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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

Efficacy of Romiplostim in Treatment of SAA in Adults Previously Untreated With or Refractory to Immunosuppressive Therapy

Phase 2
Withdrawn
Conditions
Severe Aplastic Anemia (SAA)
Interventions
Drug: Antithymocyte Globulin
First Posted Date
2022-04-12
Last Posted Date
2023-09-29
Lead Sponsor
Amgen
Registration Number
NCT05323617

Allogeneic Hematopoietic Stem Cell Transplantation for 4/M Neuroblastoma

First Posted Date
2022-03-31
Last Posted Date
2022-07-01
Lead Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Target Recruit Count
64
Registration Number
NCT05303727
Locations
🇨🇳

Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China

Evaluation of 0.05% CsA and 0.1% FK506 Eye Drops in Ocular GVHD Treatment

Phase 4
Completed
Conditions
Graft Versus Host Disease in Eye
Interventions
First Posted Date
2022-03-24
Last Posted Date
2022-03-24
Lead Sponsor
Peking University Third Hospital
Target Recruit Count
89
Registration Number
NCT05294666
Locations
🇨🇳

Peking University Third Hospital, Beijing, Beijing, China

Evaluating the Efficacy and Safety of TJO-087 in Moderate to Severe Dry Eye Disease Patients

Phase 3
Conditions
Dry Eye Syndrome
Interventions
First Posted Date
2022-02-18
Last Posted Date
2022-02-18
Lead Sponsor
Taejoon Pharmaceutical Co., Ltd.
Target Recruit Count
182
Registration Number
NCT05245604
Locations
🇰🇷

Hyo Myung, Kim, Seoul, Korea, Republic of

Efficacy of Cyclosporine Rescue Therapy in Acute Ulcerative Colitis.

Completed
Conditions
Ulcerative Colitis Acute
First Posted Date
2022-02-02
Last Posted Date
2022-02-02
Lead Sponsor
Tampere University Hospital
Target Recruit Count
182
Registration Number
NCT05219656

Drug-Drug Interaction (DDI) Study of ALXN2050 in Healthy Adult Participants

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2022-01-21
Last Posted Date
2023-04-04
Lead Sponsor
Alexion Pharmaceuticals, Inc.
Target Recruit Count
61
Registration Number
NCT05202145
Locations
🇺🇸

Clinical Study Site, Tempe, Arizona, United States

A Feasibility Study to Evaluate the Tolerability of Oph1 Compared to Restasis in Healthy Volunteers

Early Phase 1
Completed
Conditions
Dry Eye Syndromes
Interventions
First Posted Date
2022-01-11
Last Posted Date
2024-04-05
Lead Sponsor
OphRx Ltd.
Target Recruit Count
20
Registration Number
NCT05184517
Locations
🇮🇱

Shaare Zedek Medical Center, Jerusalem, Israel

A Study in Healthy Adult Participants to Assess the Effects of Ciclosporin Administration on Rilematovir

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2021-12-13
Last Posted Date
2025-02-03
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
18
Registration Number
NCT05155007
Locations
🇧🇪

Clinical Pharmacology Unit, Merksem, Belgium

Ciclosporin Followed by Low-dose IL-2 in Patients with Recently Diagnosed Type 1 Diabetes

Phase 2
Recruiting
Conditions
Type 1 Diabetes
Interventions
First Posted Date
2021-12-10
Last Posted Date
2024-11-21
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
Target Recruit Count
24
Registration Number
NCT05153070
Locations
🇫🇷

Lorenzon Roberta, Paris, France

Microvascular and Inflammatory Responses of 0.05 Cyclosporine Eye Drop (II) in Treatment of Dry Eye

Not Applicable
Conditions
Dry Eye
Interventions
Device: oculus keratograph, in vivo laser confocal microscopy, Functional slit lamp biomicroscopy
First Posted Date
2021-11-23
Last Posted Date
2022-02-11
Lead Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
Target Recruit Count
100
Registration Number
NCT05131152
Locations
🇨🇳

Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, Guangdong, China

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