Renagel

(Sevelamer)

ApprovedSmall molecule

GGenzyme, a Sanofi Company

Renagel is one of 44 small molecule programs targeting Hypophosphatemic Rickets. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Hypophosphatemic RicketsActive, not recruiting

CalcificationActive, not recruiting

Endothelial DysfunctionActive, not recruiting

Heart Valve DiseaseRecruiting

Hypophosphatemic RicketsPreclinical

Active, not recruiting

CalcificationPreclinical

Active, not recruiting

Endothelial DysfunctionApproved

Active, not recruiting

Heart Valve DiseaseApproved

Recruiting

Competition

Competitive Landscape

39 competitors in Endothelial Dysfunction

#DrugCompanyPhaseTrials

Plavix

Sanofi

Approved

2 2

Avapro

Sanofi

Approved

2 3

Onglyza

AstraZeneca

Approved

1 4

Brilinta

AstraZeneca

Approved

1 5

Zyloprim

Jazz Pharmaceuticals

Approved

1 6

Ozempic

Novo Nordisk

Approved

1 7

Crestor

AstraZeneca

Approved

1 8

Prevacid

Andriol

2 10

Jardiance

Boehringer Ingelheim

Approved

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

Clinical

Trials by Indication[1]

Insulin resistance2 trials

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

Completed·TThe University of Texas Health Science Center at San Antonio·Phase 2·NCT02124759·20 enrolled

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

Completed·TThe University of Texas Health Science Center at San Antonio·Phase 2·NCT02127125·69 enrolled

Calcification2 trials

CARE-2 (Calcium Acetate [PhosLo®]/Sevelamer[Renagel®] Evaluation Study 2) for Heart Calcification in Dialysis Patients

Completed·NNabi Biopharmaceuticals·Phase 4·NCT00211939·203 enrolled

Arterial Stiffness and Calcifications in Haemodialysis Patients on Sevelamer or Calcium Acetate

Withdrawn·RRomanian Society of Nephrology·N/A·NCT00364000

GLP-12 trials

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

Completed·SSteno Diabetes Center Copenhagen·N/A·NCT03739268·17 enrolled

Effect of Bile Acid Secretion and Sequestration on GLP-1 Secretion

Completed·UUniversity Hospital, Gentofte, Copenhagen·N/A·NCT02445508·15 enrolled

CKD2 trials

Effect of Sevelamer on P-cresol Levels in CKD

Unknown status·FFederico II University·Phase 3·NCT02199444·200 enrolled

Sevelamer in Proteinuric CKD

Completed· Mario Negri Institute for Pharmacological Research logo

Mario Negri Institute for Pharmacological Research·Phase 2·NCT01968759·53 enrolled

Absorption1 trial

Comparing Absorption of Dietary Phosphorus When Administering FOSRENOL® or RENVELA® in Healthy Adult Volunteers

Completed· Takeda logo

Takeda·Phase 1·NCT00875017·31 enrolled

9 more indications

Chronic Renal Failure1 trial

Effect of Sevelamer on Glucose Tolerance and Insulin Sensitivity in Patients With Chronic Renal Failure (CKD)

Withdrawn·KKarolinska Institutet·N/A·NCT00837655

Endothelial Dysfunction1 trial

Sevelamer, FGF-23 and Endothelial Dysfunction in Chronic Kidney Disease (CKD)

Completed·GGulhane School of Medicine·Phase 4·NCT01135615·100 enrolled

Hypophosphatemic Rickets1 trial

Hypophosphatemic Rickets in Norway

Unknown status·HHaukeland University Hospital··NCT01057186·80 enrolled

Thyroid1 trial

Parathyroid Hormone Levels in Relation to the Phosphorus Content of Meals

Completed·NNational Center for Research Resources (NCRR)·N/A·NCT00018135

ILD1 trial

A Multicenter, Active and Placebo-controlled Study of Enteric Coated Sevelamer in Patients With Mild to Moderate Hypercholesteremia

Completed· Sanofi logo

Sanofi·Phase 2·NCT00690937·120 enrolled

Hemodialysis1 trial

DS2330b Alone and With Sevelamer in Patients on Chronic Hemodialysis

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 1·NCT03305471·40 enrolled

Heart Valve Disease1 trial

Calcium-Phosphorus Regulation Therapy on Heart Valve Disease

Recruiting·CChina National Center for Cardiovascular Diseases·Phase 4·NCT06660524·196 enrolled

Nicotinamide1 trial

Nicotinamide Versus Sevelamer Hydrochloride on Phosphatemia Control on Chronic Hemodialysed Patients

Terminated·—·Phase 3·NCT01011699·176 enrolled

Gut Microbiota1 trial

Effect of Bile Acid Sequestration on Postprandial GLP-1 Secretion, Glucose Homeostasis and Gut Microbiota

Completed·UUniversity Hospital, Gentofte, Copenhagen·N/A·NCT02061124·50 enrolled

Regulatory

FDA Approval Timeline[4]

Oct 30, 1998

RENAGEL

NDA NDA020926

Jul 12, 2000

RENAGEL

NDA NDA021179

Sources

References

[1]
ClinicalTrials.gov — 18 trial records for Sevelamer. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Sevelamer compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Sevelamer. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA021179). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Genzyme, a Sanofi Company company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

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

Renagel

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Insulin resistance2 trials

Calcification2 trials

GLP-12 trials

CKD2 trials

Absorption1 trial

Chronic Renal Failure1 trial

Endothelial Dysfunction1 trial

Hypophosphatemic Rickets1 trial

Thyroid1 trial

ILD1 trial

Hemodialysis1 trial

Heart Valve Disease1 trial

Nicotinamide1 trial

Gut Microbiota1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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