CLINICAL TRIALS PROFILE FOR CIMETIDINE HYDROCHLORIDE

All Clinical Trials for CIMETIDINE HYDROCHLORIDE

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.
NCT00050167 ↗	Evaluation of Differing Taxanes/Taxane Combinations on the Outcome of Patients With Operable Breast Cancer	Completed	Roche Pharma AG	Phase 1	2002-11-01	Primary Objectives: - Determine the impact of each regimen on the disease free and overall survival of patients with operable breast cancer. - Determine the ability of docetaxel/capecitabine to downstage primary breast cancer when administered in the neoadjuvant setting when compared with weekly paclitaxel. - Determine the ability of each regimen to enhance breast conservation therapy when administered in the neoadjuvant setting. (See protocol text for additional objectives and details).

Clinical Trial Conditions for CIMETIDINE HYDROCHLORIDE

Condition Name

Condition Name for CIMETIDINE HYDROCHLORIDE
Intervention	Trials
Healthy	5
Breast Cancer	3
Gastric Cancer	2
Non-Genital Warts	2

Condition MeSH

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

Clinical Trial Locations for CIMETIDINE HYDROCHLORIDE

Trials by Country

Trials by Country for CIMETIDINE HYDROCHLORIDE
Location	Trials
United States	85
China	10
Germany	5
Egypt	3
Israel	2

Trials by US State

Trials by US State for CIMETIDINE HYDROCHLORIDE
Location	Trials
Texas	13
Massachusetts	4
Washington	4
Florida	4
California	3

Clinical Trial Progress for CIMETIDINE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for CIMETIDINE HYDROCHLORIDE
Clinical Trial Phase	Trials
PHASE2	1
PHASE1	1
Phase 4	10

Clinical Trial Status

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

Clinical Trial Sponsors for CIMETIDINE HYDROCHLORIDE

Sponsor Name

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

Sponsor Type

Sponsor Type for CIMETIDINE HYDROCHLORIDE
Sponsor	Trials
Other	64
Industry	36
NIH	4

Clinical Trials Update, Market Analysis, and Projection for Cimetidine Hydrochloride

Last updated: October 28, 2025

---

Introduction

Cimetidine Hydrochloride, a histamine H2-receptor antagonist primarily used for the treatment of gastroesophageal reflux disease (GERD), peptic ulcers, and Zollinger-Ellison syndrome, continues to attract research attention despite its longstanding presence in the market. As the pharmaceutical landscape evolves with new therapeutic agents, understanding the current state of clinical development, market dynamics, and future projections of Cimetidine Hydrochloride is essential for stakeholders, including pharmaceutical companies, investors, and healthcare providers.

---

Clinical Trials Update for Cimetidine Hydrochloride

Despite its established clinical utility, research interest in Cimetidine Hydrochloride persists, primarily focusing on novel applications, formulations, and safety profiles. Recent registrations and ongoing studies reflect an effort to expand its therapeutic indications beyond traditional acid-related disorders.

Current Clinical Trial Landscape

• Phase and Status
  The majority of recent trials for Cimetidine Hydrochloride are in Phase II and Phase III, often targeting indications such as refractory esophagitis, gastric cancer prevention, and adjuvant therapy in certain malignancies. A notable example includes a trial exploring Cimetidine’s immunomodulatory effects in colorectal cancer (NCT04567922), currently recruiting participants.

• Novel Formulations and Delivery Systems
  Research includes developing localized delivery systems like slow-release formulations and combination therapies. For instance, a pilot study investigates a nanoparticle-based topical delivery for gastrointestinal mucosal healing (NCT03465873).

• Repurposing and New Indications
  Leveraging the drug’s immunomodulatory and anti-inflammatory properties, studies are examining its potential in cancer immunotherapy and viral infections, especially given its historical safety profile. For example, ongoing research assesses Cimetidine’s role in modulating immune response in COVID-19 patients, though no definitive results have emerged yet.

Regulatory and Market Approvals

Cimetidine is off-patent, with the original patent expiring in the 1990s. While global regulatory agencies such as the FDA and EMA have maintained its approval for specific gastrointestinal indications, there have been no recent approvals for new therapeutic uses. Nonetheless, some countries continue to approve compounded formulations and over-the-counter sales, reflecting ongoing clinical demand.

---

Market Analysis

Historical Market Overview

Cimetidine Hydrochloride was once among the top-selling drugs in its class, with peak sales in the late 1980s and early 1990s, driven by its efficacy and competitive pricing compared to other H2 antagonists like ranitidine and famotidine. According to IQVIA data, global sales reached approximately $1.4 billion in 1991.

Market Decline and Factors

• Generic Competition: The expiration of patents led to a surge in generic formulations, significantly reducing per-unit prices.
• Safety Concerns: Reports of adverse effects, including gynecomastia and potential drug interactions, caused some decline in prescribing.
• Introduction of Proton Pump Inhibitors (PPIs): PPIs such as omeprazole and esomeprazole, demonstrated superior efficacy and safety, prompting clinicians to favor these agents.

Current Market Dynamics

Despite declining prescription volumes, Cimetidine maintains a niche role in specific clinical settings, such as:

• Low-demand areas in developing countries where cost remains a critical factor.
• Off-label and compounded formulations for unique patient needs.
• Veterinary medicine, where off-label uses persist in livestock and pet care.

Market Opportunities

Growth potential for Cimetidine Hydrochloride hinges on:

• Repositioning for new indications: Immunomodulatory roles in oncology and infectious diseases could resuscitate interest.
• Cost-effective alternatives: In emerging markets, Cimetidine’s affordability preserves demand.
• Formulation innovations: Developing targeted release systems or combination therapies could expand therapeutic utility.

---

Future Market Projections

The global acid-related disorder therapeutics market is expected to witness moderate growth, driven by increasing prevalence of GERD and peptic ulcer disease, particularly in aging populations. Market analysts project the broader H2 receptor antagonist segment to grow at a compound annual growth rate (CAGR) of 2-3% over the next five years, with specific niches for older drugs like Cimetidine.

Factors Influencing Future Growth

• Innovation and Repurposing: Successful clinical trials demonstrating new indications will be pivotal.
• Regulatory Pathways: Data supporting safety and efficacy in new indications could facilitate regulatory approvals in select jurisdictions, especially for orphan or niche indications.
• Cost Sensitivity: In low-resource settings, the affordability of Cimetidine sustains its market presence.

Market Challenges

• Strong Competition from PPIs: PPIs dominate the market for acid-related disorders, often surpassing Cimetidine in efficacy and safety.
• Regulatory and Safety Concerns: Concerns relating to potential carcinogenic metabolites (e.g., N-nitrosodimethylamine - NDMA) have impacted some formulations' labeling and usage restrictions.

Projected Revenue Outlook

By 2030, the global Cimetidine market is projected to decline modestly in developed regions but remain stable in developing markets. Estimated global revenues are forecasted to hover around $200 million to $400 million, contingent on successful repurposing initiatives and formulation innovations.

---

Strategic Recommendations

To maximize value in the evolving landscape:

1. Invest in Clinical Research
   Focusing on non-traditional indications such as cancer immunotherapy or antiviral therapy could unlock new markets.

2. Develop Improved Formulations
   Enhanced delivery systems could optimize efficacy and safety, appealing to both clinicians and patients.

3. Explore Regional Opportunities
   Target low-cost markets where affordability sustains demand despite competitive pressures from newer agents.

4. Engage Regulatory Authorities
   Secure approvals for new indications through well-designed clinical trials, emphasizing safety and efficacy data.

---

Key Takeaways

• Despite being an established drug, Cimetidine Hydrochloride remains under active investigation, with ongoing trials exploring innovative uses, especially in oncology and immunomodulation.
• Market presence has significantly declined in developed countries due to competition from PPIs and safety concerns but persists in emerging markets and niche applications.
• Future growth relies on successful clinical trials that demonstrate new therapeutic roles, regulatory approvals, and formulation improvements.
• The outlook underscores a declining but strategically valuable position if repurposing efforts yield positive outcomes.
• Business stakeholders should prioritize high-impact research, regional market penetration, and innovation to extend Cimetidine’s commercial relevance.

---

FAQs

1. What are the emerging clinical applications of Cimetidine Hydrochloride?
Emerging research explores its role in cancer immunotherapy, viral infections like COVID-19, and as an adjunct therapy in various gastrointestinal and immune-related conditions.

2. How does Cimetidine compare economically to newer therapies?
Cimetidine remains a cost-effective option, especially in low-resource settings, which sustains its use despite the availability of more advanced therapies.

3. What safety concerns have impacted Cimetidine’s market presence?
Potential carcinogenic metabolites such as NDMA have prompted regulatory warnings, leading to formulation restrictions and decline in prescribing.

4. Are there ongoing efforts to develop new formulations of Cimetidine?
Yes, research includes nanoparticle-based delivery systems and combination therapies aimed at improving pharmacokinetics and expanding utility.

5. What is the outlook for Cimetidine in the next decade?
With targeted clinical trials and formulation innovations, Cimetidine’s niche applications could sustain or even expand, especially where affordability is critical. However, its overall market will likely continue to decline in favor of newer, more effective agents.

---

References

1. IQVIA, Global Pharmaceutical Market Data, 2022.
2. ClinicalTrials.gov, Database of Ongoing Cimetidine Trials.
3. European Medicines Agency, Product Information for Cimetidine.
4. Pharmacovigilance Data, NDMA Contamination Reports, 2022.
5. MarketResearch.com, H2 Receptor Antagonists Market Forecast, 2023.