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
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/19 | Phase 2 | Not yet recruiting | Shanghai JMT-Bio Inc. | ||
2025/05/20 | Not Applicable | Completed | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||
2025/04/24 | Phase 3 | Not yet recruiting | Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. | ||
2025/03/25 | Phase 1 | Recruiting | |||
2025/03/14 | Phase 4 | Completed | |||
2025/02/20 | Phase 1 | Completed | |||
2025/02/13 | Phase 4 | Completed | |||
2025/02/05 | Phase 1 | Completed | |||
2025/01/30 | Phase 2 | Recruiting | |||
2025/01/23 | Phase 2 | Not yet recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Apotex Corp. | 60505-0134 | ORAL | 100 mg in 1 1 | 11/3/2023 | |
| Apotex Corp. | 60505-0133 | ORAL | 25 mg in 1 1 | 11/3/2023 | |
| Teva Pharmaceuticals USA, Inc. | 0093-9019 | ORAL | 50 mg in 1 1 | 6/8/2021 | |
| Teva Pharmaceuticals USA, Inc. | 0093-9020 | ORAL | 100 mg in 1 1 | 6/8/2021 | |
| AbbVie Inc. | 0074-0541 | ORAL | 50 mg in 1 1 | 2/28/2024 | |
| Padagis US LLC | 0574-0866 | INTRAVENOUS | 50 mg in 1 mL | 10/1/2023 | |
| Apotex Corp. | 60505-4632 | ORAL | 100 mg in 1 1 | 11/1/2023 | |
| Teva Pharmaceuticals USA, Inc. | 0093-9018 | ORAL | 25 mg in 1 1 | 6/8/2021 | |
| AbbVie Inc. | 0074-3108 | ORAL | 25 mg in 1 1 | 2/28/2024 | |
| Strides Pharma Science Limited | 64380-127 | ORAL | 25 mg in 1 1 | 2/22/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 7/6/2018 | ||
Authorised | 3/19/2015 | ||
Authorised | 9/19/2024 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| SANDIMMUN NEORAL CAPSULE 10 mg | SIN09871P | CAPSULE, LIQUID FILLED | 10.0mg | 7/2/1998 | |
| SANDIMMUN NEORAL CAPSULE 100 mg | SIN08177P | CAPSULE, LIQUID FILLED | 100.0mg | 4/27/1995 | |
| DEXIMUNE CAPSULES 100MG | SIN14049P | CAPSULE, LIQUID FILLED | 100.00MG | 11/9/2011 | |
| IKERVIS EYE DROPS, EMULSION 1MG/ML | SIN15216P | EMULSION | 1mg/ml | 4/20/2017 | |
| SANDIMMUN NEORAL DRINK SOLUTION 100 mg/ml | SIN08176P | SOLUTION | 100.0mg/ml | 4/27/1995 | |
| DEXIMUNE CAPSULES 25MG | SIN14047P | CAPSULE, LIQUID FILLED | 25.00MG | 11/9/2011 | |
| SANDIMMUN CONCENTRATE FOR INFUSION 50 mg/ml | SIN00520P | INJECTION | 50.0mg/ml | 4/28/1988 | |
| DEXIMUNE CAPSULES 50MG | SIN14048P | CAPSULE, LIQUID FILLED | 50.00MG | 11/9/2011 | |
| SANDIMMUN NEORAL CAPSULE 50 mg | SIN08178P | CAPSULE, LIQUID FILLED | 50.0mg | 4/27/1995 | |
| SANDIMMUN NEORAL CAPSULE 25 mg | SIN08179P | CAPSULE, LIQUID FILLED | 25.0mg | 4/27/1995 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| OPTIMMUNE EYE OINTMENT FOR DOGS 2MG/G (VET) | N/A | N/A | N/A | 9/6/2024 | |
| CEQUA OPHTHALMIC SOLUTION 0.09% W/V | N/A | N/A | N/A | 2/28/2023 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| APO-CICLOSPORIN ciclosporin 100 mg soft capsule blister pack | 324107 | Medicine | A | 2/9/2021 | |
| CICLOSPORIN GENPAR ciclosporin 25 mg soft capsule blister pack | 324105 | Medicine | A | 2/9/2021 | |
| CICLOSPORIN GPPL ciclosporin 100 mg soft capsule blister pack | 324117 | Medicine | A | 2/9/2021 | |
| IKERVIS ciclosporin 1 mg/mL eye drops emulsion ampoule | 319502 | Medicine | A | 12/15/2020 | |
| CICLORAL ciclosporin 50 mg soft capsule blister pack | 324120 | Medicine | A | 2/9/2021 | |
| CICLOSPORIN-APOTEX ciclosporin 50 mg soft capsule blister pack | 324118 | Medicine | A | 2/9/2021 | |
| NERIN ciclosporin 50 mg soft capsule blister pack | 324115 | Medicine | A | 2/9/2021 | |
| NEORAL ciclosporin 100mg capsule blister pack | 49724 | Medicine | A | 8/28/1995 | |
| SANDIMMUN ciclosporin 250mg/5mL injection ampoule | 47290 | Medicine | A | 12/6/1993 | |
| APO-CICLOSPORIN ciclosporin 50 mg soft capsule blister pack | 324111 | Medicine | A | 2/9/2021 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| SANDIMMUNE ORAL SOL 100MG/ML | Sandoz Canada Inc | 00593249 | Liquid - Oral | 100 MG / ML | 12/31/1984 |
| CYCLOSPORINE | 02334763 | Capsule - Oral | 25 MG | N/A | |
| APO-CYCLOSPORINE ORAL SOLUTION | 02244324 | Solution - Oral | 100 MG / ML | 7/30/2002 | |
| SANDOZ CYCLOSPORINE | 02242821 | Capsule - Oral | 100 MG | 12/27/2001 | |
| RESTASIS MULTIDOSE | 02476835 | Emulsion - Ophthalmic | 0.05 % / W/V | 8/9/2018 | |
| SANDOZ CYCLOSPORINE | 02247074 | Capsule - Oral | 50 MG | 10/18/2006 | |
| NEORAL | novartis pharmaceuticals canada inc | 02237671 | Capsule - Oral | 10 MG | 10/2/1998 |
| NEORAL | novartis pharmaceuticals canada inc | 02150662 | Capsule - Oral | 50 MG | 12/31/1995 |
| CYCLOSPORINE | 02495813 | Capsule - Oral | 100 MG | 2/3/2022 | |
| CYCLOSPORINE | 02495821 | Capsule - Oral | 50 MG | 2/3/2022 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| CIQORIN 25 MG CAPSULAS BLANDAS EFG | Teva Pharma S.L.U. | 78332 | CÁPSULA BLANDA | Diagnóstico Hospitalario | Commercialized |
| SANDIMMUN 50 mg/ml CONCENTRADO PARA SOLUCION PARA PERFUSION | Novartis Farmaceutica S.A. | 56800 | CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized |
| SANDIMMUN NEORAL 100 mg/ml SOLUCION ORAL | Novartis Farmaceutica S.A. | 56799 | SOLUCIÓN ORAL | Diagnóstico Hospitalario | Commercialized |
| VERKAZIA 1 MG/ML COLIRIO EN EMULSION | 1171219004 | COLIRIO EN EMULSIÓN | Diagnóstico Hospitalario | Not Commercialized | |
| IKERVIS 1 mg/ml colirio en emulsion | 115990001 | COLIRIO EN EMULSIÓN | Diagnóstico Hospitalario | Commercialized | |
| SANDIMMUN NEORAL 25 mg CAPSULAS BLANDAS | Novartis Farmaceutica S.A. | 60319 | CÁPSULA BLANDA | Diagnóstico Hospitalario | Commercialized |
| CIQORIN 100 MG CAPSULAS BLANDAS EFG | Teva Pharma S.L.U. | 78331 | CÁPSULA BLANDA | Diagnóstico Hospitalario | Commercialized |
| SANDIMMUN NEORAL 100 mg CAPSULAS BLANDAS | Novartis Farmaceutica S.A. | 60320 | CÁPSULA BLANDA | Diagnóstico Hospitalario | Commercialized |
| CEQUA 0,9 MG/ML COLIRIO EN SOLUCION EN ENVASE UNIDOSIS | 89655 | COLIRIO EN SOLUCIÓN EN ENVASE UNIDOSIS | Diagnóstico Hospitalario | Not Commercialized | |
| SANDIMMUN 250 mg/5 ml CONCENTRADO PARA SOLUCION PARA PERFUSION | Novartis Farmaceutica S.A. | 56798 | CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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