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Drug ReportsEpoetin beta
Epoetin beta
NeoRecormon (epoetin beta) is a protein pharmaceutical. Epoetin beta was first approved as Neorecormon on 1997-07-16. It has been approved in Europe to treat anemia, autologous blood transfusion, chronic kidney failure, and neoplasms.
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FDA approval date
EMA approval date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
urogenital diseasesD000091642
hemic and lymphatic diseasesD006425
signs and symptoms pathological conditionsD013568
therapeuticsD013812
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
No data
Labels
FDA
EMA
Brand Name
Status
Last Update
epochOTC monograph not final2022-01-12
epoch ava puhi moni anti-dandruffC2002632024-12-31
epogenBiologic Licensing Application2025-04-14
mirceraBiologic Licensing Application2024-06-05
nu skin epochOTC monograph final2009-12-14
procritBiologic Licensing Application2025-04-09
retacritBiologic Licensing Application2024-06-26
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
B: Blood and blood forming organ drugs
B03: Antianemic preparations
B03X: Other antianemic preparations in atc
B03XA: Other antianemic preparations in atc
B03XA03: Methoxy polyethylene glycol-epoetin beta
HCPCS
Code
Description
J0887
Injection, epoetin beta, 1 microgram, (for esrd on dialysis)
J0888
Injection, epoetin beta, 1 microgram, (for non esrd use)
Clinical
Clinical Trials
811 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AnemiaD000740EFO_0004272D64.9161191507873424
Kidney diseasesD007674EFO_0003086N08945492236158
Chronic renal insufficiencyD051436N181040522031152
Chronic kidney failureD007676EFO_0003884N18.6102623141482
Renal insufficiencyD051437N199222414974
NeoplasmsD009369C801171651251
SyndromeD013577326113847
Myelodysplastic syndromesD009190D46324123745
PreleukemiaD011289223123643
Iron deficienciesD000090463E61.113461022
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients1631523
LeukemiaD007938C9587116
Multiple myelomaD009101C90.038415
Wounds and injuriesD014947T14.8164514
Blood transfusionD00180345612
Plasma cell neoplasmsD05421936211
Brain injuriesD001930S06.975111
Brain diseasesD001927G93.4054511
Traumatic brain injuriesD000070642S065418
StrokeD020521EFO_0000712I63.93618
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Indications Phases 2
Indications Phases 1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
CytopeniaD00009554299
PancytopeniaD010198D61.8188
Diabetic retinopathyD003930EFO_000377022
Iron metabolism disordersD019189E83.122
Hemolytic anemiaD000743D55-D5922
Surgical blood lossD01606322
Respiratory insufficiencyD012131J96.922
Type 1 diabetes mellitusD003922EFO_0001359E1022
Continuous ambulatory peritoneal dialysisD01053111
Developmental disabilitiesD002658EFO_0003852F8911
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameEpoetin beta
INNepoetin alfa
Description
Epoetin beta (INN), sold under the brand name Neorecormon among others, is a synthetic, recombinant form of erythropoietin, a protein that promotes the production of red blood cells. It is an erythropoiesis-stimulating agent (ESA) that is used to treat anemia, commonly associated with chronic kidney failure and cancer chemotherapy.
Classification
Protein
Drug classerythropoietins
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
Identifiers
PDB
CAS-ID122312-54-3
RxCUI105695
ChEMBL IDCHEMBL2109092
ChEBI ID
PubChem CID
DrugBankDB00016
UNII ID64FS3BFH5W (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 57,651 documents
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Safety
Black-box Warning
Black-box warning for: Epogen, Mircera, Procrit, Retacrit
Adverse Events
Top Adverse Reactions
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49,350 adverse events reported
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