{"id":"lupkynis","safety":{"commonSideEffects":[{"rate":"30–40","effect":"Hypertension"},{"rate":"15–25","effect":"Hyperkalemia"},{"rate":"20–30","effect":"Increased serum creatinine"},{"rate":"10–15","effect":"Headache"},{"rate":"10–15","effect":"Diarrhea"},{"rate":"5–10","effect":"Tremor"},{"rate":"5–10","effect":"Gum hyperplasia"}]},"_chembl":{"chemblId":"CHEMBL5314379","moleculeType":"Protein","molecularWeight":"1214.65"},"_dailymed":{"setId":"9f489295-1156-52c7-5fd0-5c4c52f9b813","title":"LUPKYNIS (VOCLOSPORIN) CAPSULE [AURINIA PHARMA U.S., INC.]"},"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Voclosporin binds to cyclophilin and inhibits calcineurin, a phosphatase required for T-cell receptor signaling and IL-2 transcription. This suppresses the proliferation and activation of T lymphocytes, reducing the autoimmune response in lupus nephritis. By decreasing pathogenic T-cell activity, it reduces proteinuria and preserves kidney function in patients with lupus-induced kidney disease.","oneSentence":"LUPKYNIS (voclosporin) is a calcineurin inhibitor that suppresses T-cell activation and cytokine production to reduce lupus nephritis inflammation.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T03:38:47.958Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Lupus nephritis (Class III or IV)"}]},"trialDetails":[{"nctId":"NCT07053891","phase":"","title":"LUPKYNIS Drug-use Results Survey","status":"RECRUITING","sponsor":"Otsuka Pharmaceutical Co., Ltd.","startDate":"2025-09-17","conditions":"Lupus Nephritis","enrollment":400},{"nctId":"NCT05306873","phase":"PHASE2","title":"Examining Distinct Immunophenotypes to Validate and Enhance Rational Treatment in Systemic Lupus","status":"TERMINATED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2022-11-30","conditions":"Systemic Lupus Erythematosus","enrollment":12},{"nctId":"NCT05337124","phase":"","title":"A Prospective Observational Registry of Patients Treated With LUPKYNIS® (Voclosporin) in the US","status":"COMPLETED","sponsor":"Aurinia Pharmaceuticals Inc.","startDate":"2022-04-05","conditions":"Lupus Nephritis","enrollment":229}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[{"date":"20251008","type":"SUPPL","sponsor":"AURINIA","applicationNumber":"NDA213716"},{"date":"20240429","type":"SUPPL","sponsor":"AURINIA","applicationNumber":"NDA213716"},{"date":"20210122","type":"ORIG","sponsor":"AURINIA","applicationNumber":"NDA213716"}],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["voclosporin"],"phase":"marketed","status":"active","brandName":"LUPKYNIS","genericName":"LUPKYNIS","companyName":"Aurinia Pharmaceuticals Inc.","companyId":"aurinia-pharmaceuticals-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"LUPKYNIS (voclosporin) is a calcineurin inhibitor that suppresses T-cell activation and cytokine production to reduce lupus nephritis inflammation. Used for Lupus nephritis (Class III or IV).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}