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
Associated Therapies
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A Phase II Dose-escalation Study Characterizing the PK of Eltrombopag in Pediatric Patients With Previously Untreated or Relapsed Severe Aplastic Anemia or Recurrent Aplastic Anemia

Phase 2
Active, not recruiting
Conditions
Aplastic Anemia
Interventions
First Posted Date
2017-01-19
Last Posted Date
2024-12-06
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
51
Registration Number
NCT03025698
Locations
🇺🇸

Aflac Cancerand Blood Disorders Ctr, Atlanta, Georgia, United States

🇺🇸

Ann and Robert H Lurie Childrens Hospital of Chicago SC, Chicago, Illinois, United States

🇺🇸

Cleveland Clinic Foundation Cleveland Clinic 5, Cleveland, Ohio, United States

and more 10 locations

Brentuximab Vedotin, Cyclosporine, and Verapamil Hydrochloride in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma

Phase 1
Completed
Conditions
Recurrent Hodgkin Lymphoma
Refractory Hodgkin Lymphoma
Interventions
First Posted Date
2017-01-09
Last Posted Date
2024-02-22
Lead Sponsor
City of Hope Medical Center
Target Recruit Count
29
Registration Number
NCT03013933
Locations
🇺🇸

City of Hope Medical Center, Duarte, California, United States

Eltrombopag Combined With Cyclosporine as First Line Therapy in Patients With Severe Acquired Aplastic Anemia

Phase 2
Completed
Conditions
Severe Aplastic Anemia
Interventions
First Posted Date
2016-12-20
Last Posted Date
2023-12-11
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
54
Registration Number
NCT02998645
Locations
🇹🇷

Novartis Investigative Site, Samsun, Turkey

Clinical Study Evaluating Two Treatment Protocols for Immunosuppressive Drugs. Looking at 3-year Incidence of CLAD.

Not Applicable
Active, not recruiting
Conditions
Allografts
Lung Transplantation
Interventions
First Posted Date
2016-10-18
Last Posted Date
2023-04-26
Lead Sponsor
Vastra Gotaland Region
Target Recruit Count
249
Registration Number
NCT02936505
Locations
🇳🇴

Oslo University Hospital, Oslo, Norway

🇩🇰

Rigshospitalet, Copenhagen, Denmark

🇸🇪

Skåne University Hospital, Lund, Sweden

and more 2 locations

Efficacy and Safety Study of HU00701/HU007 Eye Drops in Patients With Dry Eye Syndrome

Phase 2
Completed
Conditions
Dry Eye Syndrome
Interventions
Drug: Placebo
Drug: HU00701
Drug: HU007
Drug: Restasis
First Posted Date
2016-09-28
Last Posted Date
2018-04-12
Lead Sponsor
Huons Co., Ltd.
Target Recruit Count
114
Registration Number
NCT02917512
Locations
🇰🇷

Huons, Seongnam-si, Gyeonggi-do, Korea, Republic of

Abatacept for GVHD Prophylaxis After Hematopoietic Stem Cell Transplantation for Pediatric Sickle Cell Disease

First Posted Date
2016-08-16
Last Posted Date
2024-06-13
Lead Sponsor
Monica Bhatia
Target Recruit Count
24
Registration Number
NCT02867800
Locations
🇺🇸

North Carolina Cancer Hospital, Chapel Hill, North Carolina, United States

🇺🇸

Columbia University Irving Medical Center, New York, New York, United States

🇺🇸

Children's National Medical Center, Washington, District of Columbia, United States

and more 4 locations

SCHEDULE Follow Up Visit 5-7 yr

Phase 4
Completed
Conditions
Heart Transplantation
Interventions
First Posted Date
2016-08-12
Last Posted Date
2019-10-03
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
95
Registration Number
NCT02864706
Locations
🇸🇪

Novartis Investigative Site, Lund, Sweden

Unrelated Donor Transplant Versus Immune Therapy in Pediatric Severe Aplastic Anemia

Not Applicable
Active, not recruiting
Conditions
Severe Aplastic Anemia
Interventions
Drug: cyclosporine
Procedure: Matched Unrelated Donor Hematopoietic Stem Cell Transplant
Drug: horse anti-thymocyte globulin (ATG)
Drug: rabbit anti-thymocyte globulin (ATG)
Procedure: Immunosuppressive Therapy (IST)
Drug: methotrexate
Drug: fludarabine
Drug: cyclophosphamide
Radiation: low-dose total body irradiation (TBI)
First Posted Date
2016-07-27
Last Posted Date
2023-10-26
Lead Sponsor
Michael Pulsipher, MD
Target Recruit Count
40
Registration Number
NCT02845596
Locations
🇺🇸

Children's Hospital Los Angeles, Los Angeles, California, United States

🇺🇸

Fred Hutchinson Cancer Research Center, Seattle, Washington, United States

🇺🇸

Hackensack University Medical Center, Hackensack, New Jersey, United States

and more 10 locations

ATG Combined With Cyclophosphamide And Cord Blood Transfusion in Treating Patients With Severe Aplastic Anemia

Phase 4
Conditions
Aplastic Anemia
Interventions
Drug: Rabbit ATG, (Genzyme)
Drug: Cy
Drug: CsA
Biological: Cord blood
First Posted Date
2016-07-20
Last Posted Date
2017-02-01
Lead Sponsor
Jinan Military General Hospital
Target Recruit Count
130
Registration Number
NCT02838992
Locations
🇨🇳

The General Hospital Of Jinan Military Command, Jinan, Shandong, China

Early Allogeneic Hematopoietic Cell Transplantation in Treating Patients With Relapsed or Refractory High-Grade Myeloid Neoplasms

Phase 2
Completed
Conditions
High Grade Malignant Neoplasm
Previously Treated Myelodysplastic Syndrome
Recurrent Acute Myeloid Leukemia
Refractory Acute Myeloid Leukemia
Myelodysplastic Syndrome With Excess Blasts-2
Myeloid Neoplasm
Blasts 10 Percent or More of Bone Marrow Nucleated Cells
Chronic Myelomonocytic Leukemia-2
Myelodysplastic Syndrome
Interventions
Drug: Cladribine
Drug: Cyclosporine
Drug: Cytarabine
Biological: Filgrastim
Drug: Fludarabine Phosphate
Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Other: Laboratory Biomarker Analysis
Drug: Melphalan
Drug: Mitoxantrone Hydrochloride
Drug: Mycophenolate Mofetil
Other: Questionnaire Administration
Drug: Sirolimus
Radiation: Total-Body Irradiation
Drug: Melphalan Hydrochloride
First Posted Date
2016-04-29
Last Posted Date
2021-11-08
Lead Sponsor
University of Washington
Target Recruit Count
30
Registration Number
NCT02756572
Locations
🇺🇸

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

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