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 18h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
RENAGEL (sevelamer hydrochloride) is a non-absorbed, crosslinked polymer oral phosphate binder approved in 1998 for managing hyperphosphatemia in dialysis patients. It works by binding dietary phosphate in the intestine through ionic and hydrogen bonding, reducing serum phosphate absorption. This mechanism addresses a critical complication in chronic kidney disease and end-stage renal disease populations.
$0.049BPart D
LOE ApproachingProduct approaching loss of exclusivity with modest Part D volume, signaling potential team consolidation and shift toward generic competition management.
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
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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.