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 12h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ILLUCCIX is a radiopharmaceutical kit for preparing Gallium Ga 68 gozetotide, a positron-emitting imaging agent that binds to PSMA-expressing prostate cancer cells. The product enables PET imaging of PSMA-positive tumors, particularly in men with prostate cancer. Gallium 68 is a β+ emitting radionuclide that localizes to malignant prostate tissue, allowing clinicians to detect metastatic disease and guide treatment decisions.
Peak8.7 years to LOE
Product is at peak commercial stage approximately 3 years post-approval, indicating stable market position and mature team structure with focus on optimization rather than rapid growth.
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.