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Drug

Sevelamer carbonate

Established medicine

ResearchOngoing clinical research

Also known as Renvela.

1

Active clinical trials

2

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase 2a, Multicenter, Randomized, Open-label, Active Drug-controlled Trial to Evaluate the Efficacy and Safety of JMKX003002 in End-Stage Renal Disease Patients on Hemodialysis with Hyperphosphatemia

Clinical trial2025-06-30Primary completion · ClinicalTrials.gov

A Randomized, Open-Label, Multi-Center, Phase 3 Study to Evaluate the Efficacy and Safety of AP301 on Serum Phosphorus Control in Chronic Kidney Disease Patients Receiving Maintenance Dialysis With Hyperphosphatemia

Clinical trial2025-05-30Completed · ClinicalTrials.gov

A Post-Marketing Open-Label, 5 Period Crossover, Drug-Drug Interaction Study of Orally Adminstered TPOXX When Co-administered With 4 Different Phosphate Binders in Healthy Subjects

Clinical trial2024-12-27Results posted · ClinicalTrials.gov

A Phase 2, Randomized, Open-Label, Active-Controlled, Multicenter Study to Evaluate the Safety and Serum Phosphorus Lowering Effect of AP-306 in Chronic Kidney Disease Patients Receiving Maintenance Hemodialysis With Hyperphosphatemia

Clinical trial2023-09-14Completed · ClinicalTrials.gov

A 26-Wk, Phase 3, Open Label (OL) Study With a 12-Wk, Placebo-Controlled, Randomized Withdrawal Period and an OL Safety Extension to Evaluate the Safety and Efficacy of Tenapanor to Treat Hyperphosphatemia in CKD Patients on Dialysis

Clinical trial2023-06-29Results posted · ClinicalTrials.gov

FGF-23 (Fibroblast Growth Factor 23) Regulation in Chronic Kidney Disease

Clinical trial2023-05-31Results posted · ClinicalTrials.gov

A Long-Term, Open Label Study to Evaluate the Ability of Tenapanor Alone or in Combination With Sevelamer to Treat to Goal Serum Phosphorus in Patients With End-Stage Kidney Disease on Dialysis (NORMALIZE)

Clinical trial2023-03-29Results posted · ClinicalTrials.gov

A Phase 2 Study to Evaluate the Safety and Efficacy of Escalated and Fixed Doses of VS-505(AP301) in Comparison With Sevelamer Carbonate to Treat Hyperphosphatemia in Chronic Kidney Disease Patients Receiving Hemodialysis

Clinical trial2022-10-15Completed · ClinicalTrials.gov

A Study to Evaluate the Efficacy and Safety of Ferric Citrate Tablet for the Treatment of Hyperphosphatemia in Patients With Chronic Kidney Disease Undergoing Hemodialysis

Clinical trial2022-09-13Completed · ClinicalTrials.gov

A Randomized, Double Blind, Parallel Group Study For Assessing The Efficacy And Safety Of Renvela® Tablets For The Treatment Of Hyperphosphatemia In Patients With Chronic Kidney Disease Not On Dialysis Versus Placebo

Clinical trial2022-03-25Results posted · ClinicalTrials.gov

Approval: Sevelamer carbonate Winthrop (previously Sevelamer carbonate Zentiva) (EMA)

Regulatory2015-01-15EMA

Approval: Renvela (EMA)

Regulatory2009-06-09EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Sevelamer carbonate

Aliases & brands

Renvela

RxNorm CUI

660890

Regulatory jurisdictions

ema

Regulatory timeline

2 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2009-06-09

Latest approval

2015-01-15

Authorities

EMA

Total events

2

emaEuropean Medicines Agency· 2 events

2015-01-15Approval

Approval: Sevelamer carbonate Winthrop (previously Sevelamer carbonate Zentiva) (EMA)

Indication: Sevelamer carbonate Winthrop is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. Sevelamer carbonate Winthrop is… Show full indication

Sevelamer carbonate Winthrop is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. Sevelamer carbonate Winthrop is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease not on dialysis with serum phosphorus > 1.78 mmol/L. Sevelamer carbonate Winthrop should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease.

2009-06-09Approval

Approval: Renvela (EMA)

Indication: Renvela is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. Renvela is also indicated for the control of… Show full indication

Renvela is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. Renvela is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease not on dialysis with serum phosphorus ? 1.78 mmol/l. Renvela should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy vitamin D3 or one of its analogues to control the development of renal bone disease.

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

34 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

34

registered trials across all phases

LATEST COMPLETION 2025

1

Active studies

1

Recruiting

23

Late-stage (III+)

29

Completed

4

Discontinued

PHASE DISTRIBUTIONn = 34

Early Phase 11Phase 12Phase 28Phase 316Phase 44Phase N / A3

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Post-Marketing Open-Label, 5 Period Crossover, Drug-Drug Interaction Study of Orally Adminstered TPOXX When Co-administered With 4 Different Phosphate Binders in Healthy Subjects

CompletedPH IVSIGA Technologiesn=442023

A Long-Term, Open Label Study to Evaluate the Ability of Tenapanor Alone or in Combination With Sevelamer to Treat to Goal Serum Phosphorus in Patients With End-Stage Kidney Disease on Dialysis (NORMALIZE)

CompletedPH IVArdelyxn=1722021

A Randomized Study on the Effects of Sevelamer Carbonate Versus Calcium Acetate on Biomarkers of Vascular Calcification, Inflammation, and Endothelial Dysfunction in Chronic Kidney Disease Stages 3 and 4

TerminatedPH IVAlbany College of Pharmacy and Health Sciencesn=302016

Randomized,Multi-center,Phase IV, 2-arm,Open-Label,Cross-over Study to Demonstrate the Equivalence of Calcium Acetate Oral Solution and Sevelamer Carbonate Tablets in Hemodialysis Patients

CompletedPH IVFresenius Medical Care North American=382012

A Randomized, Open-Label, Multi-Center, Phase 3 Study to Evaluate the Efficacy and Safety of AP301 on Serum Phosphorus Control in Chronic Kidney Disease Patients Receiving Maintenance Dialysis With Hyperphosphatemia

CompletedPH IIIAlebund Pharmaceuticalsn=4742025

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Randomized, Open-Label, Multi-Center, Phase 3 Study to Evaluate the Efficacy and Safety of AP301 on Serum Phosphorus Control in Chronic Kidney Disease Patients Receiving Maintenance Dialysis With Hyperphosphatemia

CompletedPH IIIAlebund Pharmaceuticalsn=4742025

A Phase 2, Randomized, Open-Label, Active-Controlled, Multicenter Study to Evaluate the Safety and Serum Phosphorus Lowering Effect of AP-306 in Chronic Kidney Disease Patients Receiving Maintenance Hemodialysis With Hyperphosphatemia

CompletedPH IIAlebund Pharmaceuticalsn=552023

A Post-Marketing Open-Label, 5 Period Crossover, Drug-Drug Interaction Study of Orally Adminstered TPOXX When Co-administered With 4 Different Phosphate Binders in Healthy Subjects

CompletedPH IVSIGA Technologiesn=442023

A Phase 2 Study to Evaluate the Safety and Efficacy of Escalated and Fixed Doses of VS-505(AP301) in Comparison With Sevelamer Carbonate to Treat Hyperphosphatemia in Chronic Kidney Disease Patients Receiving Hemodialysis

CompletedPH IIShanghai Alebund Pharmaceuticals Limitedn=1582022

A Study to Evaluate the Efficacy and Safety of Ferric Citrate Tablet for the Treatment of Hyperphosphatemia in Patients With Chronic Kidney Disease Undergoing Hemodialysis

CompletedPH IIISinomune Pharmaceutical Co., Ltdn=2392022

A Long-Term, Open Label Study to Evaluate the Ability of Tenapanor Alone or in Combination With Sevelamer to Treat to Goal Serum Phosphorus in Patients With End-Stage Kidney Disease on Dialysis (NORMALIZE)

CompletedPH IVArdelyxn=1722021

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ClinicalTrials.gov — clinical trials
Regulatory event sources are credited in the Regulatory Timeline above.