Last reviewed · How we verify
PI3K inhibitor BYL719
PI3K inhibitor BYL719 is a Small molecule drug developed by Vanderbilt-Ingram Cancer Center. It is currently in Phase 1 development. Also known as: BYL719, a-specific phosphoinositide 3-kinase inhibitor BYL719, BYL719, phosphoinositide 3-kinase inhibitor BYL719.
BYL719, also known as alpelisib, is a small molecule PI3K inhibitor used to treat various conditions, including breast cancer, metastatic breast cancer, and solid tumors. It has been studied in combination with other treatments, such as nab-paclitaxel, for locally recurrent or metastatic HER2-negative breast cancer.
-
Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | PI3K inhibitor BYL719 |
|---|---|
| Also known as | BYL719, a-specific phosphoinositide 3-kinase inhibitor BYL719, BYL719, phosphoinositide 3-kinase inhibitor BYL719 |
| Sponsor | Vanderbilt-Ingram Cancer Center |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
- Aspartate Aminotransferase Increased
- Hyperglycemia
- Peripheral Sensory Neuropathy
- Anemia
- Fatigue
- Alkaline Phosphatase Increased
- Hypoalbuminemia
- Hypokalemia
- Lymphocyte Count Decrease
- Platelet Count Decrease
- Cough
- Rash Maculo-papular
Key clinical trials
- Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial (PHASE2)
- Study Assessing the Efficacy and Safety of Alpelisib + Nab-paclitaxel in Subjects With Advanced TNBC Who Carry Either a PIK3CA Mutation or Have PTEN Loss (PHASE3)
- Phase 1/2 Study of ETX-636 in Participants With Advanced Solid Tumors (PHASE1, PHASE2)
- Alpelisib Plus Olaparib in Platinum-resistant/Refractory, High-grade Serous Ovarian Cancer, With no Germline BRCA Mutation Detected (PHASE3)
- First-in-Human Study of STX-478 as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors (PHASE1, PHASE2)
- 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) (PHASE2)
- Assessment of the Efficacy and Safety of Alpelisib (BYL719) in Pediatric and Adult Patients With Megalencephaly-CApillary Malformation Polymicrogyria Syndrome (MCAP) (PHASE2)
- A Trial of Targeted Therapies for Patients With Slow-Flow or Fast-Flow Vascular Malformations (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- PI3K inhibitor BYL719 CI brief — competitive landscape report
- PI3K inhibitor BYL719 updates RSS · CI watch RSS
- Vanderbilt-Ingram Cancer Center portfolio CI
Frequently asked questions about PI3K inhibitor BYL719
What is PI3K inhibitor BYL719?
Who makes PI3K inhibitor BYL719?
Is PI3K inhibitor BYL719 also known as anything else?
What development phase is PI3K inhibitor BYL719 in?
What are the side effects of PI3K inhibitor BYL719?
Related
- Manufacturer: Vanderbilt-Ingram Cancer Center — full pipeline
- Also known as: BYL719, a-specific phosphoinositide 3-kinase inhibitor BYL719, BYL719, phosphoinositide 3-kinase inhibitor BYL719
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing