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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Allogeneic Transplantation Using Total Lymphoid Irradiation (TLI) and Anti-Thymocyte Globulin (ATG) for Older Patients With Hematologic Malignancies

First Posted Date
2005-09-16
Last Posted Date
2021-06-29
Lead Sponsor
Stanford University
Target Recruit Count
303
Registration Number
NCT00185640
Locations
🇺🇸

Stanford University School of Medicine, Stanford, California, United States

Interferon-alpha2a Versus Cyclosporin A for Severe Ocular Behcet's Disease (INCYTOB)

First Posted Date
2005-09-14
Last Posted Date
2018-05-17
Lead Sponsor
University Hospital Tuebingen
Target Recruit Count
37
Registration Number
NCT00167583
Locations
🇩🇪

Department of Internal Medicine II and Department of Ophthalmology, Tuebingen, Germany

Study of Liver Transplant For End-Stage Liver Disease Caused By Chronic Hepatitis C Infection

First Posted Date
2005-09-14
Last Posted Date
2017-01-12
Lead Sponsor
Baylor Research Institute
Target Recruit Count
312
Registration Number
NCT00163657
Locations
🇺🇸

Baylor Regional Transplant Institute - Baylor University Medical Center, Dallas, Texas, United States

Study Evaluating Sirolimus in Kidney Transplant Recipients.

First Posted Date
2005-09-14
Last Posted Date
2008-03-14
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
150
Registration Number
NCT00167947

Efficacy and Safety of Everolimus With Enteric-Coated Mycophenolate Sodium (EC-MPS) in a Cyclosporine Microemulsion-free Regimen Compared to Standard Therapy in de Novo Renal Transplant Patients

First Posted Date
2005-09-12
Last Posted Date
2013-11-13
Lead Sponsor
Novartis
Target Recruit Count
300
Registration Number
NCT00154310
Locations
🇨🇭

Novartis Pharma AG, Basel, Switzerland

🇨🇭

Novartis Investigational Sites, Bern, Switzerland

Nordic Study in Cardiac and Lung Transplantation: Outcome in Relation to Cyclosporine Microemulsion C2 Levels

Phase 4
Completed
Conditions
Interventions
First Posted Date
2005-09-12
Last Posted Date
2020-02-11
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
190
Registration Number
NCT00154193
Locations
🇨🇭

Novartis, Basel, Switzerland

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