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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Events Timeline
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YTD
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Events
FDA approval date
EMA approval date
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Study first post date
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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
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
117 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 | 20 | 23 | 7 | 1 | 9 | 55 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Triple negative breast neoplasms | D064726 | — | — | 3 | 5 | 1 | — | — | 9 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 2 | — | 1 | — | — | 3 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 9 | 5 | — | — | 1 | 13 |
| Squamous cell carcinoma of head and neck | D000077195 | — | — | 4 | 5 | — | — | 1 | 8 |
| Squamous cell carcinoma | D002294 | — | — | 1 | 2 | — | — | — | 2 |
| Colorectal neoplasms | D015179 | — | — | 1 | 2 | — | — | — | 2 |
| Head and neck neoplasms | D006258 | — | — | 1 | 1 | — | — | — | 2 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | 1 | 1 | — | — | — | 2 |
| Lymphangioma | D008202 | — | D18.1 | — | 1 | — | — | 1 | 2 |
| Non-small-cell lung carcinoma | D002289 | — | — | — | 1 | — | — | — | 1 |
| Gastrointestinal neoplasms | D005770 | — | C26.9 | — | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Hyperinsulinism | D006946 | HP_0000842 | E16.1 | 2 | — | — | — | — | 2 |
| Rectal neoplasms | D012004 | — | — | 1 | — | — | — | — | 1 |
| Esophageal squamous cell carcinoma | D000077277 | — | — | 1 | — | — | — | — | 1 |
| Kidney neoplasms | D007680 | EFO_0003865 | C64 | 1 | — | — | — | — | 1 |
| Gastrointestinal stromal tumors | D046152 | EFO_0000505 | C49.A | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 1 | — | — | — | — | 1 |
| Multiple myeloma | D009101 | — | C90.0 | 1 | — | — | — | — | 1 |
| Esophageal neoplasms | D004938 | — | C15 | 1 | — | — | — | — | 1 |
| Meningioma | D008579 | EFO_0003098 | D32.9 | 1 | — | — | — | — | 1 |
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Indications Without Phase
No data
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
PIK3CA
PIK3CA
Organism
Homo sapiens
Gene name
PIK3CA
Gene synonyms
NCBI Gene ID
Protein name
phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit alpha isoform
Protein synonyms
mutant phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha, p110alpha, phosphatidylinositol 3-kinase, catalytic, 110-KD, alpha, phosphatidylinositol 3-kinase, catalytic, alpha polypeptide, Phosphatidylinositol 4,5-bisphosphate 3-kinase 110 kDa catalytic subunit alpha, phosphatidylinositol-4,5-bisphosphate 3-kinase 110 kDa catalytic subunit alpha, Phosphoinositide 3-kinase alpha, Phosphoinositide-3-kinase catalytic alpha polypeptide, phosphoinositide-3-kinase, catalytic, alpha polypeptide, PI3-kinase p110 subunit alpha, PtdIns-3-kinase subunit p110-alpha, Serine/threonine protein kinase PIK3CA
Uniprot ID
Mouse ortholog
Pik3ca (18706)
phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit alpha isoform (Q0VGQ5)
Alternate
PIK3CB
PIK3CB
PIK3CG
PIK3CG
PIK3CD
PIK3CD
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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£
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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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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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4,048 adverse events reported
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