GALLIUM GA-68 GOZETOTIDE
Gallium Ga 68 gozetotide is a diagnostic tool used for PET imaging in men with prostate cancer to locate PSMA-positive lesions. It helps patients with suspected metastasis who are candidates for initial therapy, as well as those with rising PSA levels that suggest the cancer may have returned. This agent also helps clinicians identify which individuals are suitable candidates for PSMA-directed treatments.
How GALLIUM GA-68 GOZETOTIDE Works
This agent works by targeting and binding to prostate-specific membrane antigen (PSMA), a protein often overexpressed on the surface of malignant prostate cancer cells. It contains gallium-68, a radioactive isotope that emits signals detectable by PET scans, allowing for the visualization of these cancer cells throughout the body.
Details
- Status
- Prescription
- First Approved
- 2020-12-01
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
GALLIUM GA-68 GOZETOTIDE Approval History
What GALLIUM GA-68 GOZETOTIDE Treats
3 indicationsGALLIUM GA-68 GOZETOTIDE is approved for 3 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Prostate Cancer
- Metastasis
- Recurrence
GALLIUM GA-68 GOZETOTIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in GALLIUM GA-68 GOZETOTIDE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications GALLIUM GA-68 GOZETOTIDE treats. First-in-class if their pivotal trials read out positive.
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3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
GALLIUM GA-68 GOZETOTIDE FDA Label Details
Indications & Usage
FDA Label (PDF)GALLIUM GA-68 GOZETOTIDE is indicated for the treatment of Prostate Cancer; Metastasis; Recurrence.
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ILLUCCIX
Full clinical data, patents, trials, and competitive landscape for gallium ga-68 gozetotide.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.