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CNI (50%)
CNI (calcineurin inhibitor) suppresses T-cell activation by inhibiting calcineurin phosphatase, thereby reducing production of pro-inflammatory cytokines.
CNI (calcineurin inhibitor) suppresses T-cell activation by inhibiting calcineurin phosphatase, thereby reducing production of pro-inflammatory cytokines. Used for Organ transplant rejection prophylaxis, Autoimmune and inflammatory conditions (e.g., atopic dermatitis, psoriasis).
At a glance
| Generic name | CNI (50%) |
|---|---|
| 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 block calcineurin-mediated dephosphorylation of NFAT, a transcription factor essential for IL-2 and other cytokine gene expression in T cells. This prevents T-cell proliferation and differentiation, making them potent immunosuppressants used in transplantation and autoimmune diseases.
Approved indications
- Organ transplant rejection prophylaxis
- Autoimmune and inflammatory conditions (e.g., atopic dermatitis, psoriasis)
Common side effects
- Nephrotoxicity
- Hypertension
- Neurotoxicity (tremor, headache)
- Hyperglycemia
- Gingival hyperplasia
- Infections
Key clinical trials
- Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Kidney Transplant Recipients (PHASE2)
- 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)
- Effect of Different Root Canal Disinfection Procedures on Postoperative Pain (NA)
- TTV-based mAnagement Of Long-term ImmunosuppreSsion in Kidney Transplantation (NA)
- Treg Therapy in Subclinical Inflammation in Kidney Transplantation (PHASE1, PHASE2)
- Evaluation of Donor Specific Immune Senescence and Exhaustion as Biomarkers of Tolerance Post Liver Transplantation (PHASE2)
- Spironolactone After Liver Transplant (PHASE4)
- A Study in Maintenance Kidney Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based (PHASE3)
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- CNI (50%) CI brief — competitive landscape report
- CNI (50%) updates RSS · CI watch RSS
- Hoffmann-La Roche portfolio CI