MedPath

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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Modified Stem Cell Transplant Procedure to Treat Patients With Blood and Immune System Cancers

Phase 2
Completed
Conditions
Hematologic Neoplasms
Interventions
First Posted Date
2003-01-08
Last Posted Date
2021-09-09
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
62
Registration Number
NCT00051311
Locations
🇺🇸

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

To Study the Effects of CD25 and Low Dose Cyclosporin in the Treatment of Active Psoriasis Vulgaris

Phase 1
Completed
Conditions
Psoriasis
Interventions
First Posted Date
2002-12-18
Last Posted Date
2009-03-13
Lead Sponsor
Rockefeller University
Target Recruit Count
20
Registration Number
NCT00050648
Locations
🇺🇸

Rockefeller University Hospital, New York, New York, United States

🇺🇸

Rockefeller University, New York, New York, United States

Treatment of T-Large Granular Lymphocyte (T-LGL) Lymphoproliferative Disorders With Cyclosporine

Phase 1
Completed
Conditions
Anemia
Leukemia, T-Cell
Lymphocytosis
Neutropenia
Thrombocytopenia
First Posted Date
2002-12-10
Last Posted Date
2006-07-17
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Target Recruit Count
25
Registration Number
NCT00001533
Locations
🇺🇸

National Heart, Lung and Blood Institute (NHLBI), Bethesda, Maryland, United States

Treatment of Dry Eye Syndrome With Cyclosporin A Eye Drops

Phase 2
Completed
Conditions
Keratoconjunctivitis Sicca
Sjogren's Syndrome
First Posted Date
2002-12-10
Last Posted Date
2008-03-04
Lead Sponsor
National Eye Institute (NEI)
Target Recruit Count
30
Registration Number
NCT00001731
Locations
🇺🇸

National Eye Institute (NEI), Bethesda, Maryland, United States

A Randomized Trial of Antithymocyte Globulin Versus Cyclosporine to Treat the Cytopenia of Myelodysplastic Syndrome

Phase 2
Completed
Conditions
Hematologic Diseases
Myelodysplastic Syndromes
First Posted Date
2002-12-10
Last Posted Date
2008-03-04
Lead Sponsor
National Institutes of Health Clinical Center (CC)
Target Recruit Count
182
Registration Number
NCT00001839
Locations
🇺🇸

Warren G. Magnuson Clinical Center (CC), Bethesda, Maryland, United States

A Study to Assess Use of Zenapax (Daclizumab) and CellCept (Mycophenolate Mofetil) to Improve Kidney Function in Kidney Transplant Patients

Phase 3
Completed
Conditions
Kidney Transplantation
Interventions
Drug: Corticosteroids
Drug: Neoral
Drug: Zenapax
Drug: mycophenolate mofetil [CellCept]
First Posted Date
2002-10-25
Last Posted Date
2016-11-02
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
539
Registration Number
NCT00048152

A Study to Evaluate the Efficacy and Safety of Zenapax in Combination With CellCept, Cyclosporine, and Corticosteroids in Patients Undergoing Cardiac Transplantation

Phase 4
Completed
Conditions
Heart Transplantation
Interventions
First Posted Date
2002-10-25
Last Posted Date
2016-06-13
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
434
Registration Number
NCT00048165

Stem Cell Transplantation in Patients With High-Risk and Recurrent Pediatric Sarcomas

Phase 2
Completed
Conditions
Sarcoma
Interventions
Drug: F-18 Fluorodeoxyglucose
Biological: therapeutic allogeneic lymphocytes
Procedure: Peripheral Blood Stem Cell donation
Drug: cyclophosphamide
Drug: cyclosporine
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: fludarabine phosphate
Drug: melphalan
Drug: prednisone
Drug: sirolimus
Drug: tacrolimus
Drug: vincristine sulfate
Procedure: peripheral blood stem cell transplantation
Drug: Filgrastim
First Posted Date
2002-08-16
Last Posted Date
2017-05-31
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
60
Registration Number
NCT00043979
Locations
🇺🇸

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

Study Comparing the Safety and Efficacy of Belatacept With That of Cyclosporine in Patients With a Transplanted Kidney

Phase 2
Completed
Conditions
Graft Rejection
Kidney Transplantation
Renal Transplantation
Interventions
First Posted Date
2002-05-06
Last Posted Date
2014-01-13
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
230
Registration Number
NCT00035555
Locations
🇺🇸

Medical Univ. of South Carolina, Charleston, South Carolina, United States

🇺🇸

Univ. of Nebraska Medical Center, Omaha, Nebraska, United States

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

and more 9 locations

Increasing HAART-Induced Immune Restoration With Cyclosporine

Phase 2
Completed
Conditions
HIV Infections
First Posted Date
2002-02-22
Last Posted Date
2015-03-09
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
40
Registration Number
NCT00031070
Locations
🇺🇸

Univ of Texas, Southwestern Med Ctr of Dallas, Dallas, Texas, United States

🇺🇸

Washington Univ (St. Louis), St. Louis, Missouri, United States

🇺🇸

University of Pennsylvania, Philadelphia, Philadelphia, Pennsylvania, United States

and more 12 locations
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