GOZELLIX (gallium ga-68 gozetotide)
Gozellix is a diagnostic imaging agent used for PET scans in men with prostate cancer. It helps clinicians identify prostate-specific membrane antigen (PSMA) positive lesions in patients who are suspected of having cancer that has spread before they begin their initial definitive treatment. It is also used for patients who may have a cancer recurrence, often signaled by an increase in PSA levels.
How GOZELLIX Works
This agent works by targeting and binding to PSMA, a protein frequently overexpressed on the surface of malignant prostate cancer cells. Because it contains gallium-68, a radioactive radionuclide, it allows for the visualization of these cancer cells during positron emission tomography (PET).
Development Insights
Details
- Status
- Prescription
- First Approved
- 2025-03-20
- Patent Cliff
- 2035
- Routes
- INTRAVENOUS
- Dosage Forms
- POWDER
GOZELLIX Approval History
What GOZELLIX Treats
3 indicationsGOZELLIX is approved for 3 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Prostate Cancer
- Metastasis
- Recurrence
GOZELLIX 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 GOZELLIX's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications GOZELLIX treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to GOZELLIX
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.
GOZELLIX FDA Label Details
Indications & Usage
FDA Label (PDF)GOZELLIX is indicated for the treatment of Prostate Cancer; Metastasis; Recurrence.
GOZELLIX Patents & Exclusivity
Patents (1 active)
Pro Intelligence Preview
Deep insights for GOZELLIX
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2035
- • 1 active patents
Trial Analysis
- • 6 total trials
- • Stage: Declining
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment