Reblozyl(luspatercept)
Reblozyl (luspatercept) is a protein pharmaceutical. Luspatercept was first approved as Reblozyl on 2019-11-08. It is used to treat anemia in the USA. It has been approved in Europe to treat anemia, beta-thalassemia, and myelodysplastic syndromes. It is known to target growth/differentiation factor 11, bone morphogenetic protein 10, growth/differentiation factor 2, growth/differentiation factor 8, and bone morphogenetic protein 6.
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FDA approval date
EMA approval date
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Reblozyl
Drug Products
FDA
EMA
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| luspatercept | Biologic Licensing Application | 2019-11-18 |
| reblozyl | Biologic Licensing Application | 2024-05-17 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| anemia | EFO_0004272 | D000740 | D64.9 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
luspatercept, Reblozyl, Celgene Corporation, a Bristol-Myers Squibb Company | |||
| 2030-08-28 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J0896 | Injection, luspatercept-aamt, 0.25 mg |
Clinical
Clinical Trials
56 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myelodysplastic syndromes | D009190 | — | D46 | 3 | 13 | 7 | 1 | 10 | 32 |
| Preleukemia | D011289 | — | — | 1 | 7 | 5 | 1 | 9 | 23 |
| Anemia | D000740 | EFO_0004272 | D64.9 | 1 | 10 | 4 | 1 | 2 | 18 |
| Thalassemia | D013789 | EFO_1001996 | D56 | — | 5 | 2 | 1 | 7 | 15 |
| Syndrome | D013577 | — | — | 1 | 5 | 3 | 1 | 5 | 15 |
| Beta-thalassemia | D017086 | Orphanet_848 | D56.1 | — | 4 | 2 | 2 | 6 | 14 |
| Aplastic anemia | D000741 | — | D61.9 | — | 1 | — | 1 | 1 | 3 |
| Hematologic diseases | D006402 | EFO_0005803 | D75.9 | — | — | — | 1 | — | 1 |
| Bone marrow diseases | D001855 | — | — | — | — | — | 1 | — | 1 |
| Hemoglobinopathies | D006453 | — | D58.2 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myeloproliferative disorders | D009196 | — | D47.1 | — | 3 | 2 | — | — | 5 |
| Primary myelofibrosis | D055728 | — | D47.4 | — | 2 | 2 | — | 1 | 5 |
| Neoplasms | D009369 | — | C80 | — | 2 | 1 | — | — | 3 |
| Refractory anemia with excess of blasts | D000754 | — | D46.2 | — | 1 | 1 | — | — | 2 |
| Erythrocyte transfusion | D017707 | — | — | — | — | 1 | — | — | 1 |
| Polycythemia vera | D011087 | — | D45 | — | — | 1 | — | — | 1 |
| Polycythemia | D011086 | EFO_0005804 | D75.1 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neutropenia | D009503 | — | D70 | — | 1 | — | — | 1 | 2 |
| Thrombocytopenia | D013921 | HP_0001873 | D69.6 | — | 1 | — | — | 1 | 2 |
| Cytopenia | D000095542 | — | — | — | 1 | — | — | 1 | 2 |
| Alpha-thalassemia | D017085 | Orphanet_846 | D56.0 | — | 1 | — | — | — | 1 |
| Myelodysplastic-myeloproliferative diseases | D054437 | — | — | — | 1 | — | — | — | 1 |
| Thrombocytosis | D013922 | — | D75.83 | — | 1 | — | — | — | 1 |
| Leukopenia | D007970 | EFO_0004233 | D72.819 | — | 1 | — | — | — | 1 |
| Clonal hematopoiesis | D000082182 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | — | — | — | — | 1 | 1 |
| Myeloid leukemia acute | D015470 | — | C92.0 | — | — | — | — | 1 | 1 |
| Myeloid leukemia | D007951 | — | C92 | — | — | — | — | 1 | 1 |
| Thrombocytopenic purpura idiopathic | D016553 | EFO_0007160 | D69.3 | — | — | — | — | 1 | 1 |
| Hemolysis | D006461 | — | — | — | — | — | — | 1 | 1 |
| Hemolytic anemia autoimmune | D000744 | EFO_1001264 | D59.10 | — | — | — | — | 1 | 1 |
| Hemolytic anemia | D000743 | — | D55-D59 | — | — | — | — | 1 | 1 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | — | — | — | — | 1 | 1 |
| Granulosa cell tumor | D006106 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Luspatercept |
| INN | luspatercept |
| Description | Luspatercept |
| Classification | Protein |
| Drug class | receptor molecules or membrane ligands, natural, modified or modified: transforming growth factor receptors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 1373715-00-4 |
| RxCUI | 2262544 |
| ChEMBL ID | CHEMBL3039545 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB12281 |
| UNII ID | AQK7UBA1LS (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
GDF11
GDF11
BMP10
BMP10
GDF2
GDF2
MSTN
MSTN
BMP6
BMP6
Variants
No data
Financial
Revenue by drug
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£
â‚£
Reblozyl – Bristol Myers Squibb
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Reblozyl – Merck & Co
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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 839 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2,006 adverse events reported
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