Cyclosporine

Generic Name: Cyclosporine

Brand Names: Cequa, Gengraf, Neoral, Restasis, Sandimmune, Verkazia, Vevye, Ikervis

Drug Type: Small Molecule

Chemical Formula: C_₆₂H_₁₁₁N_₁₁O_₁₂

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

Clinical Trials

Effect of Obesity on Cyclosporine Blood Trough Level in Nephrotic Syndrome Patients

Phase 4

Recruiting

Conditions: Nephrotic Syndrome

Interventions: Drug: Cyclosporine Capsule

First Posted Date: 2023-01-25

Last Posted Date: 2023-12-11

Lead Sponsor: Alexandria University

Target Recruit Count: 74

Registration Number: NCT05696977

Locations: 🇪🇬
Alexandria University, Alexandria, Egypt

Effect of Cyclosporine and Remote Ischemic Preconditioning in Reperfusion Ischemia Injury on Tetralogy Fallot Patients With Correction Surgery

Not Applicable

Completed

Conditions: Myocardial Injury
Cardiac Surgery

Interventions: Drug: Placebo
Drug: Cyclosporin
Procedure: remote ischemic preconditioning

First Posted Date: 2023-01-20

Last Posted Date: 2023-01-20

Lead Sponsor: Indonesia University

Target Recruit Count: 40

Registration Number: NCT05691764

Locations: 🇮🇩
Indonesia University, Jakarta, DKI Jakarta, Indonesia

Optimization of Cyclosporin in Atopic Dermatitis Through Multiomic Predictive Models of Treatment Response

Phase 4

Recruiting

Conditions: Atopic Dermatitis

Interventions: Other: Follow-up of Cyclospoin treatment already started
Drug: Cyclosporin A

First Posted Date: 2023-01-20

Last Posted Date: 2023-04-28

Lead Sponsor: Instituto de Investigación Hospital Universitario La Paz

Target Recruit Count: 100

Registration Number: NCT05692843

Locations: 🇪🇸
Hospital La Paz, Madrid, Spain

Spanish Academy of Dermatology and Venereology Registry of Atopic Dermatitis Therapy

Recruiting

Conditions: Dermatitis, Atopic

First Posted Date: 2023-01-06

Last Posted Date: 2023-01-06

Lead Sponsor: Fundación Academia Española de Dermatología

Target Recruit Count: 2500

Registration Number: NCT05674695

Locations: 🇪🇸
Hospital Universitario de la Princesa, Madrid, Spain
🇪🇸
Hospital General Universitario de Alicante, Alicante, Spain
🇪🇸
Hospital del Mar IMIM, Barcelona, Spain

and more 6 locations

A Trial Comparing Unrelated Donor BMT With IST for Pediatric and Young Adult Patients With Severe Aplastic Anemia (TransIT, BMT CTN 2202)

Phase 3

Recruiting

Conditions: Severe Aplastic Anemia

Interventions: Drug: cyclosporine
Procedure: Matched Unrelated Donor Hematopoetic Stem Cell Transplant
Drug: horse anti-thymocyte globulin (ATG)
Procedure: Immunosuppressive Therapy (IST)
Drug: rabbit anti-thymocyte globulin (ATG)
Drug: Methotrexate
Drug: Fludarabine
Drug: Cyclophosphamide
Radiation: low-dose total body irradiation (TBI)

First Posted Date: 2022-10-31

Last Posted Date: 2025-05-07

Lead Sponsor: Boston Children's Hospital

Target Recruit Count: 234

Registration Number: NCT05600426

Locations: 🇺🇸
University of Alabama at Birmingham, Birmingham, Alabama, United States
🇺🇸
Phoenix Children's Hospital, Phoenix, Arizona, United States
🇺🇸
Arkansas, Little Rock, Arkansas, United States

and more 47 locations