NDAORALSOLUTION
Approved
Apr 2011
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
1
Data completeness
5/8 — Partial
PHOSLYRA (calcium acetate) by Fresenius Kabi is (calcium acetate capsules) when taken with meals, combines with dietary phosphate to form an insoluble calcium phosphate complex, which is excreted in the feces, resulting in decreased serum phosphorus concentration. First approved in 2011.
Drug data last refreshed 34m ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PHOSLYRA is an oral calcium acetate solution indicated for phosphate control in patients with chronic kidney disease. When taken with meals, it binds dietary phosphate to form insoluble calcium phosphate complexes that are excreted in feces, reducing serum phosphorus levels. This is a small-molecule, non-systemic therapeutic addressing a critical mineral metabolism complication in dialysis and pre-dialysis populations.
$0.388MPart D
Peak3.3 years to LOEPeak-stage asset with modest Part D uptake (966 claims in 2023) and high competitive pressure (score 8/10) suggests mature portfolio defending market position against generics and alternative binders.
Mechanism of Action
(calcium acetate capsules) when taken with meals, combines with dietary phosphate to form an insoluble calcium phosphate complex, which is excreted in the feces, resulting in decreased serum phosphorus concentration.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (1)
Study of Safety and Efficacy of Renagel® Compared With Calcium Acetate in Patients With Peritoneal Dialysis
Started Dec 2004
138 enrolled
Peritoneal DialysisChronic Kidney Disease
Why This Matters for Your Career
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.