{"id":"gallium-68ga-gozetotide","rwe":[],"tags":[{"label":"Peptide","category":"modality"},{"label":"Glutamate carboxypeptidase 2","category":"target"},{"label":"FOLH1","category":"gene"},{"label":"KLK3","category":"gene"},{"label":"V09IX14","category":"atc"},{"label":"Intravenous","category":"route"},{"label":"Injection","category":"form"},{"label":"Active","category":"status"},{"label":"Positron emission tomography","category":"indication"},{"label":"Univ Ca Los Angeles","category":"company"},{"label":"Approved 2020s","category":"decade"}],"phase":"discontinued","safety":{"commonSideEffects":[{"effect":"Fatigue","drugRate":"1.2%","severity":"mild"},{"effect":"Nausea","drugRate":"0.8%","severity":"mild"},{"effect":"Diarrhea","drugRate":"0.5%","severity":"mild"},{"effect":"Constipation","drugRate":"0.5%","severity":"mild"},{"effect":"Vomiting","drugRate":"0.5%","severity":"mild"},{"effect":"Dry mouth","drugRate":"reported","severity":"unknown"},{"effect":"Injection site reactions","drugRate":"reported","severity":"unknown"},{"effect":"Injection site hematoma","drugRate":"reported","severity":"unknown"},{"effect":"Injection site warmth","drugRate":"reported","severity":"unknown"},{"effect":"Chills","drugRate":"reported","severity":"unknown"}],"specialPopulations":{"Lactation":"LOCAMETZ is not indicated for use in females. There are no data on the presence of gallium Ga 68 gozetotide in human milk, the effect on the breastfed infant, or the effect on milk production.","Pregnancy":"LOCAMETZ is not indicated for use in females. There are no available data with gallium Ga 68 gozetotide use in pregnant women to evaluate for drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. All radiopharmaceuticals, including LOCAMETZ have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of radiation dose. Animal reproduction studies have not been conducted with gallium Ga 68 gozetotide.","Geriatric use":"The efficacy of LOCAMETZ in geriatric patients with prostate cancer is based on data from three prospective studies [see Clinical Studies (14)].Of the total number of subjects in the PSMA-PreRP and PSMA-BCR studies, 691 of 960 (72%) patients were 65 years of age and older while 195 (20%) were 75 years of age and older.Of the total number of subjects in the VISION study, 752 of 1003 (75%) patients were 65 years of age and older while 284 (28%) were 75 years of age and older.The efficacy and safety profiles of gallium Ga 68 gozetotide appeared similar in younger adult and geriatric patients.","Paediatric use":"The safety and effectiveness of gallium Ga 68 gozetotide in pediatric patients have not been established."}},"trials":[],"aliases":["Locametz","Illuccix"],"company":"Univ Ca Los Angeles","patents":[{"source":"FDA Orange Book via DrugCentral","expires":"2028-08-15","territory":"US","patentNumber":"11369590"}],"pricing":[],"allNames":"locametz","offLabel":[],"synonyms":["gallium Ga68 PSMA-11","Ga68 PSMA-11","gallium (68Ga) gozetotide","gozetotide","locametz"],"timeline":[{"date":"2020-12-01","type":"positive","source":"DrugCentral","milestone":"FDA approval (Univ Ca Los Angeles)"},{"date":"2022-12-09","type":"positive","source":"DrugCentral","milestone":"EMA approval (Novartis Europharm Limited)"}],"aiSummary":"Locametz (Gallium (68Ga) gozetotide) is a positron emission tomography (PET) imaging agent developed by the University of California, Los Angeles (UCLA). It targets glutamate carboxypeptidase 2 (GCPII), a protein overexpressed in certain types of cancer. Locametz was approved by the FDA in 2020 for use in PET imaging. The commercial status of Locametz is patented, and it is not yet available as a generic product. As a PET imaging agent, Locametz is used to help diagnose and monitor cancer.","approvals":[{"date":"2020-12-01","orphan":false,"company":"UNIV CA LOS ANGELES","regulator":"FDA"},{"date":"2022-12-09","orphan":false,"company":"NOVARTIS EUROPHARM LIMITED","regulator":"EMA"}],"brandName":"Locametz","ecosystem":[{"indication":"Positron emission tomography","otherDrugs":[{"name":"AMMONIA N-13","slug":"ammonia-n-13","company":"Feinstein"},{"name":"Florbetapir F-18","slug":"florbetapir-f-18","company":"Avid Radiopharms Inc"},{"name":"Flutemetamol (18F)","slug":"flutemetamol-(18f)","company":"Ge Healthcare"},{"name":"Gallium Ga 68 dotatate","slug":"gallium-ga-68-dotatate","company":"Advanced Accelerator Applications Usa Inc"}],"globalPrevalence":null}],"mechanism":{"target":"Glutamate carboxypeptidase 2","novelty":"Follow-on","targets":[{"gene":"FOLH1","source":"DrugCentral","target":"Glutamate carboxypeptidase 2","protein":"Glutamate carboxypeptidase 2"},{"gene":"KLK3","source":"DrugCentral","target":"Prostate-specific antigen","protein":"Prostate-specific antigen"}],"modality":"Peptide","explanation":"Gallium Ga 68 gozetotide binds to PSMA. It binds to cells that express PSMA, including malignant prostate cancer cells, which usually overexpress PSMA. Gallium-68 is + emitting radionuclide that allows PET.","oneSentence":"Locametz works by binding to glutamate carboxypeptidase 2, a protein overexpressed in certain types of cancer, allowing for visualization of cancer cells through PET imaging.","technicalDetail":"Locametz is a small molecule radiopharmaceutical that selectively binds to glutamate carboxypeptidase 2 (GCPII) through a high-affinity interaction, allowing for specific targeting and visualization of GCPII-expressing cancer cells via positron emission tomography (PET) imaging."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Gallium_(68Ga)_gozetotide","title":"Gallium (68Ga) gozetotide","extract":"Gallium (68Ga) gozetotide or Gallium (68Ga) PSMA-11, sold under the brand name Illuccix among others, is a radiopharmaceutical made of 68Ga conjugated to a inhibitor of the enzyme prostate-specific membrane antigen (PSMA) known as Glu-Urea-Lys(Ahx)-HBED-CC. It is used for imaging prostate cancer by positron emission tomography (PET). The PSMA inhibitor specifically directs the radiolabeled imaging agent towards the prostate cancerous lesions in men.","wiki_history":"==History==\nIn the early 2000s, researchers began exploring the use of PSMA as a target for imaging and therapy. The first PSMA-targeted radiotracer was developed using a different radioactive element, technetium-99m. This radiotracer, called 99mTc-MIP-1404, showed promise in preclinical studies but did not perform well in clinical trials.\n\nIn 2011, researchers started investigating the use of gallium-68, a different radioactive element, as a more suitable alternative for PSMA-targeted radiotracers. In 2013, the first Ga-PSMA radiotracer was developed by researchers at DKFZ in Germany, and it showed promising results in early clinical studies.\n\nSince then, Ga-PSMA has been extensively studied in clinical trials, and it has been found to be a highly effective imaging agent for detecting prostate cancer lesions. It is now widely used in clinical practice, particularly for patients with recurrent prostate cancer and those with high-risk disease.\n\nInitially gallium (<sup>68</sup>Ga) chloride solution injections used for radiolabelling, in 2019 European Pharmacopoeia mentions gallium (<sup>68</sup>Ga) DOTATOC injection for radiolabelling and PET imaging.\n\nGa 68 PSMA-11 was co-developed by researchers at University of California, Los Angeles and University of California, San Francisco, who conducted a phase III clinical trial. In December 2020, the drug was first approved by the US Food and Drug Administration (FDA) for PET imaging.","wiki_society_and_culture":"== Society and culture ==\n=== Legal status ===\nOn 13 October 2022, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Locametz, intended for the diagnosis of prostate cancer. Locametz was approved for medical use in the European Union in December 2022.\n\n=== Names ===\nGallium (<sup>68</sup>Ga) gozetotide is the international nonproprietary name (INN)."},"commercial":{"launchDate":"2020","_launchSource":"DrugCentral (FDA 2020-12-01, UNIV CA LOS ANGELES)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/5429","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=Gallium%20%2868Ga%29%20gozetotide","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Gallium (68Ga) gozetotide","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Gallium_(68Ga)_gozetotide","fields":["history","overview"],"source":"Wikipedia"}],"_emaChecked":true,"_enrichedAt":"2026-03-30T13:46:30.099162","biosimilars":[],"competitors":[{"drugName":"iobenguane (123I)","drugSlug":"iobenguane-(123i)","fdaApproval":"2008-09-19","relationship":"same-class"},{"drugName":"iobenguane (131I)","drugSlug":"iobenguane-(131i)","fdaApproval":"1994-03-25","relationship":"same-class"},{"drugName":"fludeoxyglucose (18F)","drugSlug":"fludeoxyglucose-(18f)","fdaApproval":"1994-08-19","relationship":"same-class"},{"drugName":"fluorodopa (18F)","drugSlug":"fluorodopa-(18f)","fdaApproval":"2019-10-10","relationship":"same-class"},{"drugName":"sodium fluoride F-18","drugSlug":"sodium-fluoride-f-18","fdaApproval":"1972-02-24","genericCount":23,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"gallium (68Ga) 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