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

Associated Therapies: -

Clinical Trials

Autologous Followed by Non-myeloablative Allogeneic Transplantation for Non-Hodgkin's Lymphoma

Phase 2

Terminated

Conditions: Lymphoma, Non-Hodgkin

Interventions: Drug: Cyclophosphamide
Drug: BCNU
Drug: Etoposide
Drug: Filgrastim
Drug: Antithymocyte globulin
Drug: Cyclosporine
Drug: Mycophenolate mofetil
Drug: Rituximab
Procedure: Autologous hematopoietic stem cell transplantation (auto-HSCT)
Procedure: Allogeneic hematopoietic stem cell transplantation (allo-HSCT)
Procedure: Total lymphoid irradiation
Drug: CD34+ Cells
Drug: Solu-Medrol

First Posted Date: 2007-06-04

Last Posted Date: 2018-02-14

Lead Sponsor: Stanford University

Target Recruit Count: 50

Registration Number: NCT00481832

Locations: 🇺🇸
Stanford University School of Medicine, Stanford, California, United States

Feasibility of Haploidentical Hematopoietic Stem Cell Transplantation Using CAMPATH-1H

Phase 1

Completed

Conditions: Leukemia, Myeloid, Acute
Leukemia, Lymphoblastic, Acute

First Posted Date: 2007-04-10

Last Posted Date: 2008-11-18

Lead Sponsor: Tehran University of Medical Sciences

Target Recruit Count: 10

Registration Number: NCT00458250

Locations: 🇮🇷
Hematology-Oncology & BMT Research Center, Tehran, Iran, Islamic Republic of

Fludarabine Phosphate, Cyclophosphamide, and Total-Body Irradiation Followed by Donor Bone Marrow Transplant, Mycophenolate Mofetil, and Cyclosporine in Treating Patients With Fanconi Anemia

Phase 2

Completed

Conditions: Acute Myeloid Leukemia in Remission
de Novo Myelodysplastic Syndrome
Fanconi Anemia
Previously Treated Myelodysplastic Syndrome

Interventions: Procedure: Allogeneic Bone Marrow Transplantation
Drug: Cyclophosphamide
Drug: Cyclosporine
Drug: Fludarabine Phosphate
Other: Laboratory Biomarker Analysis
Drug: Mycophenolate Mofetil
Procedure: Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation
Radiation: Total-Body Irradiation

First Posted Date: 2007-03-28

Last Posted Date: 2020-01-29

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 6

Registration Number: NCT00453388

Locations: 🇺🇸
Children's Hospital and Research Center at Oakland, Oakland, California, United States
🇺🇸
Children's Hospital of Wisconsin, Milwaukee, Wisconsin, United States
🇺🇸
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington, United States

and more 2 locations