NDAORALTABLET, CHEWABLE
Approved
Oct 2004
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
Drug data last refreshed 4h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FOSRENOL (lanthanum carbonate) is an oral phosphate binder approved in 2004 for managing serum phosphate levels in end-stage renal disease (ESRD) patients. It works by binding dietary phosphate in the gastrointestinal tract, preventing absorption and reducing serum phosphate and calcium-phosphate product levels. Administered as a chewable tablet, it addresses a critical mineral metabolism complication in dialysis populations.
$6MPart D
LOE ApproachingDeclining
Product is entering loss-of-exclusivity phase with modest Part D penetration (~3,000 claims annually), signaling smaller marketing teams and shift toward generic/competitive positioning.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study to Assess the Tolerability of Oxylanthanum Carbonate in Patients With Chronic Kidney Disease on Dialysis
Started Dec 2023
106 enrolled
Chronic Kidney Disease Requiring Chronic Dialysis
A Drug Interaction Study to Evaluate the Pharmacokinetics of ASP1517 and Lanthanum Carbonate Hydrate
Started Nov 2016
18 enrolled
Healthy Subjects
Fosrenol Post-marketing Surveillance in Japan
Started Oct 2013
343 enrolled
HyperphosphatemiaKidney Disease
A Study to Assess the Pharmacokinetics of Lanthanum Carbonate, Investigate and Compare the Efficacy, Safety and Tolerability of Lanthanum Carbonate With Calcium Carbonate in Hyperphosphataemic Children and Adolescents With Chronic Kidney Disease on Dialysis
Started Feb 2013
63 enrolled
Chronic Kidney DiseaseHyperphosphatemia
Fosrenol and Phosphorus Balance - Lanthanum Carbonate
Started Mar 2012
9 enrolled
Chronic Kidney FailureEnd-stage Renal DiseaseDisorders Associated With Peritoneal Dialysis
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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.