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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Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
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
Trade Name
FDA
EMA
Reblozyl
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)
Luspatercept
Tradename
Proper name
Company
Number
Date
Products
Reblozylluspatercept-aamtCelgeneN-761136 RX2019-11-08
2 products
Labels
FDA
EMA
Brand Name
Status
Last Update
luspaterceptBiologic Licensing Application2019-11-18
reblozylBiologic Licensing Application2024-05-17
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
anemiaEFO_0004272D000740D64.9
Agency Specific
FDA
EMA
Expiration
Code
luspatercept, Reblozyl, Celgene Corporation, a Bristol-Myers Squibb Company
2030-08-28Orphan excl.
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
— B03XA06: Luspatercept
HCPCS
Code
Description
J0896
Injection, luspatercept-aamt, 0.25 mg
Clinical
Clinical Trials
48 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 syndromesD009190—D46122138
PreleukemiaD011289———12137
AnemiaD000740EFO_0004272D64.9—311—5
ThalassemiaD013789EFO_1001996D56—2—125
Beta-thalassemiaD017086Orphanet_848D56.1—1—124
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SyndromeD013577———12—36
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C80—1———1
Myeloproliferative disordersD009196—D47.1—1———1
NeutropeniaD009503—D70—1———1
ThrombocytopeniaD013921HP_0001873D69.6—1———1
LeukopeniaD007970EFO_0004233D72.819—1———1
Clonal hematopoiesisD000082182———1———1
CytopeniaD000095542———1———1
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameLuspatercept
INNluspatercept
Description
Luspatercept
Classification
Protein
Drug classreceptor molecules or membrane ligands, natural, modified or modified: transforming growth factor receptors
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID1373715-00-4
RxCUI2262544
ChEMBL IDCHEMBL3039545
ChEBI ID—
PubChem CID—
DrugBankDB12281
UNII IDAQK7UBA1LS (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
GDF11
GDF11
BMP10
BMP10
GDF2
GDF2
MSTN
MSTN
BMP6
BMP6
Organism
Homo sapiens
Gene name
GDF11
Gene synonyms
BMP11
NCBI Gene ID
Protein name
growth/differentiation factor 11
Protein synonyms
BMP-11, Bone morphogenetic protein 11, GDF-11
Uniprot ID
Mouse ortholog
Gdf11 (14561)
growth/differentiation factor 11 (Q9Z1W4)
Variants
No data
Financial
Revenue by drug
$
€
£
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 729 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,508 adverse events reported
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