Treats hormone receptor (HR)-positive, human epidermal growth … metastatic breast cancer. Sold as Piqray, Vijoice. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 3 applications for Alpelisib (sold as Piqray, Vijoice), first approved May 24, 2019, with 3 new uses approved and 0 published complete response letters.
| Piqray | Part D | $85.5M | -22% | 884 |
| Vijoice | Part D | $15.8M | +85% | 61 |
| Alpelisib Challenge Test (ACT)Insulin Resistance, Type 2 Diabetes · Columbia University | Phase 1 | Recruiting | Aug 21, 2026 |
| A Study of Clinical Practice and Real-world Care of Patients Treated With mTOR, PI3K, and MEK Inhibitors for Extracranial Vascular AnomaliesVascular Anomalies · Novartis Pharmaceuticals | — | Not yet recruiting | Aug 17, 2026 |
| Roll-Over Study of Alpelisib (BYL719) for Continued Access and Long-Term Safety.PIK3CA-Related Overgrowth Spectrum (PROS), Breast Neoplasms (Including Advanced or Metastatic Breast Cancer With PIK3CA Mutation) · Novartis Pharmaceuticals | Phase 2 | Not yet recruiting | Jul 1, 2026 |
| EVERST- Everolimus After Alpelisib in Women With Hormone Receptor-positive (HR+) Metastatic Breast Cancer (MBC)Hormone Receptor Positive Breast Cancer · Tel-Aviv Sourasky Medical Center | — | Recruiting | Jun 12, 2026 |
| Multidisciplinary Treatment of Stage III ALK+ NSCLC With Neoadjuvant Alectinib and ChemotherapyNonsmall Cell Lung Cancer Stage III · Wen-zhao ZHONG | Phase 2 | Not yet recruiting | May 7, 2026 |
| 24VA022; VATCH Alpelisib for TIE2/PIK3CA Pathway VAsVascular Anomalies, Vascular Anomaly · Children's Hospital of Philadelphia | Phase 2 | Recruiting | Apr 22, 2026 |
| 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)PIK3CA-related Overgrowth Spectrum (PROS) · Novartis Pharmaceuticals | Phase 2 | Recruiting | May 30, 2025 |
| Phase 1/2 Study of ETX-636 in Participants With Advanced Solid TumorsAdvanced Solid Tumors, Advanced Breast Cancer · Ensem Therapeutics | Phase 1 / Phase 2 | Recruiting | May 29, 2025 |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Novartis