You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 21, 2024

CLINICAL TRIALS PROFILE FOR CYCLOSPORINE


✉ Email this page to a colleague

« Back to Dashboard


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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for CYCLOSPORINE

Condition Name

Condition Name for CYCLOSPORINE
Intervention Trials
Leukemia 108
Myelodysplastic Syndromes 72
Lymphoma 68
Kidney Transplantation 60
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for CYCLOSPORINE
Intervention Trials
Leukemia 175
Syndrome 144
Myelodysplastic Syndromes 141
Preleukemia 138
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

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
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for CYCLOSPORINE
Location Trials
California 134
Washington 114
Maryland 100
New York 96
Texas 89
This preview shows a limited data set
Subscribe for full access, or try a Trial

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
[disabled in preview] 410
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for CYCLOSPORINE
Clinical Trial Phase Trials
Completed 635
Unknown status 102
Terminated 102
[disabled in preview] 145
This preview shows a limited data set
Subscribe for full access, or try a Trial

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
[disabled in preview] 99
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for CYCLOSPORINE
Sponsor Trials
Other 1120
Industry 402
NIH 293
[disabled in preview] 6
This preview shows a limited data set
Subscribe for full access, or try a Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.