TheraRadar
Data updated: May 26, 2026

RENAGEL (sevelamer hydrochloride)

Trial Activity: Declining
Renal Approved 1998-10-30
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

Medical University of Lodz conducting 1 trials (20%)
6 indications explored (Moderate)
→ chronic kidney disease (3 trials)
→ hemodialysis (1 trials)
→ hyperphosphatemia (1 trials)
5
Indications
--
Phase 3 Trials
27
Years on Market

Details

Status
Discontinued
First Approved
1998-10-30
Routes
ORAL
Dosage Forms
CAPSULE, TABLET

Companies

Sanofi
Active Ingredient: SEVELAMER HYDROCHLORIDE

RENAGEL Approval History

1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
35 FDA actions from 1998 to 2023 · 3 indication expansions
Dec 2023 SUPPL
Mfg · Manufacturing (CMC)
FDA Letter Label
Apr 2020 SUPPL
Label · Labeling
FDA Letter Label
Feb 2019 SUPPL
Label · Labeling
FDA Letter Label

What RENAGEL Treats

5 FDA approvals

Originally approved for its first indication in 1998 . Covers 5 distinct patient populations.

  • Other (5)
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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
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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.

RENAGEL FDA Label Details

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Data Sources

FDA Approval: NDA020926 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment