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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EMA approval date
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| hemic and lymphatic diseases | D006425 |
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 |
|---|---|---|---|---|
| VANFLYTA | Daiichi Pharmaceutical | N-216993 RX | 2023-07-20 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| vanflyta | New Drug Application | 2025-11-12 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| myeloid leukemia acute | — | D015470 | C92.0 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
QUIZARTINIB DIHYDROCHLORIDE, VANFLYTA, DAIICHI SANKYO INC | |||
| 2030-07-20 | ODE-437 | ||
| 2028-07-20 | NCE | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Quizartinib Dihydrochloride, Vanflyta, Daiichi Sankyo Inc | |||
| 9675549 | 2033-09-30 | DP | |
| 8357690 | 2031-02-26 | U-3661 | |
| 9555040 | 2030-05-14 | U-3661 | |
| 8836218 | 2030-03-23 | U-3661 | |
| 7968543 | 2029-08-15 | DP | U-3661 |
| 8865710 | 2029-08-15 | DP | |
| 7820657 | 2028-09-26 | DP | |
| 8129374 | 2027-03-16 | U-3661 | |
| 8557810 | 2027-03-16 | DP | |
| 8883783 | 2027-03-16 | DP | |
| 9585892 | 2027-03-16 | U-3661 | |
HCPCS
No data
Clinical
Clinical Trials
49 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 |
|---|---|---|---|---|---|---|---|---|---|
| Myeloid leukemia acute | D015470 | — | C92.0 | 19 | 18 | 5 | — | 3 | 34 |
| Leukemia | D007938 | — | C95 | 14 | 14 | 4 | — | 2 | 26 |
| Myeloid leukemia | D007951 | — | C92 | 13 | 13 | 2 | — | 2 | 22 |
| Myelodysplastic syndromes | D009190 | — | D46 | 9 | 8 | 1 | — | — | 10 |
| Preleukemia | D011289 | — | — | 4 | 4 | 1 | — | — | 5 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Syndrome | D013577 | — | — | 4 | 3 | — | — | — | 4 |
| Myelomonocytic leukemia chronic | D015477 | — | C93.1 | 2 | 2 | — | — | — | 2 |
| Recurrence | D012008 | — | — | 2 | 1 | — | — | — | 2 |
| Myeloproliferative disorders | D009196 | — | D47.1 | 1 | 1 | — | — | — | 1 |
| Myelomonocytic leukemia acute | D015479 | — | C92.5 | 1 | 1 | — | — | — | 1 |
| Myelomonocytic leukemia juvenile | D054429 | — | C93.3 | 1 | 1 | — | — | — | 1 |
| Biphenotypic leukemia acute | D015456 | — | C95.0 | 1 | 1 | — | — | — | 1 |
| Promyelocytic leukemia acute | D015473 | — | C92.4 | — | 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 |
| Pharmacokinetics | D010599 | — | — | 2 | — | — | — | — | 2 |
| Drug interactions | D004347 | — | — | 2 | — | — | — | — | 2 |
| Neoplasms | D009369 | — | C80 | 2 | — | — | — | — | 2 |
| Hepatic insufficiency | D048550 | — | — | 2 | — | — | — | — | 2 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 1 | — | — | — | — | 1 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | 1 | — | — | — | — | 1 |
| Hematologic neoplasms | D019337 | — | — | 1 | — | — | — | — | 1 |
| Myeloid sarcoma | D023981 | — | C92.3 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Peripheral arterial disease | D058729 | EFO_0004265 | — | — | — | — | — | 1 | 1 |
| Peripheral vascular diseases | D016491 | EFO_0003875 | I73.9 | — | — | — | — | 1 | 1 |
| Diabetic foot | D017719 | EFO_1001459 | — | — | — | — | — | 1 | 1 |
| Ulcer | D014456 | MPATH_579 | — | — | — | — | — | 1 | 1 |
| Foot ulcer | D016523 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Quizartinib |
| INN | quizartinib |
| 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 class | tyrosine kinase inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC(C)(C)c1cc(NC(=O)Nc2ccc(-c3cn4c(n3)sc3cc(OCCN5CCOCC5)ccc34)cc2)no1 |
Identifiers
| PDB | — |
| CAS-ID | 950769-58-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL576982 |
| ChEBI ID | 90217 |
| PubChem CID | 24889392 |
| DrugBank | DB12874 |
| UNII ID | 7LA4O6Q0D3 (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
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
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 2,336 documents
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Safety
Black-box Warning
Black-box warning for: Vanflyta
Adverse Events
Top Adverse Reactions
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364 adverse events reported
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