{"id":"cni-75","safety":{"commonSideEffects":[{"rate":null,"effect":"Nephrotoxicity"},{"rate":null,"effect":"Hypertension"},{"rate":null,"effect":"Neurotoxicity (tremor, headache)"},{"rate":null,"effect":"Hyperglycemia"},{"rate":null,"effect":"Gingival hyperplasia"},{"rate":null,"effect":"Infections"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"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.","oneSentence":"CNI (calcineurin inhibitor) suppresses T-cell activation by inhibiting calcineurin phosphatase, thereby blocking IL-2 production and T-cell proliferation.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:29:20.944Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Organ transplant rejection prophylaxis (renal, cardiac, hepatic)"},{"name":"Autoimmune diseases (atopic dermatitis, psoriasis, rheumatoid arthritis)"}]},"trialDetails":[{"nctId":"NCT06291103","phase":"PHASE2, PHASE3","title":"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)","status":"NOT_YET_RECRUITING","sponsor":"University Hospital, Rouen","startDate":"2026-03-01","conditions":"Kidney Transplant Rejection","enrollment":290},{"nctId":"NCT06829719","phase":"NA","title":"TTV-based mAnagement Of Long-term ImmunosuppreSsion in Kidney Transplantation","status":"RECRUITING","sponsor":"Hospices Civils de Lyon","startDate":"2025-04-23","conditions":"Infection, Cancer, Rejection","enrollment":300},{"nctId":"NCT02474199","phase":"PHASE1, PHASE2","title":"Donor Alloantigen Reactive Tregs (darTregs) for Calcineurin Inhibitor (CNI) Reduction","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2016-06-06","conditions":"Liver Transplant Recipient, Living Donor (of the Respective Liver Transplant Recipient)","enrollment":15},{"nctId":"NCT00377962","phase":"PHASE4","title":"Nordic Everolimus (Certican) Trial in Heart and Lung Transplantation","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2005-12","conditions":"Disorder Related to Cardiac Transplantation","enrollment":282},{"nctId":"NCT02864706","phase":"PHASE4","title":"SCHEDULE Follow Up Visit 5-7 yr","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2016-01-18","conditions":"Heart Transplantation","enrollment":95},{"nctId":"NCT01169701","phase":"PHASE4","title":"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","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2010-08","conditions":"Renal Transplant","enrollment":71},{"nctId":"NCT01266148","phase":"PHASE4","title":"SCHEDULE - Scandinavian Heart Transplant Everolimus de Novo Study With Early Calcineurin Inhibitor (CNI) Avoidance","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2009-11","conditions":"Renal Function and Chronic Allograft Vasculopathy","enrollment":115},{"nctId":"NCT00717314","phase":"PHASE4","title":"A Study of CellCept (Mycophenolate Mofetil) Combined With Calcineurin Inhibitors in Liver Transplant Patients.","status":"COMPLETED","sponsor":"Hoffmann-La Roche","startDate":"2008-05","conditions":"Liver Transplantation","enrollment":87},{"nctId":"NCT00634920","phase":"PHASE4","title":"Evaluation of Early Conversion to Everolimus From Cyclosporine in de Novo Renal Transplant Recipients","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2008-03","conditions":"Renal Function","enrollment":204}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":181,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"CNI (≥75%)","genericName":"CNI (≥75%)","companyName":"Hoffmann-La Roche","companyId":"hoffmann-la-roche","modality":"Small molecule","firstApprovalDate":"","aiSummary":"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).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}