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Drug ReportsTagraxofusp
Elzonris(tagraxofusp)
Elzonris (tagraxofusp) is a protein pharmaceutical. Tagraxofusp was first approved as Elzonris on 2018-12-21. It is used to treat malignant histiocytic disorders in the USA. It has been approved in Europe to treat lymphoma.
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Events Timeline
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YTD
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FDA approval date
EMA approval date
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Study first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
hemic and lymphatic diseasesD006425
immune system diseasesD007154
Trade Name
FDA
EMA
Elzonris
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)
Tagraxofusp
Tradename
Proper name
Company
Number
Date
Products
Elzonristagraxofusp-erzsStemline TherapeuticsN-761116 RX2018-12-21
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
elzonrisBiologic Licensing Application2023-07-31
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
malignant histiocytic disorders—D015620—
Agency Specific
FDA
EMA
Expiration
Code
tagraxofusp, Elzonris, Stemline Therapeutics, Inc.
2025-12-21Orphan excl.
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01X: Other antineoplastic agents in atc
— L01XX: Other antineoplastic agents in atc
— L01XX67: Tagraxofusp
HCPCS
Code
Description
J9269
Injection, tagraxofusp-erzs, 10 micrograms
Clinical
Clinical Trials
21 clinical trials
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Indications Phases 4
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Indications Phases 3
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LeukemiaD007938—C95109———13
Myeloid leukemia acuteD015470—C92.097———12
Myeloid leukemiaD007951—C9276———9
NeoplasmsD009369—C8044———6
Myelodysplastic syndromesD009190—D4631———3
Primary myelofibrosisD055728—D47.421———3
Myelomonocytic leukemia chronicD015477—C93.122———3
Myelomonocytic leukemia juvenileD054429—C93.322———3
PreleukemiaD011289——21———2
SyndromeD013577——21———2
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Residual neoplasmD018365——1————1
Hematologic neoplasmsD019337——1————1
T-cell lymphomaD016399——1————1
Hodgkin diseaseD006689—C811————1
B-cell lymphomaD016393——1————1
DiphtheriaD004165EFO_0005549A361————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTAGRAXOFUSP
INNtagraxofusp
Description
Tagraxofusp, sold under the brand name Elzonris, is an anti-cancer medication for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN).
Classification
Protein
Drug classfusion proteins
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID2055491-00-2
RxCUI—
ChEMBL IDCHEMBL4297573
ChEBI ID—
PubChem CID—
DrugBankDB14731
UNII ID8ZHS5657EH (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 438 documents
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Safety
Black-box Warning
Black-box warning for: Elzonris
Adverse Events
Top Adverse Reactions
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426 adverse events reported
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