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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Drug Interaction Study of Isavuconazole and Cyclosporine

Phase 1
Completed
Conditions
Interventions
First Posted Date
2011-12-19
Last Posted Date
2011-12-19
Lead Sponsor
Astellas Pharma Inc
Target Recruit Count
24
Registration Number
NCT01494597
Locations
🇺🇸

Covance, Madison, Wisconsin, United States

Effect of Switching to Certican® in Viremia of Hepatitis C Virus in Adult Renal Allograft Recipients

First Posted Date
2011-11-10
Last Posted Date
2015-04-03
Lead Sponsor
Irmandade Santa Casa de Misericórdia de Porto Alegre
Target Recruit Count
30
Registration Number
NCT01469884
Locations
🇧🇷

Irmandade Da Santa Casa de Misericórdia de Porto Alegre, Porto Alegre, Rio Grande Do Sul, Brazil

Treatment of Children With Kidney Transplants by Injection of CD4+CD25+FoxP3+ T Cells to Prevent Organ Rejection

First Posted Date
2011-10-05
Last Posted Date
2011-11-18
Lead Sponsor
Pirogov Russian National Research Medical University
Target Recruit Count
30
Registration Number
NCT01446484
Locations
🇷🇺

The Russian State Medical University, Moscow, Russian Federation

🇷🇺

Boris Petrovsky Scientific Center of Surgery Russian Academy of Medical Sciencies, Moscow, Russian Federation

Tacrolimus Versus Cyclosporine for Immunosuppression After Lung Transplantation

First Posted Date
2011-09-07
Last Posted Date
2011-09-07
Lead Sponsor
Universitätsklinikum Hamburg-Eppendorf
Target Recruit Count
274
Registration Number
NCT01429844
Locations
🇩🇪

Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany

🇧🇪

Universitaire Ziekenhuizen, Leuven, Belgium

🇩🇪

Universitätsklinikum Essen, Essen, Germany

and more 11 locations

Dasatinib and Cyclosporine in Treating Patients With Chronic Myelogenous Leukemia Refractory or Intolerant to Imatinib Mesylate

First Posted Date
2011-08-31
Last Posted Date
2014-04-02
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
4
Registration Number
NCT01426334
Locations
🇺🇸

University of Colorado Cancer Center - Anschutz Cancer Pavilion, Aurora, Colorado, United States

🇺🇸

University of Colorado, Denver, Colorado, United States

Everolimus in de Novo Kidney Transplant Recipients

First Posted Date
2011-08-05
Last Posted Date
2017-06-16
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
383
Registration Number
NCT01410448
Locations
🇮🇹

Novartis Investigative Site, Novara, Italy

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