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Drug ReportsRomiplostim
Nplate(romiplostim)
Nplate (romiplostim) is a protein pharmaceutical. Romiplostim was first approved as Nplate on 2008-08-22. It is used to treat thrombocytopenic purpura idiopathic in the USA. It has been approved in Europe to treat thrombocytopenic purpura idiopathic. The pharmaceutical is active against thrombopoietin receptor.
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Clinical
Drug
Target
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Financial
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Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
hemic and lymphatic diseasesD006425
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Nplate
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Romiplostim
Tradename
Proper name
Company
Number
Date
Products
NplateromiplostimAmgenN-125268 RX2008-08-22
3 products
Labels
FDA
EMA
Brand Name
Status
Last Update
nplateBiologic Licensing Application2022-02-17
Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration
Code
romiplostim, Nplate, Amgen Inc.
2028-01-28Orphan excl.
Patent Expiration
No data
ATC Codes
B: Blood and blood forming organ drugs
— B02: Antihemorrhagics
— B02B: Vitamin k and other hemostatics
— B02BX: Other systemic hemostatics in atc
— B02BX04: Romiplostim
HCPCS
Code
Description
J2796
Injection, romiplostim, 10 micrograms
Clinical
Clinical Trials
88 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ThrombocytopeniaD013921HP_0001873D69.65261651260
Thrombocytopenic purpura idiopathicD016553EFO_0007160D69.33121541040
Thrombocytopenic purpuraD011696——27112524
PurpuraD011693HP_0000979D69.227112524
Aplastic anemiaD000741HP_0001915D61.91633111
AnemiaD000740HP_0001903D64.9—633110
Liver diseasesD008107HP_0002910K70-K77———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C80341——6
Ovarian neoplasmsD010051EFO_0003893C56—11——2
Non-small-cell lung carcinomaD002289———11——2
Lung neoplasmsD008175HP_0100526C34.90—11——2
Ovarian epithelial carcinomaD000077216———11——2
Colorectal neoplasmsD015179————1——1
Vaccine immunogenicityD000071497————1——1
Healthy volunteers/patients—————1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SyndromeD013577———6——28
Myelodysplastic syndromesD009190—D4615——17
PreleukemiaD011289——15——17
LymphomaD008223—C85.925———5
Non-hodgkin lymphomaD008228—C85.924———4
Wiskott-aldrich syndromeD014923EFO_0003903D82.0—1——12
PancytopeniaD010198HP_0001876D61.8111———2
CytopeniaD000095542——11———2
Multiple myelomaD009101—C90.0—2———2
Hodgkin diseaseD006689—C8112———2
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Bone marrow failure disordersD000080983——1————1
Hematologic neoplasmsD019337——1————1
PharmacokineticsD010599——1————1
Therapeutic equivalencyD013810——1————1
Pharmacological phenomenaD000069437——1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SplenectomyD013156——————11
Congenital abnormalitiesD000013EFO_0003915Q89.9————11
Spontaneous abortionD000022EFO_1001255O00.1————11
Birth weightD001724EFO_0004344—————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameRomiplostim
INNromiplostim
Description
L-methionyl[human immunogloblin heavy constant gamma 1-(227 C-terminal residues)-peptide (Fc fragment)] fusion protein with 41 amino acids peptide, (7-7':10,10')-bisdisulfide dimer
Classification
Protein
Drug classcolony-stimulating factors
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL1201832
ChEBI ID—
PubChem CID—
DrugBankDB05332
UNII IDGN5XU2DXKV (ChemIDplus, GSRS)
Target
Agency Approved
MPL
MPL
Organism
Homo sapiens
Gene name
MPL
Gene synonyms
TPOR
NCBI Gene ID
Protein name
thrombopoietin receptor
Protein synonyms
CD110, Myeloproliferative leukemia protein, myeloproliferative leukemia virus oncogene, Proto-oncogene c-Mpl, TPO-R
Uniprot ID
Mouse ortholog
Mpl (17480)
thrombopoietin receptor (Q08351)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Nplate – Amgen
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,896 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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18,854 adverse events reported
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