Drugs / Alpelisib
Alpelisib
also known as
BYL719 · ALPELISIB (BYL719) · BYL-719A-1214(S)-N1-(4-METHYL-5-(2-(1,1,1-TRIFLUORO-2-METHYLPROPAN-2-YL)PYRIDIN-4-YL)THIAZOL-2-YL)PYRROLIDINE-1,2-DICARBOXAMIDE · BYL719 (IND 107078) · NVP-BYL719 · PIQRAY · Vijoice
Small molecule targets PIK3CA via inhibition
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | VIJOICE | — | 2024-04-24 | fda.gov ↗ |
| Label expansions (2) | US (FDA) | PIQRAY | — | 2022-11-22 – 2024-01-18 | fda.gov ↗ |
| Approved | EU (EMA) | Piqray | — | 2020-07-27 | europa.eu ↗ |
| Approved | US (FDA) | PIQRAY | — | 2019-05-24 | fda.gov ↗ |
Trials 98 · started per year
today
US approved 2019
EU approved 2020
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT05238831 | Jan 2023 → May 2026 | female breast carcinoma, ovarian carcinoma, pancreatic ductal adenocarcinoma, pancreatic large cell neuroendocrine carcinoma +2 | OHSU Knight Cancer Institute | Withdrawn | No outcome recorded |
| Phase 136 trials | ||||||
| Phase 1 | NCT07778524 | Sep 2026 → Aug 2028 expected | obesity disorder, type 2 diabetes mellitus | Columbia University | Recruiting | No outcome recorded |
| Phase 1 | NCT06545682 | Oct 2024 → Aug 2027 expected | breast cancer, melanoma, metastatic malignant neoplasm in the brain | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT06354088 | Apr 2024 → Dec 2026 expected | NAFLD1, prediabetes syndrome | Columbia University | Recruiting | No outcome recorded |
| Phase 1 | NCT05733455 | May → Dec 2023 | hyperinsulinism, hyperlipidemia | Columbia University | Completed | No outcome recorded |
| Phase 1 | NCT05472220 | Nov 2022 → Apr 2028 | human papillomavirus-related squamous cell carcinoma, metastatic malignant neoplasm | Pamela Munster | Withdrawn | No outcome recorded Stop: Business |
| Phase 1 | NCT05508906 | Aug 2022 → Dec 2027 expected | Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer | Olema Pharmaceuticals, Inc. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05143229 | Mar 2022 → Jan 2025 overdue | breast cancer | University of Kansas Medical Center | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04188548 | Dec 2019 → Jun 2020 overdue | breast cancer, endometrial cancer | Eli Lilly and Company | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03631953 | Sep 2019 → Jan 2026 overdue | meningioma | Assistance Publique Hopitaux De Marseille | Recruiting | No outcome recorded |
| Phase 1 | NCT03207529 | Jun 2019 → Dec 2023 | triple-negative breast carcinoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT02620839 | Dec 2016 → Jan 2019 | cancer | Pamela Munster | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT02734615 | Jun 2016 → Sep 2021 | estrogen-receptor positive breast cancer | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 1 | NCT02550743 | Jun 2016 → Nov 2018 | rectal cancer | Howard Safran | Terminated | No outcome recorded |
| Phase 1 | NCT02624557 | Dec 2015 → Oct 2017 | — | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02537223 | Sep 2015 → Jun 2018 | head and neck squamous cell carcinoma | University Health Network, Toronto | Completed | No outcome recorded |
| Phase 1 | NCT02273219 | Nov 2014 → Oct 2017 | uveal melanoma | Columbia University | Completed | No outcome recorded |
| Phase 1 | NCT02155088 | Oct 2014 → Dec 2016 | malignant pancreatic neoplasm | H. Lee Moffitt Cancer Center and Research Institute | Completed | No outcome recorded |
| Phase 1 | NCT02282371 | Oct 2014 → Oct 2021 | head and neck squamous cell carcinoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT02144038 | Jul 2014 → Oct 2015 | refractory plasma cell neoplasm | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02167854 | Jun 2014 → Jul 2021 | breast cancer | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT02038010 | May 2014 → Apr 2015 | HER2 positive breast carcinoma | Northwestern University | Completed | No outcome recorded |
| Phase 1 | NCT02088684 | May 2014 → Apr 2018 | breast cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02077933 | May 2014 → Apr 2019 | breast neoplasm, kidney neoplasm, pancreatic neuroendocrine tumor | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02058381 | May 2014 → Jun 2018 | breast carcinoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02051751 | Mar 2014 → Aug 2016 | neoplasm | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01928459 | Oct 2013 → Aug 2016 | cancer, metastatic neoplasm | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01822613 | Jul 2013 → Jun 2016 | esophageal squamous cell carcinoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01870505 | May 2013 → Feb 2022 | female breast carcinoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT01791478 | Apr 2013 → Dec 2014 overdue | Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer, female breast carcinoma, invasive ductal breast carcinoma +1 | Vanderbilt-Ingram Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1 | NCT01735968 | Feb 2013 → Oct 2018 | gastrointestinal stromal tumor | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01613950 | Dec 2012 → Mar 2014 | gastric cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01623349 | Sep 2012 → May 2019 | breast cancer, ovarian cancer | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 1 | NCT01449058 | Mar 2012 → Aug 2016 | acute myeloid leukemia, myelodysplastic syndrome | Array BioPharma | Completed | No outcome recorded |
| Phase 1 | NCT01387321 | Sep 2011 → Nov 2015 | neoplasm | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01300962 | Aug 2011 → Feb 2017 | breast cancer | UNC Lineberger Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT01219699 | Oct 2010 → Feb 2015 | estrogen-receptor positive breast cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/211 trials · 1 missed | ||||||
| Phase 1/2 | NCT05563220 | Jan 2023 → Dec 2026 expected | breast cancer | Stemline Therapeutics, Inc. | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05230810 | Aug 2022 → Mar 2026 overdue | HER2 positive breast carcinoma | Criterium, Inc. | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04997902 | Dec 2021 → Aug 2025 | head and neck squamous cell carcinoma | Kura Oncology, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT04753203 | Feb 2021 → Feb 2024 | colorectal cancer | Korean Cancer Study Group | Unknown | No outcome recorded |
| Phase 1/2 | NCT04526470 | Sep 2020 → Jun 2023 | gastric cancer | Seoul National University Bundang Hospital | Unknown | No outcome recorded |
| Phase 1/2 | NCT03284957 | Sep 2017 → Nov 2024 | breast cancer | Sanofi | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT02298595 | Aug 2016 → Aug 2019 | oropharynx squamous cell carcinoma | Julie E. Bauman, MD, MPH | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT02379247 | Feb 2015 → Sep 2017 | breast cancer | Priyanka Sharma | Completed | No outcome recorded |
| Phase 1/2 | NCT01872260 | Oct 2013 → Feb 2027 expected | breast cancer | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT01708161 | Nov 2012 → Dec 2014 | — | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 1/2 | NCT01602315 | Nov 2012 → Sep 2016 | head and neck squamous cell carcinoma | Novartis Pharmaceuticals | Terminated | Missed primary Stop: Enrollment |
| Phase 237 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT07679269 | Dec 2026 → Mar 2032 expected | PIK3CA-related overgrowth spectrum, breast neoplasm | Novartis Pharmaceuticals | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07573696 | Jun 2026 → Feb 2030 expected | non-small cell lung carcinoma | Wen-zhao ZHONG | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06997588 | Oct 2025 → Jan 2029 expected | PIK3CA-related overgrowth spectrum | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 2 | NCT07543822 | Aug 2025 → Aug 2029 expected | vascular malformation | Children's Hospital of Philadelphia | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06739395 | Nov 2024 → Dec 2026 expected | cancer | Tianjin Medical University Second Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05933395 | Sep 2024 → Oct 2030 expected | breast cancer | Dartmouth-Hitchcock Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05983159 | Sep 2024 → Jan 2027 expected | PIK3CA-related overgrowth spectrum, arteriovenous hemangioma/malformation, cystic hygroma, lymphatic malformation +1 | Murdoch Childrens Research Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT05154487 | Sep 2024 → May 2028 expected | endometrial endometrioid adenocarcinoma | GOG Foundation | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05967286 | Oct 2023 → Apr 2025 | Her2-receptor negative breast cancer, female breast carcinoma | National Cancer Institute (NCI) | Withdrawn | No outcome recorded |
| Phase 2 | NCT05625087 | Oct 2023 → Jul 2028 expected | breast cancer | UNICANCER | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06837792 | Oct 2023 → Oct 2026 expected | Her2-receptor negative breast cancer | Yonsei University | Recruiting | No outcome recorded |
| Phase 2 | NCT06145308 | Aug 2023 → Jul 2028 expected | salivary gland carcinoma | Peking Union Medical College | Recruiting | No outcome recorded |
| Phase 2 | NCT05826964 | Jun 2023 → Jul 2026 overdue | Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer | University of Miami | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05564377 | Apr 2023 → Jul 2030 expected | Her2-receptor negative breast cancer, endometrial carcinoma, fallopian tube carcinoma, female breast carcinoma +3 | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT05101564 | Mar 2023 → Jun 2024 | Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer | Jennifer Lee Caswell-Jin | Completed | No outcome recorded |
| Phase 2 | NCT05577754 | Nov 2022 → Mar 2027 expected | megalencephaly-capillary malformation-polymicrogyria syndrome | Centre Hospitalier Universitaire Dijon | Recruiting | No outcome recorded |
| Phase 2 | NCT05392608 | Jun 2022 → May 2026 overdue | breast neoplasm | Dutch Breast Cancer Research Group | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04862143 | Mar → Sep 2022 | breast cancer | Novartis Pharmaceuticals | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04980833 | Jan 2022 → Aug 2027 expected | PIK3CA-related overgrowth spectrum | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04965688 | Aug 2021 → Mar 2024 | Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer | Inova Health Care Services | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04589650 | Apr 2021 → Mar 2024 overdue | PIK3CA-related overgrowth spectrum | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04817956 | Apr 2021 → Mar 2040 expected | metastatic malignant neoplasm | Oslo University Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT04762979 | Feb 2021 → Oct 2025 overdue | hormone receptor-positive breast cancer | Marina N Sharifi | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04544189 | Jan 2021 → Jan 2027 expected | breast neoplasm | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04524000 | Jan 2021 → Feb 2027 expected | breast cancer | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04591431 | Oct 2020 → Dec 2024 | breast cancer, digestive system cancer, non-small cell lung carcinoma | Fondazione per la Medicina Personalizzata | Unknown | Met primary |
| Phase 2 | NCT04216472 | Jul 2020 → Sep 2025 | female breast carcinoma, triple-negative breast carcinoma | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 2 | NCT03601507 | Mar 2019 → May 2022 | oropharynx squamous cell carcinoma | University of Arizona | Terminated | No outcome recorded |
| Phase 2 | NCT03386162 | Mar 2018 → Nov 2022 | breast cancer | UNICANCER | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03292250 | Sep 2017 → Mar 2020 | head and neck squamous cell carcinoma | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 2 | NCT03056755 | Aug 2017 → Jun 2021 | breast cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT02145312 | Oct 2016 → May 2019 | head and neck squamous cell carcinoma | Yonsei University | Unknown | No outcome recorded |
| Phase 2 | NCT02925234 | Aug 2016 → Sep 2027 expected | cancer | The Netherlands Cancer Institute | Recruiting | Mixed |
| Phase 2 | NCT02506556 | Sep 2015 → Oct 2021 | breast cancer | Peter MacCallum Cancer Centre, Australia | Completed | No outcome recorded |
| Phase 2 | NCT02276027 | Jan 2015 → Oct 2019 | lung adenocarcinoma, squamous cell lung carcinoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01923168 | Mar 2014 → Jul 2017 | breast cancer | Novartis Pharmaceuticals | Completed | Missed primary |
| Phase 2 | NCT01719380 | Nov 2012 → Oct 2015 | colorectal cancer | Pfizer | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT05948943 | Nov 2023 → May 2028 expected | lymphatic malformation | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 37 trials · 1 met primary · 2 missed | ||||||
| Phase 3 | NCT05038735 | Dec 2021 → Jan 2027 expected | female breast carcinoma | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05063786 | Sep 2021 → Jun 2026 overdue | breast cancer | Spanish Breast Cancer Research Group | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04729387 | Jul 2021 → Apr 2023 | ovarian cancer | Novartis Pharmaceuticals | Terminated | Missed primary Stop: Business |
| Phase 3 | NCT04208178 | Jul 2020 → Feb 2027 expected | HER2 positive breast carcinoma | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04251533 | Jun 2020 → May 2023 | triple-negative breast carcinoma | Novartis Pharmaceuticals | Terminated | Missed primary Stop: Enrollment |
| Phase 3 | NCT03439046 | Feb 2018 → Dec 2023 | breast cancer | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 3 | NCT02437318 | Jul 2015 → Jun 2018 | breast cancer | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT05631795 | Aug 2022 → Jun 2025 | breast cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT04801966 | Sep 2021 → Dec 2022 | cancer | Peter MacCallum Cancer Centre, Australia | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT03138070 | Oct 2017 → Sep 2021 | head and neck squamous cell carcinoma | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Completed | No outcome recorded |
| Phase not stated2 trials | ||||||
| — | NCT03941782 | — | lymphangioma | New Mexico Cancer Research Alliance | No longer available | No outcome recorded |
| — | NCT03706573 | — | hormone receptor-positive breast cancer | Novartis Pharmaceuticals | No longer available | No outcome recorded |
| Comparator or background therapy7 trials | ||||||
| Phase 2 | NCT05966584 Background | Jul 2023 → Aug 2024 | breast cancer | Memorial Sloan Kettering Cancer Center | Terminated | No outcome recorded |
| Phase 2 | NCT04899349 Background | Apr 2022 → May 2023 | breast cancer | Novartis Pharmaceuticals | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT05090358 Background | Oct 2021 → Oct 2026 expected | breast cancer | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04300790 Background | Oct 2020 → Jun 2022 | breast cancer | MedSIR | Completed | No outcome recorded |
| Phase 3 | NCT05646862 Comparator | Jun 2023 → Nov 2026 expected | breast cancer | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 3 | NCT05501886 Comparator | Dec 2022 → Jun 2026 overdue | breast cancer | Celcuity Inc | Active not recruiting | Met primary |
| — | NCT04085653 Background | — | PIK3CA-related overgrowth spectrum, breast cancer | Novartis Pharmaceuticals | Available | No outcome recorded |
News releases announcing trial results or a regulatory action · 17
| Date | Issuer | Release |
|---|---|---|
| 2025-10-18 | Kura Oncology, Inc. | Results Kura Oncology Announces Preliminary Data from Its Farnesyl Transferase Inhibitor (FTI) Programs at the 2025 European Society for Medical Oncology (ESMO) Congress kuraoncology.com ↗
Robust antitumor activity was observed in heavily pretreated patients with relapsed or metastatic HNSCC with PIK3CA alterations |
| 2024-05-24 | Menarini Group | Results Menarini Group Presents Updated Data from ELECTRA and ELEVATE Combination Studies of Elacestrant (ORSERDU®) in Patients with ER+, HER2- Metastatic Breast Cancer (mBC) at the ASCO 2024 Annual Meeting menarini.com ↗
Updated analysis from the ELEVATE study demonstrates that all evaluable elacestrant plus targeted therapy combination arms are consistent with the known safety profiles of everolimus, alpelisib, ribociclib and palbociclib plus standard of care endocrine therapy. |
| 2023-12-11 | Menarini Group | Results Menarini Group Presented Initial Safety and Efficacy Data from Phase 1b/2 ELEVATE and ELECTRA Combination Studies of ORSERDU® (Elacestrant) in Patients with ER+, HER2- Metastatic Breast Cancer (mBC) at the 2023 San Antonio Breast Cancer Symposium menarini.com ↗
A preliminary analysis of data in the phase 1b part of the ELEVATE trial demonstrates antitumor activity of the combination evaluating ORSERDU with inhibitors of the PI3K/AKT/mTOR pathway and CDK 4/6 inhibitors. |
| 2023-10-20 | Eli Lilly and Company | Results Landmark 5-Year monarchE Outcome Data Demonstrate Verzenio® (abemaciclib)'s Long-Term Impact on Cancer Recurrence in High-Risk Early Breast Cancer lilly.com ↗
Results demonstrated that single agent imlunestrant had a clinical benefit rate of 42% and this increased to 62% when given in combination with everolimus or alpelisib (both approved agents in the second-line setting). |
| 2022-10-26 | Kura Oncology, Inc. | Results Kura Oncology Reports Preliminary Proof of Mechanism in Phase 1/2 Clinical Trial of Tipifarnib Plus Alpelisib in Head and Neck Squamous Cell Carcinoma kuraoncology.com ↗
Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today reported proof of mechanism in KURRENT-HN, the Company’s Phase 1/2 clinical trial of tipifarnib in combination with alpelisib in patients with HRAS- and/or PIK3CA-dependent head and neck squamous cell carcinoma (HNSCC). |
| 2022-08-30 | Novartis Pharmaceuticals | Results Novartis presents new data in breast and prostate cancer at ESMO novartis.com ↗
Clinical benefit of alpelisib in pediatric patients with PIK3CA-related overgrowth spectrum (PROS): an EPIK-P1 analysis |
| 2022-06-03 | Novartis Pharmaceuticals | Results New Novartis data show Piqray® effectiveness across key biomarkers in patients with HR+/HER2- metastatic breast cancer novartis.com ↗ |
| 2022-04-06 | Novartis Pharmaceuticals | Regulatory FDA approves Novartis Vijoice® (alpelisib) as first and only treatment for select patients with PIK3CA-Related Overgrowth Spectrum (PROS) novartis.com ↗
Novartis today announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval to Vijoice ® (alpelisib) for the treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy. |
| 2021-12-10 | Novartis Pharmaceuticals | Results Novartis data highlight efficacy of Piqray® in HR+/HER2- metastatic breast cancer with a PIK3CA driver mutation immediately post-CDK4/6i novartis.com ↗ |
| 2021-09-17 | Novartis Pharmaceuticals | Results Novartis announces findings from a real-world study of alpelisib demonstrating clinical benefit in people with PIK3CA-Related Overgrowth Spectrum (PROS) novartis.com ↗
Results from EPIK-P1 showed alpelisib effectively reduced volume of clinically significant PROS-related lesions and improved signs and symptoms in pediatric and adult patients. |
| 2020-09-19 | Novartis Pharmaceuticals | Results Novartis Piqray® data show survival benefit for patients with HR+/HER2- advanced breast cancer with a PIK3CA mutation novartis.com ↗
In SOLAR-1 final analysis, Piqray (alpelisib) plus fulvestrant demonstrated 8 months clinically relevant improvement in overall survival (OS) in HR+/HER2- advanced breast cancer (aBC) patients with a PIK3CA mutation compared to fulvestrant alone |
| 2020-07-29 | Novartis Pharmaceuticals | Regulatory Novartis receives Piqray® approval in Europe – the first and only targeted medicine for HR+/HER2- advanced breast cancer with a PIK3CA mutation novartis.com ↗ |
| 2020-05-29 | Novartis Pharmaceuticals | Regulatory Novartis Piqray® receives positive CHMP opinion to treat HR+/HER2- advanced breast cancer with a PIK3CA mutation novartis.com ↗ |
| 2019-05-24 | Novartis Pharmaceuticals | Regulatory FDA approves Novartis Piqray® - the first and only treatment specifically for patients with a PIK3CA mutation in HR+/HER2- advanced breast cancer novartis.com ↗
Novartis today announced the US Food and Drug Administration (FDA) has approved Piqray ® (alpelisib, formerly BYL719) in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-), PIK3CA-mutated, advanced or metastatic breast cancer, as detected by an FDA-approved test following progression on or after an endocrine-based regimen[1]. |
| 2018-12-06 | Novartis Pharmaceuticals | Results Novartis investigational BYL719 (alpelisib) plus fulvestrant consistently improved PFS in patients with PIK3CA mutated HR+/HER2- advanced breast cancer in new SOLAR-1 analyses novartis.com ↗
In SOLAR-1, the addition of BYL719 to fulvestrant nearly doubled median progression-free survival (PFS) in patients with PIK3CA mutated HR+/HER2- advanced breast cancer who progressed on or after an aromatase inhibitor (AI) compared to fulvestrant alone. |
| 2018-10-20 | Novartis Pharmaceuticals | Results Novartis investigational BYL719 (alpelisib) plus fulvestrant nearly doubles median PFS in patients with PIK3CA mutated HR+/HER2- advanced breast cancer compared to fulvestrant alone novartis.com ↗
Novartis today announced positive results from the global Phase III SOLAR-1 trial evaluating the investigational alpha-specific PI3K inhibitor BYL719 (alpelisib) in combination with fulvestrant. |
| 2018-08-23 | Novartis Pharmaceuticals | Results SOLAR-1 trial of Novartis investigational alpha-specific PI3K inhibitor BYL719 (alpelisib) meets primary endpoint in HR+/HER2- advanced breast cancer with PIK3CA mutation novartis.com ↗
Novartis today announced the global Phase III SOLAR-1 trial evaluating the investigational alpha-specific PI3K inhibitor BYL719 (alpelisib) has met the primary endpoint showing an improvement in progression-free survival (PFS). |
All press releases naming this drug 23 releases
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 108 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | alpelisib | “Participants will receive standard of care one PI3K inhibitor therapy (Alpelisib), in combination with SERD therapy (Fulvestrant) in Step 2 Arm 2 and Step 3.” NCT05826964 ↗75“Phosphatidylinositol 3-Kinase α-Selective Inhibition With Alpelisib (BYL719) in PIK3CA-Altered Solid Tumors: Results From the First-in-Human Study.” PMID 29401002 ↗ Feb 2018 “A Phase 1b/2 Study of Alpelisib in Combination with Cetuximab in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma.” PMID 37875771 ↗ Oct 2023 “2. Fulvestrant (administered same as above) + alpelisib 300mg oral administration every day” NCT06837792 ↗ “PI3K inhibitor + anti-estrogen therapy ( alpelisib + fulvestrant)” NCT04965688 ↗ “Alpelisib used outside of indication, based on biomarker” NCT04817956 ↗ “ribociclib plus alpelisib plus fulvestrant” PMID 32887722 ↗ Sep 2020 “Drug: Alpelisib” NCT05646862 ↗ |
| Known as | ALPELISIB (BYL719) | ChEMBL registry synonym — accepted as the source's own label CHEMBL2396661 ↗ |
| Known as | BYL-719A-1214(S)-N1-(4-METHYL-5-(2-(1,1,1-TRIFLUORO-2-METHYLPROPAN-2-YL)PYRIDIN-4-YL)THIAZOL-2-YL)PYRROLIDINE-1,2-DICARBOXAMIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL2396661 ↗ |
| Known as | BYL719 | “The purpose of this study is to complement Study CBYL719C2301 (SOLAR-1) and obtain more comprehensive data on the efficacy and safety of alpelisib (BYL719) in combination with...” NCT05038735 ↗37“Alpelisib (BYL719): starting dose at 300 mg/QD.; 2 tablets once a day, oral administration, continuously during 28-day cycles until disease progression or unacceptable toxicity.” NCT04300790 ↗ “A Phase Ib, Open-label Study of Alpelisib (BYL719) in Combination With Cisplatin in Patients With HPV+ Solid Tumor Malignancies” NCT02620839 ↗ “BYL719 200mg PO BID for 21 days (3 weeks) in combination with capecitabine 1000 mg/m2 PO BID for 2 weeks” NCT01300962 ↗ “treatment with alpelisib (BYL719) in combination with fulvestrant” NCT04899349 ↗ “Alpelisib (BYL719) is a PIK3CA-specific inhibitor” NCT04526470 ↗ “BYL-719 (alpelisib)” NCT02379247 ↗ “alpelisib (BYL719)” NCT02058381 ↗ “Drug: BYl719” NCT02506556 ↗ |
| Known as | BYL719 (IND 107078) | “BYL719 (IND 107078)” NCT01623349 ↗ |
| Known as | NVP-BYL719 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2396661 ↗ |
| Known as | PIQRAY | ChEMBL registry synonym — accepted as the source's own label CHEMBL2396661 ↗ |
| Known as | Vijoice | “Alpelisib (Vijoice) is a recently FDA-approved PI3Kα-specific inhibitor for patients with PIK3CA-related overgrowth spectrum (PROS).” PMID 39806603 ↗ Dec 2024 |
| Action | Inhibit | “BYL719 is an oral α-specific phosphatidylinositol-3-kinase (PI3K) inhibitor.” NCT01219699 ↗ |
| Modality | Small molecule | — CHEMBL2396661 ↗ |
| Route | Oral | “BYL719 is an oral α-specific phosphatidylinositol-3-kinase (PI3K) inhibitor.” NCT01219699 ↗ |
| Target | PIK3CA | “Study treatments, BYL719, INC280, LDK378 and MEK162, which target PIK3CA, c-MET, ALK/ROS1 and MEK respectively, have shown promising data in either preclinical or clinical lung...” NCT02276027 ↗ |