NDAINTRAVENOUSPOWDER
Approved
Dec 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
2
Data completeness
5/8 — Partial
ILLUCCIX (kit for the preparation of gallium ga 68 gozetotide injection) by Telix Pharmaceuticals is 12. Approved for prostate cancer. First approved in 2021.
Drug data last refreshed 10h ago · AI intelligence enriched 4d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ILLUCCIX is a kit for preparing gallium Ga 68 gozetotide injection, a positron emission tomography (PET) radiopharmaceutical diagnostic agent. It binds to PSMA (prostate-specific membrane antigen) expressed on prostate cancer cells, enabling imaging of malignant lesions. The product combines a targeting peptide with the Ga 68 radionuclide, a β+ emitter that permits real-time PET visualization.
Peak8.8 years to LOE
Product is at peak commercial maturity with ~9 years of patent protection remaining; team size likely stable with focus on market penetration rather than growth scaling.
Mechanism of Action
12.1 Mechanism of Action Gallium Ga 68 gozetotide binds to PSMA. It binds to cells that express PSMA, including malignant prostate cancer cells, which usually overexpress PSMA. Gallium 68 (Ga 68) is a β+ emitting radionuclide that allows positron emission tomography. 12.2 Pharmacodynamics The…
Indications (1)
Clinical Trials (2)
Non-significant Risk (NSR) Study of [68Ga]-PSMA-11 (Illuccix) as a BgRT BioGuide on RefleXion X1
Started Dec 2024
25 enrolled
Prostate Cancer
Total Body PET-CT Imaging of Prostate Cancer Using Illuccix
Started Nov 2022
100 enrolled
Metastatic Castration-resistant Prostate Cancer
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.