{"id":"imvt-1402","safety":{"commonSideEffects":[{"rate":null,"effect":"Infection (including upper respiratory tract infection)"},{"rate":null,"effect":"Infusion-related reactions"},{"rate":null,"effect":"Headache"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"FcRn is responsible for the recycling and prolonged half-life of IgG antibodies in the bloodstream. By antagonizing FcRn, IMVT-1402 increases the catabolism of pathogenic IgG autoantibodies, thereby reducing their circulating levels. This mechanism is intended to treat autoimmune diseases driven by IgG-mediated pathology.","oneSentence":"IMVT-1402 is a neonatal Fc receptor (FcRn) antagonist that reduces circulating immunoglobulin levels by blocking FcRn-mediated recycling of IgG antibodies.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:15:49.168Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Generalized myasthenia gravis (gMG)"},{"name":"Thyroid eye disease (TED)"}]},"trialDetails":[{"nctId":"NCT06980805","phase":"PHASE2","title":"A Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants With Cutaneous Lupus Erythematosus (CLE)","status":"RECRUITING","sponsor":"Immunovant Sciences GmbH","startDate":"2025-02-19","conditions":"Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus","enrollment":56},{"nctId":"NCT06727604","phase":"PHASE2","title":"A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease","status":"RECRUITING","sponsor":"Immunovant Sciences GmbH","startDate":"2024-12-17","conditions":"Graves' Disease","enrollment":240},{"nctId":"NCT06979531","phase":"PHASE2","title":"Efficacy and Safety of IMVT-1402 in Adult Participants With Primary Sjogren's Disease With Moderate to Severe Systemic Disease Activity","status":"RECRUITING","sponsor":"Immunovant Sciences GmbH","startDate":"2025-06-30","conditions":"Primary Sjögren's Syndrome","enrollment":180},{"nctId":"NCT07039916","phase":"PHASE3","title":"Study to Assess the Efficacy and Safety of IMVT-1402 in Participants With Mild to Severe Generalized Myasthenia Gravis","status":"RECRUITING","sponsor":"Immunovant Sciences GmbH","startDate":"2025-05-27","conditions":"Generalized Myasthenia Gravis","enrollment":231},{"nctId":"NCT07018323","phase":"PHASE2","title":"A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease","status":"RECRUITING","sponsor":"Immunovant Sciences GmbH","startDate":"2025-06-19","conditions":"Graves' Disease","enrollment":210},{"nctId":"NCT07286006","phase":"PHASE2","title":"A Long-Term Extension Study of IMVT-1402 in Adult Participants With Graves' Disease (GD)","status":"ENROLLING_BY_INVITATION","sponsor":"Immunovant Sciences GmbH","startDate":"2026-01-26","conditions":"Graves' Disease","enrollment":372},{"nctId":"NCT07032662","phase":"PHASE2","title":"IMVT-1402 in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)","status":"RECRUITING","sponsor":"Immunovant Sciences GmbH","startDate":"2025-03-18","conditions":"Chronic Inflammatory Demyelinating Polyneuropathy","enrollment":162},{"nctId":"NCT06754462","phase":"PHASE2","title":"A Study to Evaluate the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants With Active, Difficult to Treat Rheumatoid Arthritis","status":"ACTIVE_NOT_RECRUITING","sponsor":"Immunovant Sciences GmbH","startDate":"2025-01-10","conditions":"Rheumatoid Arthritis","enrollment":120}],"_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":"IMVT-1402","genericName":"IMVT-1402","companyName":"Immunovant Sciences GmbH","companyId":"immunovant-sciences-gmbh","modality":"Small molecule","firstApprovalDate":"","aiSummary":"IMVT-1402 is a neonatal Fc receptor (FcRn) antagonist that reduces circulating immunoglobulin levels by blocking FcRn-mediated recycling of IgG antibodies. Used for Generalized myasthenia gravis (gMG), Thyroid eye disease (TED).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}