PYLARIFY
Details
- Status
- Prescription
- First Approved
- 2021-05-26
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
PYLARIFY Approval History
What PYLARIFY Treats
3 indicationsPYLARIFY is approved for 3 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Prostate Cancer
- Metastasis
- Recurrence
PYLARIFY Competitors
Pro5 other drugs also target PSMA. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (PSMA). Earlier expiry dates signal biosimilar/generic opportunities.
Drugs Similar to PYLARIFY
FDA-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.
PYLARIFY FDA Label Details
ProPYLARIFY Patents & Exclusivity
Patents (6 active)
Exclusivity
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.