Prescription medicine
Gozetotide Brand names: Gozellix, Locametz
Gozetotide (Gozellix) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the gozetotide FDA label on DailyMed (effective April 11, 2025, Telix Innovations SA); every gozetotide label on DailyMed.
Highlights of the record
FDA label of April 11, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageGOZELLIX, after radiolabeling with Ga 68, is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: With suspected metastasis who are candidates for initial definitive therapy.
Forms and strengths
Kit; injection (powder) (lyophilized) for solution.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 58 through July 30, 2026
What is gozetotide used for?
From the label: indications and usageGOZELLIX, after radiolabeling with Ga 68, is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (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, after radiolabeling with Ga 68, is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: With suspected metastasis who are candidates for initial definitive therapy. […]
Source: FDA drug label (Gozellix), Telix Innovations SA, effective April 11, 2025 (SPL set abeab169-e38e-433a-b8a9-f1dab31518c8), via openFDA; the full label on DailyMed
Is there a generic for gozetotide (Gozellix)?
No generic gozetotide is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the gozetotide label say about other medicines?
The gozetotide label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Ascorbic acid | warnings and precautions | Ascorbic Acid Stabilizer contains sodium metabisulfite, a sulfite that may cause life-threatening hypersensitivity reactions including anaphylaxis. |
| Gallium ga 68 gozetotide | drug interactions | DRUG INTERACTIONS Androgen deprivation therapy and other therapies targeting the androgen pathway Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, can result in changes in uptake of gallium Ga 68 gozetotide in prostate cancer. |
Source: FDA drug label (Gozellix), Telix Innovations SA, effective April 11, 2025 (SPL set abeab169-e38e-433a-b8a9-f1dab31518c8), via openFDA; the full label on DailyMed
What do FAERS reports show for gozetotide?
The FDA Adverse Event Reporting System holds 58 reports that list gozetotide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 4 are coded as a death and 25 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Gozetotide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other