 blockers
• regional footprint changes

Projection framework (directional):

Metric	Base case trajectory	Business meaning
Real-world demand	stable to slightly down	legacy use persists, substitution continues
Net selling price	down over time	generic competition and re-pricing cycles
Revenue	flat to declining	value erodes faster than volume stabilizes
Share	stable at low level or slowly drifting	determined by formulary decisions and supplier availability
Margin	compressed	manufacturing and contracting pressure

Working projection range (generic acid-suppression segment logic):

• Near term (1-2 years): flat-to-down low single digits on revenue
• Medium term (3-5 years): down mid single digits as pricing pressure persists and substitution to PPIs continues

This is a category-consistent view for an older H2 blocker where differentiation is limited and clinical practice is stable toward PPIs.

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What are the main risks to the downside/upside balance?

Downside risks

• Stronger PPI substitution driven by guideline adherence and payer protocols
• Further price compression among generic suppliers
• Reduced reimbursement support for older acid-suppressants in some systems

Upside risks

• OTC channel expansion in specific countries for certain symptom-based use patterns
• Short-term prescribing rebounds during PPI access or tolerability concerns
• Supplier consolidation that briefly supports pricing

These swings affect revenue, not clinical relevance.

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Commercial takeaways: how to treat TAGAMET in a portfolio

For R&D portfolios, TAGAMET is not a “pipeline story.” For commercial portfolios, the right treatment is:

• a supply-chain and pricing discipline case,
• a contracting and distribution case,
• a region-by-region volume retention case.

If a company holds manufacturing capability for cimetidine, value comes from minimizing cost variance, preventing stock-outs, and negotiating volume-based pharmacy and institutional contracts.

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Key Takeaways

• TAGAMET is cimetidine, a mature H2 blocker with a clinical footprint rooted in historical trials and routine use.
• The clinical-trials outlook is not dominated by new pivotal readouts that would change the label.
• The market is mature and price-competitive, with demand stable-to-declining and value constrained by generic price erosion and continued substitution toward PPIs.
• Revenue projections for the next 1-5 years are best treated as flat-to-declining under a commodity pricing model, with margin pressure the central constraint.
• Commercial success depends on pricing discipline, supply continuity, and formulary/contract execution, not differentiation through new clinical efficacy.

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FAQs

1. Is TAGAMET still used for ulcer disease and GERD symptoms?
Yes. Cimetidine use persists for acid-related conditions, but treatment pathways increasingly favor PPIs for many GERD and ulcer-related indications.

2. Does TAGAMET have ongoing Phase 3 development that could renew exclusivity?
No. The drug does not have an active late-stage development profile that would materially alter exclusivity or label scope in the near term.

3. How does cimetidine differ commercially from famotidine and PPIs?
Commercially it competes on availability and price within H2 blockers, while PPIs typically dominate clinical pathways where stronger acid suppression is preferred.

4. What is the dominant factor for revenue changes for TAGAMET?
Generic price erosion and payer/formulary dynamics. Volume retention plays a secondary role.

5. What is the main strategic lever for companies selling TAGAMET?
Cost-efficient manufacturing and contracting execution to defend net selling price and institutional/OTC volume.

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References

[1] APA: FDA. Drug Labeling (cimetidine products) and associated prescribing information for TAGAMET and authorized generic equivalents. U.S. Food and Drug Administration.
[2] APA: NICE. Gastro-oesophageal reflux disease and dyspepsia management guidance (context for acid suppression therapy sequencing). National Institute for Health and Care Excellence.
[3] APA: EMA. Assessment and public summaries related to H2-receptor antagonists and historical therapeutic positioning for acid-related disorders. European Medicines Agency.