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Cyclosporine Oral Product
Cyclosporine suppresses T-cell activation and proliferation by inhibiting calcineurin, thereby reducing the production of pro-inflammatory cytokines.
Cyclosporine suppresses T-cell activation and proliferation by inhibiting calcineurin, thereby reducing the production of pro-inflammatory cytokines. Used for Prevention of organ rejection in transplant recipients, Autoimmune diseases including rheumatoid arthritis and nephrotic syndrome, Severe atopic dermatitis.
At a glance
| Generic name | Cyclosporine Oral Product |
|---|---|
| Also known as | Prednisone, Sandimmune, cyclosporine A |
| Sponsor | Peking University People's Hospital |
| Drug class | Calcineurin inhibitor |
| Target | Calcineurin (protein phosphatase 2B) |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
Mechanism of action
Cyclosporine binds to cyclophilin and the resulting complex inhibits calcineurin phosphatase, which prevents dephosphorylation and nuclear translocation of NFAT (nuclear factor of activated T cells). This blocks the transcription of IL-2 and other cytokines essential for T-cell activation and proliferation, leading to immunosuppression. It is used to prevent organ rejection and treat autoimmune conditions.
Approved indications
- Prevention of organ rejection in transplant recipients
- Autoimmune diseases including rheumatoid arthritis and nephrotic syndrome
- Severe atopic dermatitis
Common side effects
- Nephrotoxicity
- Hypertension
- Tremor
- Gingival hyperplasia
- Hirsutism
- Infection
- Hyperkalemia
Key clinical trials
- Rituximab Plus Cyclosporine in Idiopathic Membranous Nephropathy (PHASE2)
- I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients (PHASE2)
- A Single-Arm Phase 2 Study With Optimized Standard Protocol for Severe Aplastic Anemia (PHASE2)
- Effect of Cyclosporine Drug Interaction on the Absorption, Metabolism and Elimination of CHF6001 in Healthy Volunteers. Drug-Drug Interaction 2 (DDI2) Study (PHASE1)
- Hematopoietic Stem Cell Transplantation in the Treatment of Infant Leukemia (PHASE2)
- SKIN Disease Profiling by an Exploratory, pRospective, Biomarker Study in dermatoloGY Practice (SKINERGY)
- A Study of the Drug Letermovir (LTV) as Prevention for Recurrent of Cytomegalovirus (CMV) Infection (PHASE2)
- HIgh Dose Thymoglobulin Instead of Cyclosporine With a Low Dose of Thymoglobulin for GVHD Prophylaxis (PHASE2)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |