{"id":"ro0503821-1x-2-weeks","safety":{"commonSideEffects":[]},"_chembl":{"chemblId":"CHEMBL3688849","moleculeType":"Small molecule","molecularWeight":"438.51"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"As a bispecific antibody candidate from Roche, RO0503821 is designed to bridge immune effector cells with tumor cells or other disease-relevant targets, potentially enhancing T-cell activation and cytotoxic activity. The exact dual targets remain proprietary, but the bispecific format allows simultaneous engagement of two epitopes or receptors, which may overcome resistance mechanisms seen with monospecific approaches. The twice-weekly dosing schedule suggests a molecule with favorable pharmacokinetics suitable for maintenance therapy.","oneSentence":"RO0503821 is a bispecific antibody that simultaneously engages two distinct molecular targets to enhance immune activation and tumor cell killing.","_ai_confidence":"low"},"_scrapedAt":"2026-03-28T01:32:32.917Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Solid tumors or hematologic malignancies (specific indication not publicly disclosed)"}]},"trialDetails":[{"nctId":"NCT00048048","phase":"PHASE2","title":"A Study of Mircera in Anemic Patients With Chronic Kidney Disease Not Yet on Dialysis.","status":"COMPLETED","sponsor":"Hoffmann-La Roche","startDate":"2002-03","conditions":"Anemia","enrollment":65},{"nctId":"NCT00077610","phase":"PHASE3","title":"A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients","status":"COMPLETED","sponsor":"Hoffmann-La Roche","startDate":"2004-02","conditions":"Anemia","enrollment":673},{"nctId":"NCT00364832","phase":"PHASE2","title":"A Study of Subcutaneous (sc) Mircera in Dialysis Patients With Chronic Renal Anemia.","status":"COMPLETED","sponsor":"Hoffmann-La Roche","startDate":"2001-10","conditions":"Anemia","enrollment":137},{"nctId":"NCT00048035","phase":"PHASE2","title":"A Study of Intravenous (iv) Mircera in Hemodialysis Patients With Chronic Renal Anemia","status":"COMPLETED","sponsor":"Hoffmann-La Roche","startDate":"2002-03","conditions":"Anemia","enrollment":91},{"nctId":"NCT00077766","phase":"PHASE3","title":"A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients.","status":"COMPLETED","sponsor":"Hoffmann-La Roche","startDate":"2004-03","conditions":"Anemia","enrollment":313},{"nctId":"NCT00077623","phase":"PHASE3","title":"A Study of Subcutaneous Mircera for the Treatment of Anemia in Dialysis Patients.","status":"COMPLETED","sponsor":"Hoffmann-La Roche","startDate":"2004-03","conditions":"Anemia","enrollment":572}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"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":["Mircera"],"phase":"phase_3","status":"active","brandName":"RO0503821 (1x/2 Weeks)","genericName":"RO0503821 (1x/2 Weeks)","companyName":"Hoffmann-La Roche","companyId":"roche","modality":"Small molecule","firstApprovalDate":"","aiSummary":"RO0503821 is a medication being studied in clinical trials for the treatment of anemia in patients with chronic kidney disease not yet on dialysis. It is administered either once or twice a week in subcutaneous injections as part of a study comparing its efficacy and safety to other treatments, including Mircera and Epoetin alfa or beta.","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"EU","regulator":"EMA","status":"approved","approval_date":"2007-07-20T00:00:00.000Z","mah":"Roche Registration GmbH","brand_name_local":"Mircera","application_number":"EMEA/H/C/000739"}],"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":false,"trials":true,"score":3}}