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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Calcineurin Inhibitor (CNI) Versus Steroid Cessation in Renal Transplantation

First Posted Date
2009-05-18
Last Posted Date
2009-05-18
Lead Sponsor
University Hospital, Antwerp
Target Recruit Count
152
Registration Number
NCT00903188
Locations
🇧🇪

Erasme University Hospital, Brussels, Belgium

🇧🇪

University Hospital, Ghent, Gent, Belgium

🇧🇪

University Hospital Brussels, Brussels, Belgium

and more 2 locations

Ph II of Non-myeloablative Allogeneic Transplantation Using TLI & ATG In Patients w/ Cutaneous T Cell Lymphoma

First Posted Date
2009-05-11
Last Posted Date
2023-05-11
Lead Sponsor
Stanford University
Target Recruit Count
38
Registration Number
NCT00896493
Locations
🇺🇸

Stanford University School of Medicine, Stanford, California, United States

Alemtuzumab and Low-Dose Cyclosporine in Treating Patients With Severe Aplastic Anemia or Acquired Marrow Failure

Phase 2
Conditions
First Posted Date
2009-05-08
Last Posted Date
2013-08-12
Lead Sponsor
Federico II University
Target Recruit Count
50
Registration Number
NCT00895739
Locations
🇮🇹

Federico II University Medical School, Naples, Italy

Efficacy and Safety of Human Lipoprotein Lipase (LPL)[S447X] Expressed by an Adeno-Associated Viral Vector in LPL-deficient Subjects

First Posted Date
2009-05-01
Last Posted Date
2011-09-29
Lead Sponsor
Amsterdam Molecular Therapeutics
Target Recruit Count
5
Registration Number
NCT00891306
Locations
🇨🇦

ECOGENE-21 Clinical Trial Center / Centre de santé et de services sociaux de Chicoutimi, Chicoutimi, Quebec, Canada

🇨🇦

Centre des Maladies Lipidiques de Québec, Quebec, Canada

Allogeneic Hematopoietic Stem Cell Transplantation for Relapsed or Refractory High-Risk NBL.

Phase 2
Withdrawn
Conditions
First Posted Date
2009-04-02
Last Posted Date
2015-10-16
Lead Sponsor
Nationwide Children's Hospital
Registration Number
NCT00874315
Locations
🇺🇸

Children's Memorial Hospital, Chicago, Illinois, United States

🇺🇸

Children's Hopsital of Wisconsin, Milwaukee, Wisconsin, United States

🇺🇸

Morgan Stanley Children's Hospital of NY, New York, New York, United States

and more 1 locations

Prevention of Skin Cancer in High Risk Patients After Conversion to a Sirolimus-based Immunosuppressive Protocol

First Posted Date
2009-03-20
Last Posted Date
2015-09-02
Lead Sponsor
Charite University, Berlin, Germany
Target Recruit Count
44
Registration Number
NCT00866684
Locations
🇩🇪

Universitätsklinikum Erlangen, Medizinische Klinik IV, Erlangen, Bavaria, Germany

🇩🇪

Universitätsklinikum Münster, Klinik und Poliklinik für Hautkrankheiten, Münster, North Rhine-Westphalia, Germany

🇩🇪

Universitätsklinikum Münster, Med. Klinik und Poliklinik D, Münster, North Rhine-Westphalia, Germany

and more 12 locations

Cyclosporine in Hepatitis C Infection Viral Clearance Following Liver Transplantation

Phase 4
Completed
Conditions
Interventions
First Posted Date
2009-01-13
Last Posted Date
2023-06-01
Lead Sponsor
University of Florida
Target Recruit Count
39
Registration Number
NCT00821587

Study of Methotrexate Efficacy Versus Cyclosporine in Moderate to Severe Atopic Dermatitis Patients

Phase 3
Completed
Conditions
Interventions
First Posted Date
2008-12-17
Last Posted Date
2013-05-14
Lead Sponsor
Hospices Civils de Lyon
Target Recruit Count
100
Registration Number
NCT00809172
Locations
🇫🇷

Hospices Civils de Lyon, Lyon, France

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