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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 Study to Evaluate the Benefits and Risks of Conversion of Existing Adolescent Kidney Transplant Recipients Aged 12 to <18 Years to a Belatacept-based Immunosuppressive Regimen as Compared to Continuation of a Calcineurin Inhibitor-based Regimen, and Their Adherence to Immunosuppressive Medications

Phase 3
Recruiting
Conditions
Renal Allograft Recipients
Interventions
First Posted Date
2021-05-07
Last Posted Date
2025-04-08
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
102
Registration Number
NCT04877288
Locations
🇺🇸

Local Institution - 0022, Hollywood, Florida, United States

🇺🇸

Local Institution - 0045, Miami, Florida, United States

🇺🇸

Local Institution - 0049, Atlanta, Georgia, United States

and more 34 locations

CEQUA for Sjogren's Syndrome Dry Eye

Phase 4
Completed
Conditions
Dry Eye Syndromes
Sjogren's Syndrome
Dry Eye
Interventions
First Posted Date
2021-04-08
Last Posted Date
2024-04-16
Lead Sponsor
Center for Ophthalmic and Vision Research, LLC
Target Recruit Count
50
Registration Number
NCT04835623
Locations
🇺🇸

Center for Ophthalmic and Vision Recearch, Manhattan, New York, United States

Cyclosporine in Combination With Carfilzomib and Dexamethasone in Relapsed Multiple Myeloma Refractory to Carfilzomib and High Expression of PPIA Gene in Myeloma Cells

Phase 1
Recruiting
Conditions
Multiple Myeloma, Refractory
Multiple Myeloma in Relapse
Interventions
First Posted Date
2021-03-24
Last Posted Date
2024-08-22
Lead Sponsor
Tel-Aviv Sourasky Medical Center
Target Recruit Count
10
Registration Number
NCT04813653
Locations
🇮🇱

Tel Aviv Sourasky Medical Center, Tel Aviv, Israel

Cyclosporine 0.1% Eye Drops as Prophylactic Treatment In Cataract Surgery

Early Phase 1
Completed
Conditions
Ocular Surface Disease
Ocular Inflammation
Interventions
First Posted Date
2021-03-24
Last Posted Date
2023-02-14
Lead Sponsor
Campus Bio-Medico University
Target Recruit Count
101
Registration Number
NCT04812951
Locations
🇮🇹

University Campus Bio Medico, Rome, Italy

Prospective, Randomized, Masked, Controlled Trial To Evaluate The Safety And Effectiveness Of The TearCare® System In The Treatment Of The Signs And Symptoms Of Dry Eye Disease (SAHARA)

Not Applicable
Active, not recruiting
Conditions
Dry Eye
Meibomian Gland Dysfunction
Interventions
Device: TearCare System
First Posted Date
2021-03-12
Last Posted Date
2022-09-13
Lead Sponsor
Sight Sciences, Inc.
Target Recruit Count
350
Registration Number
NCT04795752
Locations
🇺🇸

Harvard Eye Associates, Laguna Hills, California, United States

🇺🇸

Eye Research Foundation, Newport Beach, California, United States

🇺🇸

Doctor My Eyes, Scottsdale, Arizona, United States

and more 11 locations

Study to Assess the Effect of Sodium Zirconium Cyclosilicate on the Pharmacokinetics of Tacrolimus and Cyclosporin in Healthy Subjects

Phase 1
Completed
Conditions
Hyperkalaemia
Interventions
First Posted Date
2021-03-09
Last Posted Date
2024-04-05
Lead Sponsor
AstraZeneca
Target Recruit Count
62
Registration Number
NCT04788641
Locations
🇩🇪

Research Site, Berlin, Germany

Cyclosporine on Day Zero as Prophylaxis for Cytokine Release Syndrome

Phase 2
Conditions
Stem Cell Transplant Complications
Cytokine Release Syndrome
Interventions
First Posted Date
2021-03-04
Last Posted Date
2021-03-05
Lead Sponsor
Hospital Universitario Dr. Jose E. Gonzalez
Target Recruit Count
32
Registration Number
NCT04781803
Locations
🇲🇽

Hospital Universitario Dr. José E. González, Centro Universitario contra el Cáncer, Monterrey, Nuevo Leon, Mexico

A Clinical Trial to Evaluate the Clinical Efficacy of Cyclosporine 0.1% (Ikervis®) for Moderate to Severe Dry Eye Patients. (IKE-03-SWITCHING)

Phase 4
Conditions
Moderate to Severe Dry Eye
Interventions
First Posted Date
2021-03-01
Last Posted Date
2021-03-01
Lead Sponsor
Yonsei University
Target Recruit Count
90
Registration Number
NCT04775303
Locations
🇰🇷

Severance Hospital, Seoul, Korea, Republic of

Rituximab Combined With Cyclosporine Versus Rituximab Alone in the Treatment of iMN

Phase 3
Recruiting
Conditions
Idiopathic Membranous Nephropathy
Interventions
First Posted Date
2021-02-08
Last Posted Date
2021-05-18
Lead Sponsor
Peking Union Medical College Hospital
Target Recruit Count
126
Registration Number
NCT04743739
Locations
🇨🇳

Peking Union Medical College Hospital, Beijing, Beijing, China

🇨🇳

Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing, China

🇨🇳

Beijing Tongren Hospital, Capital Medical University, Beijing, Beijing, China

and more 4 locations

Novel Use of Restasis and PROSE Devices

Phase 3
Withdrawn
Conditions
Ocular Surface Disease
Interventions
First Posted Date
2021-02-03
Last Posted Date
2023-04-19
Lead Sponsor
Boston Sight
Registration Number
NCT04735510
Locations
🇺🇸

BostonSight, Needham, Massachusetts, United States

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