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drugsProductApproved2020🇪🇺🇬🇧🇦🇺

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.

UCLA/UCSF academic NDA (2020) established PSMA PET; Telix's Illuccix (kit, 2021) and Gozellix (2025, longer shelf-life), Novartis' Locametz (2022, companion for Pluvicto). Competes with 18F agents (Pylarify, Posluma) that offer central distribution.

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PSMA-11 (Ga-68 chelated in the product) · 2D coordinates (no PubChem conformer)
PubChem
Modality
PET imaging agent
Mechanism
68Ga-labelled urea-based PSMA ligand.
Brand / code
Illuccix / Gozellix / Locametz
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.

Not appraisedSearch NICE
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.

Regulatory

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Approvals

RegionYearIndication
US2020PSMA PET (UCLA/UCSF NDA); kits 2021-2022

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
19 studies6 recruiting15 Phase 24 Phase 3
Search “Gallium-68 gozetotide” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Gallium-68 gozetotide (PSMA-11)
intervention: Gallium-68 gozetotide
Open on ClinicalTrials.gov →

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Latest papers

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Literature trend178 papers in the last 12 months+7% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

Query 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 (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.

Connected

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