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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Cyclophosphamide in Treating Patients Who Are Undergoing a Donor Bone Marrow Transplant for Fanconi's Anemia

Phase 1
Completed
Conditions
First Posted Date
2006-04-25
Last Posted Date
2012-04-20
Lead Sponsor
Fred Hutchinson Cancer Center
Target Recruit Count
25
Registration Number
NCT00317876
Locations
🇺🇸

Fred Hutchinson Cancer Research Center, Seattle, Washington, United States

🇧🇷

Universidade Federal do Parana, Curitiba, Parana, Brazil

🇺🇸

Seattle Cancer Care Alliance, Seattle, Washington, United States

Total-Body Irradiation and Cyclophosphamide in Treating Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer and Other Diseases

First Posted Date
2006-04-25
Last Posted Date
2010-05-07
Lead Sponsor
Fred Hutchinson Cancer Center
Target Recruit Count
50
Registration Number
NCT00317785
Locations
🇺🇸

Seattle Cancer Care Alliance, Seattle, Washington, United States

🇺🇸

Fred Hutchinson Cancer Research Center, Seattle, Washington, United States

Combination Chemotherapy Followed By Stem Cell Transplant in Treating Young Patients With Progressive or Relapsed Anaplastic Large Cell Lymphoma

Not Applicable
Conditions
First Posted Date
2006-04-24
Last Posted Date
2015-09-25
Lead Sponsor
European Inter-group Cooperation on Childhood and Adolescent Non Hodgkin Lymphoma
Target Recruit Count
96
Registration Number
NCT00317408
Locations
🇨🇿

University Hospital Brno, Brno, Czech Republic

🇧🇪

U.Z. Gasthuisberg, Leuven, Belgium

🇩🇪

Krankenhaus Muenchen Schwabing, Munich, Germany

and more 91 locations

Myeloablative Umbilical Cord Blood Transplantation in Hematological Diseases

First Posted Date
2006-04-03
Last Posted Date
2020-09-10
Lead Sponsor
Masonic Cancer Center, University of Minnesota
Target Recruit Count
213
Registration Number
NCT00309842
Locations
🇺🇸

Masonic Cancer Center at University of Minnesota, Minneapolis, Minnesota, United States

🇺🇸

Fred Hutchinson Cancer Research Center, Seattle, Washington, United States

Donor Stem Cell Transplant Followed By Donor White Blood Cell Infusions in Treating Young Patients With Hematologic Cancer

Not Applicable
Terminated
Conditions
First Posted Date
2006-03-13
Last Posted Date
2013-07-15
Lead Sponsor
University of California, San Francisco
Target Recruit Count
8
Registration Number
NCT00301860
Locations
🇺🇸

UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States

Efficacy and Safety of Everolimus in Recipients of Heart Transplants to Prevent Acute and Chronic Rejection

First Posted Date
2006-03-08
Last Posted Date
2012-08-16
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
721
Registration Number
NCT00300274
Locations
🇺🇸

Hahnemann University Hospital, Philadelphia, Pennsylvania, United States

🇺🇸

Temple University Hospital, Philadelphia, Pennsylvania, United States

🇺🇸

Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States

and more 61 locations

Immunosuppression Impact on the Metabolic Control of Kidney Transplant With Pre-Existing Type 2 Diabetes (DM)

First Posted Date
2006-02-24
Last Posted Date
2017-10-06
Lead Sponsor
Stanford University
Target Recruit Count
29
Registration Number
NCT00296296
Locations
🇺🇸

Stanford university Hospital and Clinics, Stanford, California, United States

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