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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Tacrolimus/Sirolimus/Methotrexate vs Tacrolimus/Methotrexate or Cyclosporine/Mycophenolate Mofetil for GVHD Prophylaxis After Reduced Intensity Allogeneic Stem Cell Transplantation for Patients With Lymphoma

First Posted Date
2009-06-25
Last Posted Date
2019-02-01
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
139
Registration Number
NCT00928018
Locations
🇺🇸

Emory University Hospital, Atlanta, Georgia, United States

🇺🇸

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

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Ciclosporin in the Management of Steroid Resistant Type 1 Reactions in Leprosy

Phase 2
Completed
Conditions
Interventions
First Posted Date
2009-06-12
Last Posted Date
2015-03-25
Lead Sponsor
London School of Hygiene and Tropical Medicine
Target Recruit Count
16
Registration Number
NCT00919451
Locations
🇪🇹

Alert Hospital, Addis Abeba, Ethiopia

Ciclosporin in the Management of New Erythema Nodosum Leprosum

Phase 2
Completed
Conditions
Interventions
First Posted Date
2009-06-12
Last Posted Date
2015-03-24
Lead Sponsor
London School of Hygiene and Tropical Medicine
Target Recruit Count
12
Registration Number
NCT00919542
Locations
🇪🇹

Alert Hospital, Addis Abeba, Ethiopia

Ciclosporin in the Management of New Type 1 Reactions in Leprosy

Phase 2
Completed
Conditions
Interventions
First Posted Date
2009-06-12
Last Posted Date
2015-03-24
Lead Sponsor
London School of Hygiene and Tropical Medicine
Target Recruit Count
73
Registration Number
NCT00919815
Locations
🇪🇹

Alert Hospital, Addis Abeba, Ethiopia

Ciclosporin in the Management of Chronic or Recurrent Erythema Nodosum Leprosum

Phase 2
Completed
Conditions
Interventions
First Posted Date
2009-06-12
Last Posted Date
2015-03-26
Lead Sponsor
London School of Hygiene and Tropical Medicine
Target Recruit Count
20
Registration Number
NCT00919776
Locations
🇪🇹

Alert Hospital, Addis Abeba, Ethiopia

Carmustine, Etoposide, Cytarabine, Melphalan, and Alemtuzumab Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma

Phase 2
Conditions
First Posted Date
2009-05-25
Last Posted Date
2013-08-02
Lead Sponsor
Cancer Research UK
Target Recruit Count
47
Registration Number
NCT00908180

Fludarabine Phosphate, Melphalan, and Alemtuzumab Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed Hodgkin Lymphoma

Phase 2
Conditions
First Posted Date
2009-05-22
Last Posted Date
2013-08-02
Lead Sponsor
Cancer Research UK
Target Recruit Count
49
Registration Number
NCT00907036

Optima: Optimizing Prograf Therapy in Maintenance Allografts II

First Posted Date
2009-05-20
Last Posted Date
2023-09-07
Lead Sponsor
East Carolina University
Target Recruit Count
63
Registration Number
NCT00905515
Locations
🇺🇸

Brody School of Medicine at East Carolina University, Greenville, North Carolina, United States

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