Cyclosporine

Generic Name
Cyclosporine
Brand Names
Cequa, Gengraf, Neoral, Restasis, Sandimmune, Verkazia, Vevye, Ikervis
Drug Type
Small Molecule
Chemical Formula
C62H111N11O12
CAS Number
59865-13-3
Unique Ingredient Identifier
83HN0GTJ6D
Background

Cyclosporine is a calcineurin inhibitor known for its immunomodulatory properties that prevent organ transplant rejection and treat various inflammatory and autoimmune conditions. It is isolated from the fungus Beauveria nivea. Initially manufactured by Sandoz and approved for use by the FDA in 1983, cyclosporine is now available in various products by Novartis (previously known as Sandoz).

Indication

Cyclosporine is approved for a variety of conditions. Firstly, it is approved for the prophylaxis of organ rejection in allogeneic kidney, liver, and heart transplants. It is also used to prevent bone marrow transplant rejection. For the above indications, cyclosporine can be used in conjunction with azathioprine and corticosteroids. Finally, cyclosporine can be used in patients who have chronic transplant rejection and have received previous immunosuppressive therapy and to prevent or treat graft-versus-host disease (GVHD).

Secondly, cyclosporine is used for the treatment of patients with severe active rheumatoid arthritis (RA) when they no longer respond to methotrexate alone. It can be used for the treatment of adult non-immunocompromised patients with severe, recalcitrant, plaque psoriasis that have failed to respond to at least one systemic therapy or when systemic therapies are not tolerated or contraindicated. The ophthalmic solution of cyclosporine is indicated to increase tear production in patients suffering from keratoconjunctivitis sicca. In addition, cyclosporine is approved for the treatment of steroid dependent and steroid-resistant nephrotic syndrome due to glomerular diseases which may include minimal change nephropathy, focal and segmental glomerulosclerosis or membranous glomerulonephritis.

A cyclosporine ophthalmic emulsion is indicated in the treatment of vernal keratoconjunctivitis in adults and children.

Off-label, cyclosporine is commonly used for the treatment of various autoimmune and inflammatory conditions such as atopic dermatitis, blistering disorders, ulcerative colitis, juvenile rheumatoid arthritis, uveitis, connective tissue diseases, as well as idiopathic thrombocytopenic purpura.

Associated Conditions
Atopic Dermatitis, Bone Marrow Transplant Rejection, Chronic transplant rejection, Connective Tissue Disorders, Dry Eyes, Graft-versus-host Disease (GVHD), Heart Transplant Rejection, Immune Thrombocytopenia (ITP), Interstitial Cystitis, Juvenile Idiopathic Arthritis (JIA), Kidney Transplant Rejection, Liver Transplant Rejection, Lupus Nephritis, Nephrotic Syndrome, Ocular Rosacea, Rheumatoid Arthritis, Severe Ulcerative Colitis, Steroid Dependent Nephrotic Syndrome, Steroid Resistant Nephrotic Syndrome, Uveitis, Vernal Keratoconjunctivitis, Blistering disorder, Refractory Ulcerative colitis, Severe Psoriasis, Severe, active Rheumatoid arthritis, Severe, recalcitrant Plaque psoriasis, Suppressed tear production
Associated Therapies
-

G-CSF-Treated Donor Bone Marrow Transplant in Treating Patients With Hematologic Disorders

First Posted Date
2005-11-15
Last Posted Date
2012-05-28
Lead Sponsor
OHSU Knight Cancer Institute
Target Recruit Count
4
Registration Number
NCT00253552
Locations
🇺🇸

OHSU Knight Cancer Institute, Portland, Oregon, United States

Fludarabine and Total-Body Irradiation in Treating Patients Who Are Undergoing a Donor Stem Cell Transplant for Metastatic Kidney Cancer That Cannot Be Removed By Surgery

Phase 2
Terminated
Conditions
First Posted Date
2005-10-21
Last Posted Date
2012-05-28
Lead Sponsor
OHSU Knight Cancer Institute
Target Recruit Count
1
Registration Number
NCT00243009
Locations
🇺🇸

OHSU Knight Cancer Institute, Portland, Oregon, United States

Long-term Study of Ciclosporin for Atopic Dermatitis

Phase 3
Completed
Conditions
First Posted Date
2005-10-04
Last Posted Date
2011-11-02
Lead Sponsor
Novartis Pharmaceuticals
Registration Number
NCT00232063

Verification Study of Ciclosporin for Atopic Dermatitis

Phase 3
Completed
Conditions
First Posted Date
2005-10-04
Last Posted Date
2011-11-02
Lead Sponsor
Novartis Pharmaceuticals
Registration Number
NCT00232076

Polymorphism of the Cytochrome P450-system in Renal Transplants

Completed
Conditions
First Posted Date
2005-09-22
Last Posted Date
2011-08-04
Lead Sponsor
University Hospital Schleswig-Holstein
Target Recruit Count
200
Registration Number
NCT00223054
Locations
🇩🇪

University of Schleswig-Holstein, Campus Kiel, Department of Nephrology, Kiel, Germany

Study Comparing Cyclosporine Dose Reduction vs. Cyclosporine Elimination in Kidney Transplant Recipients Taking Sirolimus

Phase 4
Completed
Conditions
First Posted Date
2005-09-19
Last Posted Date
2011-03-08
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
280
Registration Number
NCT00195468

Alemtuzumab to Treat Severe Aplastic Anemia

First Posted Date
2005-09-19
Last Posted Date
2020-07-07
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Target Recruit Count
47
Registration Number
NCT00195624
Locations
🇺🇸

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

The Vienna Prograf and Endothelial Progenitor Cell Study

Phase 4
Completed
Conditions
Interventions
First Posted Date
2005-09-16
Last Posted Date
2014-02-05
Lead Sponsor
Medical University of Vienna
Target Recruit Count
148
Registration Number
NCT00182559
Locations
🇦🇹

Medical University of Vienna, Vienna, Austria

© Copyright 2024. All Rights Reserved by MedPath