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
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Chemotherapy and Total-Body Irradiation Followed by Donor Umbilical Cord Blood Transplant, Cyclosporine, and Mycophenolate Mofetil in Treating Patients With Hematologic Cancer

First Posted Date
2006-02-13
Last Posted Date
2017-11-29
Lead Sponsor
Masonic Cancer Center, University of Minnesota
Target Recruit Count
68
Registration Number
NCT00290641
Locations
🇺🇸

University of Minnesota Cancer Center, Minneapolis, Minnesota, United States

Donor Umbilical Cord Blood Transplant in Treating Patients With Hematologic Cancer

First Posted Date
2006-02-13
Last Posted Date
2017-11-29
Lead Sponsor
Masonic Cancer Center, University of Minnesota
Target Recruit Count
43
Registration Number
NCT00290628
Locations
🇺🇸

University of Minnesota Cancer Center, Minneapolis, Minnesota, United States

Randomized Controlled Trial in Liver Transplant Recipients Treated in Steroid Sparing Regimen

First Posted Date
2006-02-06
Last Posted Date
2014-09-22
Lead Sponsor
Duke University
Target Recruit Count
40
Registration Number
NCT00286871
Locations
🇺🇸

Duke University Medical Center, Durham, North Carolina, United States

Anti-Thymocyte Globulin, Cyclosporine, and RAD in Islet Transplantation

First Posted Date
2006-02-03
Last Posted Date
2008-05-08
Lead Sponsor
University of Minnesota
Target Recruit Count
6
Registration Number
NCT00286624
Locations
🇺🇸

University of Minnesota, Minneapolis, Minnesota, United States

Aerosol Cyclosporine for Prevention of Lung Rejection

Phase 2
Completed
Conditions
First Posted Date
2005-12-22
Last Posted Date
2016-05-13
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Registration Number
NCT00268515

Three Immunosuppressive Treatment Regimens for Severe Aplastic Anemia

First Posted Date
2005-12-01
Last Posted Date
2017-06-08
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Target Recruit Count
136
Registration Number
NCT00260689
Locations
🇺🇸

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

Study Evaluating Cyclosporine Dose Reduction and Cyclosporine Elimination in Chinese Kidney Transplants

Phase 1
Completed
Conditions
First Posted Date
2005-11-22
Last Posted Date
2011-02-02
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
120
Registration Number
NCT00257387
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