Ayvakit, Ayvakyt(avapritinib)
Ayvakit, Ayvakyt (avapritinib) is a small molecule pharmaceutical. Avapritinib was first approved as Ayvakit on 2020-01-09. It is used to treat gastrointestinal stromal tumors in the USA. It has been approved in Europe to treat gastrointestinal stromal tumors. It is known to target mast/stem cell growth factor receptor Kit.
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FDA Novel Drug Approvals 2020
Commercial
Trade Name
FDA
EMA
Ayvakit
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Avapritinib
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| AYVAKIT | Blueprint Medicines | N-212608 RX | 2020-01-09 | 5 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| ayvakit | New Drug Application | 2020-01-21 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| gastrointestinal stromal tumors | EFO_0000505 | D046152 | C49.A |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
AVAPRITINIB, AYVAKIT, BLUEPRINT MEDICINES | |||
| 2028-06-16 | ODE-356 | ||
| 2027-01-09 | ODE-366 | ||
| 2025-01-09 | NCE | ||
| 2024-06-16 | I-863, I-864 | ||
HCPCS
No data
Clinical
Clinical Trials
15 clinical trials
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Mock data
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Gastrointestinal stromal tumors | D046152 | EFO_0000505 | C49.A | 3 | 1 | 1 | 1 | 3 | 8 |
Indications Phases 3
No data
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Systemic mastocytosis | D034721 | C96.21 | 1 | 2 | — | — | 1 | 4 | |
| Mast-cell leukemia | D007946 | C94.3 | 1 | 1 | — | — | 1 | 3 | |
| Neoplasms | D009369 | C80 | 2 | 1 | — | — | — | 2 | |
| Hematologic neoplasms | D019337 | — | 1 | — | — | 1 | 2 | ||
| Colorectal neoplasms | D015179 | — | 1 | — | — | — | 1 | ||
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 1 | — | — | — | 1 |
| Lung neoplasms | D008175 | C34.90 | — | 1 | — | — | — | 1 | |
| Sarcoma | D012509 | — | 1 | — | — | — | 1 | ||
| Central nervous system neoplasms | D016543 | — | 1 | — | — | — | 1 | ||
| Melanoma | D008545 | — | 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 name | AVAPRITINIB |
| INN | avapritinib |
| Description | Avapritinib, sold under the brand name Ayvakit among others, is a medication used for the treatment of advanced systemic mastocytosis and for the treatment of tumors due to one specific rare mutation: it is specifically intended for adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) that harbor a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation. Avapritinib is a kinase inhibitor.
|
| Classification | Small molecule |
| Drug class | tyrosine kinase inhibitors |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | Cn1cc(-c2cc3c(N4CCN(c5ncc([C@@](C)(N)c6ccc(F)cc6)cn5)CC4)ncnn3c2)cn1 |
Identifiers
| PDB | — |
| CAS-ID | 1703793-34-3 |
| RxCUI | 2272107 |
| ChEMBL ID | CHEMBL4204794 |
| ChEBI ID | — |
| PubChem CID | 118023034 |
| DrugBank | DB15233 |
| UNII ID | 513P80B4YJ (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
KIT
KIT
Organism
Homo sapiens
Gene name
KIT
Gene synonyms
SCFR
NCBI Gene ID
Protein name
mast/stem cell growth factor receptor Kit
Protein synonyms
c-Kit protooncogene, CD117, p145 c-kit, PBT, Piebald trait protein, Proto-oncogene c-Kit, proto-oncogene tyrosine-protein kinase Kit, Tyrosine-protein kinase Kit, v-kit Hardy-Zuckerman 4 feline sarcoma viral oncogene homolog, v-kit Hardy-Zuckerman 4 feline sarcoma viral oncogene-like protein
Uniprot ID
Mouse ortholog
Kit (16590)
mast/stem cell growth factor receptor Kit (Q8C8K9)
Variants
Clinical Variant
No data
Financial
Ayvakit - Blueprint Medicines
$
€
£
₣
Mock data
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 435 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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13,346 adverse events reported
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