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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Commercial
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 |
|---|---|---|---|---|---|
| Nplate | romiplostim | Amgen Inc. | N-125268 RX | 2008-08-22 | 3 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| nplate | Biologic Licensing Application | 2021-02-17 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| thrombocytopenic purpura idiopathic | EFO_0007160 | D016553 | D69.3 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
romiplostim, Nplate, Amgen Inc. | |||
| 2028-01-28 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J2796 | Injection, romiplostim, 10 micrograms |
Clinical
Clinical Trials
61 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Thrombocytopenic purpura idiopathic | D016553 | EFO_0007160 | D69.3 | 2 | 8 | 12 | 2 | 1 | 23 |
| Thrombocytopenia | D013921 | HP_0001873 | D69.6 | 3 | 12 | 6 | 1 | 2 | 22 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Aplastic anemia | D000741 | HP_0001915 | D61.9 | 1 | 5 | 3 | — | — | 6 |
| Thrombocytopenic purpura | D011696 | 1 | 1 | 3 | — | — | 4 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myelodysplastic syndromes | D009190 | D46 | 1 | 5 | — | — | 1 | 7 | |
| Neoplasms | D009369 | C80 | 2 | 4 | — | — | — | 4 | |
| Non-hodgkin lymphoma | D008228 | C85.9 | 1 | 3 | — | — | — | 3 | |
| Wiskott-aldrich syndrome | D014923 | D82.0 | — | 1 | — | — | 1 | 2 | |
| Lymphoma | D008223 | C85.9 | 1 | 2 | — | — | — | 2 | |
| Multiple myeloma | D009101 | C90.0 | — | 2 | — | — | — | 2 | |
| Hodgkin disease | D006689 | C81 | 1 | 2 | — | — | — | 2 | |
| Glioblastoma | D005909 | EFO_0000515 | — | 2 | — | — | — | 2 | |
| Thrombotic thrombocytopenic purpura | D011697 | M31.19 | — | 1 | — | — | — | 1 | |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | — | 1 | — | — | — | 1 |
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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 disorders | D000080983 | 1 | — | — | — | — | 1 | ||
| Hematologic neoplasms | D019337 | 1 | — | — | — | — | 1 | ||
| Pharmacokinetics | D010599 | 1 | — | — | — | — | 1 | ||
| Therapeutic equivalency | D013810 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | ROMIPLOSTIM |
| INN | romiplostim |
| 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 class | colony-stimulating factors |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 267639-76-9 |
| RxCUI | 805452 |
| ChEMBL ID | CHEMBL1201832 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB05332 |
| UNII ID | GN5XU2DXKV (ChemIDplus, GSRS) |
Target
Agency Approved
MPL
MPL
Alternate
No data
Variants
Clinical Variant
No data
Financial
Nplate - Amgen
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€
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₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,484 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3,427 adverse events reported
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