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

Gemtuzumab Ozogamicin, Fludarabine, and Total-body Irradiation Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Advanced Acute Myeloid Leukemia or Myelodysplastic Syndrome

Phase 2

Completed

Conditions: Leukemia
Myelodysplastic Syndromes

First Posted Date: 2004-03-25

Last Posted Date: 2010-04-02

Lead Sponsor: Fred Hutchinson Cancer Center

Registration Number: NCT00008151

Locations: 🇺🇸
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States

Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myeloid Leukemia

Phase 3

Completed

Conditions: Leukemia

First Posted Date: 2004-03-19

Last Posted Date: 2010-03-30

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 100

Registration Number: NCT00002789

Locations: 🇺🇸
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States

S9920 Busulfan Compared With Cyclophosphamide in Patients Undergoing Total-Body Irradiation Plus Peripheral Stem Cell Transplantation for Advanced Myelodysplastic Syndrome or Related Acute Myeloid Leukemia

Phase 3

Completed

Conditions: Myelodysplastic Syndromes
Leukemia

Interventions: Drug: busulfan
Drug: cyclophosphamide
Drug: cyclosporine
Drug: methotrexate
Procedure: allogeneic bone marrow transplantation
Radiation: radiation therapy

First Posted Date: 2004-03-16

Last Posted Date: 2015-03-06

Lead Sponsor: SWOG Cancer Research Network

Target Recruit Count: 240

Registration Number: NCT00005866

Locations: 🇺🇸
University of Mississippi Medical Center, Jackson, Mississippi, United States
🇺🇸
CCOP - Virginia Mason Research Center, Seattle, Washington, United States
🇺🇸
St. Louis University Health Sciences Center, Saint Louis, Missouri, United States

and more 63 locations

Mycophenolate Mofetil and Cyclosporine in Reducing Graft-Versus-Host Disease in Patients With Hematologic Malignancies or Metastatic Kidney Cancer Undergoing Donor Stem Cell Transplant

Phase 1

Completed

Conditions: Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Adult Nasal Type Extranodal NK/T-cell Lymphoma
Childhood Myelodysplastic Syndromes
Childhood Nasal Type Extranodal NK/T-cell Lymphoma
Chronic Myelomonocytic Leukemia
Accelerated Phase Chronic Myelogenous Leukemia
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Anaplastic Large Cell Lymphoma
Angioimmunoblastic T-cell Lymphoma

Interventions: Drug: fludarabine phosphate
Radiation: total-body irradiation
Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation
Drug: cyclosporine
Drug: mycophenolate mofetil
Other: laboratory biomarker analysis

First Posted Date: 2004-03-09

Last Posted Date: 2020-01-18

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 37

Registration Number: NCT00078858

Locations: 🇺🇸
Stanford University Hospitals and Clinics, Stanford, California, United States
🇺🇸
Rocky Mountain Cancer Centers-Midtown, Denver, Colorado, United States
🇺🇸
Emory University/Winship Cancer Institute, Atlanta, Georgia, United States

and more 7 locations

Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia or Myelodysplastic Syndrome

Phase 2

Completed

Conditions: Leukemia
Myelodysplastic Syndromes

First Posted Date: 2004-02-16

Last Posted Date: 2010-04-02

Lead Sponsor: Fred Hutchinson Cancer Center

Registration Number: NCT00027924

Locations: 🇺🇸
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States

Total-Body Irradiation With or Without Fludarabine Phosphate Followed By Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer

Phase 3

Completed

Conditions: Acute Lymphoblastic Leukemia in Remission
Refractory Hodgkin Lymphoma
Waldenstrom Macroglobulinemia
Acute Myeloid Leukemia in Remission
Aggressive Non-Hodgkin Lymphoma
Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Hematopoietic and Lymphoid Cell Neoplasm
Diffuse Large B-Cell Lymphoma
Indolent Non-Hodgkin Lymphoma
Mantle Cell Lymphoma

Interventions: Procedure: Total-Body Irradiation
Drug: Fludarabine Phosphate
Drug: Mycophenolate Mofetil
Drug: Cyclosporine
Procedure: Peripheral Blood Stem Cell Transplantation

First Posted Date: 2004-01-12

Last Posted Date: 2017-05-15

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 87

Registration Number: NCT00075478

Locations: 🇺🇸
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington, United States
🇺🇸
VA Puget Sound Health Care System, Seattle, Washington, United States
🇩🇪
Medizinische Univ Klinik Koln, Koln, Germany

and more 7 locations