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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A Study to Examine the Effects of Telaprevir on the Pharmacokinetics of Cyclosporine and Tacrolimus in Healthy Adults

First Posted Date
2009-12-23
Last Posted Date
2010-04-08
Lead Sponsor
Vertex Pharmaceuticals Incorporated
Target Recruit Count
20
Registration Number
NCT01038167

Efficacy of Topical Cyclosporine A for Treatment and Prevention of Graft Rejection in Corneal Grafts With Previous Rejection Episodes

Phase 4
Completed
Conditions
Interventions
First Posted Date
2009-12-09
Last Posted Date
2009-12-09
Lead Sponsor
Shahid Beheshti University of Medical Sciences
Registration Number
NCT01028443
Locations
🇮🇷

Ophthalmic Research Center, Tehran, Iran, Islamic Republic of

Once-a-day Regimen With Everolimus, Low Dose Cyclosporine and Steroids in Comparison With Steroid Withdrawal or Twice a Day Regimen With Everolimus, Low Dose Cyclosporine and Steroids.

First Posted Date
2009-12-02
Last Posted Date
2016-07-19
Lead Sponsor
Novartis
Target Recruit Count
330
Registration Number
NCT01023815
Locations
🇮🇹

Novartis Investigative Site, Vicenza, Italy

🇮🇹

Novartis InvestigativeSite, Udine, Italy

🇮🇹

Novarits Investigative Site, Pisa, Italy

Donor Stem Cell Transplant or Bone Marrow Transplant in Treating Patients With Acute Myeloid Leukemia in Remission

First Posted Date
2009-11-25
Last Posted Date
2015-12-31
Lead Sponsor
Asan Medical Center
Target Recruit Count
263
Registration Number
NCT01020734
Locations
🇰🇷

Inje University - Haeundae Paik Hospital, Busan, Korea, Republic of

🇰🇷

Asan Medical Center - University of Ulsan College of Medicine, Seoul, Korea, Republic of

Trial of Cyclosporine for Myocardial Protection During Open Heart Surgery

First Posted Date
2009-10-07
Last Posted Date
2010-11-02
Lead Sponsor
The University of Texas Health Science Center, Houston
Target Recruit Count
72
Registration Number
NCT00990795
Locations
🇺🇸

University of Texas Medical School Houston, Houston, Texas, United States

A Trial Comparing Prograf and Neoral Use in Kidney Transplant Recipients of Hispanic Ethnicity

Phase 4
Terminated
Conditions
Interventions
First Posted Date
2009-09-24
Last Posted Date
2016-06-03
Lead Sponsor
Loma Linda University
Target Recruit Count
15
Registration Number
NCT00983645
Locations
🇺🇸

Loma Linda University Medical Center, Loma Linda, California, United States

Drug-Drug Interaction Study Between Colchicine and Cyclosporine

Phase 1
Completed
Conditions
Interventions
First Posted Date
2009-09-24
Last Posted Date
2009-10-15
Lead Sponsor
Mutual Pharmaceutical Company, Inc.
Target Recruit Count
24
Registration Number
NCT00983931
Locations
🇺🇸

PRACS Institute, Ltd. - Cetero Research, Fargo, North Dakota, United States

Oral Cyclosporine in Chronic Obstructive Pulmonary Disease

First Posted Date
2009-09-10
Last Posted Date
2018-05-09
Lead Sponsor
Michael Donahoe
Target Recruit Count
43
Registration Number
NCT00974142
Locations
🇺🇸

University of Pittsburgh, Pittsburgh, Pennsylvania, United States

Donor Umbilical Cord Blood Transplant After Cyclophosphamide, Fludarabine Phosphate, and Total-Body Irradiation in Treating Patients With Hematologic Disease

First Posted Date
2009-08-14
Last Posted Date
2013-08-26
Lead Sponsor
Cancer Research UK
Target Recruit Count
60
Registration Number
NCT00959231
Locations
🇬🇧

Great Ormond Street Hospital for Children, London, England, United Kingdom

🇬🇧

UCL Cancer Institute, London, England, United Kingdom

🇬🇧

Bristol Royal Hospital for Children, Bristol, England, United Kingdom

and more 3 locations
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