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

Tear Film Stability and Improvement of Asthenopia: Efficacy Observation of 0.05% Cyclosporine in Dry Eye Patients With Short BUT

Not Applicable
Completed
Conditions
Dry Eye Disease (DED)
Asthenopia
Interventions
Drug: 0.1% sodium hyaluronate eye drop
First Posted Date
2025-05-20
Last Posted Date
2025-05-20
Lead Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Target Recruit Count
60
Registration Number
NCT06981104
Locations
🇨🇳

1 Xihu Avenue, Shangcheng District, Hangzhou, Zhejiang, China, Hangzhou, Zhejiang, China

A Study to Evaluate the Efficacy and Safety of Treatment With CsA-PG Ophthalmic Gel in Dry Eye Patients

Phase 3
Not yet recruiting
Conditions
Dry Eye Disease
Interventions
Drug: CsA-PG Ophthalmic Gel
First Posted Date
2025-04-24
Last Posted Date
2025-04-29
Lead Sponsor
Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
Target Recruit Count
396
Registration Number
NCT06942793

A Study Investigating the Effect of Different Approved Medications on How the Body Processes the Study Compound RO7795081

Phase 1
Active, not recruiting
Conditions
Healthy Participants
Interventions
First Posted Date
2025-03-25
Last Posted Date
2025-03-27
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
50
Registration Number
NCT06809608
Locations
🇳🇱

ICON, Groningen, Netherlands

Effect of Cyclosporine Drug Interaction on the Absorption, Metabolism and Elimination of CHF6001 in Healthy Volunteers. Drug-Drug Interaction 2 (DDI2) Study

Phase 1
Recruiting
Conditions
Chronic Obstructive Pulmonary Disease (COPD)
Interventions
Drug: CHF6001 dry powder inhaler (DPI)
First Posted Date
2025-03-25
Last Posted Date
2025-04-02
Lead Sponsor
Chiesi Farmaceutici S.p.A.
Target Recruit Count
24
Registration Number
NCT06892756
Locations
🇧🇬

Medical Centre Comac Medical Ltd, Sofia, Bulgaria

Once-daily Fluorometholone Vs Twice-daily Cyclosporine in Dry Eye Disease

Phase 4
Completed
Conditions
Dry Eye Disease (DED)
Interventions
First Posted Date
2025-03-14
Last Posted Date
2025-03-14
Lead Sponsor
Korea University Anam Hospital
Target Recruit Count
32
Registration Number
NCT06876116
Locations
🇰🇷

Korea University Anam Hospital, Seoul, Korea, Republic of

A Study to Learn if Study Medicines Called Cyclosporine and Clarithromycin Affect How the Body Processes the Other Study Medicine Called PF-07328948 in Healthy Adults

Phase 1
Active, not recruiting
Conditions
Healthy Adults
Interventions
First Posted Date
2025-02-20
Last Posted Date
2025-04-13
Lead Sponsor
Pfizer
Target Recruit Count
26
Registration Number
NCT06837259
Locations
🇧🇪

Pfizer Clinical Research Unit - Brussels, Brussels, Bruxelles-capitale, Région DE, Belgium

The Effect of 0.05% CsA Eye Drops on Diabetic Patients with Dry Eye Disease

Phase 4
Completed
Conditions
Dry Eye
Interventions
Drug: artificial tear eyedrops
First Posted Date
2025-02-13
Last Posted Date
2025-02-13
Lead Sponsor
Peking University Third Hospital
Target Recruit Count
60
Registration Number
NCT06824844
Locations
🇨🇳

Peking University Third Hospital, Peking, Beijing, China

Efficacy and Safety of Sirolimus with or Without Cyclosporin a in Chinese Patients with Aplastic Anemia Refractory/Intolerant to Cyclosporin a

Phase 2
Not yet recruiting
Conditions
Aplastic Anaemia
Interventions
First Posted Date
2025-01-30
Last Posted Date
2025-01-30
Lead Sponsor
Peking Union Medical College Hospital
Target Recruit Count
50
Registration Number
NCT06802055
Locations
🇨🇳

Peking Union Medical College Hospital, Beijing, Beijing, China

TRACK-TBI Precision Medicine Part 3 - Option II

Phase 2
Not yet recruiting
Conditions
Traumatic Brain Injury
Interventions
First Posted Date
2025-01-23
Last Posted Date
2025-01-23
Lead Sponsor
University of California, San Francisco
Target Recruit Count
26
Registration Number
NCT06790095
Locations
🇺🇸

University of California, San Francisco, San Francisco, California, United States

Ruxolitinib Based GVHD Prophylaxis Regimen Before, During, and After Hematopoietic Cell Transplantation in Older Adult Patients With Acquired Aplastic Anemia

Phase 2
Recruiting
Conditions
Aplastic Anemia
Interventions
Procedure: Biospecimen Collection
Procedure: Bone Marrow Aspiration
Procedure: Bone Marrow Biopsy
Procedure: Bone Marrow Transplantation
Procedure: Computed Tomography
Drug: Granulocyte Colony-Stimulating Factor
Procedure: Peripheral Blood Stem Cell Transplantation
Radiation: Total-Body Irradiation
Procedure: Multigated Acquisition Scan
Procedure: Echocardiography
First Posted Date
2024-12-31
Last Posted Date
2025-04-17
Lead Sponsor
Fred Hutchinson Cancer Center
Target Recruit Count
20
Registration Number
NCT06752694
Locations
🇺🇸

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

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