PHOSLYRA (calcium acetate) · Fresenius Kabi
PHOSLYRA is FDA-approved to treat 2 conditions (same as CALCIUM ACETATE).
Details
- Status
- Discontinued
- First Approved
- 2011-04-18
- Patent Cliff
- 2030
- Routes
- ORAL
- Dosage Forms
- SOLUTION
PHOSLYRA Approval History
What PHOSLYRA Treats
2 indicationsPHOSLYRA is approved for 2 conditions since its original approval in 2011. These indications span multiple therapeutic areas including oncology, immunology, and more.
- End stage renal disease
- High serum phosphorus
Same approved indications as CALCIUM ACETATE (same active ingredient).
Fresenius Kabi's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04299633 | AKB-6548-CI-0037 | Ph 1 | completed | Study in Healthy Adult Subjects to Assess the Effect of Phosphate Binders on the Pharmacokinetics of a Single Dose of Vadadustat |
| NCT01277497 | 2902 | Ph 4 | terminated | Effect of Phosphate Binders on Markers of Vascular Health in Chronic Kidney Disease Stages 3 and 4 |
| NCT01135615 | GATAFGF23Sevelamer | Ph 4 | completed | Sevelamer, FGF-23 and Endothelial Dysfunction in Chronic Kidney Disease (CKD) |
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.
PHOSLYRA FDA Label Details
Indications & Usage
FDA Label (PDF)PHOSLYRA is FDA-approved to treat 2 conditions — same approved indications as CALCIUM ACETATE.
Pro Intelligence Preview
Deep insights for PHOSLYRA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2030
- • 3 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • Competitor tracking
- • 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.