NDAORALTABLETPriority Review
Approved
May 2019
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 9h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PIQRAY (alpelisib) is an oral small-molecule PI3K inhibitor approved in 2019 for hormone receptor-positive, HER2-negative breast cancer. It is used in combination with hormone therapy to block the PI3K signaling pathway that drives tumor growth in PIK3CA-mutant cancers.
$0.138BPart D
Peak6.9 years to LOEStrong commercial momentum at peak lifecycle stage with $138M in Part D spending; brand team likely at full operational capacity.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
EPIK-P4: A Phase II Single-arm Study to Assess the Efficacy, Safety and Pharmacokinetics of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum (PROS)
Started Oct 2025
104 enrolled
PIK3CA-related Overgrowth Spectrum (PROS)
24VA022; VATCH Alpelisib for TIE2/PIK3CA Pathway VAs
Started Aug 2025
61 enrolled
Vascular AnomaliesVascular AnomalyTIE2/PIK3CA Pathway Driven Vascular Anomalies
A Study of Alpelisib and Fulvestrant to Treat Endometrial Cancer
Started Sep 2024
51 enrolled
Endometroid Endometrial Cancer
Alpelisib in Pediatric and Adult Patients With Lymphatic Malformations Associated With a PIK3CA Mutation.
Started Nov 2023
232 enrolled
Lymphatic Malformations
Detection of Tumor DNA in the Blood of Patients Receiving Standard Therapy for Hormone Receptor-positive (HR+) Non-HER2 Expressing (HER2-) Metastatic Breast Cancer as a Tool to Select Those Who May Benefit From the Next Course of Fulvestrant in Combination With Alpelisib or Ribociclib
Started Oct 2023
162 enrolled
Breast Cancer Stage IV
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.