{"id":"medi-546","safety":{"commonSideEffects":[{"rate":null,"effect":"Infection"},{"rate":null,"effect":"Nasopharyngitis"},{"rate":null,"effect":"Infusion reactions"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"MEDI-546 binds to BAFF, a key cytokine involved in B-cell survival and activation. By neutralizing BAFF, the drug reduces the number and activity of B cells, thereby suppressing autoimmune and inflammatory responses. This mechanism is intended to treat B-cell-mediated autoimmune diseases.","oneSentence":"MEDI-546 is a monoclonal antibody that targets and inhibits B-cell activating factor (BAFF) to reduce B-cell proliferation and autoimmune responses.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:20:30.170Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Systemic lupus erythematosus (SLE)"},{"name":"Rheumatoid arthritis"}]},"trialDetails":[{"nctId":"NCT04877691","phase":"PHASE3","title":"Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus","status":"ACTIVE_NOT_RECRUITING","sponsor":"AstraZeneca","startDate":"2021-06-08","conditions":"Systemic Lupus Erythematosus","enrollment":367},{"nctId":"NCT05835310","phase":"PHASE3","title":"An Efficacy and Safety Study of Intravenous Anifrolumab to Treat Systemic Lupus Erythematosus in Pediatric Participants","status":"RECRUITING","sponsor":"AstraZeneca","startDate":"2024-03-14","conditions":"Systemic Lupus Erythematosus","enrollment":100},{"nctId":"NCT05138133","phase":"PHASE3","title":"Phase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis","status":"ACTIVE_NOT_RECRUITING","sponsor":"AstraZeneca","startDate":"2022-02-15","conditions":"Lupus Nephritis","enrollment":359},{"nctId":"NCT04726553","phase":"EARLY_PHASE1","title":"Nature of Anifrolumab Impact on Vaccine-Emergent Immunity in SLE","status":"UNKNOWN","sponsor":"Oklahoma Medical Research Foundation","startDate":"2021-01-20","conditions":"Systemic Lupus Erythematosus (SLE)","enrollment":20},{"nctId":"NCT04750057","phase":"","title":"Anifrolumab Early Access Program","status":"NO_LONGER_AVAILABLE","sponsor":"AstraZeneca","startDate":"","conditions":"Systemic Lupus Erythematosus","enrollment":""},{"nctId":"NCT01753193","phase":"PHASE2","title":"An Open-label Study to Evaluate the Long-term Safety of MEDI-546, for the Treatment of SLE, in Adults","status":"COMPLETED","sponsor":"MedImmune LLC","startDate":"2013-03-28","conditions":"Lupus Erythematosus, Systemic","enrollment":218},{"nctId":"NCT01559090","phase":"PHASE2","title":"Safety and Tolerability of Intravenous Dose of MEDI-546 in Japanese Subjects With Systemic Lupus Erythematosus.","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2012-04-20","conditions":"Systemic Lupus Erythematosus","enrollment":17},{"nctId":"NCT01438489","phase":"PHASE2","title":"A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus Erythematosus","status":"COMPLETED","sponsor":"MedImmune LLC","startDate":"2012-01","conditions":"Systemic Lupus Erythematosus","enrollment":626},{"nctId":"NCT00930683","phase":"PHASE1","title":"A Study to Evaluate Safety and Tolerability of Multiple Doses of MEDI-546 in Adult Subjects With Scleroderma","status":"COMPLETED","sponsor":"MedImmune LLC","startDate":"2009-09","conditions":"Scleroderma","enrollment":34}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":6,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"MEDI-546","genericName":"MEDI-546","companyName":"MedImmune LLC","companyId":"medimmune-llc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"MEDI-546 is a monoclonal antibody that targets and inhibits B-cell activating factor (BAFF) to reduce B-cell proliferation and autoimmune responses. Used for Systemic lupus erythematosus (SLE), Rheumatoid arthritis.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}