Drug

Sevelamer

Approved · EMA

Emerging researchLate-stage development

Also known as RenaGel, Renvela, Sevelamer Carbonate, Sevelamero+2 more

RenaGel, Renvela, Sevelamer Carbonate, Sevelamero, Sevelamer Hydrochloride, Sevelamerum.

RxNorm214824UNII941N5DUU5C

Research papers

Active clinical trials

Regulatory events

Latest activity

beta

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

Clinical Study on the Influence of Calcium and Phosphorus Regulation Therapy on Valvular Heart Disease.

Clinical trial2025-06-01Primary completion · ClinicalTrials.gov

Mechanism of Microbiome-induced Insulin Resistance in Humans (Aim 1)

Clinical trial2021-10-15Results posted · ClinicalTrials.gov

GLP-1-mediated Gluco-metabolic Effects of Bile Acid Sequestration

Clinical trial2021-09-01Completed · ClinicalTrials.gov

An Open-label, Phase I, One-dose, One-meal, Balance Study Comparing the Absorption of Dietary Phosphorus When Administering FOSRENOL® (Lanthanum Carbonate) or RENVELA® (Sevelamer Carbonate) in Healthy Adult Volunteers

Clinical trial2021-06-15Results posted · ClinicalTrials.gov

A Prospective, Multicenter, Open-label, Randomized, Cross-over Study to Compare the Efficacy and Safety of Fosrenol® and Sevelamer Hydrochloride in Patients Receiving Hemodialysis for End Stage Renal Disease

Clinical trial2021-06-11Results posted · ClinicalTrials.gov

Effect of Lanthanum Carbonate and Sevelamer Hydrochloride on Gastrointestinal Calcium Absorption in Patients With Moderate to Advanced Chronic Kidney Disease

Clinical trial2020-12-30Completed · ClinicalTrials.gov

Mechanism of Microbiome-induced Insulin Resistance in Humans (Aim2)

Clinical trial2020-09-11Results posted · ClinicalTrials.gov

A Phase 1b Study, to Assess the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Repeated Doses of DS-2330b Alone and When Co-administered With Sevelamer in Patients on Chronic Hemodialysis

Clinical trial2019-01-03Completed · ClinicalTrials.gov

A Phase III Study of PA21 in Hemodialysis Patients With Hyperphosphatemia

Clinical trial2018-10-09Results posted · ClinicalTrials.gov

Differences in gastrointestinal calcium absorption after the ingestion of calcium-free phosphate binders.

Research2013-11-06American journal of physiology. Renal physiology

Comparison of dietary phosphate absorption after single doses of lanthanum carbonate and sevelamer carbonate in healthy volunteers: a balance study.

Research2011-02-26American journal of kidney diseases : the official journal of the National Kidney Foundation

Approval: Renagel (EMA)

Regulatory2000-01-28EMA

Profile

Identifiers & mechanism

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

Canonical name

Sevelamer

Aliases & brands

RenaGelRenvelaSevelamer CarbonateSevelameroSevelamer HydrochlorideSevelamerum

RxNorm CUI

214824

UNII

941N5DUU5C

Regulatory jurisdictions

ema

Regulatory timeline

1 event

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

2000-01-28

Latest approval

2000-01-28

Authorities

EMA

Total events

emaEuropean Medicines Agency· 1 event

2000-01-28Approval

Approval: Renagel (EMA)

Indication: Renagel is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. Renagel should be used within the context of a… Show full indication

Renagel is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. Renagel should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 1,25 - dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease.

Evidence ↗

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