{"id":"68ga-psma-0057","phase":"phase_1","safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[],"contraindications":[],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[]},"status":"active","trials":["NCT07310355"],"aliases":[],"patents":[],"pricing":[],"modality":"Small molecule","timeline":[],"aiSummary":"","brandName":"68Ga-PSMA-0057","companyId":"chengdu-starray-therapeutics-co-ltd","mechanism":{"target":"PSMA (Prostate-Specific Membrane Antigen)","novelty":"","modality":"Small molecule","drugClass":"","explanation":"68Ga-PSMA-0057 is a small molecule radioligand that selectively binds to PSMA, a transmembrane protein highly expressed on prostate cancer cells. Upon binding, the gallium-68 isotope emits positrons that are detected by PET scanners, allowing visualization and localization of PSMA-positive tumors.","oneSentence":"A gallium-68 labeled radiotracer that binds to PSMA-expressing cells, enabling PET/CT visualization of prostate cancer lesions.","technicalDetail":""},"commercial":null,"_claudeStub":{"ts":1779123356,"model":"claude-sonnet-4-5-20250929"},"companyName":"Chengdu StarRay Therapeutics Co., Ltd","competitors":[{"name":"68Ga-PSMA-11","brand":null,"company":null,"rationale":"PSMA-targeted PET imaging agent for prostate cancer"},{"name":"piflufolastat F-18","brand":"Pylarify","company":"Lantheus","rationale":"FDA-approved PSMA PET imaging agent for prostate cancer"},{"name":"flotufolastat F-18","brand":"Posluma","company":"Blue Earth Diagnostics","rationale":"FDA-approved PSMA PET tracer for prostate cancer imaging"}],"description":"68Ga-PSMA-0057 is a gallium-68 labeled radiotracer developed by Chengdu StarRay Therapeutics for molecular imaging. It targets prostate-specific membrane antigen (PSMA) and is being investigated as a diagnostic agent for prostate cancer detection and staging using PET/CT imaging.","genericName":"68Ga-PSMA-0057","indications":{"approved":[{"status":"investigational","condition":"Prostate cancer imaging","patientPopulation":"Adult males with suspected or confirmed prostate cancer"}],"offLabel":[],"pipeline":[]},"labelChanges":[],"trialDetails":[],"manufacturing":[],"administration":{"icon":"","route":"","frequency":"","formulation":""},"formularyStatus":[],"apiManufacturers":[],"developmentCodes":[],"ownershipHistory":[],"biosimilarFilings":[],"firstApprovalDate":"","companionDiagnostics":[],"firstApprovalCountry":null,"rwe":[],"genericFilers":[],"relatedDrugs":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"partial","dataCompleteness":{"mechanism":true,"indications":true,"safety":false,"trials":false,"score":2}}