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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 Randomized Controlled Study of High-dose Cyclophosphamide Induction Therapy in Adult Patients With HLH

Not Applicable
Recruiting
Conditions
Hemophagocytic Syndrome
Interventions
First Posted Date
2023-07-07
Last Posted Date
2023-08-30
Lead Sponsor
shifeng Lou
Target Recruit Count
160
Registration Number
NCT05936086
Locations
🇨🇳

The Second affiliated Hosptial of Chongqing medical University, Chongqing, China

Feasibility Pilot Sequential Multiple Assignment Randomized Trial (SMART) for Acute Severe Ulcerative Colitis

First Posted Date
2023-05-22
Last Posted Date
2025-04-15
Lead Sponsor
Berinstein, Jeffrey
Target Recruit Count
162
Registration Number
NCT05867329
Locations
🇺🇸

University of Michigan, Ann Arbor, Michigan, United States

A Clinical Study of MIL62 in Primary Membranous Nephropathy

Phase 3
Recruiting
Conditions
Primary Membranous Nephropathy
Interventions
First Posted Date
2023-05-17
Last Posted Date
2024-11-20
Lead Sponsor
Beijing Mabworks Biotech Co., Ltd.
Target Recruit Count
150
Registration Number
NCT05862233
Locations
🇨🇳

Peking University First Hospital, Beijing, China

Effect of Huaier Granule on the Treatment of Idiopathic Membranous Nephropathy

Phase 4
Recruiting
Conditions
Glomerular Diseases
Nephropathy
Idiopathic Membranous Nephropathy
Interventions
Drug: Renin-angiotensin-aldosterone system inhibitors (RASI)
First Posted Date
2023-05-03
Last Posted Date
2024-06-04
Lead Sponsor
Chinese PLA General Hospital
Target Recruit Count
480
Registration Number
NCT05839314
Locations
🇨🇳

Chinese PLA general hospital, Beijing, Beijing, China

Safety and Effectiveness of Trappa Ethanolamine Tablets Combined With Ciclosporin in the Treatment of Primary Treatment of Non-severe Aplastic Anemia

Phase 2
Recruiting
Conditions
Non-severe Aplastic Anemia
Interventions
First Posted Date
2023-04-04
Last Posted Date
2023-09-01
Lead Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Target Recruit Count
78
Registration Number
NCT05797623
Locations
🇨🇳

Hematology Hospital of Chinese Academy of Medical Sciences, Tianjin, Tianjin, China

Clinical Study of UCB Combined With UC-MSCs in the Treatment of Bone Marrow Failure Disorders

Phase 1
Recruiting
Conditions
Bone Marrow Failure Disorders
Interventions
Biological: Umbilical cord blood & Umbilical cord derived mesenchymal stem cells
First Posted Date
2023-04-03
Last Posted Date
2023-11-29
Lead Sponsor
Shandong Qilu Stem Cells Engineering Co., Ltd.
Target Recruit Count
100
Registration Number
NCT05794425
Locations
🇨🇳

Jining first people's Hospital, Jining, Shandong, China

🇨🇳

Shandong Provincial Third Hospital, Jinan, Shandong, China

🇨🇳

Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, Shandong, China

and more 5 locations

Topical Cyclosporin A 0.05% Eye Drops for Management of Symptomatic Acquired Punctal Stenosis. A Prospective, Controlled Clinical Study.

Not Applicable
Completed
Conditions
Management of Punctal Stenosis
Interventions
First Posted Date
2023-03-16
Last Posted Date
2023-03-16
Lead Sponsor
Farwaniya Hospital
Target Recruit Count
42
Registration Number
NCT05771012
Locations
🇰🇼

Farwanyia Hospital, Al Farwānīyah, Farwanyia, Kuwait

HU007 in Patients With Dry Eye Syndrome

Phase 3
Completed
Conditions
Dry Eye Disease
Interventions
Drug: Moisview Eye drop
First Posted Date
2023-02-24
Last Posted Date
2024-05-13
Lead Sponsor
Huons Co., Ltd.
Target Recruit Count
328
Registration Number
NCT05743764
Locations
🇰🇷

Gyeongsang National University Hospital, Jinju, Korea, Republic of

Clinical Trial to Evaluate the Safety and Efficacy of SCAI-001 Compared to Restasis

Phase 2
Completed
Conditions
Dry Eye Syndromes
Interventions
Drug: SCAI-001 0.01% eyedrop
Drug: SCAI-001 0.02% eyedrop
First Posted Date
2023-02-17
Last Posted Date
2024-02-05
Lead Sponsor
SCAI Therapeutics
Target Recruit Count
116
Registration Number
NCT05733624
Locations
🇰🇷

Korea University Anam Hospital, Seoul, Korea, Republic of

🇰🇷

Kangbuk Samsung Hospital, Seoul, Korea, Republic of

🇰🇷

The Catholic University of korea, Bucheon ST.Mary's Hospital, Bucheon, Korea, Republic of

and more 8 locations

Clinical Outcomes of Cyclosporine Eye Drops in Management of Herpetic Keratitis

Phase 4
Completed
Conditions
Outcomes of Cyclosporine Eye Drops in Herpetic Keratitis
Interventions
First Posted Date
2023-02-09
Last Posted Date
2024-08-07
Lead Sponsor
Farwaniya Hospital
Target Recruit Count
30
Registration Number
NCT05720715
Locations
🇰🇼

Farwanyia Hospital, Al Farwānīyah, Farwanyia, Kuwait

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