{"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":"2026-09-06","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Gallium-68%20gozetotide"}],"tags":[],"related":[],"cancers":["prostate"],"sections":[],"technologies":["psma-pet"],"targets":["psma"],"drugs":[],"companies":["telix","novartis"],"institutions":["ucla-jonsson","ucsf"],"pathways":[],"terms":[],"trials":["psma-prerp","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":[]},"route":"/drugs/ga68-psma-11/","neighbours":{"cancer":[{"id":"prostate","kind":"cancer","name":"Prostate cancer","route":"/cancers/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":"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/"},{"id":"psma-prerp","kind":"trial","name":"PSMA-PreRP","route":"/trials/psma-prerp/"}],"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/"}],"biomarker":[{"id":"psma-pet-expression","kind":"biomarker","name":"PSMA expression by PET (PSMA-positive)","route":"/biomarkers/psma-pet-expression/"}],"paper":[{"id":"paper-psma-prerp-hope-jama-oncol-2021","kind":"paper","name":"Diagnostic accuracy of 68Ga-PSMA-11 PET for pelvic nodal metastasis detection prior to radical prostatectomy and pelvic lymph node dissection: a multicenter prospective phase 3 imaging trial","route":"/key-papers/paper-psma-prerp-hope-jama-oncol-2021/"}]}}