XBRYK (denosumab-dssb) · SAMSUNG BIOEPIS CO LTD
XBRYK is FDA-approved to treat 4 conditions (same as OSPOMYV).
Details
- Status
- Prescription
- First Approved
- 2025-02-13
- Routes
- SUBCUTANEOUS
- Dosage Forms
- INJECTABLE
XBRYK Approval History
What XBRYK Treats
4 indicationsXBRYK is approved for 4 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
Same approved indications as OSPOMYV (same active ingredient).
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.
XBRYK FDA Label Details
Indications & Usage
FDA Label (PDF)XBRYK is FDA-approved to treat 4 conditions — same approved indications as OSPOMYV.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.