CLINICAL TRIALS PROFILE FOR CYCLOSPORINE

505(b)(2) Clinical Trials for cyclosporine

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT00373815 ↗	Everolimus in Combination With Cyclosporine A and Prednisolone for the Treatment of Graft Versus Host Disease	Terminated	University Hospital Tuebingen	Phase 1	2006-09-01	The present protocol is a dose-finding and toxicity study in preparation of a randomised study comparing current standard treatment CSA/prednisolone with the new combination CSA/prednisolone/everolimus.
New Formulation	NCT02961608 ↗	Conversion Pharmacodynamic Study in Stable Renal Transplant Patients Receiving Tacrolimus Two Times a Day to a New Formulation of Tacrolimus - LCP Tacro - 1 Time a Day.	Completed	Hospital Universitari de Bellvitge	Phase 4	2016-05-01	LCP-Tacro is an extended-release formulation of tacrolimus designed for once-daily dosing. Phase 1 studies demonstrated greater bioavailability than twice-daily tacrolimus capsules and no new safety concerns. - Stable kidney transplant patients can be safely converted from Adoport® twice-daily to LCP-Tacro®. - The greater bioavailability of LCP-Tacro after once-daily dosing results in similar (AUC) exposure, at a dose approximately 30% less, than the total daily dose of Adoport®. - LCP-Tacro provides a slow drug release and this results in flatter kinetics characterized by significantly lower peak-trough fluctuations. - CN is the major cellular target of the calcineurin inhibitors (CNIs) cyclosporine A (CsA) and tacrolimus. The ability of these drugs to inhibit CN activity is dependent on their binding to the respective immunophilins, cyclophilins A and B for CsA and FKBP12 for tacrolimus. - CN inhibition is a rate limiting phenomenon. Over concentrations of tacrolimus does not correlate with an increase in the CN activity.
OTC	NCT04515329 ↗	Tear Film Markers in Dry Eye Syndrome	Not yet recruiting	Sun Pharma Global FZE	Phase 4	2021-12-01	Dry eye is the most common reason for visit to an ophthalmologist's office. The prevalence is on the rise and is mainly attributed to factors such as increased environmental pollution and contact lens use. The current management options are limited to over the counter artificial tear drops and three FDA-approved drugs. Of these, cyclosporine has been used worldwide for treating mild to moderate dry eyes. The earlier version consisted of 0.05% cyclosporine which worked well for a limited number of inflammatory dry eye conditions. Recently, 0.09% cyclosporine was approved by the FDA. The nearly double concentration is expected to be more beneficial for severe inflammation which is often seen in Sjögren syndrome and other Rheumatological conditions associated with dry eyes. In this pilot project, the investigator proposes to evaluate the change in expression of SLURP1 and other markers of ocular surface inflammation before and after treatment with 0.09% cyclosporine eye drops.
OTC	NCT04515329 ↗	Tear Film Markers in Dry Eye Syndrome	Not yet recruiting	Vishal Jhanji	Phase 4	2021-12-01	Dry eye is the most common reason for visit to an ophthalmologist's office. The prevalence is on the rise and is mainly attributed to factors such as increased environmental pollution and contact lens use. The current management options are limited to over the counter artificial tear drops and three FDA-approved drugs. Of these, cyclosporine has been used worldwide for treating mild to moderate dry eyes. The earlier version consisted of 0.05% cyclosporine which worked well for a limited number of inflammatory dry eye conditions. Recently, 0.09% cyclosporine was approved by the FDA. The nearly double concentration is expected to be more beneficial for severe inflammation which is often seen in Sjögren syndrome and other Rheumatological conditions associated with dry eyes. In this pilot project, the investigator proposes to evaluate the change in expression of SLURP1 and other markers of ocular surface inflammation before and after treatment with 0.09% cyclosporine eye drops.

All Clinical Trials for cyclosporine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000524 ↗	Myocarditis Treatment Trial	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 2	1986-07-01	To determine whether immunosuppressive treatment improved cardiac function in patients with biopsy-proven myocarditis.
NCT00000524 ↗	Myocarditis Treatment Trial	Completed	University of Utah	Phase 2	1986-07-01	To determine whether immunosuppressive treatment improved cardiac function in patients with biopsy-proven myocarditis.
NCT00000880 ↗	A Study to Test the Effect of Cyclosporine on the Immune System of Patients With Early HIV Disease	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	The purpose of this study is to determine the safety and effectiveness of low doses of cyclosporine (CsA) in patients with early HIV infection and to evaluate its effect on the immune system. Activation of T cells (cells of the immune system) leads to HIV replication. Inhibition of immune activation is therefore a potentially important area of therapy for patients with early HIV infection. CsA is capable of decreasing T cell activation, which in turn may decrease HIV replication.
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.
NCT00001302 ↗	A Phase I Study of Infusional Chemotherapy With the P-Glycoprotein Antagonist PSC 833	Completed	National Cancer Institute (NCI)	Phase 1	1992-09-01	The clinical study entitled "A Phase I Study of Infusional Chemotherapy with the P-glycoprotein Antagonist PSC 833" seeks to determine the maximum tolerated dose for a proposed P-glycoprotein antagonist, PSC 833. PSC 833 is a cyclosporine analogue which is purportedly non-nephrotoxic and non-immunosuppressive. It has been shown in in-vitro studies to enhance chemosensitivity as well as cyclosporine and to be far better at increasing intracellular drug accumulation than the concentrations of verapamil which are clinically achievable. The purpose of this study is to define the maximum tolerated dose in combination with vinblastine, and to determine how the drug affects the pharmacokinetics of vinblastine. PSC 833 will most likely reduce the clearance of vinblastine, as reported for the parent compound, cyclosporine. This effect will increase the area under the curve (AUC) of vinblastine, may increase toxicity, and requires that the escalation scheme for PSC 833 be a conservative one. Initially, a 120 hour infusion of vinblastine will be given alone. Then 8 days of PSC 833 will follow to allow monitoring of adverse effects of PSC 833 alone. This first cycle of vinblastine will be given in the absence of PSC 833; in second and subsequent cycles both agents will be combined. Escalation of the PSC 833 will continue until a target concentration is reached, or until the maximum tolerated dose is reached. Clinical responses will be monitored in order to provide the best possible medical care to our patients.

Clinical Trial Conditions for cyclosporine

Condition Name

Condition Name for cyclosporine
Intervention	Trials
Leukemia	108
Myelodysplastic Syndromes	72
Lymphoma	68
Kidney Transplantation	60

Condition MeSH

Condition MeSH for cyclosporine
Intervention	Trials
Leukemia	175
Syndrome	144
Myelodysplastic Syndromes	141
Preleukemia	138

Clinical Trial Locations for cyclosporine

Trials by Country

Trials by Country for cyclosporine
Location	Trials
Canada	160
Italy	138
China	96
Germany	93
France	82

Trials by US State

Trials by US State for cyclosporine
Location	Trials
California	134
Washington	114
Maryland	100
New York	96
Texas	89

Clinical Trial Progress for cyclosporine

Clinical Trial Phase

Clinical Trial Phase for cyclosporine
Clinical Trial Phase	Trials
Phase 4	197
Phase 3	175
Phase 2/Phase 3	29

Clinical Trial Status

Clinical Trial Status for cyclosporine
Clinical Trial Phase	Trials
Completed	635
Terminated	102
Unknown status	102

Clinical Trial Sponsors for cyclosporine

Sponsor Name

Sponsor Name for cyclosporine
Sponsor	Trials
National Cancer Institute (NCI)	175
Fred Hutchinson Cancer Research Center	82
National Heart, Lung, and Blood Institute (NHLBI)	63

Sponsor Type

Sponsor Type for cyclosporine
Sponsor	Trials
Other	1120
Industry	402
NIH	293

Cyclosporine Market Analysis and Financial Projection

Cyclosporine: Clinical Trials, Market Analysis, and Projections

Introduction to Cyclosporine

Cyclosporine is an immunosuppressant drug widely used in various medical applications, including organ transplantation, autoimmune diseases, and dry eye disease. Here, we will delve into the current clinical trials, market analysis, and future projections for this versatile medication.

Clinical Trials Update

Dry Eye Disease (DED) Trials

Several clinical trials are ongoing to evaluate the efficacy and safety of cyclosporine in treating Dry Eye Disease (DED).

• A phase 4 clinical trial is assessing the effect of cyclosporine ophthalmic solution, 0.1%, on corneal endothelial cell health in subjects with DED compared to a hypotonic saline solution. This trial aims to evaluate the corneal endothelial cell density after 12 months of treatment[1].

• Another phase 3 randomized clinical trial conducted in China evaluated the efficacy and safety of a water-free cyclosporine ophthalmic solution, 0.1%, versus a vehicle in participants with moderate to severe DED. The results showed significant improvement in total corneal fluorescein staining (tCFS) scores in the cyclosporine group compared to the vehicle group[4].

Other Clinical Applications

While the focus here is on DED, cyclosporine is also used in various other clinical contexts, such as preventing organ transplant rejection and treating autoimmune diseases like rheumatoid arthritis and psoriasis. These applications continue to be vital areas of research and clinical use.

Market Analysis

Current Market Size and Growth

The global cyclosporine market has been experiencing significant growth. As of 2024, the market size was valued at approximately $2.99 billion and is projected to reach $8.26 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 14.96% from 2024 to 2031[3].

Market Segmentation

The cyclosporine market is segmented based on indication, end-use industry, and geographic region.

• By Indication: The largest segment is transplant rejection prophylaxis, driven by the increasing number of organ transplants globally. Other significant segments include rheumatoid arthritis, psoriasis, autoimmune myasthenia gravis, and dry eye disease[5].

• By End-Use Industry: Hospitals are the largest segment, holding a market share of 31% in 2022. The growth in multi-specialty hospitals and hospital infrastructure post-pandemic is expected to drive this segment further[5].

• Geographic Regions: The market is spread across North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa. Each region has its unique growth drivers and challenges[2][3].

Market Projections

Growth Drivers

Several factors are driving the growth of the cyclosporine market:

• Increasing Organ Transplants: The continuous rise in organ transplants globally is a major driver, as cyclosporine is crucial in preventing transplant rejection[5].

• Autoimmune Diseases: The growing demand for cyclosporine in treating autoimmune diseases such as rheumatoid arthritis, psoriasis, and multiple sclerosis is another significant factor[2][3].

• Dry Eye Disease: The increasing use of technology and the subsequent rise in dry eye cases are making this segment a growing part of the market[5].

• Geriatric Population: The rise in the geriatric population is also contributing to the demand for cyclosporine, as older individuals are more prone to conditions requiring this medication[3].

Challenges and Opportunities

Despite the growth, the market faces some challenges:

• Side Effects: Cyclosporine is associated with side effects such as kidney problems, high blood pressure, gum diseases, tremors, and increased body hair. These health concerns can impact market growth[2].

• Regulatory Policies: Changes in regulatory policies and government funding can influence the market. However, advancements in research and development are expected to balance these challenges[2].

Key Trends and Opportunities

Technological Advancements

Advancements in drug delivery systems, such as the development of water-free cyclosporine ophthalmic solutions, are enhancing the efficacy and safety of the drug. These innovations are expected to drive market growth further[4].

Geographic Expansion

The cyclosporine market is expanding globally, with significant growth anticipated in regions like Asia Pacific and Latin America. This expansion is driven by increasing healthcare infrastructure and awareness of autoimmune diseases[2][3].

Conclusion

Cyclosporine remains a critical medication in various clinical contexts, from organ transplantation to the treatment of autoimmune diseases and dry eye disease. Ongoing clinical trials are refining its use, particularly in DED, while market projections indicate robust growth driven by increasing demand and technological advancements.

Key Takeaways

• Cyclosporine is being evaluated in clinical trials for its efficacy in treating Dry Eye Disease, showing promising results.
• The global cyclosporine market is projected to grow significantly, driven by increasing organ transplants, autoimmune disease treatments, and the rising geriatric population.
• The market is segmented by indication, end-use industry, and geographic region, with hospitals being the largest end-use segment.
• Technological advancements and geographic expansion are key trends and opportunities in the cyclosporine market.

FAQs

What is the primary use of cyclosporine in clinical settings?

Cyclosporine is primarily used as an immunosuppressant to prevent organ transplant rejection and to treat autoimmune diseases such as rheumatoid arthritis and psoriasis.

What are the current clinical trials focusing on for cyclosporine?

Current clinical trials are focusing on evaluating the efficacy and safety of cyclosporine ophthalmic solutions in treating Dry Eye Disease (DED), comparing it to vehicle or saline solutions.

What is the projected growth rate of the global cyclosporine market?

The global cyclosporine market is projected to grow at a CAGR of 14.96% from 2024 to 2031, reaching a market size of $8.26 billion by 2031[3].

What are the main drivers of the cyclosporine market growth?

The main drivers include the increasing number of organ transplants, growing demand for treating autoimmune diseases, and the rise in the geriatric population.

What are some of the challenges associated with the cyclosporine market?

Challenges include side effects such as kidney problems and high blood pressure, as well as regulatory policies and health concerns associated with the drug.

Sources

1. CenterWatch: A Clinical Trial to Evaluate the Corneal Endothelial Health of DED Subjects Treated with Cyclosporine.
2. OpenPR: Cyclosporine Market Set to Witness Significant Growth by 2024-2031.
3. Verified Market Research: Cyclosporine Market Size, Share, Trends & Forecast.
4. PubMed: Water-Free Cyclosporine Ophthalmic Solution vs Vehicle for Dry Eye Disease.
5. Maximize Market Research: Cyclosporine Market – Global Industry Analysis and Forecast (2023-2029).