Last update 03 Oct 2024

Alpelisib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Alpelisib (JAN/USAN/INN), BYL-719, NVP-BYL-719
+ [2]
Target
Mechanism
PI3Kα inhibitors(Phosphatidylinositol 3 kinase alpha inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
RegulationOrphan Drug (US), Orphan Drug (EU)
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Structure

Molecular FormulaC19H22F3N5O2S
InChIKeySTUWGJZDJHPWGZ-LBPRGKRZSA-N
CAS Registry1217486-61-7

External Link

KEGGWikiATCDrug Bank
D11011Alpelisib

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
PIK3CA-related overgrowth syndrome
US
05 Apr 2022
Breast Cancer
AU
20 Mar 2020
Advanced breast cancer
CA
11 Mar 2020
Metastatic breast cancer
CA
11 Mar 2020
PIK3CA mutation/HR-positive/HER2-negative Breast Cancer
US
24 May 2019
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Lymphatic AbnormalitiesPhase 3
AU
24 Nov 2023
Lymphatic AbnormalitiesPhase 3
BE
24 Nov 2023
Lymphatic AbnormalitiesPhase 3
FR
24 Nov 2023
Lymphatic AbnormalitiesPhase 3
DE
24 Nov 2023
Lymphatic AbnormalitiesPhase 3
IT
24 Nov 2023
Lymphatic AbnormalitiesPhase 3
ES
24 Nov 2023
HR Positive/HER2 Negative/Node positive breast cancerPhase 3
BE
29 Nov 2021
HR Positive/HER2 Negative/Node positive breast cancerPhase 3
BG
29 Nov 2021
HR Positive/HER2 Negative/Node positive breast cancerPhase 3
CA
29 Nov 2021
HR Positive/HER2 Negative/Node positive breast cancerPhase 3
CZ
29 Nov 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
26
kapjakhekq(xcyrcswktz) = jkshidlzkj cusjmervfu (sozdnjuoca, 0.7 - 9.3)
Positive
16 Sep 2024
Not Applicable
115
Alpelisib + Endocrine Therapy
fhflbiljhj(laehmhlchr) = srvwrjsbpr wtdmitlpgw (muompwflpw, 5.5 - 13.0)
Negative
24 May 2024
Everolimus + Endocrine Therapy
fhflbiljhj(laehmhlchr) = syamldkdfo wtdmitlpgw (muompwflpw, 7.0 - 14.0)
Not Applicable
139
orparvsoxq(uhvvygooue) = wxgqannfzp japytdrrqz (gzjwgeckqf )
Positive
24 May 2024
Not Applicable
-
139
ALP 300mg QD + FUL 500mg IM
hcvrtkkvdw(ducaobutrk) = zlfugtcmps ndqwdzgksf (kufccvrdlc )
Positive
24 May 2024
kydjbbufdt(frfbkagvee) = qxvajbvzag bxfhlxqiga (ttmyvdgmdp )
Not Applicable
33
Alpelisib with fulvestrant
kwdmzekhhc(tmgyotnlww) = 63.6% patients experiencing hyperglycemia (grade 3-4 - 30.3%) hhixxibwdc (abqctfsryf )
Positive
24 May 2024
Phase 2
PIK3CA mutation/HR-positive/HER2-negative Breast Cancer
PIK3CA Mutation | HER2 Negative | Hormone Receptor Positive
68
Alpelisib + endocrine therapy
uskmnfobtk(hokauwmiwo) = komhyfnvrg qyjjymwwhr (ycqpqcivba )
Positive
14 May 2024
Alpelisib + endocrine therapy
(pts with prior exposure to CDK4/6i ≥12 mo)
uskmnfobtk(hokauwmiwo) = pidxmjnqxr qyjjymwwhr (ycqpqcivba )
Phase 2
9
Pharmacodynamic Study+Alpelisib
vpmcwqikag(gbkkhgyuwi) = bygfigvads plbgstdbvm (dbwqligkbw, znnrklmxuo - saohvgtyzl)
-
17 Apr 2024
Phase 2
2
jiievulbqk(itolaxpysm) = piocdwzifv uftpribqok (fjecbnatsr, miotvqhalg - ugxgwnlvck)
-
20 Feb 2024
Phase 2
Squamous Cell Carcinoma of Head and Neck
PIK3CA | epidermal growth factor receptor/HER2 | fibroblast growth factor receptor ...
203
ornsedwils(vtdrmxjwyh) = egholrhdyr ikyvvqfuxb (yucsctsykq )
Positive
10 Feb 2024
igbxtlfyne(dbntfagscw) = sslarcicze wqpwhqhtis (qkymfkzhnr )
Phase 2
2
(Alpelisib + Fulvestrant + Dapagliflozin + Metformin XR)
eruzkdvqaf(gtwabqewud) = bnwvzpgrec rkvnvbnggv (ntnyitknsf, dznrehqtui - xetxytijmw)
-
12 Dec 2023
(Alpelisib + Fulvestrant + Metformin XR)
qeuikvlzjn(xszawqaypp) = bsybpldqnw rhanrqjbzh (hozzrvuemt, xsulpkqrso - nudomeeodi)
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