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AboutPricing
Drug ReportsQuizartinib
Vanflyta(quizartinib)
Vanflyta (quizartinib) is a small molecule pharmaceutical. Quizartinib was first approved as Vanflyta on 2023-07-20. It is used to treat myeloid leukemia acute in the USA. It has been approved in Europe to treat myeloid leukemia. The pharmaceutical is active against receptor-type tyrosine-protein kinase FLT3. In addition, it is known to target macrophage colony-stimulating factor 1 receptor, platelet-derived growth factor receptor alpha, proto-oncogene tyrosine-protein kinase receptor Ret, mast/stem cell growth factor receptor Kit, and platelet-derived growth factor receptor beta.
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Financial
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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
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
hemic and lymphatic diseasesD006425
Trade Name
FDA
EMA
Vanflyta
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Quizartinib dihydrochloride
Tradename
Company
Number
Date
Products
VANFLYTADaiichi PharmaceuticalN-216993 RX2023-07-20
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
vanflytaNew Drug Application2024-07-01
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
myeloid leukemia acute—D015470C92.0
Agency Specific
FDA
EMA
Expiration
Code
QUIZARTINIB DIHYDROCHLORIDE, VANFLYTA, DAIICHI SANKYO INC
2030-07-20ODE-437
2028-07-20NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Quizartinib Dihydrochloride, Vanflyta, Daiichi Sankyo Inc
96755492033-09-30DP
83576902031-02-26U-3661
95550402030-05-14U-3661
88362182030-03-23U-3661
79685432029-08-15DPU-3661
88657102029-08-15DP
78206572028-09-26DP
81293742027-03-16U-3661
85578102027-03-16DP
88837832027-03-16DP
95858922027-03-16U-3661
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01E: Protein kinase inhibitors, antineoplastic and immunomodulating agents
— L01EX: Other protein kinase inhibitors in atc
— L01EX11: Quizartinib
HCPCS
No data
Clinical
Clinical Trials
47 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LeukemiaD007938—C95873—117
Myeloid leukemia acuteD015470—C92.0882—117
Myeloid leukemiaD007951—C92872—116
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myelodysplastic syndromesD009190—D4621———2
RecurrenceD012008——11———1
PreleukemiaD011289——11———1
SyndromeD013577——11———1
Pathologic complete responseD000095384———1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———5————5
PharmacokineticsD010599——2————2
Drug interactionsD004347——2————2
Liver diseasesD008107EFO_0001421K70-K772————2
Hepatic insufficiencyD048550——2————2
NeoplasmsD009369—C801————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameQuizartinib
INNquizartinib
Description
Quizartinib is a member of the class of phenylureas that is urea in which one of the amino groups has been substituted by a 5-tert-butyl-1,2-oxazol-3-yl group while the other has been substituted by a phenyl group substituted at the para- position by an imidazo[2,1-b][1,3]benzothiazol-2-yl group that, in turn, is substituted at position 7 by a 2-(morpholin-4-yl)ethoxy group. It has a role as an EC 2.7.10.1 (receptor protein-tyrosine kinase) inhibitor, an antineoplastic agent and a necroptosis inhibitor. It is a benzoimidazothiazole, a member of morpholines, a member of isoxazoles and a member of phenylureas.
Classification
Small molecule
Drug classtyrosine kinase inhibitors
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Structure (InChI/SMILES or Protein Sequence)
CC(C)(C)c1cc(NC(=O)Nc2ccc(-c3cn4c(n3)sc3cc(OCCN5CCOCC5)ccc34)cc2)no1
Identifiers
PDB—
CAS-ID950769-58-1
RxCUI—
ChEMBL IDCHEMBL576982
ChEBI ID90217
PubChem CID24889392
DrugBankDB12874
UNII ID7LA4O6Q0D3 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
RET
RET
Organism
Homo sapiens
Gene name
RET
Gene synonyms
CDHF12, CDHR16, PTC, RET51
NCBI Gene ID
5979
Protein name
proto-oncogene tyrosine-protein kinase receptor Ret
Protein synonyms
Cadherin family member 12, cadherin-related family member 16, Proto-oncogene c-Ret, rearranged during transfection, ret proto-oncogene (multiple endocrine neoplasia and medullary thyroid carcinoma 1, Hirschsprung disease), RET receptor tyrosine kinase
Uniprot ID
Q9BTB0
Mouse ortholog
Ret (19713)
proto-oncogene tyrosine-protein kinase receptor Ret (P35546)
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,169 documents
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Safety
Black-box Warning
Black-box warning for: Vanflyta
Adverse Events
Top Adverse Reactions
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219 adverse events reported
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