MedPath

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

Efficacy and Safety of Anti-CD25 rhMAb in the Treatment of Steroid-Refractory cGVHD

Phase 4
Not yet recruiting
Conditions
cGVHD
Interventions
First Posted Date
2024-04-15
Last Posted Date
2024-04-15
Lead Sponsor
Peking University People's Hospital
Target Recruit Count
118
Registration Number
NCT06364319

Evaluation of Safety & Efficacy for the Prevention of Ocular GVHD With Ophthalmic Tacrolimus vs Cyclosporine in Allo-HSCT

Phase 1
Recruiting
Conditions
Ocular Graft-versus-host Disease
Interventions
First Posted Date
2024-04-04
Last Posted Date
2024-04-08
Lead Sponsor
Hospital Universitario Dr. Jose E. Gonzalez
Target Recruit Count
60
Registration Number
NCT06348602
Locations
🇲🇽

Hospital Universitario de la U.A.N.L., Nuevo León, Monterrey, Mexico

A Clinical Trial to Evaluate the Corneal Endothelial Health of DED Subjects Treated With Cyclosporine

Phase 4
Active, not recruiting
Conditions
Dry Eye Disease
Interventions
First Posted Date
2024-03-26
Last Posted Date
2024-07-12
Lead Sponsor
Novaliq GmbH
Target Recruit Count
204
Registration Number
NCT06329661
Locations
🇺🇸

CYS-007 Investigational Site, Memphis, Tennessee, United States

Breast/Cyclosporin A/TNBC (Triple Negative Breast Cancer)

Early Phase 1
Recruiting
Conditions
Triple Negative Breast Cancer
DNA Damage Repair Deficiency
Interventions
First Posted Date
2024-02-07
Last Posted Date
2024-08-29
Lead Sponsor
Virginia G. Kaklamani
Target Recruit Count
24
Registration Number
NCT06246786
Locations
🇺🇸

Mays Cancer Center, UT Health San Antonio, San Antonio, Texas, United States

The Effect of 0.05% CsA Eye Drops on Post-refractive Surgery Dry Eye

Phase 4
Recruiting
Conditions
Dry Eye
Interventions
Drug: artificial tear eyedrops
First Posted Date
2023-09-21
Last Posted Date
2023-09-21
Lead Sponsor
Peking University Third Hospital
Target Recruit Count
60
Registration Number
NCT06043908
Locations
🇨🇳

Hong Qi, Beijing, Beijing, China

Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With High-Risk Hematologic Diseases

Phase 2
Recruiting
Conditions
Acute Leukemia of Ambiguous Lineage
Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Blastic Plasmacytoid Dendritic Cell Neoplasm
Hematopoietic and Lymphatic System Neoplasm
Mixed Phenotype Acute Leukemia
Myelodysplastic Syndrome
Myeloproliferative Neoplasm
Non-Hodgkin Lymphoma
Chronic Myeloid Leukemia, BCR-ABL1 Positive
Interventions
Procedure: Biospecimen Collection
Procedure: Bone Marrow Aspirate
Procedure: Diagnostic Imaging
Procedure: Echocardiography
Procedure: Multigated Acquisition Scan
Other: Survey Administration
Radiation: Total-Body Irradiation
Procedure: Umbilical Cord Blood Transplantation
First Posted Date
2023-08-28
Last Posted Date
2025-01-31
Lead Sponsor
Fred Hutchinson Cancer Center
Target Recruit Count
54
Registration Number
NCT06013423
Locations
🇺🇸

Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States

Romiplostim in Combination With CsA vs. CsA in the Treatment of Newly Diagnosed NSAA

Phase 4
Not yet recruiting
Conditions
Non Severe Aplastic Anemia
Interventions
First Posted Date
2023-08-24
Last Posted Date
2023-08-24
Lead Sponsor
Peking Union Medical College Hospital
Target Recruit Count
44
Registration Number
NCT06009497
Locations
🇨🇳

Peking union medical college hospital, Beijing, China

Efficacy and Safety of CsA+AVA in the Treatment of NSAA in the Elderly

Phase 2
Recruiting
Conditions
Aplastic Anemia
Interventions
First Posted Date
2023-08-22
Last Posted Date
2023-12-08
Lead Sponsor
Peking Union Medical College Hospital
Target Recruit Count
30
Registration Number
NCT06004752
Locations
🇨🇳

Peking union medical college hospital, Beijing, China

CsA+ATG+AVA vs. CsA+AVA for the Treatment of Newly-diagnosed SAA in the Elderly

First Posted Date
2023-08-18
Last Posted Date
2025-04-30
Lead Sponsor
Peking Union Medical College Hospital
Target Recruit Count
86
Registration Number
NCT05996393
Locations
🇨🇳

Peking union medical college hospital, Beijing, China

Cyclosporine In Takotsubo Syndrome

Phase 2
Recruiting
Conditions
Takotsubo Cardiomyopathy
Interventions
First Posted Date
2023-07-14
Last Posted Date
2025-04-08
Lead Sponsor
University Hospital Heidelberg
Target Recruit Count
204
Registration Number
NCT05946772
Locations
🇩🇪

Leipzig Heart Center, Leipzig, Germany

🇩🇪

Kerckhoff Heart Center, Bad Nauheim / Gießen University, Bad Nauheim, Germany

🇩🇪

Heart Centre - University Hospital Bonn, Bonn, Germany

and more 18 locations
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