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Drug ReportsAlpelisib
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
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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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
VIJOICENovartisN-218466 RX2024-04-24
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
piqrayNew Drug Application2024-07-18
vijoiceNew Drug Application2024-07-23
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
82274622033-04-29DS, DPU-3809
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
116 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 neoplasmsD001943EFO_0003869C502529811370
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Triple negative breast neoplasmsD064726——561——12
Ovarian neoplasmsD010051EFO_0003893C56211——4
Ovarian epithelial carcinomaD000077216——2—1——3
LymphangiomaD008202—D18.1—21—13
Congenital abnormalitiesD000013EFO_0003915Q89.9—31——3
Lymphatic abnormalitiesD044148———21——2
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C80117——116
CarcinomaD002277—C80.088———13
Squamous cell carcinomaD002294——76——111
Squamous cell carcinoma of head and neckD000077195——67——110
Squamous cell neoplasmsD018307——31——14
RecurrenceD012008——22———3
Endometrial neoplasmsD016889EFO_0004230—12———3
Non-small-cell lung carcinomaD002289——11———2
Lung neoplasmsD008175HP_0100526C34.9011———2
Colorectal neoplasmsD015179——12———2
Show 24 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HyperglycemiaD006943HP_0003074R73.91———23
Liver diseasesD008107HP_0002910K70-K772————2
Pancreatic neoplasmsD010190EFO_0003860C252————2
Insulin resistanceD007333HP_0000855—2————2
Non-alcoholic fatty liver diseaseD065626EFO_0003095K75.812————2
HyperinsulinismD006946HP_0000842E16.12————2
Rectal neoplasmsD012004——1————1
Esophageal squamous cell carcinomaD000077277——1————1
Renal cell carcinomaD002292EFO_0000376—1————1
Kidney neoplasmsD007680EFO_0003865C641————1
Show 19 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Disease progressionD018450——————11
Diabetes mellitusD003920HP_0000819E08-E13————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)Loading
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-ID1217486-47-9
RxCUI—
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
No data
Financial
Revenue by drug
$
€
£
â‚£
Piqray – Novartis
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,336 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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7,852 adverse events reported
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