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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Eltrombopag in Combination With Rabbit Anti-thymocyte Globulin/Cyclosporine A in Naive Aplastic Anemia (AA) Subjects

Phase 2
Completed
Conditions
Interventions
First Posted Date
2015-03-31
Last Posted Date
2019-07-26
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
10
Registration Number
NCT02404025
Locations
🇯🇵

Novartis Investigative Site, Tokyo, Japan

Ciclosporin to Protect Renal Function In Cardiac Surgery

Phase 2
Completed
Conditions
Interventions
First Posted Date
2015-03-24
Last Posted Date
2016-10-13
Lead Sponsor
Region Skane
Target Recruit Count
155
Registration Number
NCT02397213
Locations
🇸🇪

Skane University Hospital, Lund, Sweden

Ciclosporin to Reduce Reperfusion Injury in Primary PCI

Phase 2
Completed
Conditions
Interventions
First Posted Date
2015-03-17
Last Posted Date
2018-03-29
Lead Sponsor
Newcastle-upon-Tyne Hospitals NHS Trust
Target Recruit Count
54
Registration Number
NCT02390674
Locations
🇬🇧

Newcastle Clinical Trials Unit, Newcastle upon Tyne, Tyne And Wear, United Kingdom

Cyclosporine A in the TReatment of Interstitial Pneumonitis Associated With Sjogren's Syndrome

First Posted Date
2015-02-25
Last Posted Date
2020-05-22
Lead Sponsor
Peking University People's Hospital
Target Recruit Count
240
Registration Number
NCT02370550
Locations
🇨🇳

Peking University People's Hospital, Beijing, Beijing, China

The Effect of Locally Delivered Ciclosporin as an Adjunct to Healing After Treatment of Periodontal Pockets

Phase 2
Completed
Conditions
Interventions
First Posted Date
2015-02-19
Last Posted Date
2017-04-07
Lead Sponsor
PerioC Limited
Target Recruit Count
23
Registration Number
NCT02366585
Locations
🇸🇪

The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden

Drug-drug Interaction Study of Eltrombopag and Cyclosporine in Healthy Subjects

First Posted Date
2014-11-02
Last Posted Date
2017-11-13
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
39
Registration Number
NCT02281370
Locations
🇺🇸

GSK Investigational Site, Overland Park, Kansas, United States

Drug-Drug Interaction Study in Healthy Adult Volunteers

Phase 1
Completed
Conditions
Interventions
First Posted Date
2014-10-27
Last Posted Date
2014-10-27
Lead Sponsor
Kowa Research Institute, Inc.
Target Recruit Count
20
Registration Number
NCT02276001
Locations
🇺🇸

PPD, Austin, Texas, United States

A Multicenter Investigation of Recombinant Human Thrombopoietin (rhTPO) Combining Cyclosporin A Versus Cyclosporin A in Management of Steroid-Resistant/Relapsed Immune Thrombocytopenia (ITP)

Phase 3
Withdrawn
Conditions
Interventions
First Posted Date
2014-07-29
Last Posted Date
2016-04-20
Lead Sponsor
Shandong University
Registration Number
NCT02203422
Locations
🇨🇳

Qilu Hospital, Shandong University, Jinan, Shandong, China

Selumetinib and Cyclosporine in Treating Patients With Advanced Solid Tumors or Advanced or Metastatic Colorectal Cancer

First Posted Date
2014-07-11
Last Posted Date
2024-07-03
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
40
Registration Number
NCT02188264
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

🇺🇸

Siteman Cancer Center at West County Hospital, Creve Coeur, Missouri, United States

🇺🇸

Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States

and more 7 locations
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