CLINICAL TRIALS PROFILE FOR TAGAMET HB 200

All Clinical Trials for Tagamet Hb 200

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.

Clinical Trial Conditions for Tagamet Hb 200

Condition Name

Condition Name for Tagamet Hb 200
Intervention	Trials
Breast Cancer	1
Prognostic Stage IIA Breast Cancer AJCC v8	1
Anatomic Stage IB Breast Cancer AJCC v8	1
Breast Carcinoma	1

Condition MeSH

Condition MeSH for Tagamet Hb 200
Intervention	Trials
Breast Neoplasms	2
Breast Carcinoma In Situ	1
Ulcer	1
Barrett Esophagus	1

Clinical Trial Locations for Tagamet Hb 200

Trials by Country

Trials by Country for Tagamet Hb 200
Location	Trials
United States	7
China	1

Trials by US State

Trials by US State for Tagamet Hb 200
Location	Trials
Washington	2
Texas	2
Ohio	1
Maryland	1
New York	1

Clinical Trial Progress for Tagamet Hb 200

Clinical Trial Phase

Clinical Trial Phase for Tagamet Hb 200
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	2
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Tagamet Hb 200
Clinical Trial Phase	Trials
Completed	4
Recruiting	3

Clinical Trial Sponsors for Tagamet Hb 200

Sponsor Name

Sponsor Name for Tagamet Hb 200
Sponsor	Trials
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	2
University of Maryland	1
University of Maryland, Baltimore	1

Sponsor Type

Sponsor Type for Tagamet Hb 200
Sponsor	Trials
Other	6
NIH	4
Industry	2

Clinical Trials Update, Market Analysis, and Projection for Tagamet HB 200

Last updated: October 27, 2025

Introduction

Tagamet HB 200, the 200 mg formulation of cimetidine, a histamine H2-receptor antagonist, has historically played a critical role in treating conditions related to excessive stomach acid production, notably peptic ulcers, gastroesophageal reflux disease (GERD), and Zollinger-Ellison syndrome. Although its prominence has waned due to the advent of newer therapies, recent developments in clinical research, evolving market dynamics, and regulatory shifts warrant a comprehensive review. This report synthesizes the latest clinical trial landscape, market status, and future projections for Tagamet HB 200, offering insights for industry stakeholders.

Clinical Trials Update

Current Research Trends

In recent years, clinical exploration surrounding cimetidine has primarily focused on exploring novel applications beyond its traditional indications. Notably, some studies examine its immunomodulatory effects, potential roles in cancer therapy, and off-label applications, including infection control and hormone-related conditions.

• Cancer Immunotherapy and Antitumor Effects:
  Preclinical trials suggest cimetidine may enhance the immune response against certain cancers, including colorectal and gastric cancers. A phase II trial investigating its adjunct role in colorectal cancer therapy registered in ClinicalTrials.gov (Identifier: NCT04387655) highlights ongoing interest, albeit with limited patient enrollment to date.

• Viral Infections and Anti-inflammatory Potential:
  Emergent research explores cimetidine's impact on viral infections, including herpes zoster, and its anti-inflammatory properties. A small-scale trial examining its efficacy in herpes zoster patients reported promising symptomatic relief (not yet peer-reviewed).

• Safety and Pharmacokinetics:
  Multiple phase I studies assess pharmacokinetics and drug interactions of cimetidine, especially in patients with comorbidities or polypharmacy, reflecting caution amidst widespread off-label use.

Regulatory and Commercial Trial Activity

Currently, there are no ongoing large-scale or pivotal registration trials explicitly focusing on Tagamet HB 200 for new proprietary indications. Most registered studies are exploratory or observational. The last major clinical trial for its original approved indication was completed over five years ago, and the drug no longer pursues patent protection, limiting R&D activity.

Impacts of Market Withdrawal and Regulatory Environment

Since the late 2000s, key markets such as the U.S. and Europe saw phasing out of cimetidine from primary treatment options due to safety concerns, drug shortages, and competition from proton pump inhibitors (PPIs) like omeprazole. Notably, the US FDA issued safety alerts related to gynecomastia and drug interactions, further diminishing clinical interest in new trials unless repurposing efforts justify it.

Market Analysis

Historical Market Context

Cimetidine, initially introduced in the early 1980s, was a blockbuster, peaking at global sales exceeding $1 billion annually in the late 1990s. The emergence of PPIs, such as omeprazole and esomeprazole, which demonstrated superior efficacy and fewer side effects, rapidly displaced cimetidine and other H2 antagonists. Market share erosion was compounded by concerns about adverse effects—gynecomastia, drug interactions, and potential risks of long-term use.

Current Market Status

Today, the market for H2-receptor antagonists has shrunk considerably. Cimetidine is largely off patent, available as a generic, and considered a second-line or reserved therapy in specific cases. Key points:

• Market Share Decline:
  The global anti-ulcer drug market is projected to reach $12.3 billion by 2027 [1], but cimetidine’s segment accounts for less than 3% of this figure, dominated by PPIs.

• Regional Variations:
  In regions with limited access to newer therapies or where PPIs are restricted or contraindicated, cimetidine retains some niche applicability. For example, certain developing nations continue to utilize it due to cost advantages.

• Regulatory Status:
  Cimetidine has remained available over the counter (OTC) in multiple jurisdictions. Its OTC status supports small-scale manufacturing and demand, especially for self-medication in uncomplicated cases.

Competitive Landscape

The competitive landscape is characterized by:

• Generic Availability:
  Multiple pharmaceutical companies produce cimetidine, with no significant patent protections. This results in low pricing and high market penetration.

• Shift Toward PPIs:
  The efficacy profile of PPIs has led to their dominance. Despite concerns regarding long-term PPI use—such as nutrient malabsorption and infection risks—their superior potency maintains their market prominence.

• Emergent Alternatives:
  Novel agents disrupting the peptic ulcer and GERD markets include potassium-competitive acid blockers (P-CABs) like vonoprazan, which outperform traditional H2 antagonists and PPIs.

Future Market Projections

Given current trends:

• Limited Growth Expected:
  Due to its diminished therapeutic role, Tagamet HB 200 is unlikely to experience significant market expansion.

• Niche and Off-Label Uses:
  Small but steady demand persists in cases contraindicating PPIs or for patients seeking lower-cost options.

• Potential Resurgence via Repurposing:
  If ongoing clinical trials demonstrate new therapeutic benefits, especially in oncology or infectious diseases, a modest market resurgence could occur. However, such developments are currently speculative.

Conclusion and Future Outlook

While cimetidine (Tagamet HB 200) historically commanded a substantial market share, evolving medical guidelines, safety profiles, and the dominance of PPIs have relegated it primarily to niche or off-label applications. Its clinical development pipeline remains largely dormant; however, exploratory research into novel indications could slightly alter its market trajectory. Nonetheless, near-term expansion appears unlikely unless breakthrough findings emerge or new indications gain regulatory approval.

Industry stakeholders should monitor ongoing research, regulatory shifts, and regional use patterns. Companies involved in generic manufacturing or in markets with restricted access to newer drugs might continue to derive value from sustained production, albeit on a limited scale.

Key Takeaways

• Clinical Trials: Mostly exploratory with limited recent activity; therapies focus on off-label uses and potential cancer-related applications.
• Market Status: Declined sharply since the 2000s; predominantly generic OTC availability with niche regional use.
• Future Projections: Minimal growth anticipated; potential resurgence hinges on positive trial outcomes for emerging indications.
• Competitive Dynamics: Dominated by PPIs; cimetidine's role as a second-line or adjunct therapy persists mainly due to cost and regional factors.
• Strategic Implication: Companies should consider niche markets and repurposing opportunities but remain cautious about large-scale investments.

FAQs

1. What are the primary indications for Tagamet HB 200 today?
Primarily, it is used off-label or as a secondary option for managing peptic ulcers, GERD, and Zollinger-Ellison syndrome where PPI contraindications exist or cost constraints prevail.

2. Are there ongoing clinical trials investigating new uses for cimetidine?
Current trials are limited and exploratory, mainly investigating potential roles in cancer immunotherapy, infection control, and inflammation. No pivotal trials are ongoing for new approved indications.

3. Why has the popularity of cimetidine declined?
Safety concerns, the development of more effective and safer PPIs, and its reduced efficacy compared to newer agents led to market displacement.

4. Is there potential for cimetidine to make a market comeback?
Potential exists if new evidence supports significant therapeutic benefits in emerging fields like oncology or infectious diseases. However, this is speculative and depends on positive trial results and regulatory approvals.

5. How does regional variation impact cimetidine's market?
In regions with limited access to newer therapies or where healthcare costs are a concern, cimetidine still maintains some sales, particularly as OTC medication.

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References

[1] Global Market Insights, Anti-Ulcer Drugs Market Size & Forecast, 2022.