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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Cyclosporine in Interstitial Cystitis: Efficacy, Safety and Mechanism of Action

Phase 2
Completed
Conditions
Interventions
First Posted Date
2013-11-25
Last Posted Date
2017-04-19
Lead Sponsor
The Cleveland Clinic
Target Recruit Count
26
Registration Number
NCT01990898
Locations
🇺🇸

Cleveland Clinic - Main Campus Only, Cleveland, Ohio, United States

Gengraf Conversion Study in Stable Renal Allograft Transplant Recipients

First Posted Date
2013-11-21
Last Posted Date
2013-11-21
Lead Sponsor
Penang Hospital, Malaysia
Target Recruit Count
106
Registration Number
NCT01990118
Locations
🇲🇾

Clinical Research Centre, Penang Hospital, George Town, Penang, Malaysia

A Study of Baricitinib and Ciclosporin in Healthy Participants

Phase 1
Completed
Conditions
Interventions
First Posted Date
2013-10-23
Last Posted Date
2017-06-06
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
18
Registration Number
NCT01968057
Locations
🇬🇧

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Leeds, West Yorkshire, United Kingdom

12 Month Athena Study: Everolimus vs. Standard Regimen in de Novo Kidney Transplant Patients

First Posted Date
2013-04-30
Last Posted Date
2017-05-01
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
612
Registration Number
NCT01843348
Locations
🇩🇪

Novartis Investigative Site, Tübingen, Germany

A Study in Maintenance Kidney Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based

First Posted Date
2013-03-29
Last Posted Date
2021-01-05
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
446
Registration Number
NCT01820572
Locations
🇺🇸

Transplant Research Institute (PI Address), Los Angeles, California, United States

🇺🇸

Cedars-Sinai Medical Center, Los Angeles, California, United States

🇺🇸

Saint Barnabas Medical Center, Livingston, New Jersey, United States

and more 59 locations

Lotemax® Gel 0.5% and Restasis 0.05% in Participants With Mild or Moderate Keratoconjunctivitis Sicca (Dry Eye Disease)

First Posted Date
2013-03-25
Last Posted Date
2019-08-30
Lead Sponsor
Bausch & Lomb Incorporated
Target Recruit Count
102
Registration Number
NCT01817582
Locations
🇺🇸

Bausch & Lomb Incorporated, Irvine, California, United States

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