Drugs / Alisertib
last change Aug 2026 re-read 2 minutes ago

Alisertib

Small molecule targets AURKA via inhibition

Developed for
cancer · mantle cell lymphoma · Burkitt lymphoma · diffuse large B-cell lymphoma · lymphoma · small cell lung carcinoma · acute myeloid leukemia · anaplastic large cell lymphoma
+104 more · angioimmunoblastic T-cell lymphoma · breast cancer · digestive system cancer · follicular lymphoma · head and neck squamous cell carcinoma · neuroblastoma · non-small cell lung carcinoma · Waldenstrom macroglobulinemia · adenocarcinoma · adult T-cell leukemia/lymphoma · breast carcinoma · chronic lymphocytic leukemia/small lymphocytic lymphoma · estrogen-receptor positive breast cancer · female breast carcinoma · hepatosplenic T-cell lymphoma · Hodgkins lymphoma · hormone receptor-positive breast cancer · lung cancer · MALT lymphoma · nodal marginal zone B-cell lymphoma · ovarian carcinoma · peripheral T-cell lymphoma, not otherwise specified · plasma cell myeloma · prostate adenocarcinoma · splenic marginal zone lymphoma · acute megakaryoblastic leukemia · adult anaplastic ependymoma · adult brainstem glioma · adult glioblastoma · adult oligodendroglioma · anaplastic astrocytoma · anaplastic oligodendroglioma · atypical teratoid rhabdoid tumor · B-cell adult acute lymphocytic leukemia · central nervous system cancer · childhood acute lymphoblastic leukemia · childhood acute myeloid leukemia · childhood kidney neoplasm · childhood malignant neoplasm · colon mucinous adenocarcinoma · colon signet ring cell adenocarcinoma · diffuse astrocytoma · enteropathy-associated T-cell lymphoma · Ewing sarcoma/peripheral primitive neuroectodermal tumor · extranodal nasal NK/T cell lymphoma · fallopian tube cancer · female reproductive organ cancer · gastroesophageal adenocarcinoma · giant cell glioblastoma · gliosarcoma · grade III lymphomatoid granulomatosis · hairy cell leukemia · head and neck cancer · head and neck neoplasm · hepatoblastoma · Her2-receptor negative breast cancer · high grade B-cell lymphoma with MYC and/ or BCL2 and/or BCL6 rearrangement · hormone-resistant prostate carcinoma · intraocular lymphoma · invasive breast carcinoma · large-cell immunoblastic lymphoma · leiomyosarcoma · leiomyosarcoma of the corpus uteri · liposarcoma · male reproductive organ cancer · malignant childhood germ cell neoplasm · malignant peripheral nerve sheath tumor · malignant urinary system neoplasm · marginal zone lymphoma · mature T-cell and NK-cell non-Hodgkin lymphoma · melanoma · mesothelioma · metastatic melanoma · mycosis fungoides and variants · myelodysplastic syndrome · myelofibrosis · myxofibrosarcoma · neoplasm · neoplastic disease or syndrome · non-Hodgkin lymphoma · osteosarcoma · ovarian cancer · pancreatic acinar cell carcinoma · pancreatic ductal adenocarcinoma · pancreatic neoplasm · peritoneum cancer · pilocytic astrocytoma · pineal gland astrocytoma · primary cutaneous B-cell lymphoma · primary myelofibrosis · progesterone-receptor positive breast cancer · prostate small cell carcinoma · rectal signet ring cell adenocarcinoma · rectum mucinous adenocarcinoma · rhabdomyosarcoma · small intestine lymphoma · subependymal giant cell astrocytoma · T-cell adult acute lymphocytic leukemia · T-cell large granular lymphocyte leukemia · T-cell non-Hodgkin lymphoma · testicular lymphoma · transitional cell carcinoma · undifferentiated pleomorphic sarcoma · urinary bladder cancer
Investigated by
Millennium Pharmaceuticals, Inc. · National Cancer Institute (NCI) · M.D. Anderson Cancer Center · Puma Biotechnology, Inc. · Mayo Clinic · Children's Oncology Group
+27 more · Massachusetts General Hospital · Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Takeda · Abramson Cancer Center at Penn Medicine · Collin Blakely · Edward Kim · Eric Bernicker, MD · Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Fox Chase Cancer Center · Millennium: The Takeda Oncology Company · NRG Oncology · New Approaches to Neuroblastoma Therapy Consortium · Northwestern University · Ohio State University Comprehensive Cancer Center · St. Jude Children's Research Hospital · Takeda Pharmaceuticals U.S.A., Inc. · The Leukemia and Lymphoma Society · The Methodist Hospital Research Institute · UNC Lineberger Comprehensive Cancer Center · US Oncology Research · University of California, Davis · University of Colorado, Denver · University of Illinois at Chicago · University of Wisconsin, Madison · Vanderbilt-Ingram Cancer Center · Washington University School of Medicine · Weill Medical College of Cornell University

Trials 65 · started per year

today
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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 134 trials
Phase 1 NCT04479306 Jun 2020 → Jul 2023 non-small cell lung carcinoma M.D. Anderson Cancer Center Completed No outcome recorded
Phase 1 NCT04085315 Nov 2019 → Dec 2026 expected lung cancer Collin Blakely Recruiting No outcome recorded
Phase 1 NCT02700022 Oct → Nov 2016 Burkitt lymphoma, diffuse large B-cell lymphoma, follicular lymphoma UNC Lineberger Comprehensive Cancer Center Terminated No outcome recorded
Phase 1 NCT02812056 Sep 2016 → Sep 2021 digestive system cancer, female reproductive organ cancer, head and neck cancer, male reproductive organ cancer M.D. Anderson Cancer Center Withdrawn No outcome recorded
Phase 1 NCT02719691 May 2016 → Mar 2020 breast cancer University of Colorado, Denver Completed No outcome recorded
Phase 1 NCT02780011 Dec 2015 → Sep 2018 non-Hodgkin lymphoma Eric Bernicker, MD Withdrawn No outcome recorded
Phase 1 NCT02551055 Oct 2015 → Feb 2017 adenocarcinoma Millennium Pharmaceuticals, Inc. Terminated No outcome recorded
Phase 1 NCT02319018 Aug 2015 → Sep 2018 digestive system cancer National Cancer Institute (NCI) Completed No outcome recorded
Phase 1 NCT02367352 Mar 2015 → May 2017 ovarian cancer, small cell lung carcinoma Millennium Pharmaceuticals, Inc. Terminated No outcome recorded
Phase 1 NCT02186509 Jan 2015 → Mar 2017 adult anaplastic ependymoma, adult brainstem glioma, adult glioblastoma, adult oligodendroglioma +8 Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University Completed No outcome recorded
Phase 1/27 trials
Phase 1/2 NCT04555837 Sep 2020 → Apr 2025 head and neck squamous cell carcinoma M.D. Anderson Cancer Center Completed No outcome recorded
Phase 1/2 NCT01848067 Aug 2013 → Mar 2015 hormone-resistant prostate carcinoma, prostate adenocarcinoma Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University Completed No outcome recorded
Phase 1/2 NCT01601535 May 2012 → Jul 2018 neuroblastoma New Approaches to Neuroblastoma Therapy Consortium Completed No outcome recorded
Phase 1/2 NCT01471964 Oct 2011 → Feb 2017 non-small cell lung carcinoma Fox Chase Cancer Center Terminated No outcome recorded
Phase 1/2 NCT01397825 Aug 2011 → Feb 2015 Burkitt lymphoma, diffuse large B-cell lymphoma, mantle cell lymphoma Millennium Pharmaceuticals, Inc. Completed No outcome recorded
Phase 1/2 NCT01045421 Feb 2010 → May 2013 breast cancer, gastroesophageal adenocarcinoma, head and neck squamous cell carcinoma, non-small cell lung carcinoma +1 Millennium Pharmaceuticals, Inc. Completed No outcome recorded
Phase 1/2 NCT01034553 Feb 2010 → Sep 2014 plasma cell myeloma Mayo Clinic Completed No outcome recorded
Phase 222 trials
Phase 2 NCT07465757 Sep 2026 → Mar 2028 expected small cell lung carcinoma Puma Biotechnology, Inc. Not yet recruiting No outcome recorded
Phase 2 NCT07706179 Aug 2026 → Aug 2028 expected hormone receptor-positive breast cancer University of Wisconsin, Madison Not yet recruiting No outcome recorded
Phase 2 NCT06369285 Nov 2024 → Jun 2027 expected hormone receptor-positive breast cancer Puma Biotechnology, Inc. Recruiting No outcome recorded
Phase 2 NCT06095505 Feb 2024 → Oct 2027 expected small cell lung carcinoma Puma Biotechnology, Inc. Recruiting No outcome recorded
Phase 2 NCT02860000 Jul 2017 → Jan 2022 Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer, female breast carcinoma, invasive breast carcinoma Mayo Clinic Completed No outcome recorded
Phase 2 NCT02560025 Dec 2015 → Oct 2017 acute myeloid leukemia Massachusetts General Hospital Completed No outcome recorded
Phase 2 NCT02293005 May 2015 → Jul 2021 lung cancer, mesothelioma M.D. Anderson Cancer Center Completed No outcome recorded
Phase 2 NCT02187991 Feb 2015 → Apr 2024 breast carcinoma US Oncology Research Completed No outcome recorded
Phase 2 NCT02109328 Aug 2014 → Jul 2015 transitional cell carcinoma, urinary bladder cancer Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Completed No outcome recorded
Phase 2 NCT02114229 May 2014 → Sep 2025 overdue atypical teratoid rhabdoid tumor St. Jude Children's Research Hospital Active not recruiting No outcome recorded
Phase 31 trial
Phase 3 NCT01482962 Jun 2012 → Jun 2015 peripheral T-cell lymphoma, not otherwise specified Millennium Pharmaceuticals, Inc. Completed No outcome recorded
Phase not applicable1 trial
NCT02530619 Oct 2015 → May 2018 acute megakaryoblastic leukemia, myelofibrosis, primary myelofibrosis Northwestern University Unknown No outcome recorded
Also used as a comparator or background therapy in 1 trial
PhaseRegistry idDatesIndicationSponsorStatusOutcome
NCT03005262 Background prostate cancer The University of Texas Health Science Center at San Antonio No longer available No outcome recorded

Press releases naming this drug 1 release

DateIssuerRelease
2015-05-13 Takeda Takeda Announces Termination of Alisertib Phase 3 Trial in Relapsed or Refractory Peripheral T-cell Lymphoma takeda.com

Evidence & citations 11 cited values

Every value below carries the sentence it was read from. 69 sources stand behind the page.

FieldValueCited text
Known as alisertib “MLN8237 Aurora A kinase inhibitor, alisertibNCT01471964
56

NCT01639911

NCT01637961

NCT04555837

NCT01812005

NCT00962091

NCT01653028

NCT00853307

NCT00500903

NCT01397825

NCT02530619

NCT01714947

NCT06369285

NCT02719691

NCT04085315

NCT01897012

NCT02551055

NCT00697346

NCT02367352

NCT02259010

NCT02219789

NCT02038647

NCT00651664

NCT01512758

NCT01613261

NCT01567709

NCT02327169

NCT02186509

NCT02860000

NCT01779843

NCT00807495

NCT02214147

NCT07706179

NCT01844583

NCT01924260

NCT02560025

NCT02700022

NCT02109328

NCT01466881

NCT01094288

NCT02293005

NCT01154816

NCT02187991

NCT07465757

NCT01695941

NCT02812056

NCT01848067

NCT06095505

NCT01091428

NCT02114229

NCT01923337

NCT04479306

NCT01482962

NCT01898078

NCT02319018

NCT01045421

NCT00830518

Known as ALISERTIB (MLN8237) ChEMBL registry synonym — accepted as the source's own label CHEMBL483158
Known as ALISERTIB SODIUM ChEMBL registry synonym — accepted as the source's own label CHEMBL483158
Known as Alsertib ClinicalTrials.gov intervention name — accepted as the source's own label NCT02780011
Known as CHEMBL483158 ChEMBL registry synonym — accepted as the source's own label CHEMBL483158
Known as MLN-8237-004 ChEMBL registry synonym — accepted as the source's own label CHEMBL483158
Known as MLN8237 “A Phase Ib Study of the Combination of MLN0128 (Dual TORC1/2 Inhibitor) and MLN8237 (Aurora A Inhibitor, Alisertib) in Patients With Advanced Solid Tumors With an Expansion...” NCT02719691
12

“BACKGROUND: This phase 1b study evaluated an enteric-coated tablet (ECT) formulation of the investigational Aurora A kinase inhibitor, alisertib (MLN8237).” PMID 24879333 Jun 2014

“Alisertib (MLN8237) will be supplied in capsules of 5 or 25 mg” NCT00500903

“Alisertib (MLN8237) enteric coated tablet (ECT).” NCT01397825

“Aurora A kinase inhibitor MLN8237NCT01316692

NCT01471964

NCT01677559

NCT01799278

NCT01540682

NCT03005262

NCT02444884

NCT01601535

NCT01034553

Action Inhibit “a Novel Aurora A Kinase Inhibitor” NCT00500903
Modality Small molecule “Alisertib (MLN8237) is an investigational, oral, small-molecule, selective inhibitor of Aurora A kinase.” PMID 26073352 Jul 2015
Route Oral “Each dose will be given by mouth with 8 ounces of water” NCT00500903
Target AURKA AURKA inhibitor, MLN8237” NCT01316692