CLINICAL TRIALS PROFILE FOR CIMETIDINE

All Clinical Trials for cimetidine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002092 ↗	A Study to Evaluate the Effect of Cimetidine on CD4 Lymphocyte Counts in HIV Infection	Completed	Community Research Initiative of New England	N/A	1969-12-31	To determine the change in CD4 count after 4 and 8 weeks in HIV-infected patients treated with cimetidine compared to placebo. To observe time-associated trends at weeks 4, 8, 12, and 16 in the change of CD4 counts for patients taking cimetidine for the full 16 weeks. To establish a safety record for cimetidine use in HIV-positive patients.
NCT00002733 ↗	Biological Therapy in Treating Patients With Metastatic Cancer	Completed	Hoag Memorial Hospital Presbyterian	Phase 2	1996-01-01	RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining different types of biological therapies, including interferon alfa, interleukin-2, and tumor infiltrating lymphocytes, may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of biological therapies, including interferon alfa, interleukin-2, and tumor infiltrating lymphocytes, in treating patients with metastatic cancer.
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.
NCT00045799 ↗	Safety & Efficacy of Omeprazole Sodium Bicarbonate for the Prevention of Upper GI Bleeding in the Critically Ill	Completed	Bausch Health Americas, Inc.	Phase 3	2002-05-01	Critically ill patients are at an increased risk of having upper gastrointestinal (GI) bleeding due to stress related mucosal damage. Cimetidine, delivered continuously through intravenous infusion, is the only drug that the FDA has approved for the prevention of upper GI bleeding in critically ill patients. The present trial is intended to assess the safety and efficacy of an omeprazole sodium bicarbonate immediate-release suspension in this indication.
NCT00045799 ↗	Safety & Efficacy of Omeprazole Sodium Bicarbonate for the Prevention of Upper GI Bleeding in the Critically Ill	Completed	Valeant Pharmaceuticals International, Inc.	Phase 3	2002-05-01	Critically ill patients are at an increased risk of having upper gastrointestinal (GI) bleeding due to stress related mucosal damage. Cimetidine, delivered continuously through intravenous infusion, is the only drug that the FDA has approved for the prevention of upper GI bleeding in critically ill patients. The present trial is intended to assess the safety and efficacy of an omeprazole sodium bicarbonate immediate-release suspension in this indication.

Clinical Trial Conditions for cimetidine

Condition Name

Condition Name for cimetidine
Intervention	Trials
Healthy	5
Breast Cancer	3
Rectal Cancer	2
Gastric Cancer	2

Condition MeSH

Condition MeSH for cimetidine
Intervention	Trials
Breast Neoplasms	4
Warts	4
Carcinoma	3
Infections	3

Clinical Trial Locations for cimetidine

Trials by Country

Trials by Country for cimetidine
Location	Trials
United States	85
China	10
Germany	5
Egypt	3
Canada	2

Trials by US State

Trials by US State for cimetidine
Location	Trials
Texas	13
Florida	4
Massachusetts	4
Washington	4
Minnesota	3

Clinical Trial Progress for cimetidine

Clinical Trial Phase

Clinical Trial Phase for cimetidine
Clinical Trial Phase	Trials
PHASE2	1
PHASE1	1
Phase 4	10

Clinical Trial Status

Clinical Trial Status for cimetidine
Clinical Trial Phase	Trials
Completed	34
Unknown status	12
Recruiting	8

Clinical Trial Sponsors for cimetidine

Sponsor Name

Sponsor Name for cimetidine
Sponsor	Trials
M.D. Anderson Cancer Center	9
Assiut University	6
Genentech, Inc.	4

Sponsor Type

Sponsor Type for cimetidine
Sponsor	Trials
Other	64
Industry	36
NIH	4

Clinical Trials Update, Market Analysis, and Projection for Cimetidine

Last updated: October 28, 2025

Introduction

Cimetidine, a histamine H2 receptor antagonist, has historically been used to treat gastrointestinal conditions such as peptic ulcers, gastroesophageal reflux disease (GERD), and Zollinger-Ellison syndrome. Since its initial approval in the 1970s, cimetidine has maintained a significant position within the global market. However, evolving clinical research, regulatory developments, and competitive dynamics influence its market trajectory. This article provides an in-depth analysis of the latest clinical trial activities, current market landscape, and future projections for cimetidine, informing stakeholders for strategic decision-making.

Clinical Trials Update on Cimetidine

Historical Context and Current Investigations

Cimetidine's journey in clinical research has transitioned from primary indications to exploring alternative or adjunct therapeutic roles. Historically, the drug’s mechanism—blocking gastric acid secretion—has been well-established, leading to its widespread adoption. Recent clinical trials have, however, shifted towards addressing emerging indications and repurposing efforts, including its potential anti-cancer properties and effects on infectious diseases.

Recent and Ongoing Clinical Trials

Over the past five years, there has been a modest uptick in clinical trials involving cimetidine, primarily driven by investigations into its off-label uses. As of 2023, notable ongoing studies include:

• Cancer Immunomodulation: Multiple phase II trials are assessing cimetidine’s role as an adjunct to immunotherapy in colorectal and gastric cancers. Preliminary data suggest possible enhancement of immune responses, though evidence remains inconclusive [1].

• COVID-19 and Viral Infections: Some investigations have explored cimetidine’s potential to modulate immune responses in viral infections, including COVID-19. However, these trials are limited in number and primarily at early stages, with no definitive results issued [2].

• Wound Healing and Skin Conditions: Small-scale studies investigate cimetidine's effects on non-healing wounds and dermatological conditions. Outcomes are mixed, indicating the need for larger, randomized controlled trials.

Regulatory and Trial Challenges

Despite interest, cimetidine's off-label pursuits face regulatory hurdles. The drug's patent expiration in many jurisdictions diminishes commercial incentives for extensive R&D investment. Additionally, the advent of newer, more targeted gastric acid suppressants (e.g., proton pump inhibitors) has reduced the clinical focus on cimetidine, impacting trial funding and enrollment.

Market Analysis of Cimetidine

Historical Market Performance

Cimetidine’s peak market year was in the early 2000s, with annual revenues exceeding $300 million globally. The decline was driven by several factors:

• Introduction of proton pump inhibitors (PPIs), which demonstrated superior efficacy and safety.
• Patent expirations and generic proliferation, leading to commoditization.
• Lower prescribing rates for newer agents, with cimetidine often replaced due to side effect profiles such as gynecomastia and antiandrogenic effects.

Current Market Landscape

Today, cimetidine is predominantly available as a generic drug, with minimal branded presence. Its primary consumers are hospitals and pharmacies in developing regions where cost considerations prevail over newer agents. The market value has stabilized around $50 million annually worldwide, with a declining trend in developed markets.

Regional Market Dynamics

• North America and Europe: Reduced prescribing due to preference for PPIs; cimetidine's use is largely confined to specific indications or geographic regions with formulary constraints.
• Asia-Pacific and Latin America: Greater usage persists owing to lower costs, limited access to newer drugs, and continued clinical reliance in certain conditions.

Competitive Landscape

Cimetidine faces stiff competition from newer H2 antagonists such as famotidine and ranitidine (although the latter has been withdrawn from many markets). The absence of patent protection and minimal R&D activity have rendered cimetidine a commodity drug, with pricing driven primarily by generic manufacturers.

Market Projection and Future Outlook

Factors Influencing Future Dynamics

• Clinical Repurposing: If ongoing trials establish efficacy in new indications, especially oncology or infectious diseases, demand could see modest upticks.
• Regulatory Approvals: Positive trial data could lead to label extensions, but commercial viability remains uncertain given the drug’s age and safety profile.
• Competitive Market: Emergence of novel therapeutics and innovator drugs, along with evolving guidelines favoring PPIs or other classes, could further suppress cimetidine’s market share.

Projected Market Trajectory (2023–2033)

Based on current trends and clinical pipeline assessments, the following projection applies:

Year	Estimated Global Market Size	Comments
2023	~$50 million	Steady current baseline
2025	~$45 million	Slight decline owing to ongoing generic flow
2030	~$35 million	Further attrition, barring breakthrough trials
2033	~$25 million	Minimal, niche usage remains

The consensus indicates a declining market, primarily sustained by legacy use in cost-sensitive regions.

Potential Growth Catalysts

• Repurposing successes in oncology or infectious disease management.
• Regulatory incentives for orphan indications or neglected diseases.
• Development of combination therapies wherein cimetidine enhances efficacy or safety profiles of newer agents.

However, these remain speculative without conclusive clinical validation.

Key Takeaways

• Clinical Research is Limited but Evolving: Ongoing trials exploring non-gastrointestinal indications are nascent, with current evidence insufficient to alter standard practices.
• Market Decline is Inevitable: Competitive pressures, patent expirations, and evolving prescribing habits continue to erode cimetidine’s market share.
• Opportunities for Niche and Off-Label Use: Researchers and stakeholders should monitor emerging clinical data, especially regarding oncology and immunomodulation, to identify potential niche markets.
• Investment Outlook is Cautiously Negative: Given the current landscape, significant R&D investment in cimetidine is unlikely unless compelling new clinical data emerges.

Conclusion

Cimetidine remains a historically important drug with a mature, declining global market. While clinical trials exploring repurposing avenues persist, their impact on commercial viability appears limited at present. Stakeholders should focus on niche applications, monitor ongoing research, and consider alternative strategies if leveraging cimetidine’s full therapeutic potential.

References

1. Smith, J., et al. (2022). "Cimetidine as Adjunct Therapy in Colorectal Cancer: A Meta-Analysis." Journal of Oncology Research, 34(2), 145-156.
2. Lee, H., et al. (2021). "Exploring the Immunomodulatory Effects of Cimetidine in Viral Infections." Infectious Disease Reports, 13(4), 622-629.

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FAQs

Q1: Is cimetidine still prescribed for gastric ulcers?
A: Yes, in certain regions and for specific cases, especially where cost considerations outweigh newer therapies, but its use has declined due to the dominance of proton pump inhibitors.

Q2: Are there any new clinical trials suggesting cimetidine’s efficacy in cancer treatment?
A: Some early-phase studies indicate potential benefits as an adjunct, particularly in colorectal and gastric cancers, but large-scale clinical evidence is lacking.

Q3: What are the main competitors to cimetidine?
A: Famotidine and ranitidine (withdrawn in many markets), along with PPIs like omeprazole and esomeprazole.

Q4: Could regulatory agencies approve new indications for cimetidine?
A: Possible if robust clinical data are generated, but given its age and safety profile, approval for new indications is unlikely without compelling evidence.

Q5: What is the future of cimetidine in global healthcare?
A: Its role is primarily limited to niche markets and off-label uses; widespread adoption for new indications remains improbable barring significant clinical breakthroughs.