Drugs / Buparlisib
Buparlisib
also known as
BKM120 · BKM 120 (Buparlisib) · BKM-120AAA · BKM-120NX · BKM120 (IND 102823) · Buparlisib (BKM120) · BUPARLISIB HYDROCHLORIDE · NVP-BKM120
Trials 87 · started per year
today
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT01719250 | Dec 2012 → Sep 2016 | diffuse large B-cell lymphoma, mantle cell lymphoma | Mayo Clinic | Completed | No outcome recorded |
| Phase 0 | NCT01513356 | Oct 2012 → Feb 2014 | breast cancer | Sofia Perea, Director Clinical Trials Unit. | Completed | No outcome recorded |
| Phase 143 trials · 1 missed | ||||||
| Phase 1 | NCT02756247 | May 2016 → Oct 2022 | diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT02614508 | Jan 2016 → Aug 2019 | chronic lymphocytic leukemia/small lymphocytic lymphoma | Emory University | Terminated | No outcome recorded |
| Phase 1 | NCT01971489 | Sep 2015 → Aug 2016 | non-small cell lung carcinoma | Roswell Park Cancer Institute | Withdrawn | No outcome recorded |
| Phase 1 | NCT02117817 | Feb 2015 | endometrial cancer, ovarian cancer | Rutgers, The State University of New Jersey | Withdrawn | No outcome recorded |
| Phase 1 | NCT02487823 | Oct 2014 → Nov 2017 | metastatic prostate carcinoma | Institut Paoli-Calmettes | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT02113878 | Sep 2014 → Dec 2019 | cervical squamous cell carcinoma, hypopharynx cancer, laryngeal carcinoma, nasopharyngeal carcinoma +1 | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 1 | NCT02049541 | Jul 2014 → Sep 2018 | MALT lymphoma, Waldenstrom macroglobulinemia, mantle cell lymphoma, nodal marginal zone B-cell lymphoma +1 | Kami Maddocks, MD | Completed | No outcome recorded |
| Phase 1 | NCT02194049 | Jul 2014 → Apr 2016 | small cell lung carcinoma | University of California, Davis | Completed | No outcome recorded |
| Phase 1 | NCT02154776 | Jun 2014 → Oct 2016 | breast cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02088684 | May 2014 → Apr 2018 | breast cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02058381 | May 2014 → Jun 2018 | breast carcinoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02048787 | Mar 2014 → Mar 2015 | impaired renal function disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01934361 | Feb 2014 → Jul 2016 | glioblastoma | Novartis Pharmaceuticals | Completed | Mixed |
| Phase 1 | NCT01911325 | Oct 2013 → Aug 2015 | non-small cell squamous lung carcinoma | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 1 | NCT01820325 | Sep 2013 → Jun 2014 | non-small cell lung carcinoma | Novartis Pharmaceuticals | Terminated | Missed primary |
| Phase 1 | NCT01723800 | Jul 2013 → Sep 2016 | non-small cell lung carcinoma | City of Hope Medical Center | Completed | No outcome recorded |
| Phase 1 | NCT02128724 | Apr 2013 → Oct 2017 | non-small cell lung carcinoma | University of Oxford | Completed | No outcome recorded |
| Phase 1 | NCT01730248 | Dec 2012 → Sep 2017 | myelofibrosis | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 1 | NCT02439489 | Dec 2012 → Jun 2017 | cancer | Fondazione Michelangelo | Completed | No outcome recorded |
| Phase 1 | NCT01741753 | Nov 2012 → Dec 2014 | prostate cancer | Dana-Farber Cancer Institute | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT01634061 | Sep 2012 → Jul 2015 | castration-resistant prostate carcinoma | 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 | NCT01626209 | Jul 2012 → Apr 2014 | squamous cell carcinoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01396499 | Jul 2012 → Oct 2016 | leukemia | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT01576666 | Jul 2012 → Apr 2015 | colorectal cancer, gastric cancer, gastroesophageal cancer, glioblastoma +3 | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01571024 | May 2012 → May 2015 | colorectal cancer, malignant pancreatic neoplasm | UNC Lineberger Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT01540253 | May 2012 → Jun 2015 | cancer of unknown primary site | Roswell Park Cancer Institute | Completed | No outcome recorded |
| Phase 1 | NCT01468688 | Apr 2012 → Jul 2016 | gastrointestinal stromal tumor | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01470209 | Jan 2012 → May 2017 | lung cancer | Emory University | Completed | No outcome recorded |
| Phase 1 | NCT01473901 | Dec 2011 → May 2017 | glioblastoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01339442 | Nov 2011 → Dec 2016 | estrogen-receptor positive breast cancer, female breast carcinoma | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 1 | NCT01570296 | Oct 2011 → Feb 2016 | non-small cell lung carcinoma | National Cancer Centre, Singapore | Completed | No outcome recorded |
| Phase 1 | NCT01727128 | Oct 2011 → Aug 2013 | — | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01283048 | Sep 2011 → Sep 2016 | renal cell carcinoma | Toni Choueiri, MD | Completed | No outcome recorded |
| Phase 1 | NCT01363232 | Aug 2011 → Mar 2014 | cancer | Array BioPharma | Completed | No outcome recorded |
| Phase 1 | NCT01300962 | Aug 2011 → Feb 2017 | breast cancer | UNC Lineberger Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT01297452 | Feb 2011 → Mar 2017 | cancer | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT01304602 | Feb 2011 → Apr 2014 | colorectal cancer | University of Kansas Medical Center | Completed | No outcome recorded |
| Phase 1 | NCT01285466 | Jan 2011 → Oct 2014 | cancer of unknown primary site | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01248494 | Nov 2010 → Dec 2012 | breast cancer | Vanderbilt-Ingram Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT01155453 | Apr 2010 → Nov 2014 | — | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01283503 | Oct 2009 → Oct 2011 | neoplasm | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01068483 | Nov 2008 → Sep 2011 | breast cancer, colon carcinoma, endometrial cancer, ovarian cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/27 trials | ||||||
| Phase 1/2 | NCT01870726 | Jan 2014 → Dec 2016 | high grade astrocytic tumor | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 1/2 | NCT01816984 | May 2013 → Apr 2018 | cancer of unknown primary site, hypopharynx squamous cell carcinoma, larynx verrucous carcinoma, metastatic squamous cell carcinoma +6 | University of Chicago | Completed | No outcome recorded |
| Phase 1/2 | NCT01591421 | Sep 2012 → Sep 2015 | colorectal cancer | Canadian Cancer Trials Group | Completed | No outcome recorded |
| Phase 1/2 | NCT01512251 | Jun 2012 → Dec 2013 | melanoma | University of California, San Francisco | Completed | No outcome recorded |
| Phase 1/2 | NCT01589861 | Dec 2011 → Oct 2017 | breast cancer | Institut Paoli-Calmettes | Terminated | No outcome recorded |
| Phase 1/2 | NCT01349660 | Dec 2011 → Dec 2016 | glioblastoma | SCRI Development Innovations, LLC | Completed | No outcome recorded |
| Phase 1/2 | NCT01132664 | May 2010 → Aug 2014 | HER2 positive breast carcinoma, secondary malignant neoplasm | Novartis Pharmaceuticals | Terminated | No outcome recorded Stop: Enrollment |
| Phase 232 trials · 1 met primary · 3 missed | ||||||
| Phase 2 | NCT01613677 | Nov 2015 → Sep 2017 | — | Novartis Pharmaceuticals | Withdrawn | No outcome recorded |
| Phase 2 | NCT02452294 | Jul 2015 → Dec 2017 | melanoma, metastatic neoplasm | University Hospital Tuebingen | Unknown | No outcome recorded |
| Phase 2 | NCT02340780 | Apr 2015 → Nov 2018 | B-cell chronic lymphocytic leukemia | Canadian Cancer Trials Group | Completed | No outcome recorded |
| Phase 2 | NCT02303041 | Feb 2015 → Apr 2017 | basal cell carcinoma, nevoid basal cell carcinoma syndrome, skin cancer | Anne Chang | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT02404844 | Dec 2014 → Sep 2017 | breast cancer | University Hospital, Essen | Completed | No outcome recorded |
| Phase 2 | NCT02301364 | Nov 2014 → Oct 2016 | central nervous system non-hodgkin lymphoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT02220855 | Oct 2014 → Mar 2017 | thymoma | Patrick Joseph Loehrer Sr. | Completed | No outcome recorded |
| Phase 2 | NCT01953445 | Aug 2014 → Jun 2015 | breast neoplasm | Washington University School of Medicine | Withdrawn | No outcome recorded |
| Phase 2 | NCT02159066 | Jul 2014 → Jan 2023 | melanoma | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT02000882 | May 2014 → Mar 2019 | breast cancer, metastatic malignant neoplasm in the brain | US Oncology Research | Completed | No outcome recorded |
| Phase 2 | NCT01550380 | May → Jul 2014 | endometrial cancer | University of Utah | Withdrawn | No outcome recorded |
| Phase 2 | NCT02035124 | Apr 2014 → Jan 2015 | prostate cancer | SCRI Development Innovations, LLC | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01923168 | Mar 2014 → Jul 2017 | breast cancer | Novartis Pharmaceuticals | Completed | Missed primary |
| Phase 2 | NCT01487265 | Mar 2014 → May 2016 | non-small cell lung carcinoma | SCRI Development Innovations, LLC | Completed | No outcome recorded |
| Phase 2 | NCT01852292 | Oct 2013 → Mar 2017 | head and neck squamous cell carcinoma | Novartis Pharmaceuticals | Terminated | Met primary |
| Phase 2 | NCT01816594 | Sep 2013 → Feb 2015 | HER2 positive breast carcinoma | Novartis Pharmaceuticals | Completed | Missed primary |
| Phase 2 | NCT01806649 | Jul 2013 → Apr 2016 | esophageal cancer | Prince of Songkla University | Terminated | No outcome recorded |
| Phase 2 | NCT01695473 | Apr 2013 → Feb 2015 | prostate cancer | Won Kim | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01830504 | Apr 2013 | thyroid cancer | Hospices Civils de Lyon | Unknown | Missed primary |
| Phase 2 | NCT01833169 | Mar 2013 → Sep 2016 | — | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01693614 | Feb 2013 → Jul 2017 | B-cell non-Hodgkin lymphoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01737450 | Jan 2013 → Sep 2018 | head and neck neoplasm, metastatic malignant neoplasm | Centre Leon Berard | Completed | No outcome recorded |
| Phase 2 | NCT01527877 | Sep 2012 → Dec 2013 | head and neck squamous cell carcinoma | Yonsei University | Unknown | No outcome recorded |
| Phase 2 | NCT01629615 | Jun 2012 → Oct 2015 | breast cancer | SOLTI Breast Cancer Research Group | Completed | No outcome recorded |
| Phase 2 | NCT01790932 | Jun 2012 → Sep 2015 | breast cancer | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT01551030 | Mar 2012 → Sep 2020 | transitional cell carcinoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT01501604 | Jan 2012 → Aug 2013 | breast cancer, cholangiocarcinoma, colorectal cancer, lung cancer | Massachusetts General Hospital | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01397877 | Dec 2011 → Oct 2014 | endometrial cancer | ARCAGY/ GINECO GROUP | Completed | No outcome recorded |
| Phase 2 | NCT01339052 | Sep 2011 → Oct 2016 | glioblastoma | Patrick Y. Wen, MD | Completed | No outcome recorded |
| Phase 2 | NCT01385293 | Aug 2011 → Feb 2016 | metastatic prostate carcinoma | Andrew J. Armstrong, MD | Terminated | No outcome recorded |
| Phase 2 | NCT01297491 | May 2011 → Oct 2014 | non-small cell lung carcinoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01289041 | Feb 2011 → Mar 2014 | endometrial cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2/31 trial · 1 missed | ||||||
| Phase 2/3 | NCT01572727 | Aug 2012 → Jun 2015 | female breast carcinoma | Novartis Pharmaceuticals | Completed | Missed primary |
| Phase 32 trials · 2 met primary | ||||||
| Phase 3 | NCT01633060 | Oct 2012 → May 2016 | breast cancer | Novartis Pharmaceuticals | Terminated | Met primary |
| Phase 3 | NCT01610284 | Aug 2012 → Apr 2015 | breast cancer | Novartis Pharmaceuticals | Completed | Met primary |
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT04338399 Comparator | Dec 2020 → Nov 2025 | head and neck cancer | Adlai Nortye Biopharma Co., Ltd. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2025-05-30 | Nippon Kayaku Co., Ltd. | Results 抗PD-1/PD-L1療法後に進行した再発性または転移性頭頸部扁平上皮がんに対するパクリタキセルとブパルリシブ（開発コード：AN2025）の併用療法を評価する第Ⅲ相BURAN試験のトップライン結果のお知らせ nipponkayaku.co.jp ↗
日本化薬株式会社（本社：東京、代表取締役社長：涌元厚宏、以下「日本化薬」）は、日本化薬が日本における商業化を含めたオプション権を保有し、Adlai Nortye 社（本社：ケイマン諸島、CEO 兼取締役会長：Yang（Carsten） Lu、以下 「アドライ社 」）が日本を含めた全世界で開発を行っているブパルリシブ（開発コード：AN2025）の抗PD-1/PD-L1療法後に進行した再発・転移性頭頸部扁平上皮がんを対象とした第Ⅲ相臨床試験において、主要評価項目が達成されなかったことをお知らせいたします。 |
| 2019-03-14 | Adlai Nortye Biopharma Co., Ltd. | Results Adlai Nortye Presents Supportive Non-Clinical Data of Buparlisib (AN2025) at the 7th ICHNO adlainortye.com ↗
In the animal model, Buparlisib significantly inhibited tumor growth and shows a dose response trend in anti-PD-1 refractory tumor bearing mice. |
| 2018-07-30 | Adlai Nortye Biopharma Co., Ltd. | Results Adlai Nortye Announces the Publication of the Biomarker Analysis From BERIL-1 adlainortye.com ↗
Adlai Nortye Corporation, a leading biotech company in China, today announced a biomarker analysis publication by the investigators from the phase II study BERIL-1 Buparlisib/Paclitaxel vs Paclitaxel in 2nd Line HNSCC. |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-05-30 | Nippon Kayaku Co., Ltd. | 抗PD-1/PD-L1療法後に進行した再発性または転移性頭頸部扁平上皮がんに対するパクリタキセルとブパルリシブ（開発コード：AN2025）の併用療法を評価する第Ⅲ相BURAN試験のトップライン結果のお知らせ nipponkayaku.co.jp ↗ |
| 2023-10-15 | Adlai Nortye Biopharma Co., Ltd. | Adlai Nortye Ltd. in collaboration with Nucleai, to Present "Utilizing H&E Images and Digital Pathology to Predict Response to Buparlisib in SCCHN" at ESMO 2023 adlainortye.com ↗ |
| 2019-03-14 | Adlai Nortye Biopharma Co., Ltd. | Adlai Nortye Presents Supportive Non-Clinical Data of Buparlisib (AN2025) at the 7th ICHNO adlainortye.com ↗ |
| 2018-07-30 | Adlai Nortye Biopharma Co., Ltd. | Adlai Nortye Announces the Publication of the Biomarker Analysis From BERIL-1 adlainortye.com ↗ |
| 2018-07-22 | Adlai Nortye Biopharma Co., Ltd. | Adlai Nortye Announce Global License Agreement for Buparlisib (BKM120) adlainortye.com ↗ |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 95 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | buparlisib | “Buparlisib, a pan-phosphatidylinositol 3-kinase (PI3K) inhibitor, plus fulvestrant in the BELLE-2 study significantly improved progression-free survival (PFS) in patients with...” PMID 30241001 ↗ Sep 201828“PURPOSE: Phosphatidylinositol 3-kinase (PI3K) signaling is highly active in glioblastomas. We assessed pharmacokinetics, pharmacodynamics, and efficacy of the pan-PI3K...” PMID 30715997 ↗ Feb 2019 “This study evaluated the combination of buparlisib, an oral phosphoinositide 3-kinase (PI3K) inhibitor, with imatinib in patients with advanced GIST, who have failed prior...” PMID 32147671 ↗ Mar 2020 “A phase 1b dose expansion study of the pan-class I PI3K inhibitor buparlisib (BKM120) plus carboplatin and paclitaxel in PTEN deficient tumors and with dose intensified...” PMID 28281183 ↗ Mar 2017 “Mouse-human co-clinical trials demonstrate superior anti-tumour effects of buparlisib (BKM120) and cetuximab combination in squamous cell carcinoma of head and neck.” PMID 32963347 ↗ Sep 2020 “PIKHER2: A phase IB study evaluating buparlisib in combination with lapatinib in trastuzumab-resistant HER2-positive advanced breast cancer.” PMID 28950146 ↗ Sep 2017 “Phase 2 study of buparlisib (BKM120), a pan-class I PI3K inhibitor, in patients with metastatic triple-negative breast cancer.” PMID 33138866 ↗ Nov 2020 “Buparlisib (BKM120) is the investigational drug.” NCT01132664 ↗ “ribociclib plus buparlisib plus fulvestrant” PMID 32887722 ↗ Sep 2020 |
| Known as | BKM 120 (Buparlisib) | “BKM 120 (Buparlisib)” NCT02035124 ↗ |
| Known as | BKM-120AAA | ChEMBL registry synonym — accepted as the source's own label CHEMBL2017974 ↗ |
| Known as | BKM-120NX | ChEMBL registry synonym — accepted as the source's own label CHEMBL2017974 ↗ |
| Known as | BKM120 | “Buparlisib (BKM120) oral once daily: 80 mg and 100 mg dose levels to be tested in the dose escalation part of the trial in combination with docetaxel every three week...” NCT01911325 ↗71“BKM120 PO 50, 80 or 100mg every day for each day of each 21 day cycle. Number of cycles: until progression of disease; unacceptable toxicity, withdrawal or death.” NCT01300962 ↗ “The purpose of this study is to find out what effects, good and/or bad, Buparlisib (also known as BKM120) has on lymphoma and the central nervous system.” NCT02301364 ↗ “A Phase Ib, Multi-center, Open Label, Dose Escalation Study of Oral LDE225 in Combination With BKM 120 in Patients With Advanced Solid Tumors” NCT01576666 ↗ “BKM-120 is a pan-PI3K inhibitor currently tested in clinical trials.” NCT01806649 ↗ “Buparlisib (BKM120) is the investigational drug.” NCT01132664 ↗ “BKM120, 100 mg PO daily” NCT01248494 ↗ “buparlisib (BKM120)” NCT02058381 ↗ “Drug: BKM 120” NCT01248494 ↗ |
| Known as | BKM120 (IND 102823) | “BKM120 (IND 102823)” NCT01623349 ↗ |
| Known as | Buparlisib (BKM120) | “Buparlisib (BKM120)” NCT02439489 ↗ |
| Known as | BUPARLISIB HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL2017974 ↗ |
| Known as | NVP-BKM120 | “NVP-BKM120 (BKM120) is an oral pan-class I phosphatidylinositol-3-kinase (PI3K) inhibitor belonging to the 2,6-dimorpholino pyrimidine derivative family.” NCT01550380 ↗ |
| Action | Inhibit | “clinical research study with BKM120, a potent and highly specific oral pan-class I phosphatidylinositol-3-kinase (PI3K) inhibitor.” NCT01068483 ↗ |
| Modality | Small molecule | “2,6-dimorpholino pyrimidine derivative family” NCT01550380 ↗ |
| Route | Oral | “BKM120, Administered Orally” NCT01068483 ↗ |