SEVELAMER HYDROCHLORIDE
Sevelamer hydrochloride helps patients with chronic kidney disease who are undergoing dialysis manage their serum phosphorus levels. It is used to lower the concentration of phosphate in the blood, which can become elevated in these patients. This medication is specifically for those currently on dialysis, as its effects in other stages of kidney disease have not been established.
How SEVELAMER HYDROCHLORIDE Works
This drug works by binding to phosphate molecules within the digestive tract using a non-absorbed polymer. The polymer contains amines that become protonated in the intestine, allowing them to capture dietary phosphate through ionic and hydrogen bonding. By preventing the absorption of this phosphate, the medication effectively lowers the amount of phosphorus that enters the bloodstream.
Details
- Status
- Discontinued
- First Approved
- 2019-02-08
- Routes
- ORAL
- Dosage Forms
- TABLET
SEVELAMER HYDROCHLORIDE Approval History
What SEVELAMER HYDROCHLORIDE Treats
1 indicationsSEVELAMER HYDROCHLORIDE is approved for 1 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Chronic Kidney Disease
SEVELAMER HYDROCHLORIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03451019 | S-L2018 | Ph 4 | completed | Different Effects of Non-calcium Phosphate Binders on Serum Calcium |
| NCT01850602 results posted | PA1301 | Ph 3 | completed | A Phase III Study of PA21 in Hemodialysis Patients With Hyperphosphatemia |
| NCT01057407 | 1585-CL-0003 | Ph 3 | completed | A Comparative Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia on Hemodialysis |
| NCT00824460 PA21 results posted | PA-CL-03A 75610 | Ph 2 | completed | Study of Phosphate Levels in Patients With Chronic Kidney Disease |
| NCT00844662 | ACT 402 2008-004730-25 | Ph 3 | terminated | Phase III Study to Investigate the Safety and Efficacy of Fermagate and Sevelamer Hydrochloride |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SEVELAMER HYDROCHLORIDE FDA Label Details
Indications & Usage
SEVELAMER HYDROCHLORIDE is indicated for the treatment of Chronic Kidney Disease.
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RENAGEL
Full clinical data, patents, trials, and competitive landscape for sevelamer hydrochloride.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.