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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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FDA Novel Drug Approvals 2019
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
skin and connective tissue diseasesD017437
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)
Alpelisib
Tradename
Company
Number
Date
Products
PIQRAYNovartisN-212526 RX2019-05-24
3 products, RLD, RS
VIJOICENovartisN-215039 RX2022-04-05
3 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
piqrayNew Drug Application2020-09-17
vijoiceNew Drug Application2022-04-07
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
breast neoplasmsEFO_0003869D001943C50
male breast neoplasms—D018567—
Agency Specific
FDA
EMA
Expiration
Code
ALPELISIB, VIJOICE, NOVARTIS
2029-04-05ODE-396
2024-05-24NCE
ALPELISIB, PIQRAY, NOVARTIS
2024-05-24NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Alpelisib, Piqray, Novartis
82274622030-09-28DS, DPU-2539
84762682029-09-10DS, DP
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01E: Protein kinase inhibitors, antineoplastic and immunomodulating agents
— L01EM: Phosphatidylinositol-3-kinase (pi3k) inhibitors
— L01EM03: Alpelisib
HCPCS
No data
Clinical
Clinical Trials
94 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
Breast neoplasmsD001943EFO_0003869C50182171750
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Triple negative breast neoplasmsD064726331——7
Ovarian neoplasmsD010051EFO_0003893C56111——3
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369C8094——112
Squamous cell carcinoma of head and neckD00007719545——18
Squamous cell carcinomaD00229412———2
Colorectal neoplasmsD01517912———2
Head and neck neoplasmsD00625811———2
Endometrial neoplasmsD016889EFO_000423011———2
Non-small-cell lung carcinomaD002289—1———1
Gastrointestinal neoplasmsD005770C26.9—1———1
Oropharyngeal neoplasmsD00995911———1
Squamous cell neoplasmsD01830711———1
Show 2 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Rectal neoplasmsD0120041————1
Esophageal squamous cell carcinomaD0000772771————1
Kidney neoplasmsD007680EFO_0003865C641————1
Gastrointestinal stromal tumorsD046152EFO_0000505C49.A1————1
Hepatic insufficiencyD0485501————1
Pancreatic neoplasmsD010190EFO_0003860C251————1
Multiple myelomaD009101C90.01————1
Esophageal neoplasmsD004938C151————1
MeningiomaD008579EFO_0003098D32.91————1
Uveal neoplasmsD014604EFO_10012301————1
Show 4 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LymphangiomaD008202D18.1————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameALPELISIB
INNalpelisib
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 classphosphatidylinositol 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-ID1217486-61-7
RxCUI2169285
ChEMBL IDCHEMBL2396661
ChEBI ID—
PubChem CID56649450
DrugBankDB12015
UNII ID08W5N2C97Q (ChemIDplus, GSRS)
Target
Agency Approved
PIK3CA
PIK3CA
Organism
Homo sapiens
Gene name
PIK3CA
Gene synonyms
NCBI Gene ID
5290
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
Q99762
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
5291
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
Q24JU2
Mouse ortholog
Pik3cb (74769)
phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit beta isoform (Q8BTI9)
Variants
Clinical Variant
No data
Financial
Piqray - Novartis
$
€
£
₣
Mock data
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,401 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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16,020 adverse events reported
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