{"id":"sel-212-high-dose","safety":{"commonSideEffects":[{"rate":null,"effect":"Infusion reactions"},{"rate":null,"effect":"Gout flares"},{"rate":null,"effect":"Methotrexate-related toxicity (hepatotoxicity, myelosuppression)"},{"rate":null,"effect":"Anti-drug antibody formation"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"SEL-212 combines pegsiticase (a recombinant uricase that breaks down uric acid into allantoin) with methotrexate as an immunosuppressant. The methotrexate component is designed to prevent the formation of anti-drug antibodies that typically develop against pegsiticase, allowing sustained uric acid reduction in patients with severe gout who are refractory to conventional therapies.","oneSentence":"SEL-212 is a combination therapy that pairs a uricase enzyme with an immunosuppressant to lower uric acid levels while preventing immune reactions against the enzyme.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:53:00.272Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Refractory gout (severe, uncontrolled hyperuricemia in patients inadequately responsive to conventional urate-lowering therapy)"}]},"trialDetails":[{"nctId":"NCT04596540","phase":"PHASE3","title":"A Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy II","status":"COMPLETED","sponsor":"Swedish Orphan Biovitrum","startDate":"2020-11-30","conditions":"Chronic Gout","enrollment":153},{"nctId":"NCT04513366","phase":"PHASE3","title":"A Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy","status":"COMPLETED","sponsor":"Swedish Orphan Biovitrum","startDate":"2020-08-18","conditions":"Chronic Gout","enrollment":112},{"nctId":"NCT02959918","phase":"PHASE2","title":"Multi-Dose Safety/Pharmacodynamic Study of SEL-212/SEL-037 in Subjects With Symptomatic Gout & Elevated Blood Uric Acid","status":"COMPLETED","sponsor":"Selecta Biosciences, Inc.","startDate":"2016-10","conditions":"Gout Chronic, Hyperuricemia","enrollment":152},{"nctId":"NCT02648269","phase":"PHASE1","title":"Safety and Pharmacodynamics of SEL-212 (Pegsiticase + SEL-110) in Subjects With Elevated Blood Uric Acid Levels","status":"COMPLETED","sponsor":"Selecta Biosciences, Inc.","startDate":"2015-12","conditions":"Gout","enrollment":63}],"_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":[],"phase":"phase_3","status":"active","brandName":"SEL-212 high-dose","genericName":"SEL-212 high-dose","companyName":"Swedish Orphan Biovitrum","companyId":"swedish-orphan-biovitrum","modality":"Small molecule","firstApprovalDate":"","aiSummary":"SEL-212 is a small molecule being studied for the treatment of conditions such as gout, chronic gout, and hyperuricemia. It is administered in combination with SEL-110 as part of a Phase I clinical trial to assess its safety and pharmacodynamics.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":2,"withResults":2},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}