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
Therapeutic Areas
Trade Name
FDA
EMA
Nplate
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| nplate | Biologic Licensing Application | 2025-03-13 |
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
109 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Thrombocytopenia | D013921 | HP_0001873 | D69.6 | 3 | 13 | 11 | 1 | 2 | 28 |
| Thrombocytopenic purpura idiopathic | D016553 | EFO_0007160 | D69.3 | 2 | 4 | 9 | 1 | 2 | 16 |
| Thrombocytopenic purpura | D011696 | — | — | 2 | 4 | 8 | 1 | 2 | 15 |
| Purpura | D011693 | HP_0000979 | D69.2 | 2 | 4 | 7 | 1 | 2 | 14 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Non-small-cell lung carcinoma | D002289 | — | — | — | 1 | 1 | — | — | 2 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | — | 1 | — | — | 1 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | — | — | 1 | — | — | 1 |
| Colorectal neoplasms | D015179 | — | — | — | — | 1 | — | — | 1 |
| Hematologic diseases | D006402 | EFO_0005803 | D75.9 | — | — | 1 | — | — | 1 |
| Hemostatic disorders | D020141 | — | — | — | — | 1 | — | — | 1 |
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 |
| Preleukemia | D011289 | — | — | 1 | 5 | — | — | 1 | 7 |
| Syndrome | D013577 | — | — | — | 5 | — | — | 1 | 6 |
| Lymphoma | D008223 | — | C85.9 | 2 | 5 | — | — | — | 5 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 2 | 4 | — | — | — | 4 |
| Neoplasms | D009369 | — | C80 | 2 | 3 | — | — | — | 3 |
| Aplastic anemia | D000741 | — | D61.9 | 1 | 1 | — | — | — | 2 |
| Pancytopenia | D010198 | — | D61.81 | 1 | 1 | — | — | — | 2 |
| Cytopenia | D000095542 | — | — | 1 | 1 | — | — | — | 2 |
| Hodgkin disease | D006689 | — | C81 | 1 | 2 | — | — | — | 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 disorders | D000080983 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Congenital abnormalities | D000013 | EFO_0003915 | Q89.9 | — | — | — | — | 1 | 1 |
| Spontaneous abortion | D000022 | EFO_1001255 | O00.1 | — | — | — | — | 1 | 1 |
| Birth weight | D001724 | EFO_0004344 | — | — | — | — | — | 1 | 1 |
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 | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201832 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB05332 |
| UNII ID | GN5XU2DXKV (ChemIDplus, GSRS) |
Target
Agency Approved
MPL
MPL
Alternate
No data
Variants
No data
Financial
Revenue by drug
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Nplate – Amgen
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Estimated US medical usage
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,365 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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19,519 adverse events reported
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