CLINICAL TRIALS PROFILE FOR CHOLYBAR

All Clinical Trials for CHOLYBAR

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT05443425 ↗	Leflunomide in Combination With Steroids for the Treatment of Acute Graft-versus-Host Disease After Donor Stem Cell Transplant for Hematologic Malignancies	Not yet recruiting	National Cancer Institute (NCI)	Phase 1	2022-12-10	This phase I trial tests the safety and side effects of leflunomide in combination with steroids in treating patients with acute graft versus host disease who have undergone done stem cell transplant for blood cancers (hematologic malignancies). Sometimes the transplanted cells from a donor can attack the body's normal cells (called graft-versus-host disease). Leflunomide and steroids are immunosuppressive drugs that work in different ways to lower the body's immune response so that the new donor immune cells do not attack the body's normal cells. Giving leflunomide in combination with steroids may help treat acute graft versus host disease in patients after stem cell transplant for hematologic malignancies.
NCT05443425 ↗	Leflunomide in Combination With Steroids for the Treatment of Acute Graft-versus-Host Disease After Donor Stem Cell Transplant for Hematologic Malignancies	Not yet recruiting	City of Hope Medical Center	Phase 1	2022-12-10	This phase I trial tests the safety and side effects of leflunomide in combination with steroids in treating patients with acute graft versus host disease who have undergone done stem cell transplant for blood cancers (hematologic malignancies). Sometimes the transplanted cells from a donor can attack the body's normal cells (called graft-versus-host disease). Leflunomide and steroids are immunosuppressive drugs that work in different ways to lower the body's immune response so that the new donor immune cells do not attack the body's normal cells. Giving leflunomide in combination with steroids may help treat acute graft versus host disease in patients after stem cell transplant for hematologic malignancies.
NCT05014646 ↗	Leflunomide for the Treatment of High-Risk Smoldering Multiple Myeloma in African-American and European-American Patients	Recruiting	National Cancer Institute (NCI)	Phase 2	2021-11-15	This phase II trial studies the effects of leflunomide in treating African-American and European-American patients with high-risk smoldering multiple myeloma. Leflunomide is used to decrease the body's immune response and may delay the symptoms of multiple myeloma in patients of African-American and European decent.
NCT05014646 ↗	Leflunomide for the Treatment of High-Risk Smoldering Multiple Myeloma in African-American and European-American Patients	Recruiting	City of Hope Medical Center	Phase 2	2021-11-15	This phase II trial studies the effects of leflunomide in treating African-American and European-American patients with high-risk smoldering multiple myeloma. Leflunomide is used to decrease the body's immune response and may delay the symptoms of multiple myeloma in patients of African-American and European decent.

Clinical Trial Conditions for CHOLYBAR

Condition Name

Condition Name for CHOLYBAR
Intervention	Trials
Acute Graft Versus Host Disease	1
Hematopoietic and Lymphoid System Neoplasm	1
Smoldering Plasma Cell Myeloma	1

Condition MeSH

Condition MeSH for CHOLYBAR
Intervention	Trials
Graft vs Host Disease	1
Smoldering Multiple Myeloma	1
Neoplasms, Plasma Cell	1
Multiple Myeloma	1

Clinical Trial Locations for CHOLYBAR

Trials by Country

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−

Trials by Country for CHOLYBAR
Location	Trials
United States	4

Trials by US State

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−

Trials by US State for CHOLYBAR
Location	Trials
California	2
North Carolina	1
Michigan	1

Clinical Trial Progress for CHOLYBAR

Clinical Trial Phase

Clinical Trial Phase for CHOLYBAR
Clinical Trial Phase	Trials
Phase 2	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status for CHOLYBAR
Clinical Trial Phase	Trials
Not yet recruiting	1
Recruiting	1

Clinical Trial Sponsors for CHOLYBAR

Sponsor Name

Sponsor Name for CHOLYBAR
Sponsor	Trials
National Cancer Institute (NCI)	2
City of Hope Medical Center	2

Sponsor Type

Sponsor Type for CHOLYBAR
Sponsor	Trials
NIH	2
Other	2

Clinical Trials, Market Analysis, and Projections for Cholybar

Introduction to Cholybar

Cholybar, also known as cholestyramine, is a bile acid sequesterant used to treat high cholesterol and certain other conditions. It works by binding to bile acids in the intestine, which helps to reduce the amount of cholesterol produced in the liver.

Clinical Trials Involving Bile Acid Sequesterants

While specific clinical trials focused solely on Cholybar may be limited, the broader category of bile acid sequesterants, which includes Cholybar, has been subject to various clinical studies.

Efficacy and Safety

Clinical trials involving bile acid sequesterants have generally shown positive outcomes in terms of reducing cholesterol levels and managing symptoms associated with dyslipidemia. For instance, studies have demonstrated that these drugs can significantly lower LDL cholesterol and sometimes increase HDL cholesterol levels[2].

Recent Developments

Although there are no recent clinical trials specifically highlighted for Cholybar, the ongoing development and testing of new bile acid sequesterants indicate a continued interest in this class of drugs. For example, the ELATIVE clinical trial, which tested Elafibranor for primary biliary cholangitis, showed significant improvements in biomarkers and symptoms, suggesting a broader potential for bile acid-related therapies[1].

Market Analysis for Bile Acid Sequesterants

Global Market Size and Growth

The global dyslipidemia drugs market, which includes bile acid sequesterants like Cholybar, is projected to expand at a robust CAGR during the forecast period of 2021-2028. This growth is driven by the increasing prevalence of cholesterol abnormalities and lipid-associated disorders, particularly among the rising geriatric population[2].

Market Segmentation

The dyslipidemia drugs market is segmented by products, including statins, bile acid sequesterants, niacin, fibric acid derivatives, and cholesterol absorption inhibitors. The bile acid sequesterants segment, which includes Cholybar, is expected to grow rapidly due to the development of new pipeline drugs[2].

Regional Market

North America is anticipated to dominate the market due to the high incidence of diabetes and obesity. The Asia Pacific region is also expected to grow rapidly, driven by biotechnological advancements and improvements in healthcare infrastructure[2].

Market Trends and Drivers

Increasing Prevalence of Chronic Diseases

The rising prevalence of chronic diseases such as heart failure and coronary diseases, which are often linked to dyslipidemia, is a major driver for the market. According to the CDC, heart failure is one of the leading causes of death worldwide, highlighting the need for effective treatments[2].

Technological Advancements

Advancements in biotechnology and improvements in healthcare infrastructure, particularly in the Asia Pacific region, are expected to fuel the growth of the dyslipidemia drugs market[2].

Pipeline Drugs

The presence of a large array of pipeline drugs under clinical trial phases is another significant factor driving the market growth for bile acid sequesterants[2].

Projections for the Future

Market Growth

The global dyslipidemia drugs market, including the segment for bile acid sequesterants, is projected to continue growing at a robust CAGR. This growth is expected to be driven by the increasing demand for effective treatments for cholesterol-related diseases and the ongoing development of new drugs[2].

Regional Expansion

The market in the Asia Pacific region is anticipated to expand rapidly, driven by biotechnological developments and improvements in healthcare infrastructure. North America is expected to remain a key market due to the high incidence of related health issues[2].

Safety and Side Effects of Cholybar

Common Side Effects

Cholybar, like other bile acid sequesterants, is generally well-tolerated but can cause side effects such as abdominal pain, diarrhea, nausea, and vomiting. These side effects are often manageable and do not significantly differ from those of the placebo group in clinical trials[1].

Key Players in the Market

Major Pharmaceutical Companies

Companies such as Pfizer, Inc., Abbott Laboratories, Merck & Co., Inc., Novartis AG, Amgen, Inc., Astra Zeneca Plc., and Mylan N.V are key players in the dyslipidemia drugs market. These companies are involved in the development and marketing of various dyslipidemia treatments, including bile acid sequesterants like Cholybar[2].

Conclusion

Cholybar, as a bile acid sequesterant, is part of a broader market segment that is experiencing significant growth due to the increasing prevalence of cholesterol-related diseases. Clinical trials and market analyses indicate a strong potential for this class of drugs in managing dyslipidemia and related conditions.

Key Takeaways

• Clinical Trials: While specific trials for Cholybar may be limited, the broader category of bile acid sequesterants shows positive outcomes.
• Market Growth: The global dyslipidemia drugs market is projected to grow at a robust CAGR, driven by increasing chronic disease prevalence and technological advancements.
• Regional Expansion: North America and the Asia Pacific region are key markets, with the latter expected to grow rapidly.
• Safety and Side Effects: Cholybar is generally well-tolerated but can cause common side effects like abdominal pain and diarrhea.
• Key Players: Major pharmaceutical companies are driving the development and marketing of dyslipidemia treatments.

FAQs

What is Cholybar used for?

Cholybar, or cholestyramine, is used to treat high cholesterol and certain other conditions by binding to bile acids in the intestine.

What are the common side effects of Cholybar?

Common side effects include abdominal pain, diarrhea, nausea, and vomiting.

How does the global dyslipidemia drugs market project to grow?

The market is projected to expand at a robust CAGR during the forecast period, driven by the increasing prevalence of cholesterol-related diseases and technological advancements.

Which regions are expected to dominate the dyslipidemia drugs market?

North America is expected to dominate, while the Asia Pacific region is anticipated to grow rapidly.

Who are the key players in the dyslipidemia drugs market?

Key players include Pfizer, Inc., Abbott Laboratories, Merck & Co., Inc., Novartis AG, Amgen, Inc., Astra Zeneca Plc., and Mylan N.V.

Sources

1. UC Davis Health: "Clinical trial results suggest potential new treatment for primary biliary cholangitis"[1]
2. Growth Market Reports: "Dyslipidemia Drugs Market Size, Share & Growth Report | 2030"[2]
3. Visiongain: "Dyslipidemia Drugs Market Report 2021-2031"[3]