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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Exchange of Azathioprine by Mycophenolatmofetile and Cyclosporine A Dose Reduction After Heart Transplantation

Not Applicable
Completed
Conditions
Interventions
First Posted Date
2006-08-02
Last Posted Date
2009-02-16
Lead Sponsor
Hannover Medical School
Target Recruit Count
23
Registration Number
NCT00359814
Locations
πŸ‡©πŸ‡ͺ

Hannover Medical School, Department of Thoracic and Cardiovascular Surgery, Hannover, Germany

Withdrawal of Steroids, Cyclosporine A Dose Reduction and Switch to Mycophenolatmofetile After Heart Transplantation

First Posted Date
2006-08-02
Last Posted Date
2009-02-13
Lead Sponsor
Hannover Medical School
Target Recruit Count
40
Registration Number
NCT00359658
Locations
πŸ‡©πŸ‡ͺ

Hannover Medical School, Department of Thoracic and Cardiovascular Surgery, Hannover, Germany

Cyclophosphamide and Anti-thymocyte Globulin Followed By Methotrexate and Cyclosporine in Preventing Chronic Graft-Versus-Host Disease in Patients With Severe Aplastic Anemia Undergoing Donor Bone Marrow Transplant

First Posted Date
2006-06-23
Last Posted Date
2017-04-13
Lead Sponsor
Fred Hutchinson Cancer Center
Target Recruit Count
21
Registration Number
NCT00343785
Locations
πŸ‡ΊπŸ‡Έ

Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States

πŸ‡ΊπŸ‡Έ

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington, United States

πŸ‡ΊπŸ‡Έ

Froedtert and the Medical College of Wisconsin, Milwaukee, Wisconsin, United States

Combination Chemotherapy Followed By Donor Stem Cell Transplant in Treating Patients With Hemophagocytic Lymphohistiocytosis

Phase 3
Conditions
First Posted Date
2006-06-08
Last Posted Date
2013-09-17
Lead Sponsor
Children's Cancer and Leukaemia Group
Target Recruit Count
288
Registration Number
NCT00334672
Locations
πŸ‡¬πŸ‡§

Birmingham Children's Hospital, Birmingham, England, United Kingdom

πŸ‡¬πŸ‡§

Watford General Hospital, Herts, England, United Kingdom

πŸ‡¬πŸ‡§

Leeds Cancer Centre at St. James's University Hospital, Leeds, England, United Kingdom

and more 9 locations

Low-Dose or High-Dose Conditioning Followed by Peripheral Blood Stem Cell Transplant in Treating Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia

First Posted Date
2006-05-04
Last Posted Date
2014-10-31
Lead Sponsor
Fred Hutchinson Cancer Center
Target Recruit Count
25
Registration Number
NCT00322101
Locations
πŸ‡ΊπŸ‡Έ

Weill Cornell University, New York, New York, United States

πŸ‡ΊπŸ‡Έ

HealthOne Presbyterian St. Lukes Medical Center, Denver, Colorado, United States

πŸ‡ΊπŸ‡Έ

Emory University, Altanta, Georgia, United States

and more 5 locations

Sirolimus and Cyclosporine for Treatment-Resistant Aplastic Anemia

First Posted Date
2006-04-27
Last Posted Date
2008-10-07
Lead Sponsor
Office of Rare Diseases (ORD)
Target Recruit Count
52
Registration Number
NCT00319878
Locations
πŸ‡ΊπŸ‡Έ

Lee Moffitt Cancer Center, Tampa, Florida, United States

πŸ‡ΊπŸ‡Έ

Taussig Cancer Center, Cleveland Clinic Foundation, Cleveland, Ohio, United States

πŸ‡ΊπŸ‡Έ

UCLA Center for Health Sciences, Los Angeles, California, United States

and more 1 locations
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