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
- -
Cyclophosphamide Plus Cyclosporine in Treatment-Naive Severe Aplastic Anemia
- Conditions
- Interventions
- First Posted Date
- 2010-09-01
- Last Posted Date
- 2017-05-22
- Target Recruit Count
- 22
- Registration Number
- NCT01193283
- Locations
- 🇺🇸
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States
MEmbranous Nephropathy Trial Of Rituximab
- Conditions
- Interventions
- First Posted Date
- 2010-08-11
- Last Posted Date
- 2019-04-30
- Lead Sponsor
- Mayo Clinic
- Target Recruit Count
- 130
- Registration Number
- NCT01180036
- Locations
- 🇨🇦
Toronto General Hospital, Toronto, Ontario, Canada
🇺🇸Ohio State University, Columbus, Ohio, United States
🇺🇸University of Alabama at Birmingham, Birmingham, Alabama, United States
High-Dose Busulfan and High-Dose Cyclophosphamide Followed By Donor Bone Marrow Transplant in Treating Patients With Leukemia, Myelodysplastic Syndrome, Multiple Myeloma, or Recurrent Hodgkin or Non-Hodgkin Lymphoma
- Conditions
- Accelerated Phase Chronic Myelogenous LeukemiaAdult Acute Lymphoblastic Leukemia in RemissionAdult Acute Megakaryoblastic Leukemia (M7)Adult Acute Monoblastic Leukemia (M5a)Adult Acute Monocytic Leukemia (M5b)Adult Acute Myeloblastic Leukemia With Maturation (M2)Adult Acute Myeloblastic Leukemia Without Maturation (M1)Adult Acute Myeloid Leukemia in RemissionAdult Acute Myeloid Leukemia With 11q23 (MLL) AbnormalitiesAdult Acute Myeloid Leukemia With Del(5q)
- Interventions
- First Posted Date
- 2010-08-09
- Last Posted Date
- 2010-08-09
- Lead Sponsor
- Case Comprehensive Cancer Center
- Target Recruit Count
- 13
- Registration Number
- NCT01177371
- Locations
- 🇺🇸
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center, Cleveland, Ohio, United States
Infusion of Off-the-Shelf Expanded Cord Blood Cells to Augment Cord Blood Transplant in Patients With Hematologic Malignancies
- Conditions
- Adult Acute Myeloid Leukemia in RemissionAdult Acute Myeloid Leukemia With 11q23 (MLL) AbnormalitiesAdult Acute Myeloid Leukemia With Del(5q)Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)Accelerated Phase Chronic Myelogenous LeukemiaAdult Acute Myeloid Leukemia With t(15;17)(q22;q12)Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)Childhood Acute Lymphoblastic Leukemia in RemissionChildhood Acute Myeloid Leukemia in Remission
- Interventions
- First Posted Date
- 2010-08-05
- Last Posted Date
- 2019-03-05
- Lead Sponsor
- Nohla Therapeutics, Inc.
- Target Recruit Count
- 15
- Registration Number
- NCT01175785
- Locations
- 🇺🇸
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington, United States
Study of First Line Treatment of Chronic Graft Versus Host Disease With the Association of Ciclosporine, Corticosteroids and Rituximab (Protocol R-GVHD)
- Conditions
- Interventions
- First Posted Date
- 2010-06-03
- Last Posted Date
- 2014-04-03
- Lead Sponsor
- Nantes University Hospital
- Target Recruit Count
- 25
- Registration Number
- NCT01135641
- Locations
- 🇫🇷
Nantes University Hospital, Nantes, France
Safety and Efficacy in LPL-Deficient Subjects of AMT-011, an Adeno-Associated Viral Vector Expressing Human Lipoprotein Lipase [S447X]
- First Posted Date
- 2010-04-23
- Last Posted Date
- 2011-09-30
- Lead Sponsor
- Amsterdam Molecular Therapeutics
- Target Recruit Count
- 14
- Registration Number
- NCT01109498
- Locations
- 🇨🇦
Ecogene-21 Clinical Trial Center/ Centre de santé et de services sociaux de Chicoutimi, Chicoutimi, Quebec, Canada
Allogeneic Natural Killer (NK) Cells for Ovarian, Fallopian Tube, Peritoneal and Metastatic Breast Cancer
- First Posted Date
- 2010-04-16
- Last Posted Date
- 2017-12-28
- Lead Sponsor
- Masonic Cancer Center, University of Minnesota
- Target Recruit Count
- 13
- Registration Number
- NCT01105650
- Locations
- 🇺🇸
Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota, United States
Donor Umbilical Cord Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies
- Conditions
- Adult Acute Minimally Differentiated Myeloid Leukemia (M0)Adult Acute Monocytic Leukemia (M5b)Adult Acute Monoblastic Leukemia (M5a)Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)Childhood Acute Megakaryocytic Leukemia (M7)Childhood Acute Monocytic Leukemia (M5b)Childhood Myelodysplastic SyndromesRecurrent Childhood Large Cell LymphomaRecurrent Mantle Cell LymphomaAcute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome
- Interventions
- Procedure: double-unit umbilical cord blood transplantationOther: cytogenetic analysisProcedure: bone marrow aspirationOther: fluorescence in situ hybridizationDrug: busulfanDrug: cyclophosphamideDrug: anti-thymocyte globulinDrug: methylprednisoloneDrug: cyclosporineDrug: mycophenolate mofetilOther: flow cytometryProcedure: allogeneic hematopoietic stem cell transplantation
- First Posted Date
- 2010-03-26
- Last Posted Date
- 2019-01-23
- Lead Sponsor
- Case Comprehensive Cancer Center
- Target Recruit Count
- 14
- Registration Number
- NCT01093586
- Locations
- 🇺🇸
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland, Ohio, United States
Progression of Renal Interstitial Fibrosis / Tubular Atrophy (IF/TA) According to Epithelial-mesenchymal Transition (EMT) and Immunosuppressive Regimen (Everolimus Based Versus CNI Based) in de Novo Renal Transplant Recipients
- Conditions
- Interventions
- First Posted Date
- 2010-03-02
- Last Posted Date
- 2014-03-18
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 194
- Registration Number
- NCT01079143
- Locations
- 🇫🇷
Novartis Investigative Site, Vandoeuvre Les Nancys, France
Clofarabine and Low Dose Total Body Irradiation as a Preparative Regimen for Stem Cell Transplant in Leukemia.
- First Posted Date
- 2009-12-31
- Last Posted Date
- 2024-02-01
- Target Recruit Count
- 18
- Registration Number
- NCT01041508
- Locations
- 🇺🇸
Nationwide Childrens Hospital, Columbus, Ohio, United States
🇺🇸Oregon Health and Science University, Portland, Oregon, United States
🇺🇸Vanderbilt Children's Hospital, Nashville, Tennessee, United States
Drug Development Updates
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