Xospata(gilteritinib)
Xospata (gilteritinib) is a small molecule pharmaceutical. Gilteritinib was first approved as Xospata on 2018-11-28. It is used to treat myeloid leukemia acute in the USA. It has been approved in Europe to treat myeloid leukemia acute. It is known to target tyrosine-protein kinase receptor UFO, high affinity nerve growth factor receptor, proto-oncogene tyrosine-protein kinase receptor Ret, tyrosine-protein kinase Mer, leukocyte tyrosine kinase receptor, proto-oncogene tyrosine-protein kinase ROS, receptor-type tyrosine-protein kinase FLT3, and ALK tyrosine kinase receptor.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| hemic and lymphatic diseases | D006425 |
Trade Name
FDA
EMA
Xospata
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Gilteritinib fumarate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| XOSPATA | Astellas Pharma | N-211349 RX | 2018-11-28 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| xospata | New Drug Application | 2022-04-29 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| myeloid leukemia acute | — | D015470 | C92.0 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
GILTERITINIB FUMARATE, XOSPATA, ASTELLAS | |||
| 2025-11-28 | ODE-222 | ||
HCPCS
No data
Clinical
Clinical Trials
66 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 | 26 | 24 | 7 | — | 9 | 53 |
| Leukemia | D007938 | — | C95 | 24 | 19 | 6 | — | 8 | 46 |
| Myeloid leukemia | D007951 | — | C92 | 24 | 19 | 6 | — | 7 | 45 |
| Myelodysplastic syndromes | D009190 | — | D46 | 3 | 4 | 1 | — | — | 6 |
| Recurrence | D012008 | — | — | 1 | 3 | 1 | — | — | 4 |
| Preleukemia | D011289 | — | — | 2 | 2 | 1 | — | — | 4 |
| Syndrome | D013577 | — | — | 2 | 2 | 1 | — | — | 4 |
| Refractory anemia with excess of blasts | D000754 | — | D46.2 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 4 | 2 | — | — | — | 4 |
| Hematologic neoplasms | D019337 | — | — | 2 | 1 | — | — | 1 | 3 |
| Residual neoplasm | D018365 | — | — | — | 1 | — | — | 2 | 3 |
| Myelomonocytic leukemia chronic | D015477 | — | C93.1 | 2 | 2 | — | — | — | 2 |
| Myelomonocytic leukemia juvenile | D054429 | — | C93.3 | 2 | 2 | — | — | — | 2 |
| Non-small-cell lung carcinoma | D002289 | — | — | 2 | 1 | — | — | — | 2 |
| Lung neoplasms | D008175 | — | C34.90 | 2 | 1 | — | — | — | 2 |
| Myeloproliferative disorders | D009196 | — | D47.1 | 1 | 1 | — | — | — | 1 |
| Myelomonocytic leukemia acute | D015479 | — | C92.5 | 1 | 1 | — | — | — | 1 |
| Myelodysplastic-myeloproliferative diseases | D054437 | — | — | 1 | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 2 | — | — | — | — | 2 |
| Renal insufficiency | D051437 | — | N19 | 1 | — | — | — | — | 1 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
| Pharmacokinetics | D010599 | — | — | 1 | — | — | — | — | 1 |
| Neoplasms by histologic type | D009370 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pathologic complete response | D000095384 | — | — | — | — | — | — | 2 | 2 |
| Frailty | D000073496 | — | R53.1 | — | — | — | — | 1 | 1 |
| Infections | D007239 | EFO_0000544 | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Gilteritinib |
| INN | gilteritinib |
| Description | Gilteritinib is a member of the class of pyrazines that is pyrazine-2-carboxamide which is substituted by {3-methoxy-4-[4-(4-methylpiperazin-1-yl)piperidin-1-yl]phenyl}nitrilo, (oxan-4-yl)nitrilo and ethyl groups at positions 3,5 and 6, respectively. It is a potent inhibitor of FLT3 and AXL tyrosine kinase receptors (IC50 = 0.29 nM and 0.73 nM, respectively). Approved by the FDA for the treatment of acute myeloid leukemia in patients who have a FLT3 gene mutation. It has a role as an apoptosis inducer, an EC 2.7.10.1 (receptor protein-tyrosine kinase) inhibitor and an antineoplastic agent. It is a N-methylpiperazine, a member of piperidines, a secondary amino compound, a monomethoxybenzene, a member of pyrazines, a primary carboxamide, an aromatic amine and a member of oxanes. |
| Classification | Small molecule |
| Drug class | tyrosine kinase inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCc1nc(C(N)=O)c(Nc2ccc(N3CCC(N4CCN(C)CC4)CC3)c(OC)c2)nc1NC1CCOCC1 |
Identifiers
| PDB | — |
| CAS-ID | 1254053-43-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL3301622 |
| ChEBI ID | — |
| PubChem CID | 49803313 |
| DrugBank | DB12141 |
| UNII ID | 66D92MGC8M (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 2,086 documents
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Safety
Black-box Warning
Black-box warning for: Xospata
Adverse Events
Top Adverse Reactions
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3,262 adverse events reported
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