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Illuccix FDA Approval History

FDA Approved: Yes (First approved December 17, 2021)
Brand name: Illuccix
Generic name: gallium Ga 68 gozetotide
Dosage form: Injection Kit
Company: Telix Pharmaceutical, Inc.
Treatment for: Positron Emission Tomography Imaging

Illuccix (gallium Ga 68 gozetotide) is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer.

Illuccix is indicated for PET of PSMA positive lesions in men with prostate cancer:

  • with suspected metastasis who are candidates for initial definitive therapy
  • with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level
  • for selection of patients with metastatic prostate cancer, for whom lutetium Lu 177 vipivotide tetraxetan PSMA-directed therapy is indicated.

Development timeline for Illuccix

Mar 16, 2023Approval FDA Approves Expanded Indication for Telix’s Illuccix to Include Patient Selection for PSMA-Directed Radioligand Therapy
Dec 20, 2021Approval FDA Approves Illuccix (gallium Ga 68 gozetotide) for Prostate Cancer Imaging
Sep 24, 2020Telix Pharmaceuticals Submits New Drug Application to US FDA for Prostate Cancer Imaging Product

Further information

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