{"id":"fks518","safety":{"commonSideEffects":[{"rate":null,"effect":"Nephrotoxicity"},{"rate":null,"effect":"Neurotoxicity"},{"rate":null,"effect":"Hypertension"},{"rate":null,"effect":"Hyperglycemia"},{"rate":null,"effect":"Infections"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"FKS518 binds to FK-binding protein 12 (FKBP12) and inhibits calcineurin phosphatase activity, which prevents dephosphorylation and nuclear translocation of NFAT transcription factors required for T-cell cytokine production. This mechanism is similar to tacrolimus but with potentially improved pharmacokinetic properties. It is being developed as an immunosuppressant for transplantation and autoimmune conditions.","oneSentence":"FKS518 is a calcineurin inhibitor that suppresses T-cell activation by blocking the phosphatase calcineurin, thereby reducing immune-mediated rejection.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:12:42.067Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Organ transplant rejection prevention"},{"name":"Autoimmune diseases (investigational)"}]},"trialDetails":[{"nctId":"NCT04934072","phase":"PHASE3","title":"A Study to Evaluate the Efficacy, Pharmacodynamics, Safety, and Immunogenicity of FKS518 in Postmenopausal Women With Osteoporosis","status":"COMPLETED","sponsor":"Fresenius Kabi SwissBioSim GmbH","startDate":"2021-06-16","conditions":"Postmenopausal Osteoporosis","enrollment":553}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":4,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Denosumab biosimilar"],"phase":"phase_3","status":"active","brandName":"FKS518","genericName":"FKS518","companyName":"Fresenius Kabi SwissBioSim GmbH","companyId":"fresenius-kabi-swissbiosim-gmbh","modality":"Small molecule","firstApprovalDate":"","aiSummary":"FKS518 is a calcineurin inhibitor that suppresses T-cell activation by blocking the phosphatase calcineurin, thereby reducing immune-mediated rejection. Used for Organ transplant rejection prevention, Autoimmune diseases (investigational).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}