NDAORALFOR SUSPENSION
Approved
Aug 2009
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
14
Data completeness
5/8 — Partial
RENVELA (sevelamer carbonate) by Sanofi is non-absorbed phosphate-binding cross-linked polymer, free of metal and calcium. First approved in 2009.
Drug data last refreshed 18h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
RENVELA (sevelamer carbonate) is a non-absorbed, calcium- and metal-free phosphate binder indicated for hyperphosphatemia in chronic kidney disease patients on dialysis. It works by binding phosphate in the gastrointestinal tract through ionic and hydrogen bonding interactions, reducing serum phosphorus levels. The drug is administered orally as a suspension.
$0.114BPart D
LOE Approaching4.2 years to LOEAs RENVELA approaches exclusivity loss in late 2030, the brand team is likely consolidating around retention strategies and may face modest headcount reductions post-LOE.
Mechanism of Action
non-absorbed phosphate-binding cross-linked polymer, free of metal and calcium. It contains multiple amines separated by one carbon from the polymer backbone. These amines exist in a protonated form in the intestine and interact with phosphate molecules through ionic and hydrogen bonding. By…
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.