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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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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
mirceraBiologic Licensing Application2019-08-05
retacritBiologic Licensing Application2022-07-19
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
527 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AnemiaD000740EFO_0004272D64.96681125320256
Chronic renal insufficiencyD051436N1847196844
NeoplasmsD009369C80—13145739
Chronic kidney failureD007676EFO_0003884N18.637145534
Myelodysplastic syndromesD009190D4611472—23
Hiv infectionsD015658EFO_0000764B2012—4815
LymphomaD008223C85.91271112
Breast neoplasmsD001943EFO_0003869C50—161—8
Drug therapyD004358—213—6
Renal insufficiencyD051437HP_0000083N19—13116
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LeukemiaD007938C95—37—111
Plasma cell neoplasmsD054219—25—18
Cerebral palsyD002547G80121—37
Brain hypoxia-ischemiaD020925EFO_1000846P91.6433——7
Blood transfusionD001803—45—17
Orthopedic proceduresD019637—46——7
Traumatic brain injuriesD000070642S06—34—16
Multiple myelomaD009101C90.0——3—25
Precancerous conditionsD011230—22——4
Lymphoproliferative disordersD008232Orphanet_2442D47.9—22——4
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—113——214
Acquired immunodeficiency syndromeD000163EFO_0000765B20—5———5
Reperfusion injuryD01542711——13
Congenital heart defectsD006330HP_0001627Q24.912——13
Retinopathy of prematurityD012178EFO_1001158H35.111——12
Sickle cell anemiaD000755EFO_0000697D5721———2
Moyamoya diseaseD009072EFO_0004250I67.511——12
Amyotrophic lateral sclerosisD000690EFO_0000253G12.2112———2
Replacement arthroplasty kneeD019645—1——12
Chronic diseaseD002908—1——12
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Substance-related disordersD019966EFO_0003890F131———12
Pulmonary hypertensionD006976EFO_0001361I27.201————1
Autoimmune hepatitisD019693K75.41————1
Parkinson diseaseD010300EFO_0002508G201————1
Alveolar bone lossD0163011————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Developmental disabilitiesD002658EFO_0003852F89————11
Iron metabolism disordersD019189E83.1————11
Cerebrovascular disordersD002561EFO_0003763I60-I69————11
Uterine diseasesD014591N85.9————11
Heart diseasesD006331EFO_0003777I51.9————11
Myocardial reperfusion injuryD015428EFO_0002687————11
HemiarthroplastyD062785————11
FibrosisD005355————11
Crohn diseaseD003424EFO_0000384K50————11
Insulin resistanceD007333EFO_0002614————11
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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)
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
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,497 documents
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Safety
Black-box Warning
Black-box warning for: Mircera, Retacrit
Adverse Events
Top Adverse Reactions
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327 adverse events reported
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