NDAORALTABLET2 Generics Approved
Approved
Oct 2007
Lifecycle
LOE Approaching
Competitive Pressure
60/100
Clinical Trials
14
Data completeness
3/8 — Basic
Drug data last refreshed 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
RENVELA (sevelamer carbonate) is an oral non-absorbed phosphate-binding polymer approved in 2007 for managing hyperphosphatemia in patients with chronic kidney disease, end-stage renal disease, and secondary hyperparathyroidism. The drug works by binding phosphate in the gastrointestinal tract through ionic and hydrogen bonding interactions, reducing serum phosphorus absorption without requiring metal or calcium. It is a foundational therapy in the nephrology treatment landscape for controlling mineral metabolism complications in dialysis and pre-dialysis populations.
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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 (14)
Evaluation of Renvela in Patients With Chronic Kidney Disease Not On Dialysis And Hyperphosphatemia In China
Started Jun 2017
202 enrolled
Hyperphosphatemia
An Open Label, Dose Titration Study of Sevelamer Carbonate Tablets & Powder in Hyperphosphatemic CKD Patients
Started Oct 2013
96 enrolled
Renal Failure Chronic
A Phase 1 Study to Examine the Effect of Renvela on the Pharmacodynamics of AZD1722
Started Apr 2013
16 enrolled
Healthy
An Efficacy and Safety Study of Sevelamer Carbonate in Hyperphosphatemic Pediatric Participants With Chronic Kidney Disease
Started May 2012
101 enrolled
HyperphosphatemiaChronic Kidney Disease
Post Authorisation Safety Study of Renvela® in Chronic Kidney Disease Patients Not on Dialysis With Hyperphosphataemia
Started Sep 2010
210 enrolled
HyperphosphataemiaChronic Kidney Disease
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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.