{"id":"177lu-tlx591","safety":{"commonSideEffects":[{"rate":null,"effect":"Hematologic toxicity (anemia, thrombocytopenia, leukopenia)"},{"rate":null,"effect":"Xerostomia (dry mouth)"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Renal toxicity"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"TLX591 is a PSMA-targeting radiopharmaceutical that binds to PSMA-expressing cells and delivers localized radiation via lutetium-177 decay. This theranostic approach allows selective irradiation of PSMA-positive tumors while minimizing exposure to healthy tissue. The compound is designed for treatment of metastatic castration-resistant prostate cancer (mCRPC).","oneSentence":"177Lu-TLX591 is a lutetium-177 labeled radioligand that targets prostate-specific membrane antigen (PSMA) on prostate cancer cells to deliver targeted radiotherapy.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:56:23.126Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Metastatic castration-resistant prostate cancer (mCRPC) with PSMA expression"}]},"trialDetails":[{"nctId":"NCT04876651","phase":"PHASE3","title":"The Present Study Aims to Compare Patients Who Receive the Investigational Product (177Lu-DOTA-rosopatamab) Plus Standard of Care, in Comparison to Standard of Care Only","status":"TERMINATED","sponsor":"Telix Pharmaceuticals (Innovations) Pty Ltd","startDate":"2023-08-29","conditions":"Metastatic Prostate Cancer","enrollment":16},{"nctId":"NCT06520345","phase":"PHASE3","title":"The Study of 177Lu-TLX591 Plus SOC Versus SOC Alone in Patients With mCRPC (ProstACT Global)","status":"RECRUITING","sponsor":"Telix Pharmaceuticals (Innovations) Pty Limited","startDate":"2024-07-26","conditions":"Metastatic Castration-resistant Prostate Cancer","enrollment":430},{"nctId":"NCT05146973","phase":"PHASE2","title":"External Beam Therapy With Theranostic Radioligand Therapy for Oligometastatic Prostate Cancer (ProstACT TARGET)","status":"COMPLETED","sponsor":"Telix Pharmaceuticals (Innovations) Pty Limited","startDate":"2022-08-30","conditions":"Prostate Cancer","enrollment":5},{"nctId":"NCT04786847","phase":"PHASE1","title":"177Lu-DOTA-TLX591 Safety, Biodistribution and Dosimetry Study","status":"COMPLETED","sponsor":"Telix Pharmaceuticals (Innovations) Pty Limited","startDate":"2022-01-30","conditions":"Metastatic Prostate Cancer","enrollment":30}],"_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":["Lutetium (177Lu) rosopatamab tetraxetan"],"phase":"phase_3","status":"active","brandName":"177Lu-TLX591","genericName":"177Lu-TLX591","companyName":"Telix Pharmaceuticals (Innovations) Pty Limited","companyId":"telix-pharmaceuticals-innovations-pty-limited","modality":"Small molecule","firstApprovalDate":"","aiSummary":"177Lu-TLX591 is a lutetium-177 labeled radioligand that targets prostate-specific membrane antigen (PSMA) on prostate cancer cells to deliver targeted radiotherapy. Used for Metastatic castration-resistant prostate cancer (mCRPC) with PSMA expression.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}