Gozellix FDA Approval History
Last updated by Judith Stewart, BPharm on April 13, 2025.
FDA Approved: Yes (First approved March 20, 2025)
Brand name: Gozellix
Generic name: gallium Ga 68 gozetotide
Dosage form: Injection Kit
Company: Telix Pharmaceuticals Limited
Treatment for: Positron Emission Tomography Imaging
Gozellix (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.
- Gozellix 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. - Gozellix provides a longer shelf life of up to six hours and an extended distribution radius compared to existing gallium-based imaging products.
- Gozellix is administered by intravenous bolus injection. Appropriate safety measures should be taken when preparing, handling, and administering Gozellix to minimize radiation exposure.
- Warnings and precautions associated with Gozellix include a risk for misinterpretation (clinical correlation is recommended), radiation risks, and hypersensitivity reactions to sulfites.
- Common adverse reactions include nausea, diarrhea, and dizziness.
Development timeline for Gozellix
| Date | Article |
|---|---|
| Mar 21, 2025 | Approval FDA Approves Gozellix (kit for the preparation of gallium Ga 68 gozetotide injection) for Prostate Cancer Imaging |
| Jul 23, 2024 | FDA Accepts Telix NDA for New Prostate Cancer Imaging Agent |
Further information
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