Gallium Ga 68 Gozetotide · Gallium Ga-68 Psma-11, Illuccix

What is Gallium Ga 68 Gozetotide?

Gallium Ga 68 gozetotide is a radioconjugate composed of a PSMA-targeting ligand conjugated to gallium Ga 68, a β+ emitting radionuclide. It binds to prostate-specific membrane antigen (PSMA) expressed on prostate cancer cells, enabling positron emission tomography imaging.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as

Gallium Ga-68 Psma-11, Illuccix, Ga-68, 68Ga-PSMA-11, 68-Ga PSMA11, Drug: 68-Ga PSMA11, illuccix 68Ga-PSMA-11 Total Body PET-CT

Drug type

Radiopharmaceutical

Targets

prostate-specific membrane antigen (FOLH1)

Mechanism

Acts on prostate-specific membrane antigen (FOLH1)

Therapy area

Oncology

Developer

Univ Ca Los Angeles

In trials of

TLX

FDA status

Approved as Gallium Ga-68 Psma-11, Illuccix (December 1, 2020), NDA212642 · FDA label

UNII

ZJ0EKR6M10

✅ FDA-approved uses

• PET of PSMA-positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy (Illuccix)
• PET of PSMA-positive lesions in men with prostate cancer with suspected recurrence based on elevated serum PSA level (Illuccix)
• Selection of patients indicated for PSMA-directed therapy (Illuccix)
• PET of PSMA-positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy (Gallium Ga-68 Psma-11)
• PET of PSMA-positive lesions in men with prostate cancer with suspected recurrence based on elevated serum PSA level (Gallium Ga-68 Psma-11)

From the indications section of the FDA label (version of Jun 15, 2026). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Adaptive RadiotherapyCarcinoma of the ProstateCastration Sensitive Prostate CancerDiagnostic ImagingElevated PSAMetastatic Prostate CancerPCAPositron Emission TomographyProstate BiopsyProstate CancerProstatic NeoplasmPSMA PETMetastatic Castration-resistant Prostate CancerProstate Adenocarcinoma

Other drugs acting on FOLH1

Sources

• FDA label (DailyMed)
• FDA label Illuccix (2026-06-15), indications
• FDA label Gallium Ga-68 Psma-11 (2025-11-14), indications
• NCI Thesaurus
• ClinicalTrials.gov NCT04402151
• ClinicalTrials.gov NCT05558956
• ClinicalTrials.gov NCT05744115
• ClinicalTrials.gov NCT06044857

Updated Oct 3, 2026.