Piqray(alpelisib)
Piqray, Vijoice (alpelisib) is a small molecule pharmaceutical. Alpelisib was first approved as Piqray on 2019-05-24. It is used to treat breast neoplasms and male breast neoplasms in the USA. It has been approved in Europe to treat breast neoplasms. The pharmaceutical is active against phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit alpha isoform. In addition, it is known to target phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit beta isoform, phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit gamma isoform, and phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit delta isoform.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| skin and connective tissue diseases | D017437 |
Trade Name
FDA
EMA
Piqray, Vijoice
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| breast neoplasms | EFO_0003869 | D001943 | C50 |
| male breast neoplasms | — | D018567 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
ALPELISIB, VIJOICE, NOVARTIS | |||
| 2029-04-05 | ODE-396 | ||
| 2024-05-24 | NCE | ||
ALPELISIB, PIQRAY, NOVARTIS | |||
| 2024-05-24 | NCE | ||
HCPCS
No data
Clinical
Clinical Trials
123 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 16 | 17 | 5 | 1 | 10 | 46 |
| Multiple endocrine neoplasia type 1 | D018761 | — | E31.21 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Triple negative breast neoplasms | D064726 | — | — | 2 | 4 | 1 | — | — | 7 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 1 | — | 1 | — | — | 2 |
| Lymphangioma | D008202 | — | D18.1 | — | 1 | 1 | — | — | 1 |
| Lymphatic abnormalities | D044148 | — | — | — | 1 | 1 | — | — | 1 |
| Cystic lymphangioma | D018191 | — | — | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 7 | 2 | — | — | — | 8 |
| Squamous cell carcinoma | D002294 | — | — | 4 | 2 | — | — | — | 5 |
| Carcinoma | D002277 | — | C80.0 | 4 | 1 | — | — | — | 4 |
| Squamous cell carcinoma of head and neck | D000077195 | — | — | 3 | 1 | — | — | — | 3 |
| Squamous cell neoplasms | D018307 | — | — | 2 | 1 | — | — | — | 2 |
| Hereditary sensory and autonomic neuropathies | D009477 | — | — | 1 | 2 | — | — | — | 2 |
| Lung neoplasms | D008175 | — | C34.90 | — | 1 | — | — | — | 1 |
| Adenocarcinoma | D000230 | — | — | — | 1 | — | — | — | 1 |
| Adenocarcinoma of lung | D000077192 | — | — | — | 1 | — | — | — | 1 |
| Oropharyngeal neoplasms | D009959 | — | — | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 3 | — | — | — | — | 3 |
| Esophageal squamous cell carcinoma | D000077277 | — | — | 1 | — | — | — | — | 1 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 1 | — | — | — | — | 1 |
| Kidney neoplasms | D007680 | EFO_0003865 | C64 | 1 | — | — | — | — | 1 |
| Neuroendocrine tumors | D018358 | EFO_1001901 | D3A.8 | 1 | — | — | — | — | 1 |
| Gastrointestinal stromal tumors | D046152 | EFO_0000505 | C49.A | 1 | — | — | — | — | 1 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 1 | — | — | — | — | 1 |
| Multiple myeloma | D009101 | — | C90.0 | 1 | — | — | — | — | 1 |
Show 6 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Disease progression | D018450 | — | — | — | — | — | — | 1 | 1 |
| Hyperglycemia | D006943 | — | R73.9 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Alpelisib |
| INN | alpelisib |
| Description | (2S)-N1-[4-methyl-5-[2-(1,1,1-trifluoro-2-methylpropan-2-yl)-4-pyridinyl]-2-thiazolyl]pyrrolidine-1,2-dicarboxamide is a proline derivative. |
| Classification | Small molecule |
| Drug class | phosphatidylinositol 3-kinase (PI3K) inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | Cc1nc(NC(=O)N2CCC[C@H]2C(N)=O)sc1-c1ccnc(C(C)(C)C(F)(F)F)c1 |
Identifiers
| PDB | — |
| CAS-ID | 1217486-47-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL2396661 |
| ChEBI ID | — |
| PubChem CID | 56649450 |
| DrugBank | DB12015 |
| UNII ID | 08W5N2C97Q (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
PIK3CB
PIK3CB
Organism
Homo sapiens
Gene name
PIK3CB
Gene synonyms
PIK3C1
NCBI Gene ID
Protein name
phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit beta isoform
Protein synonyms
p110beta, Phosphatidylinositol 4,5-bisphosphate 3-kinase 110 kDa catalytic subunit beta, phosphoinositide-3-kinase, catalytic, beta polypeptide, PI3-kinase p110 subunit beta, PI3-kinase subunit beta, PI3K-beta, PtdIns-3-kinase p110, ptdIns-3-kinase subunit beta, PtdIns-3-kinase subunit p110-beta, Serine/threonine protein kinase PIK3CB
Uniprot ID
Mouse ortholog
Pik3cb (74769)
phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit beta isoform (Q8BTI9)
Variants
No data
Financial
Revenue by drug
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Piqray – Novartis
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 5,256 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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8,525 adverse events reported
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