NDAORALCAPSULE
Approved
Oct 1998
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
7
Data completeness
4/8 — Partial
RENAGEL (sevelamer hydrochloride) by Sanofi is hydrochloride, a non-absorbed binding crosslinked polymer. First approved in 1998.
Drug data last refreshed 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
RENAGEL (sevelamer hydrochloride) is an oral non-absorbed binding polymer that lowers serum phosphate in patients with chronic kidney disease by binding dietary phosphate in the intestine through ionic and hydrogen bonding. It is indicated for hyperphosphatemia management across multiple renal disease states including hemodialysis, peritoneal dialysis, and end-stage renal disease. The drug addresses a critical electrolyte imbalance that accelerates cardiovascular disease and mortality in dialysis populations.
$49KPart D
LOE ApproachingDeclining
Mature product in decline phase with minimal Part D claims signals erosion; brand teams are focused on managed care retention and physician loyalty rather than growth.
Mechanism of Action
hydrochloride, a non-absorbed binding crosslinked polymer. 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 binding phosphate in the…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (7)
A Phase 1 Multiple Dose Study to Compare the Effects of AMG 223 and Sevelamer HCL (Renagel®)
Started May 2008
66 enrolled
Healthy Volunteers
Head to Head Study Against Sevelamer Hydrochloride
Started Jan 2007
182 enrolled
Chronic Kidney Disease, Stage 5
Study to Compare Sevelamer Carbonate Powder to Sevelamer Hydrochloride Tablets in Patients With CKD on Hemodialysis
Started Jan 2006
217 enrolled
Kidney DiseasesChronic Renal InsufficiencyEnd-Stage Renal Disease
Cross-Over Study of Sevelamer Hydrochloride and Sevelamer Carbonate
Started Mar 2005
80 enrolled
Chronic Kidney Disease
Sevelamer Hydrochloride and Femoral and Carotid Intima Media Thickness Progression in End Stage Renal Disease
Started Feb 2005
175 enrolled
End Stage Renal DiseaseHemodialysisIntimal Media Thickness
Worked on RENAGEL at Sanofi? Share your interview experience or compensation data (+7 days Pro)
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.