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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Topical Cyclosporine and Disease Progression

First Posted Date
2007-12-05
Last Posted Date
2008-09-25
Lead Sponsor
Innovative Medical
Target Recruit Count
80
Registration Number
NCT00567983
Locations
🇺🇸

Lakeside Eye Clinic, Chicago, Illinois, United States

Study Of JAK3 Inhibitor For The Prevention Of Acute Rejection In Kidney Transplant Patients

Phase 2
Withdrawn
Conditions
Interventions
First Posted Date
2007-11-09
Last Posted Date
2008-05-30
Lead Sponsor
Pfizer
Registration Number
NCT00556257

Alemtuzumab, Fludarabine Phosphate, and Total-Body Irradiation Followed by a Donor Stem Cell Transplant in Treating Patients With Immunodeficiency or Other Nonmalignant Inherited Disorders

First Posted Date
2007-11-04
Last Posted Date
2020-02-17
Lead Sponsor
Fred Hutchinson Cancer Center
Target Recruit Count
29
Registration Number
NCT00553098
Locations
🇺🇸

Children's Hospital and Research Center at Oakland, Oakland, California, United States

🇺🇸

Oregon Health and Science University, Portland, Oregon, United States

🇺🇸

Cleveland Clinic Foundation, Cleveland, Ohio, United States

and more 3 locations

Donor Stem Cell Transplant in Treating Young Patients With Acute Myeloid Leukemia With Monosomy 7, -5/5q-, High FLT3-ITD AR, or Refractory or Relapsed Acute Myelogenous Leukemia

First Posted Date
2007-11-04
Last Posted Date
2020-04-16
Lead Sponsor
Children's Oncology Group
Target Recruit Count
158
Registration Number
NCT00553202
Locations
🇺🇸

AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus, Atlanta, Georgia, United States

🇺🇸

Alvin and Lois Lapidus Cancer Institute at Sinai Hospital, Baltimore, Maryland, United States

🇺🇸

Nationwide Children's Hospital, Columbus, Ohio, United States

and more 49 locations

Different Therapies in Treating Infants With Newly Diagnosed Acute Leukemia

Not Applicable
Conditions
First Posted Date
2007-10-30
Last Posted Date
2019-07-30
Lead Sponsor
Dutch Childhood Oncology Group
Target Recruit Count
445
Registration Number
NCT00550992
Locations
🇨🇿

University Hospital Motol, Prague, Czechia

🇫🇷

CHR Hotel Dieu, Nantes, France

🇺🇸

Children's Hospital and Regional Medical Center - Seattle, Seattle, Washington, United States

and more 10 locations

Study of Cyclosporine in the Treatment of Dry Eye Syndrome (ST-603-007)

Phase 3
Completed
Conditions
First Posted Date
2007-10-23
Last Posted Date
2011-07-01
Lead Sponsor
Sirion Therapeutics, Inc.
Registration Number
NCT00548301
Locations
🇺🇸

Eye Center Northeast, Bangor, Maine, United States

Calcineurin Inhibitor Minimisation in Renal Transplant Recipients With Stable Allograft Function

First Posted Date
2007-10-10
Last Posted Date
2008-09-08
Lead Sponsor
University Hospital Birmingham
Target Recruit Count
90
Registration Number
NCT00541814
Locations
🇬🇧

University Hospital Birmingham NHS Foundation Trust, Birmingham, West Midlands, United Kingdom

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