{"id":"ga-68-psma","safety":{"commonSideEffects":[{"rate":null,"effect":"Injection site reactions"},{"rate":null,"effect":"Radiation exposure (inherent to PET imaging)"}]},"_chembl":null,"_dailymed":{"setId":"b6253a7b-0f73-36be-e053-2a95a90a9015","title":"GALLIUM GA-68 PSMA-11 (GALLIUM GA-68 GOZETOTIDE) INJECTION, SOLUTION [UCSF RADIOPHARMACEUTICAL FACILITY]"},"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Gallium-68 is a positron-emitting radioisotope conjugated to a PSMA-targeting ligand that accumulates in PSMA-expressing prostate cancer cells. When injected intravenously, the radiotracer localizes to primary tumors and metastases, allowing PET imaging to detect and stage prostate cancer with high sensitivity and specificity. This enables clinicians to identify disease burden and guide treatment decisions.","oneSentence":"[Ga-68]PSMA is a positron emission tomography (PET) imaging agent that binds to prostate-specific membrane antigen (PSMA) on prostate cancer cells to enable visualization and localization of tumors.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T03:33:36.631Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"PET imaging of PSMA-positive lesions in men with prostate cancer"},{"name":"Detection and staging of metastatic prostate cancer"}]},"trialDetails":[],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[{"date":"20220616","type":"SUPPL","sponsor":"UNIV OF CA SAN FRAN","applicationNumber":"NDA212643"},{"date":"20201201","type":"ORIG","sponsor":"UNIV OF CA SAN FRAN","applicationNumber":"NDA212643"},{"date":"20211117","type":"SUPPL","sponsor":"UNIV OF CA SAN FRAN","applicationNumber":"NDA212643"},{"date":"20201201","type":"ORIG","sponsor":"UNIV CA LOS ANGELES","applicationNumber":"NDA212642"},{"date":"20220616","type":"SUPPL","sponsor":"UNIV CA LOS ANGELES","applicationNumber":"NDA212642"},{"date":"20211117","type":"SUPPL","sponsor":"UNIV CA LOS ANGELES","applicationNumber":"NDA212642"}],"publicationCount":118,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"[Ga-68]PSMA","genericName":"[Ga-68]PSMA","companyName":"Norbert Avril, M.D.","companyId":"norbert-avril-m-d","modality":"Small molecule","firstApprovalDate":"","aiSummary":"[Ga-68]PSMA is a positron emission tomography (PET) imaging agent that binds to prostate-specific membrane antigen (PSMA) on prostate cancer cells to enable visualization and localization of tumors. Used for PET imaging of PSMA-positive lesions in men with prostate cancer, Detection and staging of metastatic prostate cancer.","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"supplemented","approval_date":"2020-12-01T00:00:00.000Z","mah":"UNIV OF CA SAN FRAN","brand_name_local":null,"application_number":"NDA212643"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2020-12-01T00:00:00.000Z","mah":"UNIV CA LOS ANGELES","brand_name_local":null,"application_number":"NDA212642"}],"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":false,"score":3}}