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 18h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PIQRAY (alpelisib) is an oral small-molecule PI3K inhibitor approved by the FDA in May 2019. It is indicated for hormone receptor-positive, HER2-negative breast cancer in combination with hormonal therapy. Alpelisib blocks PI3K signaling to restore endocrine sensitivity and overcome resistance to hormone therapy.
$138MPart D
Peak6.6 years to LOEProduct is at peak commercial maturity with $138M in Part D spending; established brand team managing mature portfolio with stable commercial operations.
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)
Roll-Over Study of Alpelisib (BYL719) for Continued Access and Long-Term Safety.
Started Dec 2026
51 enrolled
PIK3CA-Related Overgrowth Spectrum (PROS)Breast Neoplasms (Including Advanced or Metastatic Breast Cancer With PIK3CA Mutation)
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
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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.