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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

A Research Study To See How Well an Eye Drop, SURF-100 (A Mycophenolic Acid/Betamethasone Sodium Phosphate Combination), Works and What Side Effects There Are in Subjects With Dry Eye Disease

First Posted Date
2021-02-02
Last Posted Date
2025-05-11
Lead Sponsor
Surface Ophthalmics, Inc.
Target Recruit Count
349
Registration Number
NCT04734197
Locations
🇺🇸

North Valley Eye Medical Group Inc., Mission Hills, California, United States

🇺🇸

LoBue Laser and Eye Medical Center, Murrieta, California, United States

🇺🇸

Martel Eye Medical Group, Rancho Cordova, California, United States

and more 37 locations

Topical Cyclosporine A for the Treatment of Dry Eye: A Randomized Clinical Study

Phase 3
Completed
Conditions
Dry Eye
Interventions
First Posted Date
2021-01-19
Last Posted Date
2021-01-19
Lead Sponsor
Alexandria University
Target Recruit Count
40
Registration Number
NCT04714099

Topical Immuonosuppressant Drugs in Spring Catarrh

Not Applicable
Conditions
Vernal Keratoconjunctivitis
Interventions
First Posted Date
2021-01-12
Last Posted Date
2021-01-12
Lead Sponsor
Assiut University
Target Recruit Count
180
Registration Number
NCT04705584
Locations
🇪🇬

Assiut University Hospital, Assiut, Egypt

MSC for Treatment of cGVHD After Allo-HSCT

Phase 2
Conditions
Chronic Graft-versus-host Disease
Interventions
Biological: Mesenchymal stem cells
Drug: Glucocorticoids
First Posted Date
2020-12-31
Last Posted Date
2020-12-31
Lead Sponsor
Nanfang Hospital, Southern Medical University
Target Recruit Count
152
Registration Number
NCT04692376
Locations
🇨🇳

Department of Hematology,Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China

A Single-arm Trial of Prophylactic Tocilizumab for Acute GVHD Prevention After Haploidentical HSCT.

First Posted Date
2020-12-29
Last Posted Date
2023-02-21
Lead Sponsor
Yi Luo
Target Recruit Count
46
Registration Number
NCT04688021
Locations
🇨🇳

The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China

Ikervis for DED Due to GVHD Post Allo-HSCT

Phase 4
Conditions
Leukemia (Both ALL and AML)
MDS-EB-1
Interventions
First Posted Date
2020-11-19
Last Posted Date
2020-11-19
Lead Sponsor
Singapore Eye Research Institute
Target Recruit Count
40
Registration Number
NCT04636918
Locations
🇸🇬

Singapore Eye Research Institute, Singapore, Singapore

Effect of Ciclosporin Eyedrops on Sjögren Syndrome

Not Applicable
Completed
Conditions
Dry Eye Syndromes
Interventions
First Posted Date
2020-10-22
Last Posted Date
2021-04-08
Lead Sponsor
Hospital Hietzing
Target Recruit Count
12
Registration Number
NCT04597762
Locations
🇦🇹

Augenabteilung - Klinik Hietzing, Vienna, Austria

Evaluation of the Clinical Outcome of Cyclosporine Short Infusion Versus Continuous Infusion Post Allogenic Stem Cell Transplantation

Completed
Conditions
Allogenic Bone Marrow Transplantation
Interventions
First Posted Date
2020-10-05
Last Posted Date
2023-02-01
Lead Sponsor
Shaymaa Mohammed El-Awady
Target Recruit Count
31
Registration Number
NCT04575779
Locations
🇪🇬

Shaymaa Mohammed Mohammed Youssef El-Awady, Cairo, Egypt

Comparing Treatment of Dry Eye With Intracanalicular Dexamethasone, Restasis, and/or Lotemax

First Posted Date
2020-09-21
Last Posted Date
2023-10-11
Lead Sponsor
Thomas Chester, OD
Target Recruit Count
30
Registration Number
NCT04555694
Locations
🇺🇸

Cleveland Eye Clinic, Brecksville, Ohio, United States

A Study Comparing Haploidentical Hematopoietic Stem Cell Transplantations (HSCTs) From Young Non-first-degree and Older First-degree Donors in Hematological Malignancies

First Posted Date
2020-09-14
Last Posted Date
2025-03-25
Lead Sponsor
First Affiliated Hospital of Zhejiang University
Target Recruit Count
176
Registration Number
NCT04547049
Locations
🇨🇳

The First Affiliated Hospital of Soochow University, Soochow, China

🇨🇳

Xinqiao Hospital, State Key Laboratory of Trauma and Chemical Poisoning, Army Medical University, Chongqing, China

🇨🇳

The First Affiliated Hospital of Ningbo University, Ningbo, China

and more 5 locations
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