XOFIGO (radium ra-223 dichloride)
Xofigo is a radioactive therapy used for patients with prostate cancer that has become resistant to medical or surgical treatments that lower testosterone. It helps patients who have developed symptomatic cancer spread in their bones but do not have evidence of the disease in their internal organs. This medication is specifically used to target and manage these painful bone metastases.
How XOFIGO Works
This drug works by mimicking calcium to target areas of high bone turnover where cancer is present. Once it binds to the bone mineral, it releases alpha particles that cause double-strand DNA breaks in nearby tumor cells and bone-regulating cells. Because these particles have a very short range, the treatment focuses its energy on the cancer while limiting damage to healthy surrounding tissue.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2013-05-15
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
XOFIGO Approval History
What XOFIGO Treats
2 indicationsXOFIGO is approved for 2 conditions since its original approval in 2013. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Castration-Resistant Prostate Cancer
- Bone Metastases
XOFIGO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
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 XOFIGO's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications XOFIGO treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to XOFIGO
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02283749 results posted | BrUOG 301 | Ph 2 | completed | BrUOG L301 With Non-Small Cell Lung Cancer and Bone Metastases |
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.
XOFIGO FDA Label Details
Indications & Usage
FDA Label (PDF)XOFIGO is indicated for the treatment of Castration-Resistant Prostate Cancer; Bone Metastases.
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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