# Gallium-68 gozetotide (PSMA-11)

Source: https://nuclide.cc/drugs/ga68-psma-11/  
Nuclide record `ga68-psma-11` (Agent). Data CC BY-NC 4.0, attribute "Data from Nuclide (nuclide.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Agent
- Status: approved
- Last checked: 2026-09-27
- Brand: Illuccix / Gozellix / Locametz
- Modality: PET imaging agent
- Mechanism: 68Ga-labelled urea-based PSMA ligand.
- Approvals: US 2020: PSMA PET (UCLA/UCSF NDA); kits 2021-2022

## Sources

- Drugs@FDA: ANDA 216410, gallium Ga 68 gozetotide (RadioMedix): https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216410
- FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Gallium-68%20gozetotide

## Connected records

- isotopes: [Fluorine-18](https://nuclide.cc/isotopes/f-18/), [Gallium-68](https://nuclide.cc/isotopes/ga-68/), [Germanium-68](https://nuclide.cc/isotopes/ge-68/), [Lutetium-177](https://nuclide.cc/isotopes/lu-177/)
- indications: [Prostate cancer](https://nuclide.cc/indications/prostate/)
- technologies: [PSMA PET](https://nuclide.cc/technologies/psma-pet/)
- targets: [PSMA](https://nuclide.cc/targets/psma/)
- companies: [Novartis](https://nuclide.cc/companies/novartis/), [RadioMedix](https://nuclide.cc/companies/radiomedix/), [Telix Pharmaceuticals](https://nuclide.cc/companies/telix/)
- institutions: [UCLA Jonsson Comprehensive Cancer Center](https://nuclide.cc/institutions/ucla-jonsson/), [UCSF Helen Diller Family Comprehensive Cancer Center](https://nuclide.cc/institutions/ucsf/)
- trials: [PSMA PET Combined With MRI for the Detection of PCa](https://nuclide.cc/trials/nct07052214/)
- drugs: [Illuccix (kit for Ga-68 gozetotide)](https://nuclide.cc/drugs/illuccix/), [Locametz (kit for Ga-68 gozetotide)](https://nuclide.cc/drugs/locametz/)
- bottlenecks: [Site readiness and referral pathway delays](https://nuclide.cc/bottlenecks/b-site-readiness-referral/)
- fronts: [Molecular imaging](https://nuclide.cc/fronts/f-molecular-imaging/)
- key papers: [Appropriate use criteria for prostate-specific membrane antigen (PSMA) PET imaging](https://nuclide.cc/key-papers/paper-jadvar-snmmi-psma-auc-jnm-2022/)
- people: [Andrei Iagaru](https://nuclide.cc/people/andrei-iagaru/), [Matthias Eiber](https://nuclide.cc/people/matthias-eiber/), [Stefano Fanti](https://nuclide.cc/people/stefano-fanti/)
- roadmaps: [PSMA theranostics roadmap: antigen discovery → PSMA PET → 177Lu-PSMA-617 → earlier lines and alpha](https://nuclide.cc/roadmaps/psma-theranostics-roadmap/)
- terms: [PSMA-RADS (PSMA reporting and data system)](https://nuclide.cc/terms/psma-rads/), [Theranostic pair](https://nuclide.cc/terms/theranostic-pair-term/)

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