Overview
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
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/04/30 | Phase 3 | Recruiting | |||
2024/04/15 | Phase 4 | Not yet recruiting | |||
2024/04/04 | Phase 1 | Recruiting | Hospital Universitario Dr. Jose E. Gonzalez | ||
2024/03/26 | Phase 4 | Active, not recruiting | |||
2024/02/07 | Early Phase 1 | Recruiting | Virginia G. Kaklamani | ||
2023/09/21 | Phase 4 | Recruiting | |||
2023/08/28 | Phase 2 | Recruiting | |||
2023/08/24 | Phase 4 | Not yet recruiting | |||
2023/08/22 | Phase 2 | Recruiting | |||
2023/08/18 | Phase 4 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Harrow Eye, LLC | 82667-900 | OPHTHALMIC | 1 mg in 1 mL | 11/21/2023 | |
| Physicians Total Care, Inc. | 54868-4793 | OPHTHALMIC | 0.5 mg in 1 mL | 5/18/2011 | |
| ImprimisRx NJ | 70261-514 | OPHTHALMIC | 1 mg in 1 mL | 2/26/2018 | |
| Novartis Pharmaceuticals Corporation | 0078-0109 | INTRAVENOUS | 50 mg in 1 mL | 12/23/2016 | |
| Mylan Pharmaceuticals Inc. | 0378-8760 | OPHTHALMIC | 0.5 mg in 1 mL | 1/20/2022 | |
| Teva Pharmaceuticals USA, Inc. | 0172-7313 | ORAL | 100 mg in 1 mL | 4/30/2015 | |
| AbbVie Inc. | 0074-6479 | ORAL | 100 mg in 1 1 | 2/28/2024 | |
| Apotex Corp. | 60505-4631 | ORAL | 50 mg in 1 1 | 11/1/2023 | |
| Physicians Total Care, Inc. | 54868-6232 | ORAL | 100 mg in 1 1 | 8/4/2011 | |
| Novartis Pharmaceuticals Corporation | 0078-0241 | ORAL | 100 mg in 1 1 | 12/23/2016 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Ciclosporin Soft Capsules | 国药准字HJ20140288 | 化学药品 | 胶囊剂 | 6/28/2023 | |
| Ciclosporin Soft Capsules | 国药准字H20198014 | 化学药品 | 胶囊剂(软胶囊) | 12/12/2019 | |
| Ciclosporin Soft Capsules | 国药准字H20094199 | 化学药品 | 胶囊剂 | 8/12/2019 | |
| Ciclosporin Soft Capsules | 国药准字H10960121 | 化学药品 | 胶囊剂 | 4/7/2020 | |
| Ciclosporin Soft Capsules | 国药准字H10950355 | 化学药品 | 胶囊剂 | 5/19/2020 | |
| Ciclosporin Soft Capsules | 国药准字H20055400 | 化学药品 | 胶囊剂(软胶囊) | 7/7/2020 | |
| Ciclosporin Soft Capsules | 国药准字H20103433 | 化学药品 | 软胶囊剂 | 4/22/2021 | |
| Ciclosporin Soft Capsules | 国药准字H20198013 | 化学药品 | 胶囊剂(软胶囊) | 12/12/2019 | |
| Ciclosporin Soft Capsules | 国药准字H20143041 | 化学药品 | 胶囊剂 | 12/14/2023 | |
| Ciclosporin Soft Capsules | 国药准字H20143042 | 化学药品 | 胶囊剂 | 12/14/2023 |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| CICLOSPORIN GPPL ciclosporin 50 mg soft capsule blister pack | 324121 | Medicine | A | 2/9/2021 | |
| CYCLOSPORIN SANDOZ ciclosporin 50mg capsules blister pack | 186359 | Medicine | A | 6/14/2012 | |
| CYCLOSPORIN SANDOZ ciclosporin 25mg capsules blister pack | 186358 | Medicine | A | 6/14/2012 | |
| NERIN ciclosporin 100mg soft capsule blister pack | 324103 | Medicine | A | 2/9/2021 | |
| CICLORAL ciclosporin 25 mg soft capsule blister pack | 324106 | Medicine | A | 2/9/2021 | |
| CEQUA SUN ciclosporin 900 microgram/mL eye drops ampoule | 408814 | Medicine | A | 8/7/2023 | |
| SANDIMMUN ciclosporin 50mg/1mL injection ampoule | 13370 | Medicine | A | 8/21/1991 | |
| CICLOSPORIN GENPAR ciclosporin 50 mg soft capsule blister pack | 324122 | Medicine | A | 2/9/2021 | |
| CYCLOSPORIN SANDOZ ciclosporin 100mg capsule blister pack | 186361 | Medicine | A | 6/14/2012 | |
| CICLOSPORIN GXP ciclosporin 25 mg soft capsule blister pack | 324109 | Medicine | A | 2/9/2021 |
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