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CNI (≥75%)
CNI (calcineurin inhibitor) suppresses T-cell activation by inhibiting calcineurin phosphatase, thereby blocking IL-2 production and T-cell proliferation.
CNI (calcineurin inhibitor) suppresses T-cell activation by inhibiting calcineurin phosphatase, thereby blocking IL-2 production and T-cell proliferation. Used for Organ transplant rejection prophylaxis (renal, cardiac, hepatic), Autoimmune diseases (atopic dermatitis, psoriasis, rheumatoid arthritis).
At a glance
| Generic name | CNI (≥75%) |
|---|---|
| Sponsor | Hoffmann-La Roche |
| Drug class | Calcineurin inhibitor |
| Target | Calcineurin (protein phosphatase 2B) |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
Mechanism of action
Calcineurin inhibitors bind to immunophilins (cyclophilin or FK-binding protein) and form a complex that inhibits calcineurin, a serine/threonine phosphatase essential for dephosphorylating NFAT transcription factors. This prevents NFAT nuclear translocation and subsequent IL-2 and other cytokine gene transcription, resulting in suppression of T-cell activation and proliferation. CNIs are used primarily as immunosuppressants in transplantation and autoimmune diseases.
Approved indications
- Organ transplant rejection prophylaxis (renal, cardiac, hepatic)
- Autoimmune diseases (atopic dermatitis, psoriasis, rheumatoid arthritis)
Common side effects
- Nephrotoxicity
- Hypertension
- Neurotoxicity (tremor, headache)
- Hyperglycemia
- Gingival hyperplasia
- Infections
Key clinical trials
- Screening for Subclinical Antibody Mediated Rejection and Efficacy of Belatacept in the Context of de Novo Donor Specific Antibody After Kidney Transplantation (BELA-M-R) (PHASE2, PHASE3)
- TTV-based mAnagement Of Long-term ImmunosuppreSsion in Kidney Transplantation (NA)
- Donor Alloantigen Reactive Tregs (darTregs) for Calcineurin Inhibitor (CNI) Reduction (PHASE1, PHASE2)
- Nordic Everolimus (Certican) Trial in Heart and Lung Transplantation (PHASE4)
- SCHEDULE Follow Up Visit 5-7 yr (PHASE4)
- 24 Months Follow-up, Two Arm Study to Compare the Cardiovascular Profile in a Regimen With Everolimus + Mycophenolic Acid (MPA) Versus (vs.) a Regimen of CNI+MPA in Maintenance Renal Transplant Recipients (PHASE4)
- SCHEDULE - Scandinavian Heart Transplant Everolimus de Novo Study With Early Calcineurin Inhibitor (CNI) Avoidance (PHASE4)
- A Study of CellCept (Mycophenolate Mofetil) Combined With Calcineurin Inhibitors in Liver Transplant Patients. (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |