Cyclosporine

Generic Name: Cyclosporine

Brand Names: Cequa, Gengraf, Neoral, Restasis, Sandimmune, Verkazia, Vevye, Ikervis

Drug Type: Small Molecule

Chemical Formula: C_₆₂H_₁₁₁N_₁₁O_₁₂

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

Clinical Trials

Mycophenolate Mofetil and Cyclosporine to Treat Relapsing Aplastic Anemia

Phase 2

Completed

Conditions: Aplastic Anemia

First Posted Date: 2000-07-07

Last Posted Date: 2008-03-04

Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Target Recruit Count: 130

Registration Number: NCT00005935

Locations: 🇺🇸
National Heart, Lung and Blood Institute (NHLBI), Bethesda, Maryland, United States

Allogeneic Bone Marrow Transplantation in Patients With Primary Immunodeficiencies

Not Applicable

Terminated

Conditions: Immunologic Deficiency Syndromes
Chediak-Higashi Syndrome
Common Variable Immunodeficiency
Graft Versus Host Disease
X-Linked Lymphoproliferative Syndrome
Familial Erythrophagocytic Lymphohistiocytosis
Hemophagocytic Lymphohistiocytosis
X-linked Agammaglobulinemia
Wiskott-Aldrich Syndrome
Chronic Granulomatous Disease

First Posted Date: 2000-07-06

Last Posted Date: 2009-10-15

Lead Sponsor: Fairview University Medical Center

Registration Number: NCT00006054

Locations: 🇺🇸
Fairview University Medical Center, Minneapolis, Minnesota, United States

Autologous Peripheral Blood Stem Cell Transplantation in Patients With Life Threatening Autoimmune Diseases

Not Applicable

Conditions: Purpura, Schoenlein-Henoch
Graft Versus Host Disease
Anemia, Hemolytic, Autoimmune
Rheumatoid Arthritis
Churg-Strauss Syndrome
Hypersensitivity Vasculitis
Wegener's Granulomatosis
Systemic Lupus Erythematosus
Giant Cell Arteritis
Pure Red Cell Aplasia

First Posted Date: 2000-07-06

Last Posted Date: 2005-06-24

Lead Sponsor: Fairview University Medical Center

Target Recruit Count: 10

Registration Number: NCT00006055

Locations: 🇺🇸
Fairview University Medical Center, Minneapolis, Minnesota, United States

Pilot Study of Unrelated Donor Hematopoietic Stem Cell Transplantation in Patients With Life Threatening Hemophagocytic Disorders

Not Applicable

Conditions: Chediak-Higashi Syndrome
Graft Versus Host Disease
X-Linked Lymphoproliferative Syndrome
Familial Erythrophagocytic Lymphohistiocytosis
Hemophagocytic Lymphohistiocytosis
Virus-Associated Hemophagocytic Syndrome