Renvela

(Sevelamer Carbonate)

ApprovedSmall molecule

Sanofi

Renvela is one of 144 small molecule programs targeting Renal Dialysis. It is currently in Approved.

Indications

Total Trials

Active Trials

143

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Renal DialysisActive, not recruiting

HIV-1 InfectionApproved

Secondary HyperparathyroidismActive, not recruiting

Chronic Kidney DiseaseTerminated

Kidney FailureApproved

Chronic Renal Failure SyndromeApproved

Renal DialysisApproved

Active, not recruiting

HIV-1 InfectionApproved

Approved

Secondary HyperparathyroidismPreclinical

Active, not recruiting

Chronic Kidney DiseaseApproved

Terminated

Kidney FailureApproved

Approved

Chronic Renal Failure SyndromeApproved

Approved

Competition

Competitive Landscape

169 competitors in Chronic Kidney Disease

#DrugCompanyPhaseTrials

Renvela

Sanofi

Approved

14 2

Uloric

Takeda

Preclinical

2 3

Sovaldi

Gilead

Preclinical

1 4

Glucotrol

Pfizer

Preclinical

1 5

Vemlidy

Gilead

Preclinical

1 6

Lorelco

Sanofi

Preclinical

1 7

Flomax

Activase

Januvia

ZZydus Therapeutics Inc.

Preclinical

1 10

Baraclude

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Chronic Kidney Disease14 trials

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

Completed·UUniversity of California, Los Angeles·N/A·NCT00999037·18 enrolled

Effects of a Non-Calcium Based Phosphate Binder on FGF23 Levels in Chronic Kidney Disease

Completed·MMilton S. Hershey Medical Center·Phase 1·NCT01308242·40 enrolled

A Randomised, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sevelamer Carbonate Tablets Dosed Three Times a Day in Hyperphosphataemic Chronic Kidney Disease Patients Not on Dialysis

Terminated· Sanofi logo

Sanofi·Phase 3·NCT00833768·5 enrolled

Show 11 more trials

An Efficacy and Safety Study of Sevelamer Carbonate in Hyperphosphatemic Pediatric Participants With Chronic Kidney Disease

Completed· Sanofi logo

Sanofi·Phase 2·NCT01574326·101 enrolled

Randomized Study Comparing Genz-644470, Placebo, and Sevelamer Carbonate in Chronic Kidney Disease Patients on Hemodialysis

Completed· Sanofi logo

Sanofi·Phase 2·NCT00853242·349 enrolled

Dose-Titration Study of Sevelamer Carbonate in Chronic Kidney Disease (CKD) Patients on Hemodialysis

Completed· Sanofi logo

Sanofi·Phase 3·NCT01736150·205 enrolled

Ferric Citrate for the Treatment of Hyperphosphatemia in Patients With Chronic Kidney Disease Undergoing Hemodialysis

Completed·PPanion & BF Biotech Inc.·Phase 3·NCT03984760·240 enrolled

Effects of Phosphate Binding With Sevelamer in Stage 3 Chronic Kidney Disease

Completed·UUniversity Hospital Birmingham NHS Foundation Trust·Phase 2·NCT00806481·120 enrolled

The Effect of Sevelamer Carbonate on Serum Trimethylamine-n-Oxide (TMAO) Level in Patients With Chronic Kidney Disease (CKD) Stage 3b-4

Unknown status·FFan Fan Hou·Phase 3·NCT03596749·80 enrolled

Ferric Citrate for the Treatment of Hyperphosphatemia in Patients With Chronic Kidney Disease Undergoing Hemodialysis

Completed·SSinomune Pharmaceutical Co., Ltd·Phase 3·NCT04456803·239 enrolled

Evaluation of Renvela in Patients With Chronic Kidney Disease Not On Dialysis And Hyperphosphatemia In China

Completed· Sanofi logo

Sanofi·Phase 3·NCT03001011·202 enrolled

Post Authorisation Safety Study of Renvela® in Chronic Kidney Disease Patients Not on Dialysis With Hyperphosphataemia

Completed· Sanofi logo

Sanofi··NCT01857024·210 enrolled

FGF23 Reduction : Efficacy of a New Phosphate Binder in CHronic Kidney Disease

Completed·—·Phase 3·NCT01220843·98 enrolled

Effect of Phosphate Binders on Markers of Vascular Health in Chronic Kidney Disease Stages 3 and 4

Terminated·—·Phase 4·NCT01277497·30 enrolled

Hyperphosphatemia5 trials

A Phase 3 Study of Tenapanor to Treat Hyperphosphatemia in ESRD Patients on Dialysis

Completed·AArdelyx·Phase 3·NCT03427125·1,559 enrolled

A Study to Evaluate Safety and Efficacy of AP-306 in Hyperphosphatemia Patients

Completed·AAlebund Pharmaceuticals·Phase 2·NCT05764590·55 enrolled

Evaluate the Efficacy and Safety of JMKX003002 in End-Stage Renal Disease Patients on Hemodialysis with Hyperphosphatemia

Recruiting·JJemincare·Phase 2·NCT06664125·50 enrolled

Show 2 more trials

A Phase 2 Study to Evaluate the Safety and Efficacy of VS-505(AP301) to Treat Hyperphosphatemia in Hemodialysis Patients

Completed·SShanghai Alebund Pharmaceuticals Limited·Phase 2·NCT04551300·158 enrolled

AP301 Efficacy and Safety in Chinese Dialysis Patients With Hyperphosphatemia

Completed·AAlebund Pharmaceuticals·Phase 3·NCT07030595·474 enrolled

Safety and Efficacy2 trials

PA21 Safety and Efficacy in Adult Chinese Subjects

Completed·VVifor Fresenius Medical Care Renal Pharma·Phase 3·NCT03644264·286 enrolled

A Phase 3 Study to Investigate the Safety and Efficacy of PA21, a Phosphate Binder, in Dialysis Patients

Completed·VVifor Pharma·Phase 3·NCT01324128·1,059 enrolled

Dialysis Patients2 trials

A Phase 3 Extension Study to Investigate the Long-term Safety, Tolerability and Efficacy of PA21, a Phosphate Binder in Dialysis Patients

Completed·VVifor Pharma·Phase 3·NCT01464190·659 enrolled

Equivalence of Calcium Acetate Oral Solution and Sevelamer Carbonate Tablets in Hemodialysis Patients

Completed·FFresenius Medical Care North America·Phase 4·NCT01427907·38 enrolled

Diabetic Nephropathy2 trials

Effect of Sevelamer Carbonate on Oxidative Stress in Patients With Diabetic Nephropathy

Completed·IIcahn School of Medicine at Mount Sinai·Phase 1·NCT00967629·20 enrolled

The Effects of Sevelamer Carbonate on Diabetic Nephropathy

Completed·GGary Striker·Phase 2·NCT01493050·117 enrolled

9 more indications

Dialysis2 trials

An Open Label Dose Titration of Sevelamer Carbonate Tabs 3 Times a Day in Hyperphosphatemic CKD Patients Not On Dialysis

Completed· Sanofi logo

Sanofi·Phase 3·NCT00681941·49 enrolled

A Long-Term Study of Tenapanor Alone or in Combination With Sevelamer in Patients With CKD on Dialysis and HP

Completed·AArdelyx·Phase 4·NCT03988920·172 enrolled

Secondary Hyperparathyroidism1 trial

Sevelamer and Secondary Hyperparathyroidism in Chronic Kidney Disease

Completed·—·Phase 3·NCT01191762·30 enrolled

Randomized1 trial

A Double Blind Randomized Placebo Trial of Maintenance of Normal Serum Phosphorus in CKD

Completed·DDenver Nephrologists, P.C.·N/A·NCT00785629·148 enrolled

Hemodialysis1 trial

Study to Compare Sevelamer Carbonate Powder to Sevelamer Hydrochloride Tablets in Patients With CKD on Hemodialysis

Completed· Sanofi logo

Sanofi·Phase 3·NCT00268957·217 enrolled

CAR1 trial

An Open Label, Dose Titration Study of Sevelamer Carbonate Tablets & Powder in Hyperphosphatemic CKD Patients

Completed· Sanofi logo

Sanofi·Phase 3·NCT02332811·96 enrolled

Atherosclerotic Plaque1 trial

The Effect(s) of Sevelamer Carbonate (Renvela) on Atherosclerotic Plaque Inflammation Judged by FDG-PET Scan

Terminated·—·N/A·NCT01238588·24 enrolled

Endotoxemia1 trial

Sevelamer for Reducing Endotoxemia and Immune Activation

Completed·AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·Phase 2·NCT01543958·40 enrolled

Adult Subject1 trial

Study in Healthy Adult Subjects to Assess the Effect of Phosphate Binders on the Pharmacokinetics of a Single Dose of Vadadustat

Completed·AAkebia Therapeutics·Phase 1·NCT04299633·54 enrolled

Smallpox1 trial

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

Completed·SSIGA Technologies·Approved·NCT04485039·44 enrolled

Regulatory

FDA Approval Timeline[4]

Oct 19, 2007

RENVELA

NDA NDA022127

Oct 19, 2007

RENVELA

NDA NDA022127

Feb 18, 2009

RENVELA

NDA NDA022318

Aug 12, 2009

RENVELA

NDA NDA022318

Jun 16, 2011

RENVELA

NDA NDA022318

Jun 16, 2011

RENVELA

NDA NDA022127

Nov 26, 2014

RENVELA

NDA NDA022318

Nov 26, 2014

RENVELA

NDA NDA022127

Mar 9, 2016

RENVELA

NDA NDA022318

Mar 9, 2016

RENVELA

NDA NDA022127

Nov 25, 2016

RENVELA

NDA NDA022127

Nov 25, 2016

RENVELA

NDA NDA022318

Apr 30, 2020

RENVELA

NDA NDA022318

Apr 30, 2020

RENVELA

NDA NDA022127

Jun 6, 2023

RENVELA

NDA NDA022127

Sources

References

[1]
ClinicalTrials.gov — 35 trial records for Sevelamer Carbonate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Sevelamer Carbonate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Sevelamer Carbonate. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA022127). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Renvela. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Sanofi company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Sanofi

Patent Landscape[5]

Patent Cliff

Dec 6, 2030

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9095509Dec 6, 2030

Renvela

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Chronic Kidney Disease14 trials

Hyperphosphatemia5 trials

Safety and Efficacy2 trials

Dialysis Patients2 trials

Diabetic Nephropathy2 trials

Dialysis2 trials

Secondary Hyperparathyroidism1 trial

Randomized1 trial

Hemodialysis1 trial

CAR1 trial

Atherosclerotic Plaque1 trial

Endotoxemia1 trial

Adult Subject1 trial

Smallpox1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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