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 97 · 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pancreatic ductal adenocarcinoma, pancreatic large cell neuroendocrine carcinoma +2 | OHSU Knight Cancer Institute | Withdrawn | No outcome recorded |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 135 trials | ||||||
| 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→ Apr 2028 | human papillomavirus-related squamous cell carcinoma, metastatic malignant neoplasm | Pamela Munster | Withdrawn | No outcome recorded |
| Phase 1 | NCT05508906 | Aug 2022 → Dec 2027 expected | Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer, female breast carcinoma, metastatic malignant neoplasm | Olema Pharmaceuticals, Inc. | 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 |
| 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 | NCT02282371 | Oct 2014 → Oct 2021 | head and neck squamous cell carcinoma | Memorial Sloan Kettering Cancer Center | 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 | 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 | ||||||
| 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 |
| 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 | No outcome recorded |
| Phase 237 trials | ||||||
| Phase 2 | NCT07679269 | Jan 2027 → Jun 2031 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 → Aug 2028 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 |
| 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 |
| 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 | No outcome recorded |
| 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 |
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| 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 | ||||||
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| 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 |
| — | 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 |
Also used as a comparator or background therapy in 7 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 24 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 |
| 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 32 trials | ||||||
| Phase 3 | NCT05646862 Comparator | Jun 2023 → Nov 2026 expected | breast cancer | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05501886 Comparator | Dec 2022 → Jun 2026 overdue | breast cancer | Celcuity Inc | Active not recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT04085653 Background | — | PIK3CA-related overgrowth spectrum, breast cancer | Novartis Pharmaceuticals | Available | No outcome recorded |
Press releases naming this drug 12 releases
| Date | Issuer | Release |
|---|---|---|
| 2022-06-03 | Novartis Pharmaceuticals | New Novartis data show Piqray® effectiveness across key biomarkers in patients with HR+/HER2- metastatic breast cancer novartis.com ↗ |
| 2022-04-06 | Novartis Pharmaceuticals | FDA approves Novartis Vijoice® (alpelisib) as first and only treatment for select patients with PIK3CA-Related Overgrowth Spectrum (PROS) novartis.com ↗ |
| 2021-12-10 | Novartis Pharmaceuticals | 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 | Novartis announces findings from a real-world study of alpelisib demonstrating clinical benefit in people with PIK3CA-Related Overgrowth Spectrum (PROS) novartis.com ↗ |
| 2020-09-19 | Novartis Pharmaceuticals | Novartis Piqray® data show survival benefit for patients with HR+/HER2- advanced breast cancer with a PIK3CA mutation novartis.com ↗ |
| 2020-07-29 | Novartis Pharmaceuticals | 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 | Novartis Piqray® receives positive CHMP opinion to treat HR+/HER2- advanced breast cancer with a PIK3CA mutation novartis.com ↗ |
| 2019-07-18 | Novartis Pharmaceuticals | Novartis delivers strong sales, double digit core operating income growth and launches Zolgensma and Piqray in second quarter; sales and profit guidance increased novartis.com ↗ |
| 2019-05-24 | Novartis Pharmaceuticals | FDA approves Novartis Piqray® - the first and only treatment specifically for patients with a PIK3CA mutation in HR+/HER2- advanced breast cancer novartis.com ↗ |
| 2018-12-06 | Novartis Pharmaceuticals | 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 ↗ |
| 2018-10-20 | Novartis Pharmaceuticals | 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 ↗ |
| 2018-08-23 | Novartis Pharmaceuticals | 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 ↗ |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 107 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 ↗74“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 ↗ |