NDAORALTABLETPriority Review
Approved
May 2019
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
Drug data last refreshed Yesterday · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PIQRAY (alpelisib) is an oral small-molecule PI3K inhibitor developed by Novartis and approved by the FDA on May 24, 2019. It is indicated for multiple cancer types including hormone receptor-positive breast cancer, PIK3CA-mutant ovarian and endometrial cancers, pancreatic neuroendocrine neoplasms, and rare conditions such as PIK3CA-Related Overgrowth Spectrum and lymphatic malformations. The drug works by inhibiting phosphatidylinositol 3-kinase (PI3K), a key enzyme in cell growth and survival pathways dysregulated in PIK3CA-mutant tumors, positioning it as a precision medicine option for genomically selected patient populations.
$0.1BPart D
7.0 years to LOEMechanism 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.