epoetin beta

ApprovedBiologic

epoetin beta is a biologic that works as a Erythropoietin Receptor Agonist.[2] It is being used across 3 indications, with its most advanced program in Approved.[1]

epoetin beta is one of 100 biologic programs targeting Chronic Renal Failure Syndrome. 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

Chronic Renal Failure SyndromeUnknown

Anemia (phenotype)Unknown

Chronic HepatitisCompleted

Chronic Renal Failure SyndromePreclinical

Unknown

Anemia (phenotype)Preclinical

Unknown

Chronic HepatitisApproved

Completed

Competition

Competitive Landscape

81 competitors in Chronic Hepatitis

#DrugCompanyPhaseTrials

PEG-Intron

Merck & Co.

Phase 3

43 2

PEG-IFNα

Gilead

Phase 3

12 3

Bepirovirsen

GSK

Phase 3

1 4

Opdivo

Bristol-Myers Squibb

Phase 2

2 5

epoetin beta

Roche

Approved

2 6

Hydronidone

BBeijing Continent Pharmaceutical Co, Ltd.

Phase 3

2 7

Pegylated Interferon Alfa

Merck & Co.

Phase 3

4 8

NA Therapy

GSK

Phase 3

2 9

AHB-137

AAusper Biopharma Co., Ltd.

Phase 3

3 10

Azvudine

HHenan Genuine Biotech Co., Ltd.

Phase 3

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

Clinical

Trials by Indication[1]

Anemia10 trials

Epoetin Alfa or Epoetin Beta With or Without Iron Infusion in Treating Anemia in Patients With Cancer

Unknown status·SSt. Bartholomew's Hospital·Phase 3·NCT00482716·80 enrolled

Clinical Study of Epoetin Beta to Chemotherapy-Induced Anemia (CIA) Patients

Completed· Roche logo

Roche·Phase 3·NCT00628043·160 enrolled

A Study of Epoetin Beta (NeoRecormon) in Predialysis Patients With Renal Anemia

Completed· Roche logo

Roche·Phase 4·NCT02569515·58 enrolled

Show 7 more trials

Paricalcitol Improves Anemia of Inflammation

Terminated·—·Phase 4·NCT02876211·19 enrolled

COMFORT Study: A Crossover Study of NeoRecormon (Epoetin Beta) and Darbepoetin Alfa in Patients With Renal Anemia.

Completed· Roche logo

Roche·Phase 4·NCT00377481·48 enrolled

An Observational Study of NeoRecormon (Epoetin Beta) in Cancer Patients With Anemia (FAST)

Completed· Roche logo

Roche··NCT01168349·1,060 enrolled

An Observational Study of Epoetin Beta [Neorecormon] to Evaluate the Quality of Life in Patients on Dialysis With Chronic Renal Anemia

Completed· Roche logo

Roche··NCT01105494·6,000 enrolled

A Study of NeoRecormon (Epoetin Beta) in Patients With Renal Anemia.

Terminated· Roche logo

Roche·Phase 4·NCT00440063

A Study of Treatment With NeoRecormon (Epoetin Beta) in Patients With Chronic Renal Anemia

Completed· Roche logo

Roche·Phase 3·NCT00321919·605 enrolled

A Study Comparing Maintenance of Hemoglobin Levels, Safety and Tolerability of Once Every 4 Weeks Mircera Versus Epoetin Beta in Dialysis Patients With Chronic Renal Anemia.

Completed· Roche logo

Roche·Phase 3·NCT00773331·281 enrolled

Chronic Kidney Disease5 trials

A Study of Intravenous or Subcutaneous Methoxy Polyethylene Glycol-Epoetin Beta (RO0503821, Mircera) in Chronic Kidney Disease Patients With Renal Anemia

Completed· Roche logo

Roche·Phase 3·NCT00090753·1,228 enrolled

A Study of Once Monthly Intravenous or Subcutaneous Mircera in Participants With Chronic Kidney Disease on Hemodialysis.

Completed· Roche logo

Roche·Phase 3·NCT00717821·421 enrolled

A Study to Assess All-Cause Mortality and Cardiovascular Morbidity in Participants With Chronic Kidney Disease (CKD) on Dialysis and Those Not on Renal Replacement Therapy Receiving Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) or Reference Erythropoietin Stimulating Agents (ESAs)

Completed· Roche logo

Roche·Phase 4·NCT00773513·2,825 enrolled

Show 2 more trials

A Study Comparing Mircera and Epoetin Beta for the Treatment of Anemia in Dialysis Patients With Chronic Kidney Disease.

Completed· Roche logo

Roche·Phase 3·NCT00442793·265 enrolled

A Study of NeoRecormon in Patients With Chronic Kidney Disease.

Completed· Roche logo

Roche·Phase 4·NCT00437723·90 enrolled

Myelodysplastic Syndrome3 trials

Azacitidine Combined to Epoetin Beta in International Prognostic Scoring System (IPSS) Low-risk and Intermediate-1 Myelodysplastic Syndrome (MDS) Patients, Resistant to Erythropoetin-stimulating Agents (ESA)

Completed·GGroupe Francophone des Myelodysplasies·Phase 2·NCT01015352·98 enrolled

A Study of Epoetin Beta Treatment in Anemic Participants With Myelodysplastic Syndrome (MDS)

Completed· Roche logo

Roche·Phase 4·NCT02145026·100 enrolled

Treatment of Anemia With Epoetin Beta in Low Risk Myelodysplastic Syndrome (MDS)

Completed·GGroupe Francophone des Myelodysplasies·Phase 2·NCT02428686·50 enrolled

Hematologic Malignancies2 trials

A Study to Assess the Hematopoyetic Response of Anemic Patients With Hematologic Malignancies Treated With Erythropoietin B

Terminated· Roche logo

Roche·Phase 4·NCT02608060·4 enrolled

A Study of Epoetin Beta (NeoRecormon) in Participants With Solid Tumors or Hematologic Malignancies

Completed· Roche logo

Roche·Phase 4·NCT02564094·54 enrolled

Chronic Hepatitis2 trials

A Study of NeoRecormon (Epoetin Beta) in Anemic Patients With Chronic Hepatitis C.

Completed· Roche logo

Roche·Phase 4·NCT00560274·190 enrolled

Use or Non-use of Epoetin Beta in Patients Infected by Chronic Hepatitis C

Completed·UUniversity Hospital, Angers·Phase 3·NCT00262379·229 enrolled

21 more indications

Cervical Cancer1 trial

Epoetin Beta in Treating Anemia in Patients With Cervical Cancer

Completed·AAGO Study Group·Phase 4·NCT00046969·450 enrolled

Myeloid Malignancy1 trial

A Study of Recormon (Epoetin Beta) in Anemic Patients With Non-Myeloid Malignancy

Terminated· Roche logo

Roche·Phase 4·NCT02624141·10 enrolled

Breast Cancer1 trial

A Study to Evaluate Efficacy and Safety of Epoetin Beta (NeoRecormon®) in Anemic Participants With Breast Cancer Undergoing Chemotherapy

Completed· Roche logo

Roche·Phase 2·NCT02761642·200 enrolled

Lymphoid Malignancies1 trial

A Study of the Quality of Life and Treatment Response to Once Weekly Epoetin Beta (Recormon) Treatment in Anemic Participants With Solid and Lymphoid Malignancies

Completed· Roche logo

Roche·Phase 4·NCT00776425·117 enrolled

Solid Tumors1 trial

A Study of Epoetin Beta (NeoRecormon) in Participants With Solid Tumors

Completed· Roche logo

Roche·Phase 4·NCT02554942·28 enrolled

Nephropathy1 trial

Prevention of Contrast Induced Nephropathy by Erythropoietin

Unknown status·WWestern Galilee Hospital-Nahariya·Phase 3·NCT01364402·142 enrolled

Lenalidomide1 trial

Lenalidomide in Subject With Low and Intermediate-1 Risk MDS and Without Chromosome 5 Abnormality.

Completed·GGroupe Francophone des Myelodysplasies·Phase 2·NCT01718379·132 enrolled

Transplantation1 trial

PROTECT: Prospective Trial on Erythropoietin in Clinical Transplantation

Completed·LLeiden University Medical Center·Phase 4·NCT00157300·92 enrolled

Dialysis Patients1 trial

Clinical Study of R744 to Predialysis Patients( Phase III, Comparative Study in Comparison With Epoetin Beta)

Completed· Roche logo

Roche·Phase 3·NCT00492427·187 enrolled

Low Birth Weight1 trial

Erythropoietin Treatment in Extremely Low Birth Weight Infants

Completed·—·N/A·NCT00593801·219 enrolled

Fatigue1 trial

Epoetin Beta in Treating Fatigue and Anemia in Patients Receiving Palliative Care for Malignant Solid Tumors

Completed·—·Phase 2·NCT00559195·40 enrolled

Erythropoietin1 trial

Predictors of Response to Iron and Erythropoietin Stimulating Agents

Completed·IImperial College London·Phase 4·NCT03658876·197 enrolled

Ischemia1 trial

Preliminary Administration of EPO and Markers of Cardiac Ischemia Induced by CPB

Completed·UUniversity Hospital, Grenoble·Phase 2·NCT00273767·50 enrolled

Chemotherapy1 trial

Epoetin Beta in Patients Undergoing Chemotherapy for Solid Tumors

Terminated·IInstitut du Cancer de Montpellier - Val d'Aurelle·N/A·NCT00875004·27 enrolled

Observational Study1 trial

An Observational Study of Epoetin Beta (NeoRecormon) in Participants With Cancer Receiving Chemotherapy

Completed· Roche logo

Roche··NCT01809314·1,167 enrolled

Treatment1 trial

Phase IV Study to Evaluate the Efficacy/Safety to Extend Treatment and High Dose of Ribavirin in co-Infected Patients

Unknown status·HHospital Carlos III, Madrid·Phase 4·NCT00526448·384 enrolled

Chronic Renal Failure1 trial

A Study of Epoetin Beta (NeoRecormon) in Anemic Participants With Diabetes and Chronic Renal Failure Who Are Not on Dialysis

Completed· Roche logo

Roche·Phase 3·NCT02827266·122 enrolled

End-Stage Renal Disease1 trial

A Study of NeoRecormon (Epoetin Beta) in Patients With End Stage Renal Disease.

Completed· Roche logo

Roche·Phase 4·NCT00413101·50 enrolled

Kidney Transplant1 trial

Effect of Epoetin Beta on Renal Function Within 30 Days Following a Kidney Transplant

Completed·—·Phase 3·NCT00815867·108 enrolled

Diabetic Nephropathy1 trial

(ACORD Study) - A Study of NeoRecormon (Epoetin Beta) in Patients With Early Diabetic Nephropathy

Completed· Roche logo

Roche·Phase 3·NCT00354341·170 enrolled

Unspecified1 trial

Bioequivalence of a Single Subcutaneous Dose of Epoetin Beta in Healthy Japanese and Caucasian Male Subjects

Completed·IInCROM Europe Clinical Research·Phase 1·NCT01085552·23 enrolled

Regulatory

FDA Approval Timeline[4]

Nov 14, 2007

MIRCERA

NDA BLA125164

Jul 7, 2008

MIRCERA

NDA BLA125164

Oct 1, 2014

MIRCERA

NDA BLA125164

Aug 21, 2015

MIRCERA

NDA BLA125164

Apr 28, 2016

MIRCERA

NDA BLA125164

Apr 28, 2016

MIRCERA

NDA BLA125164

Apr 28, 2016

MIRCERA

NDA BLA125164

Jun 7, 2018

MIRCERA

NDA BLA125164

Aug 30, 2022

MIRCERA

NDA BLA125164

Mar 31, 2023

MIRCERA

NDA BLA125164

Apr 30, 2024

MIRCERA

NDA BLA125164

Jun 4, 2024

MIRCERA

NDA BLA125164

Sources

References

[1]
ClinicalTrials.gov — 43 trial records for epoetin beta. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — epoetin beta compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for epoetin beta. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA BLA125164). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Roche company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Erythropoietin Receptor Agonist[2]
Modality: Biologic[2]
Highest Phase: Approved[1]
Company: Roche

epoetin beta

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Anemia10 trials

Chronic Kidney Disease5 trials

Myelodysplastic Syndrome3 trials

Hematologic Malignancies2 trials

Chronic Hepatitis2 trials

Cervical Cancer1 trial

Myeloid Malignancy1 trial

Breast Cancer1 trial

Lymphoid Malignancies1 trial

Solid Tumors1 trial

Nephropathy1 trial

Lenalidomide1 trial

Transplantation1 trial

Dialysis Patients1 trial

Low Birth Weight1 trial

Fatigue1 trial

Erythropoietin1 trial

Ischemia1 trial

Chemotherapy1 trial

Observational Study1 trial

Treatment1 trial

Chronic Renal Failure1 trial

End-Stage Renal Disease1 trial

Kidney Transplant1 trial

Diabetic Nephropathy1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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