{"id":"anti-human-thymocyte-immunoglobulin-equine","rwe":[],"tags":[],"phase":"preclinical","safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[],"contraindications":[],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[]},"status":"active","trials":["NCT04350606","NCT06039020"],"aliases":[],"patents":[],"pricing":[],"allNames":"anti-human thymocyte immunoglobulin, equine","offLabel":[],"timeline":[{"date":"2021","type":"neutral","milestone":"Phase 3 Initiated","description":"Phase 3 trial (A Study to Assess Efficacy and Safety of PF-06462700 in Japanese Participants With Aplastic Anemia) — Aplastic Anemia"}],"aiSummary":"Anti-human thymocyte immunoglobulin, equine is used to treat conditions such as Aplastic Anemia, de Novo Myelodysplastic Syndrome, Myelodysplastic Syndrome, Previously Treated Myelodysplastic Syndrome, and MDS. It is administered intravenously as part of a treatment regimen that may also include Cyclosporine.","brandName":"Anti-human thymocyte immunoglobulin, equine","companyId":"pfizer","ecosystem":[],"mechanism":{"target":"","novelty":"","modality":"","drugClass":"Usually, 40 mg of anti-human thymocyte immunoglobulin, equine per kilogram of body weight should be ","explanation":"Anti-human thymocyte immunoglobulin is made by injecting human thymus cells into horses, stimulating the horse's immune system to produce antibodies against human T cells. These antibodies are then extracted and purified from horse serum. When given to patients, these antibodies circulate through the bloodstream and bind to T lymphocytes—the primary immune cells responsible for rejecting transplanted organs and attacking bone marrow in aplastic anemia.\n\nOnce the antibodies attach to T cells, they mark them for destruction through multiple mechanisms. The body's own immune system recognizes these marked cells and eliminates them through several pathways, including complement activation (a system of proteins that destroy cells) and antibody-dependent cellular cytotoxicity (where other immune cells are recruited to kill the tagged T cells). This selective reduction in T cell numbers suppresses the overall immune response without completely shutting down immunity.\n\nBecause this is derived from horse serum rather than rabbit serum, it may have different properties regarding how long it lasts in the body and how likely it is to cause serum sickness or other reactions. The equine formulation has been used clinically for decades to help prevent organ rejection after transplantation and to treat severe aplastic anemia, where the immune system has attacked the bone marrow's ability to produce blood cells.","oneSentence":"Usually, 40 mg of anti-human thymocyte immunoglobulin, equine per kilogram of body weight should be ","technicalDetail":""},"commercial":null,"references":[],"biosimilars":[],"companyName":"Pfizer Inc.","competitors":[],"genericName":"anti-human-thymocyte-immunoglobulin-equine","indications":{"approved":[],"offLabel":[],"pipeline":[{"name":"Aplastic Anemia","phase":"preclinical","trialId":"","patients":null,"diseaseId":"obesity","trialName":"","primaryEndpoint":"","expectedCompletion":""}]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT04350606","phase":"Phase 3","title":"A Study to Assess Efficacy and Safety of PF-06462700 in Japanese Participants With Aplastic Anemia","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":3,"indication":"Aplastic Anemia","completionDate":"2021-01","primaryEndpoint":"The purpose of the study is to assess the efficacy and safety of PF-06462700 administered intravenously at 40 mg/kg/day for 4 days in Japanese participants with moderate and above aplastic anemia for "},{"nctId":"NCT06039020","phase":"N/A","title":"ATGAM General Investigation","status":"Active Not Recruiting","sponsor":"Pfizer","isPivotal":false,"enrollment":1,"indication":"Aplastic Anemia","completionDate":"2027-01","primaryEndpoint":"The objective of this study is to confirm the safety of ATGAM in patients with moderate to severe aplastic anemia under the actual use in Japan."}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"","route":"","frequency":"","formulation":""},"crossReferences":{"chemblId":"CHEMBL2108981"},"formularyStatus":[],"developmentCodes":[],"ownershipHistory":[],"therapeuticAreas":["Immunology"],"biosimilarFilings":[],"firstApprovalDate":"","companionDiagnostics":[],"firstApprovalCountry":null,"genericManufacturerList":[],"modality":"","enrichmentLevel":3,"visitCount":8,"trialStats":{"total":1,"withResults":0},"verificationStatus":"partial","dataCompleteness":{"mechanism":true,"indications":false,"safety":false,"trials":true,"score":2}}