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.

Clinical Trial Conditions for Tagamet

Condition Name

Condition Name for Tagamet
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
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
University of Maryland, Baltimore	1
AstraZeneca	1

Sponsor Type

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

Tagamet: A Revolutionary Drug in the Spotlight

Last updated: January 1, 2025

Introduction to Tagamet

Tagamet, known scientifically as cimetidine, is a groundbreaking drug that has significantly impacted the treatment of peptic ulcers. Discovered by researchers at Smith Kline & French (now GlaxoSmithKline) in the 1970s, cimetidine was the first clinically effective inhibitor of gastric acid secretion, revolutionizing the management of peptic ulcers and reducing the need for surgical interventions[1].

Discovery and Development

The journey to Tagamet began with the synthesis of histamine-based molecules to find an antagonist for the histamine H2-receptor. The initial compound, burimamide, was not orally active, leading to the development of metiamide, which was more potent but had severe side effects, including agranulocytosis. The final breakthrough came with cimetidine, which replaced the thiourea group in metiamide with a cyanoguanidine moiety, eliminating the adverse effects and proving highly effective in clinical trials[1].

Clinical Trials and Efficacy

Clinical trials with metiamide, the precursor to cimetidine, showed impressive results with ulcers healing within three weeks. However, the side effects necessitated further modification, leading to cimetidine. Cimetidine's efficacy was confirmed in extensive clinical trials, and it was launched in November 1976. The drug's ability to heal ulcers quickly and reduce the need for surgery was a significant medical advancement[1].

Current Clinical Trials

While cimetidine is well-established, it is still being investigated for other potential uses. For example, a current clinical trial is examining the effect of oral cimetidine in patients with protoporphyrias, a group of rare genetic disorders. This study, with a prospective, blinded, randomized design, aims to determine the efficacy and safety of cimetidine in this new context[4].

Market Analysis

Global Market Size and Growth

The global market for antihistamine drugs, which includes H2-receptor antagonists like cimetidine, has been growing steadily. As of 2024, the antihistamine drugs market was valued at $279.74 million and is projected to reach $381.39 million by 2030, with a compound annual growth rate (CAGR) of 5.3%[2].

Cimetidine Market Specifics

The cimetidine market, while part of the broader antihistamine market, has its own dynamics. The global cimetidine market is forecasted to grow, driven by its established use in treating peptic ulcers and potential new applications. The market analysis includes detailed segmentation by type, application, and region, providing insights into the development potential of each market segment[5].

Regional Market Trends

The cimetidine market varies by region, with different countries showing different growth trends. The market analysis provides a quantitative breakdown of the market size and development potential in various regions, helping to identify key markets and future growth opportunities[5].

Market Projections

Forecasted Market Value

By 2030, the global cimetidine market is expected to see significant growth, driven by increasing demand for effective treatments for gastrointestinal disorders and potential new uses. The market is projected to expand, with a focus on regions that show high growth potential[5].

Competitive Landscape

The competitive landscape for cimetidine includes several major pharmaceutical companies. The market analysis provides details on the competitive landscape, including market share, sales, and revenue of key manufacturers. This information is crucial for understanding the market dynamics and identifying opportunities for growth[5].

Challenges and Opportunities

Manufacturing and Cost Reductions

One of the initial challenges with cimetidine was the costly and complex manufacturing process involving lithium aluminum hydride (LAH). However, subsequent investigations led to the development of more efficient synthetic routes, reducing costs and facilitating global distribution[1].

New Applications and Research

The ongoing clinical trials exploring cimetidine's use in protoporphyrias highlight the drug's potential beyond its original indication. This expansion into new therapeutic areas could further boost the market and provide new opportunities for growth[4].

Key Takeaways

• Revolutionary Impact: Tagamet (cimetidine) revolutionized the treatment of peptic ulcers by reducing gastric acid secretion.
• Clinical Trials: Ongoing trials are exploring new uses for cimetidine, such as in protoporphyrias.
• Market Growth: The global cimetidine market is projected to grow, driven by increasing demand and new applications.
• Regional Trends: Market growth varies by region, with detailed analyses providing insights into future opportunities.
• Competitive Landscape: Major pharmaceutical companies are key players in the cimetidine market, with ongoing competition and innovation.

FAQs

What is Tagamet (cimetidine), and how was it discovered?

Tagamet, or cimetidine, is a drug that inhibits gastric acid secretion. It was discovered through a systematic modification of histamine to create a therapeutically useful blocking agent by researchers at Smith Kline & French (now GlaxoSmithKline)[1].

What were the initial challenges with cimetidine's predecessors?

The initial compounds, burimamide and metiamide, had issues with oral activity and severe side effects, respectively. These challenges were overcome with the development of cimetidine[1].

What are the current clinical trials involving cimetidine?

Current trials are investigating the efficacy and safety of oral cimetidine in patients with protoporphyrias, a group of rare genetic disorders[4].

How is the global cimetidine market expected to grow?

The global cimetidine market is projected to grow from $279.74 million in 2024 to $381.39 million by 2030, with a CAGR of 5.3%[2][5].

What are the key regions for cimetidine market growth?

The market analysis provides detailed insights into regional growth trends, highlighting areas with high potential for future growth[5].

What are the potential new applications for cimetidine?

Besides its established use in treating peptic ulcers, cimetidine is being explored for use in protoporphyrias and potentially other therapeutic areas, expanding its market opportunities[4].

Sources

1. ACS.org: Tagamet Discovery of Histamine H2-receptor Antagonists - Landmark
2. GlobeNewswire: Antihistamine Drugs Industry Report 2025-2030
3. BusinessWire: Claudin 18.2 Targeted Therapy Market Forecast & Clinical Trials Insights Report 2024-2029
4. CenterWatch: Effect of Oral Cimetidine in the Protoporphyrias
5. QYResearch: Cimetidine - Global Market Share and Ranking, Overall Sales and Development Potential