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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

Tofacitinib Versus Cyclosporine for Steroid Refractory Acute Severe Ulcerative Colitis

Not Applicable
Not yet recruiting
Conditions
Ulcerative Colitis
Interventions
First Posted Date
2021-11-08
Last Posted Date
2023-03-29
Lead Sponsor
Post Graduate Institute of Medical Education and Research, Chandigarh
Target Recruit Count
96
Registration Number
NCT05112263

A Study of the Drug Interactions Between Danicopan and Cyclosporine, Tacrolimus, Antacids, and Omeprazole in Healthy Adults

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2021-11-05
Last Posted Date
2021-11-05
Lead Sponsor
Alexion Pharmaceuticals, Inc.
Target Recruit Count
72
Registration Number
NCT05109390
Locations
🇺🇸

Clinical Trial Site, Tempe, Arizona, United States

Second-line Treatment of Primary Autoimmune Hemolytic Anemia

Phase 3
Recruiting
Conditions
Primary Autoimmune Hemolytic Anemia
Interventions
First Posted Date
2021-09-27
Last Posted Date
2025-03-20
Lead Sponsor
Assiut University
Target Recruit Count
30
Registration Number
NCT05057468
Locations
🇪🇬

Assiut university hospital, Assiut, Egypt

Cyclosporine Vs Steroids in DRESS

Early Phase 1
Conditions
Drug-Induced Hypersensitivity Syndrome
DRESS Syndrome
Interventions
First Posted Date
2021-08-03
Last Posted Date
2025-03-30
Lead Sponsor
University of Southern California
Target Recruit Count
50
Registration Number
NCT04988256
Locations
🇺🇸

USC, Los Angeles, California, United States

Safety and Effectiveness of Cyclosporin in the Management of COVID19 ARDS Patients in Alexandria University Hospital

Phase 3
Completed
Conditions
COVID-19 Acute Respiratory Distress Syndrome
Cytokine Release Syndrome
Pulmonary Fibrosis
Interventions
First Posted Date
2021-07-28
Last Posted Date
2025-05-14
Lead Sponsor
Alexandria University
Target Recruit Count
66
Registration Number
NCT04979884
Locations
🇪🇬

Alexandria university, Alexandria, Egypt

Outcomes of Patients After Allo-HSCT With Decitabine and NAC

First Posted Date
2021-06-30
Last Posted Date
2021-06-30
Lead Sponsor
The First Affiliated Hospital of Soochow University
Target Recruit Count
100
Registration Number
NCT04945096

Novel Use of Cyclosporine Ophthalmic Emulsion 0.05% in a PROSE Device

Phase 1
Completed
Conditions
Ocular Surface Disease
Interventions
First Posted Date
2021-06-09
Last Posted Date
2025-01-13
Lead Sponsor
Boston Sight
Target Recruit Count
10
Registration Number
NCT04918823
Locations
🇺🇸

BostonSight, Needham, Massachusetts, United States

Evaluation of the Effectiveness and Safety of Immunosuppressive and Biological Therapy of Atopic Dermatitis in Childhood

First Posted Date
2021-05-20
Last Posted Date
2021-05-20
Lead Sponsor
National Medical Research Center for Children's Health, Russian Federation
Target Recruit Count
160
Registration Number
NCT04895423
Locations
🇷🇺

National Medical Research Center for Children's Health, Moscow, Russian Federation

Methods of T Cell Depletion Trial (MoTD)

Phase 2
Recruiting
Conditions
Acute Myeloid Leukemia
Myelodysplastic Syndromes
Non Hodgkin Lymphoma
Hodgkin Lymphoma
Chronic Myelogenous Leukemia
Myelofibrosis
Acute Lymphoblastic Leukemia
Chronic Myelomonocytic Leukemia
Multiple Myeloma
Interventions
First Posted Date
2021-05-17
Last Posted Date
2023-09-28
Lead Sponsor
University of Birmingham
Target Recruit Count
400
Registration Number
NCT04888741
Locations
🇬🇧

Queen Elizabeth Hospital, Birmingham, United Kingdom

🇬🇧

Bristol Haematology and Oncology Centre, Bristol, United Kingdom

🇬🇧

University Hospital of Wales, Cardiff, Wales, United Kingdom

and more 12 locations

NMF-CsA-Dupi Trial

Not Applicable
Recruiting
Conditions
Dermatitis, Atopic
Interventions
Drug: Topical corticosteroids
Drug: Systemic dupilumab
First Posted Date
2021-05-07
Last Posted Date
2021-08-18
Lead Sponsor
Erasmus Medical Center
Target Recruit Count
318
Registration Number
NCT04878770
Locations
🇳🇱

Erasmus MC - Sophia Children's Hospital, Rotterdam, Zuid-Holland, Netherlands

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