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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

Study of Muromonab-CD3 and Cyclosporine in Patients With Giant Cell Myocarditis

Not Applicable
Completed
Conditions
Myocarditis
First Posted Date
2001-12-07
Last Posted Date
2015-03-25
Lead Sponsor
Mayo Clinic
Target Recruit Count
40
Registration Number
NCT00027443
Locations
🇺🇸

Mayo Clinic Rochester, Rochester, Minnesota, United States

A Study to Compare Treatment With Sirolimus Versus Standard Treatment in Patients Who Have Received a Kidney Transplant

Phase 3
Terminated
Conditions
End-Stage Renal Disease
Kidney Transplantation
Interventions
First Posted Date
2001-08-31
Last Posted Date
2012-03-13
Lead Sponsor
Boston Children's Hospital
Target Recruit Count
102
Registration Number
NCT00005113
Locations
🇺🇸

Children's Hospital Boston, Boston, Massachusetts, United States

A Study to Test the Effect of Cyclosporine on the Immune System of Patients With Early HIV Disease

Phase 2
Completed
Conditions
HIV Infections
First Posted Date
2001-08-31
Last Posted Date
2021-10-28
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
30
Registration Number
NCT00000880
Locations
🇺🇸

Bellevue Hosp / New York Univ Med Ctr, New York, New York, United States

🇺🇸

Beth Israel Med Ctr, New York, New York, United States

🇺🇸

Univ of North Carolina, Chapel Hill, North Carolina, United States

and more 9 locations

Steroid Withdrawal in Pediatric Kidney Transplant Recipients

First Posted Date
2001-08-31
Last Posted Date
2016-10-21
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
274
Registration Number
NCT00023244
Locations
🇺🇸

University of Florida Health Science Center, Jacksonville, Florida, United States

🇺🇸

The Children's Hospital of Buffalo, Buffalo, New York, United States

🇺🇸

Westchester Medical Center, Valhalla, New York, United States

and more 16 locations

A Study To Test An Anti-Rejection Therapy After Kidney Transplantation

Phase 3
Terminated
Conditions
Kidney Transplantation
Interventions
First Posted Date
2001-08-31
Last Posted Date
2017-01-11
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
292
Registration Number
NCT00000936
Locations
🇺🇸

Ilene Blechman-Krom, Rockville, Maryland, United States

Study of Allogeneic Bone Marrow and T-Cell Depleted, CD34+ Peripheral Blood Stem Cell Transplantation in Patients With Aplastic Anemia

Not Applicable
Conditions
Graft Versus Host Disease
Aplastic Anemia
First Posted Date
2001-06-06
Last Posted Date
2005-06-24
Lead Sponsor
Northwestern Memorial Hospital
Target Recruit Count
3
Registration Number
NCT00017654
Locations
🇺🇸

Northwestern Memorial Hospital, Chicago, Illinois, United States

Study of Total Body Irradiation and Fludarabine Followed By Allogeneic Peripheral Blood Stem Cell or Bone Marrow Transplantation in Combination With Cyclosporine and Mycophenolate Mofetil in Patients With Inherited Disorders

Not Applicable
Completed
Conditions
Metabolism, Inborn Errors
Granulomatous Disease, Chronic
First Posted Date
2001-02-02
Last Posted Date
2014-12-09
Lead Sponsor
Fred Hutchinson Cancer Center
Target Recruit Count
20
Registration Number
NCT00010361
Locations
🇺🇸

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

Total-Body Irradiation Followed By Cyclosporine and Mycophenolate Mofetil in Treating Patients With Severe Combined Immunodeficiency Undergoing Donor Bone Marrow Transplant

Phase 1
Completed
Conditions
Adenosine Deaminase Deficiency
Autosomal Recessive Disorder
Immune System Disorder
Purine-Nucleoside Phosphorylase Deficiency
Severe Combined Immunodeficiency
Severe Combined Immunodeficiency With Absence of T and B Cells
X-Linked Severe Combined Immunodeficiency
Interventions
Procedure: Allogeneic Bone Marrow Transplantation
Other: Laboratory Biomarker Analysis
Procedure: Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation
Radiation: Total-Body Irradiation
First Posted Date
2001-01-08
Last Posted Date
2019-07-29
Lead Sponsor
Fred Hutchinson Cancer Center
Target Recruit Count
6
Registration Number
NCT00008450
Locations
🇺🇸

Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States

Chemotherapy, Stem Cell Transplantation and Donor and Patient Vaccination for Treatment of Multiple Myeloma

Phase 2
Completed
Conditions
Multiple Myeloma
Interventions
Drug: Myeloma Immunoglobulin Idiotype Vaccine
Biological: GMCSF (granulocyte macrophage colony stimulating factor)
Biological: GCSF (granulocyte colony stimulating factor)
First Posted Date
2000-08-24
Last Posted Date
2017-10-20
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
20
Registration Number
NCT00006184
Locations
🇺🇸

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

Antithymocyte Globulin and Cyclosporine to Treat Myelodysplasia

Phase 2
Completed
Conditions
Myelodysplastic Syndrome
Interventions
Drug: Antithymocyte globulin
First Posted Date
2000-07-07
Last Posted Date
2014-10-23
Lead Sponsor
Neal Young, M.D.
Target Recruit Count
42
Registration Number
NCT00005937
Locations
🇺🇸

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

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