{"id":"piflufolastat-18f","safety":{"commonSideEffects":[{"rate":null,"effect":"Radiation exposure (inherent to PET imaging)"},{"rate":null,"effect":"Injection site reactions"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Piflufolastat is a PSMA-targeting PET imaging agent that localizes to cells expressing prostate-specific membrane antigen, a transmembrane protein highly expressed in prostate cancer and certain other malignancies. The fluorine-18 radiolabel enables detection via PET imaging, allowing visualization and localization of PSMA-positive lesions for diagnostic and staging purposes. This facilitates improved detection of metastatic disease and guides treatment planning in oncology.","oneSentence":"Piflufolastat (18F) is a fluorine-18 labeled small molecule that binds to prostate-specific membrane antigen (PSMA) for positron emission tomography (PET) imaging of PSMA-expressing tumors.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:00:20.800Z","_scrapedBy":"cloudflare-swarm","_wikipedia":{"url":"https://en.wikipedia.org/wiki/Piflufolastat_(18F)","title":"Piflufolastat (18F)","extract":"Piflufolastat (18F), sold under the brand name Pylarify among others, is a radioactive diagnostic agent used for positron emission tomography (PET) imaging. It is given by intravenous injection."},"indications":{"approved":[{"name":"PET imaging of PSMA-positive lesions in men with prostate cancer"},{"name":"Detection and localization of metastatic prostate cancer"}]},"trialDetails":[{"nctId":"NCT05939414","phase":"PHASE3","title":"An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC.","status":"RECRUITING","sponsor":"Novartis Pharmaceuticals","startDate":"2024-03-12","conditions":"Oligometastatic Prostate Cancer (OMPC)","enrollment":450},{"nctId":"NCT06099093","phase":"PHASE4","title":"Pilot of 18F-DCFPyL-PSMA PET in mCRPC Patients Receiving 117Lu-Vipivotide Tetraxetan","status":"RECRUITING","sponsor":"Brigham and Women's Hospital","startDate":"2024-04-01","conditions":"Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, Metastatic Castration-resistant Prostate Carcinoma","enrollment":30},{"nctId":"NCT06881823","phase":"PHASE1, PHASE2","title":"Study to Assess [177Lu]Lu-PSMA-R2 (AAA602) and [225Ac]Ac-PSMA-R2 (AAA802) in Participants With PSMA-positive HRLPC","status":"WITHDRAWN","sponsor":"Novartis Pharmaceuticals","startDate":"2026-06-29","conditions":"Prostate Cancer","enrollment":""},{"nctId":"NCT05470699","phase":"NA","title":"RefleXion PET/CT Imaging Performance in Patients With Prostate Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"City of Hope Medical Center","startDate":"2022-08-29","conditions":"Prostate Carcinoma","enrollment":34},{"nctId":"NCT07084909","phase":"PHASE2, PHASE3","title":"Piflufolastat F 18 PET/CT in Patients With Suspected, or at High Risk for Metastatic ccRCC","status":"WITHDRAWN","sponsor":"Lantheus Medical Imaging","startDate":"2025-11","conditions":"Clear Cell Renal Cell Carcinoma","enrollment":""},{"nctId":"NCT05919329","phase":"PHASE4","title":"Evaluation of the Change in PSMA Expression in Prostate Cancer in Response to Hormonal Therapy","status":"RECRUITING","sponsor":"OHSU Knight Cancer Institute","startDate":"2024-06-25","conditions":"Castration Resistant Prostate Cancer, Castration Sensitive Prostate Cancer, Prostate Adenocarcinoma","enrollment":80},{"nctId":"NCT06499870","phase":"PHASE2","title":"Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial","status":"RECRUITING","sponsor":"Northwestern University","startDate":"2024-09-06","conditions":"Prostate Adenocarcinoma","enrollment":50},{"nctId":"NCT06604442","phase":"PHASE4","title":"Intrapatient Comparison of Urinary Radioactivity Following Piflufolastat (18F) and Flotufolastat (18F) PET in Men With Low PSA Biochemical Recurrence of Prostate Cancer Following Radical Prostatectomy","status":"COMPLETED","sponsor":"Blue Earth Diagnostics","startDate":"2024-12-04","conditions":"Prostate Cancer","enrollment":55},{"nctId":"NCT06074510","phase":"PHASE4","title":"PYLARIFY® PET/CT or PET/MRI in Men With Favorable Intermediate Risk (FIR) Prostate Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Lantheus Medical Imaging","startDate":"2024-02-08","conditions":"Prostate Cancer","enrollment":274},{"nctId":"NCT05009979","phase":"PHASE2","title":"18F-DCFPyL PET/CT in Hepatocellular Carcinoma","status":"TERMINATED","sponsor":"National Cancer Institute (NCI)","startDate":"2023-01-18","conditions":"Hepatocellular Carcinoma","enrollment":8},{"nctId":"NCT05568537","phase":"PHASE4","title":"Prostate MRI and Pylarify PSMA PET/CT","status":"WITHDRAWN","sponsor":"Corewell Health East","startDate":"2024-10","conditions":"Prostate Cancer","enrollment":""}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":15,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Pylarify","Pylclari"],"phase":"marketed","status":"active","brandName":"piflufolastat (18F)","genericName":"piflufolastat (18F)","companyName":"Blue Earth Diagnostics","companyId":"blue-earth-diagnostics","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Piflufolastat (18F) is a fluorine-18 labeled small molecule that binds to prostate-specific membrane antigen (PSMA) for positron emission tomography (PET) imaging of PSMA-expressing tumors. Used for PET imaging of PSMA-positive lesions in men with prostate cancer, Detection and localization of metastatic prostate cancer.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}