CLINICAL TRIALS PROFILE FOR SANDIMMUNE

All Clinical Trials for Sandimmune

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000936 ↗	A Study To Test An Anti-Rejection Therapy After Kidney Transplantation	Terminated	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	1999-11-01	Kidney transplantation is often successful. However, despite aggressive anti-rejection drug therapy, some patients will reject their new kidney. This study is designed to test two anti-rejection approaches. Two medications in this study are currently used in children, but there is no information regarding which drug is safer or more effective. Survival rates in renal transplantation are unacceptably low. Therefore, there is a need for an improved post-transplant treatment, such as the induction therapy used in this study.
NCT00002831 ↗	Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous or Acute Leukemia	Completed	National Cancer Institute (NCI)	Phase 1/Phase 2	1995-08-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of high-dose chemotherapy plus peripheral stem cell transplantation in treating patients with chronic myelogenous or acute leukemia.
NCT00002831 ↗	Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous or Acute Leukemia	Completed	M.D. Anderson Cancer Center	Phase 1/Phase 2	1995-08-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of high-dose chemotherapy plus peripheral stem cell transplantation in treating patients with chronic myelogenous or acute leukemia.
NCT00002832 ↗	Decitabine and Peripheral Stem Cell Transplantation in Treating Patients Who Have Relapsed Following Bone Marrow Transplantation for Leukemia, Myelodysplastic Syndrome, or Chronic Myelogenous Leukemia	Completed	National Cancer Institute (NCI)	Phase 1/Phase 2	1995-08-01	RATIONALE: Peripheral stem cell transplantation may be an effective treatment for leukemia, myelodysplastic syndrome, or chronic myelogenous leukemia that has relapsed following bone marrow transplantation. PURPOSE: Phase I/II trial to study the effectiveness of decitabine and peripheral stem cell transplantation in treating patients who have leukemia, myelodysplastic syndrome, or chronic myelogenous leukemia that has relapsed after bone marrow transplantation.

Clinical Trial Conditions for Sandimmune

Condition Name

Condition Name for Sandimmune
Intervention	Trials
Recurrent Small Lymphocytic Lymphoma	20
Refractory Chronic Lymphocytic Leukemia	18
Adult Acute Myeloid Leukemia in Remission	18
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities	18

Condition MeSH

Condition MeSH for Sandimmune
Intervention	Trials
Leukemia	54
Leukemia, Myeloid	44
Myelodysplastic Syndromes	43
Leukemia, Myeloid, Acute	41

Clinical Trial Locations for Sandimmune

Trials by Country

Trials by Country for Sandimmune
Location	Trials
United States	247
Italy	12
Canada	9
Germany	8
Denmark	3

Trials by US State

Trials by US State for Sandimmune
Location	Trials
Washington	57
Colorado	18
California	18
Texas	15
Wisconsin	14

Clinical Trial Progress for Sandimmune

Clinical Trial Phase

Clinical Trial Phase for Sandimmune
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	7
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for Sandimmune
Clinical Trial Phase	Trials
Completed	71
Recruiting	12
Terminated	8

Clinical Trial Sponsors for Sandimmune

Sponsor Name

Sponsor Name for Sandimmune
Sponsor	Trials
National Cancer Institute (NCI)	71
Fred Hutchinson Cancer Research Center	53
National Heart, Lung, and Blood Institute (NHLBI)	17

Sponsor Type

Sponsor Type for Sandimmune
Sponsor	Trials
Other	144
NIH	90
Industry	11

Clinical Trials, Market Analysis, and Projections for Sandimmune (Cyclosporine)

Last updated: January 1, 2025

Introduction to Sandimmune (Cyclosporine)

Sandimmune, also known as cyclosporine, is an immunosuppressive drug widely used in the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. It is often administered in conjunction with adrenal corticosteroids[4].

Clinical Trials and Efficacy

Comparative Studies with Neoral

A significant clinical trial compared the efficacy of Neoral (a microemulsion formulation of cyclosporine) with Sandimmune in patients undergoing primary liver transplantation. The study found that while both drugs had similar overall rejection episode rates, Neoral resulted in a lower incidence of moderate to severe histologic rejection. Specifically, the Neoral group had only three moderate/severe rejection episodes compared to nine in the Sandimmune group. Additionally, no patients in the Neoral group required treatment with OKT3 for steroid-resistant rejection, whereas two patients in the Sandimmune group did[1].

Safety and Adverse Effects

Clinical trials have highlighted several adverse effects associated with Sandimmune, including nephrotoxicity and hepatotoxicity. Nephrotoxicity is common, affecting up to 25% of renal transplant patients, and can manifest as elevated serum creatinine and BUN levels. Hepatotoxicity, characterized by elevations in hepatic enzymes and bilirubin, has been reported in 4-7% of patients across different transplant types[4].

Use in COVID-19

Despite initial hopes, clinical trials using cyclosporine for the management of COVID-19 have been terminated due to futility. For example, the I-SPY COVID trial sponsored by Quantum Leap Healthcare Collaborative (QLHC) ended the cyclosporine arm of the study in August 2022, indicating that cyclosporine was not effective in treating COVID-19 infection[5].

Market Analysis

Global Market Size and Growth

The cyclosporine drugs market, which includes Sandimmune, is projected to grow at a CAGR of 4.1% over the forecast period. This growth is driven by factors such as the increasing prevalence of autoimmune diseases and the need for immunosuppressive therapies in organ transplantation[5].

Regional Dominance

North America is expected to dominate the market due to the presence of major market players and government initiatives aimed at preventing and treating autoimmune diseases. The region's strong healthcare infrastructure and high demand for immunosuppressive drugs also contribute to its market share[5].

Market Drivers

• Increasing Prevalence of Autoimmune Diseases: The rising incidence of autoimmune and inflammatory diseases is a significant driver for the cyclosporine market. Clinical trials, particularly interventional studies, are on the rise to address these conditions[3].
• Demand for Generic Drugs: The strong demand for generic drugs, which often involve synthetic active pharmaceutical ingredients (APIs), also drives the market. This trend benefits Contract Development and Manufacturing Organizations (CDMOs) involved in synthetic API production[2].

Market Challenges

• Adverse Effects and Toxicity: The nephrotoxic and hepatotoxic effects associated with cyclosporine can limit its use and impact market growth. Close monitoring and dosage adjustments are often necessary to manage these side effects[4].
• Failed Clinical Trials: The termination of clinical trials for non-traditional uses, such as COVID-19 treatment, can negatively impact market growth and public perception of the drug[5].

Projections and Future Outlook

Market Size Projections

The cyclosporine drugs market is expected to continue growing, albeit at a moderate rate. The increasing need for immunosuppressive therapies in organ transplantation and the management of autoimmune diseases will drive this growth.

Emerging Trends

• Outsourcing and CDMOs: The trend of outsourcing manufacturing to CDMOs is expected to continue, driven by the need to reduce production costs and enhance profitability. This could lead to increased efficiency and capacity in the production of cyclosporine and other immunosuppressive drugs[2].
• Government Initiatives: Government funding and initiatives supporting clinical trials and drug development will remain crucial for market expansion. These initiatives can accelerate the development of new treatments and improve access to existing ones[3].

Key Takeaways

• Efficacy and Safety: Sandimmune is effective in preventing organ rejection but has significant adverse effects, including nephrotoxicity and hepatotoxicity.
• Market Growth: The cyclosporine market is projected to grow at a CAGR of 4.1%, driven by the increasing prevalence of autoimmune diseases and the demand for generic drugs.
• Regional Dominance: North America is expected to dominate the market due to its strong healthcare infrastructure and government initiatives.
• Challenges: The market faces challenges from adverse effects and the failure of clinical trials for non-traditional uses.

FAQs

What is Sandimmune used for?

Sandimmune (cyclosporine) is used for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants, often in conjunction with adrenal corticosteroids[4].

What are the common adverse effects of Sandimmune?

Common adverse effects include nephrotoxicity and hepatotoxicity, which can manifest as elevated serum creatinine, BUN levels, and hepatic enzymes[4].

Was Sandimmune effective in treating COVID-19?

No, clinical trials using cyclosporine for COVID-19 treatment were terminated due to futility[5].

What drives the growth of the cyclosporine market?

The growth is driven by the increasing prevalence of autoimmune diseases, the demand for generic drugs, and government initiatives supporting clinical trials and drug development[2][3][5].

Which region is expected to dominate the cyclosporine market?

North America is expected to dominate the market due to the presence of major market players, government initiatives, and a strong healthcare infrastructure[5].

Sources

1. Neoral compared to Sandimmune is associated with a decrease in histologic severity of rejection in patients undergoing primary liver transplantation. PubMed.
2. Active Pharmaceutical Ingredients Market Size Report, 2030. Grand View Research.
3. Global Clinical Trials Market Size, Top Share, Trends, Forecast by 2033. Straits Research.
4. Sandimmune® Soft Gelatin Capsules - Novartis. Novartis.
5. Cyclosporine Drugs Market - Size, Share & Manufacturers. Mordor Intelligence.