Gallium-68 gozetotide (PSMA-11)
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.
Overview
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.
Ball-and-stick model from PubChem 2D record (no 3D conformer available). PubChem record
PubChem holds the unlabelled ligand, so the radionuclide itself is not in this drawing.
68Ga-labelled urea-based PSMA ligand. Connects to PSMA.
1.Gallium-68 gozetotide (PSMA-11) slips into a pocket on PSMA.
- PSMA PET (Ga-68 PSMA-11, F-18 piflufolastat, F-18 flotufolastat) · At least one PSMA-positive lesion and no dominant PSMA-negative lesion (VISION criteria) for lutetium-177 PSMA-617
- Medicare
- Part B (clinician-administered)
Diagnostic radiopharmaceutical billed with the PET/CT scan under Part B. Since 2025, Medicare's hospital outpatient system pays separately for diagnostic radiopharmaceuticals whose per-day cost exceeds a threshold, which covers PSMA agents. Medicare Administrative Contractors decide PET coverage for prostate cancer; all now cover PSMA PET for initial staging of unfavourable risk disease and biochemical recurrence.
- Commercial insurance
- covered with prior authorisation
PSMA PET is covered by most commercial plans for staging and recurrence with prior authorisation for the imaging procedure; radiology benefit managers apply appropriateness criteria.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B) · Medicare.gov: Diagnostic non-laboratory tests (imaging). Not medical or financial advice; verify with your plan.
- Appraised for
- PSMA PET-CT for prostate cancer staging and recurrence
- Notes
- Radiopharmaceuticals are not appraised as TAs. PSMA PET-CT is commissioned by NHS England (clinical commissioning policy) for biochemical recurrence and high-risk staging, and is required to select patients for Pluvicto. Locametz and Illuccix are MHRA-licensed kits.
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE search: gallium-68 PSMA-11 PET. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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- 8 Jun 2026ApprovalUS
Gallium Ga 68 gozetotide from RadioMedix approved under an abbreviated new drug application, ANDA 216410 (original approval) source
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2020 | PSMA PET (UCLA/UCSF NDA); kits 2021-2022 |
Trials
topTrials recruiting now
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Landmark trials
Latest papers
topQuery for this drug: (TITLE:"Gallium-68 gozetotide" OR ABSTRACT:"Gallium-68 gozetotide" OR TITLE:"PSMA-11" OR ABSTRACT:"PSMA-11" OR TITLE:"Illuccix" OR ABSTRACT:"Illuccix" OR TITLE:"Gozellix" OR ABSTRACT:"Gozellix" OR TITLE:"Locametz" OR ABSTRACT:"Locametz") AND (radiopharmaceutical OR radioligand OR radionuclide OR theranostic OR "nuclear medicine" OR "molecular imaging" OR radiotracer OR scintigraphy OR cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Gallium-68 gozetotide (PSMA-11), not a curated reading list.
Similar pages
not linked directly; found by shared links- PersonJeremie Calais
Shares UCLA Jonsson Comprehensive Cancer Center, Appropriate use criteria for prostate-specific membrane antigen (PSMA) PET imaging, PSMA, PSMA PET.
- AgentPiflufolastat F-18 / Pylarify TruVu
Shares PSMA-RADS (PSMA reporting and data system), Appropriate use criteria for prostate-specific membrane antigen (PSMA) PET imaging, Illuccix (kit for Ga-68 gozetotide), PSMA theranostics roadmap: antigen discovery → PSMA PET → 177Lu-PSMA-617 → earlier lines and alpha.
- PersonThomas A. Hope
Shares UCSF Helen Diller Family Comprehensive Cancer Center, PSMA theranostics roadmap: antigen discovery → PSMA PET → 177Lu-PSMA-617 → earlier lines and alpha, PSMA, PSMA PET.
- PairingPSMA PET → PSMA radioligand therapy
Shares Appropriate use criteria for prostate-specific membrane antigen (PSMA) PET imaging, Theranostic pair, PSMA, PSMA PET.
- PersonJohannes Czernin
Shares UCLA Jonsson Comprehensive Cancer Center, PSMA, PSMA PET, Gallium-68.
- PersonRahul Aggarwal
Shares UCSF Helen Diller Family Comprehensive Cancer Center, PSMA, PSMA PET, Prostate cancer.
- BottleneckReimbursement and coding for radiopharmaceuticals
Shares Illuccix (kit for Ga-68 gozetotide), Locametz (kit for Ga-68 gozetotide), Site readiness and referral pathway delays, Telix Pharmaceuticals.
- PersonPeter Bartenstein
Shares PSMA, PSMA PET, Fluorine-18, Gallium-68.