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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Donor Stem Cell Transplant After Conditioning Therapy in Treating Patients With Hematologic Cancer, Recurrent or Metastatic Solid Tumor, or Other Disease

First Posted Date
2007-08-27
Last Posted Date
2013-03-26
Lead Sponsor
Asan Medical Center
Target Recruit Count
30
Registration Number
NCT00521430
Locations
🇰🇷

Asan Medical Center - University of Ulsan College of Medicine, Seoul, Korea, Republic of

Treatment of Myelodysplastic Syndrome (MDS) With Cytokine-Immunotherapy for Low-Risk MDS

First Posted Date
2007-08-24
Last Posted Date
2012-08-07
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
15
Registration Number
NCT00520468
Locations
🇺🇸

U.T.M.D. Anderson Cancer Center, Houston, Texas, United States

Chemotherapy and Unrelated Donor Stem Cell Transplantation for Patients With Cancers of the Blood and Immune System

First Posted Date
2007-08-23
Last Posted Date
2019-03-05
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
92
Registration Number
NCT00520130
Locations
🇺🇸

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

Study Evaluating the Efficacy and Safety of Cyclosporine Reduction in Kidney Transplant Recipients Receiving Sirolimus

Phase 4
Completed
Conditions
First Posted Date
2007-07-27
Last Posted Date
2007-07-27
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
385
Registration Number
NCT00507793

Efficacy, Safety and Tolerability of AEB071 Versus Cyclosporine in the Novo Renal Transplant Recipients

First Posted Date
2007-07-20
Last Posted Date
2016-11-18
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
311
Registration Number
NCT00504543
Locations
🇦🇷

Argentina, Buenos Aires, Argentina

🇧🇪

Belgium, Gent, Belgium

🇨🇳

Novartis Investigative Site, Taipie, Taiwan

and more 9 locations

Study of Cyclosporine in the Treatment of Dry Eye Syndrome (ST-603-005)

Phase 3
Completed
Conditions
First Posted Date
2007-07-17
Last Posted Date
2011-07-01
Lead Sponsor
Sirion Therapeutics, Inc.
Registration Number
NCT00502073
Locations
🇺🇸

Eye Center Northeast, Bangor, Maine, United States

Fibrosis in Renal Allografts

First Posted Date
2007-06-28
Last Posted Date
2008-11-26
Lead Sponsor
University Hospital, Antwerp
Target Recruit Count
100
Registration Number
NCT00493194
Locations
🇧🇪

University Hospital Gent, Gent, Oost-Vlaanderen, Belgium

🇧🇪

University Hospital Brussels, Brussels (Jette), Brabant, Belgium

🇧🇪

University Hospital Antwerp, Edegem, Antwerp, Belgium

Antithymocyte Globulin and Cyclosporine in Treating Low Risk Patients With Myelodysplastic Syndrome

Phase 4
Completed
Conditions
First Posted Date
2007-06-20
Last Posted Date
2008-11-19
Lead Sponsor
PETHEMA Foundation
Target Recruit Count
25
Registration Number
NCT00488436
Locations
🇪🇸

Hospital de Cabueñes, Asturias, Spain

🇪🇸

Hospital Virgen de la Victoria, Malaga, Spain

🇪🇸

Hospital germans Trias i Pujol, Badalona, Spain

and more 8 locations

Study of a JAK3 Inhibitor for the Prevention of Acute Rejection in Kidney Transplant Patients

Phase 2
Completed
Conditions
Interventions
First Posted Date
2007-06-07
Last Posted Date
2013-03-14
Lead Sponsor
Pfizer
Target Recruit Count
338
Registration Number
NCT00483756
Locations
🇪🇸

Pfizer Investigational Site, Barcelona, Spain

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