{"entity":{"id":"ga68-psma-11","kind":"drug","name":"Gallium-68 gozetotide (PSMA-11)","aka":[],"tldr":"Gallium-68 PSMA-11 was the first PSMA PET tracer approved in the US (2020), and is made on site from a generator or cyclotron.","summary":"Gallium-68 gozetotide (PSMA-11) is a 68Ga-labelled urea-based ligand that binds prostate-specific membrane antigen, lighting up prostate cancer on PET wherever it has spread. It is made on site from a germanium-68 generator or cyclotron and used for initial staging of higher-risk disease, for biochemical recurrence, and to confirm PSMA expression before 177Lu-PSMA-617 therapy. The UCLA/UCSF academic NDA (2020) established PSMA PET in the US, followed by Telix's Illuccix kit (2021) and Gozellix (2025, longer shelf-life) and Novartis' Locametz (2022, companion for Pluvicto). It competes with 18F agents (Pylarify, Posluma) that offer central distribution and a longer half-life. Whether findings on PSMA PET should change treatment in the absence of outcome trials remains debated. In plain terms, it was the first PSMA PET tracer approved in the US.","status":"approved","asOf":"2026-09-27","links":[{"label":"Drugs@FDA: ANDA 216410, gallium Ga 68 gozetotide (RadioMedix)","url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216410"},{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Gallium-68%20gozetotide"}],"tags":[],"related":["f-18","ga-68","ge-68","lu-177"],"indications":["prostate"],"sections":[],"technologies":["psma-pet"],"targets":["psma"],"drugs":[],"companies":["telix","novartis","radiomedix"],"institutions":["ucla-jonsson","ucsf"],"pathways":[],"terms":[],"trials":["nct07052214"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Illuccix / Gozellix / Locametz","modality":"PET imaging agent","mechanism":"68Ga-labelled urea-based PSMA ligand.","approvals":[{"region":"US","year":2020,"indication":"PSMA PET (UCLA/UCSF NDA); kits 2021-2022"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[{"date":"2026-06-08","type":"approval","region":"US","note":"Gallium Ga 68 gozetotide from RadioMedix approved under an abbreviated new drug application, ANDA 216410 (original approval)","source":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216410"}]},"route":"/drugs/ga68-psma-11/","neighbours":{"isotope":[{"id":"f-18","kind":"isotope","name":"Fluorine-18","route":"/isotopes/f-18/"},{"id":"ga-68","kind":"isotope","name":"Gallium-68","route":"/isotopes/ga-68/"},{"id":"ge-68","kind":"isotope","name":"Germanium-68","route":"/isotopes/ge-68/"},{"id":"lu-177","kind":"isotope","name":"Lutetium-177","route":"/isotopes/lu-177/"}],"indication":[{"id":"prostate","kind":"indication","name":"Prostate cancer","route":"/indications/prostate/"}],"technology":[{"id":"psma-pet","kind":"technology","name":"PSMA PET","route":"/technologies/psma-pet/"}],"target":[{"id":"psma","kind":"target","name":"PSMA","route":"/targets/psma/"}],"company":[{"id":"novartis","kind":"company","name":"Novartis","route":"/companies/novartis/"},{"id":"radiomedix","kind":"company","name":"RadioMedix","route":"/companies/radiomedix/"},{"id":"telix","kind":"company","name":"Telix Pharmaceuticals","route":"/companies/telix/"}],"institution":[{"id":"ucla-jonsson","kind":"institution","name":"UCLA Jonsson Comprehensive Cancer Center","route":"/institutions/ucla-jonsson/"},{"id":"ucsf","kind":"institution","name":"UCSF Helen Diller Family Comprehensive Cancer Center","route":"/institutions/ucsf/"}],"trial":[{"id":"nct07052214","kind":"trial","name":"PSMA PET Combined With MRI for the Detection of PCa","route":"/trials/nct07052214/"}],"drug":[{"id":"illuccix","kind":"drug","name":"Illuccix (kit for Ga-68 gozetotide)","route":"/drugs/illuccix/"},{"id":"locametz","kind":"drug","name":"Locametz (kit for Ga-68 gozetotide)","route":"/drugs/locametz/"}],"bottleneck":[{"id":"b-site-readiness-referral","kind":"bottleneck","name":"Site readiness and referral pathway delays","route":"/bottlenecks/b-site-readiness-referral/"}],"section":[{"id":"f-molecular-imaging","kind":"section","name":"Molecular imaging","route":"/fronts/f-molecular-imaging/"}],"paper":[{"id":"paper-jadvar-snmmi-psma-auc-jnm-2022","kind":"paper","name":"Appropriate use criteria for prostate-specific membrane antigen (PSMA) PET imaging","route":"/key-papers/paper-jadvar-snmmi-psma-auc-jnm-2022/"}],"person":[{"id":"andrei-iagaru","kind":"person","name":"Andrei Iagaru","route":"/people/andrei-iagaru/"},{"id":"matthias-eiber","kind":"person","name":"Matthias Eiber","route":"/people/matthias-eiber/"},{"id":"stefano-fanti","kind":"person","name":"Stefano Fanti","route":"/people/stefano-fanti/"}],"roadmap":[{"id":"psma-theranostics-roadmap","kind":"roadmap","name":"PSMA theranostics roadmap: antigen discovery → PSMA PET → 177Lu-PSMA-617 → earlier lines and alpha","route":"/roadmaps/psma-theranostics-roadmap/"}],"term":[{"id":"psma-rads","kind":"term","name":"PSMA-RADS (PSMA reporting and data system)","route":"/terms/psma-rads/"},{"id":"theranostic-pair-term","kind":"term","name":"Theranostic pair","route":"/terms/theranostic-pair-term/"}]}}