{"id":"asp0113","safety":{"commonSideEffects":[{"rate":null,"effect":"Injection site reactions"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Headache"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"ASP0113 is a dendritic cell-targeted vaccine encoding CMV antigens (IE-1 and pp65) designed to enhance CMV-specific T-cell immunity. It works by activating dendritic cells to present CMV antigens, thereby boosting cellular immune responses against CMV-infected cells. This approach aims to prevent CMV reactivation and disease in immunocompromised patients, particularly those undergoing hematopoietic stem cell or solid organ transplantation.","oneSentence":"ASP0113 is a therapeutic vaccine that stimulates the immune system to recognize and eliminate cells infected with cytomegalovirus (CMV).","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:02:41.202Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of cytomegalovirus (CMV) reactivation in CMV-seropositive recipients of hematopoietic stem cell transplantation"},{"name":"Prevention of CMV reactivation in solid organ transplant recipients"}]},"trialDetails":[{"nctId":"NCT01974206","phase":"PHASE2","title":"A Study to Evaluate the Efficacy and Safety of a Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seronegative Kidney Transplant Recipients Receiving an Organ From a CMV-Seropositive Donor","status":"COMPLETED","sponsor":"Astellas Pharma Global Development, Inc.","startDate":"2013-11-20","conditions":"Kidney Transplantation Cytomegalovirus (CMV) Negative Recipients","enrollment":150},{"nctId":"NCT01877655","phase":"PHASE3","title":"A Study to Evaluate a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT)","status":"COMPLETED","sponsor":"Astellas Pharma Global Development, Inc.","startDate":"2013-09-11","conditions":"Cytomegalovirus (CMV)-Positive Recipients, Allogeneic, Hematopoietic Cell Transplant (HCT)","enrollment":514},{"nctId":"NCT02103426","phase":"PHASE1","title":"An Evaluation of a Cytomegalovirus (CMV) Vaccine (ASP0113) in CMV-Seropositive and CMV-Seronegative Healthy Subjects and CMV-Seronegative Dialysis Patients","status":"COMPLETED","sponsor":"Astellas Pharma Global Development, Inc.","startDate":"2013-12-30","conditions":"Dialysis, Healthy Subjects, Cytomegalovirus Infection","enrollment":48},{"nctId":"NCT01903928","phase":"PHASE2","title":"A Study to Evaluate Safety and Tolerability of a Therapeutic Vaccine, ASP0113, in Subjects Undergoing Allogeneic Hematopoietic Cell Transplant","status":"COMPLETED","sponsor":"Astellas Pharma Inc","startDate":"2013-06-20","conditions":"Allogeneic Hematopoietic Cell Transplant","enrollment":9}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":5,"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":"ASP0113","genericName":"ASP0113","companyName":"Astellas Pharma Global Development, Inc.","companyId":"astellas-pharma-global-development-inc","modality":"Biologic","firstApprovalDate":"","aiSummary":"ASP0113 is a therapeutic vaccine that stimulates the immune system to recognize and eliminate cells infected with cytomegalovirus (CMV). Used for Prevention of cytomegalovirus (CMV) reactivation in CMV-seropositive recipients of hematopoietic stem cell transplantation, Prevention of CMV reactivation in solid organ transplant recipients.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":4,"withResults":2},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}