Explore

Companies

Drugs

About·Data Management·Terms·Privacy

Stay informed

© 2026 VivoSeq. All rights reserved.

Alisertib

Phase 3Small molecule

Alisertib is used to treat certain types of cancer, particularly a blood cancer called peripheral T-cell lymphoma. It works by blocking a protein that helps cancer cells divide and grow.[1] Alisertib is currently being investigated across 33 indications[3], with its most advanced program in Phase 3.[1]

Alisertib is one of 825 small molecule programs targeting Glioma. It is currently in Phase 3.

33

Indications

53

Total Trials

6

Active Trials

824

Competitors

Pipeline

Status by Indication[3][1]

Indication

GliomaActive, not recruiting

Prostate AdenocarcinomaActive, not recruiting

LeiomyosarcomaActive, not recruiting

Unspecified Peripheral T-Cell LymphomaActive, not recruiting

Lung CancerActive, not recruiting

T-Cell Non-Hodgkin LymphomaActive, not recruiting

LymphomaActive, not recruiting

Head and Neck Malignant NeoplasiaActive, not recruiting

LeukemiaActive, not recruiting

NeuroblastomaActive, not recruiting

GliomaPhase 1

Active, not recruiting

Prostate AdenocarcinomaPhase 2

Active, not recruiting

LeiomyosarcomaPhase 2

Active, not recruiting

Unspecified Peripheral T-Cell LymphomaPhase 3

Active, not recruiting

Lung CancerPhase 1

Active, not recruiting

T-Cell Non-Hodgkin LymphomaPhase 2

Active, not recruiting

LymphomaPhase 1

Active, not recruiting

Head and Neck Malignant NeoplasiaPhase 1

Active, not recruiting

LeukemiaPhase 2

Active, not recruiting

NeuroblastomaPhase 1

Active, not recruiting

Showing 10 of 33 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Alisertib

Tykerb

Halaven

Nolvadex

SSan Diego Pacific Oncology & Hematology Associates

Megace

Bristol-Myers Squibb

Lexiscan

Methylthioninium Chloride

PProvepharm SAS

Effexor

WWyeth-Lederle Vaccines

Feraheme

AAzurity Pharmaceuticals

Aquasol E

NNational Eye Institute (NEI)

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1Recruiting

Lung Cancer

NCT04085315

Q1 2027

Phase 1Active, not recruiting

Recurrent B-Cell Non-Hodgkin Lymphoma

NCT01695941

Q3 2027

Phase 2Active, not recruiting

Rhabdoid Tumor

NCT02114229

Q4 2027

Phase 2Recruiting

Small Cell Lung Cancer

NCT06095505

Clinical

Trials by Indication[1]

Lymphoma11 trials

MLN8237 in Patients With Relapsed or Refractory Aggressive B-Cell Lymphoma Treated With Rituximab +/- Vincristine

Completed· Takeda logo

Takeda·Phase 1/2·NCT01397825·45 enrolled

Study of Alisertib (MLN8237) in Adults With Aggressive Non-Hodgkin's Lymphoma

Completed· Takeda logo

Takeda·Phase 2·NCT00807495·48 enrolled

Food Effect Study of Alisertib (MLN8237) in Participants With Advanced Solid Tumors or Lymphomas

Completed· Takeda logo

Takeda·Phase 1·NCT01898078·26 enrolled

Show 8 more trials

Alisertib (MLN8237) or Investigator's Choice in Patients With Relapsed/Refractory Peripheral T-Cell Lymphoma

Completed· Takeda logo

Takeda·Phase 3·NCT01482962·271 enrolled

Pharmacokinetics of Alisertib in Adults With Advanced Solid Tumors or Relapsed/Refractory Lymphoma With Varying Degrees of Hepatic Function

Completed· Takeda logo

Takeda·Phase 1·NCT02214147·36 enrolled

A Study of Alisertib (MLN8237) in Adult East Asian Participants With Advanced Solid Tumors or Lymphomas

Completed· Takeda logo

Takeda·Phase 1·NCT01512758·36 enrolled

Alisertib in Combination With Vorinostat in Treating Patients With Relapsed or Recurrent Hodgkin Lymphoma, B-Cell Non-Hodgkin Lymphoma, or Peripheral T-Cell Lymphoma

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT01567709·34 enrolled

A Phase I Study of Alisertib + R-EPOCH for Treatment of Myc-Positive Aggressive B-cell Lymphomas

Terminated·UUNC Lineberger Comprehensive Cancer Center·Phase 1·NCT02700022·1 enrolled

A Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of Alisertib in Participants With Advanced Solid Tumors or Relapsed/Refractory Lymphoma

Completed· Takeda logo

Takeda·Phase 1·NCT02259010·24 enrolled

Alisertib and Romidepsin in Treating Patients With Relapsed or Refractory B-Cell or T-Cell Lymphomas

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT01897012·26 enrolled

Alisertib With and Without Rituximab in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

Terminated·OOhio State University Comprehensive Cancer Center·Phase 2·NCT01812005·14 enrolled

Breast Cancer5 trials

Alisertib (MLN8237) in Participants With Ovarian, Fallopian Tube or Peritoneal Cancer Preceded by Phase 1 Study of MLN8237 Plus Paclitaxel Treatment of Ovary or Breast Cancer

Completed· Takeda logo

Takeda·Phase 2·NCT01091428·191 enrolled

Alisertib and Fulvestrant in Treating Patients With Hormone Receptor Positive Breast Cancer That is Metastatic or Locally Advanced and Cannot Be Removed by Surgery

Completed·MMayo Clinic·Phase 1·NCT02219789·10 enrolled

Alisertib With or Without Fulvestrant in Treating Patients With Locally Advanced or Metastatic, Endocrine-Resistant Breast Cancer

Completed·MMayo Clinic·Phase 2·NCT02860000·96 enrolled

Show 2 more trials

Study to Compare Alisertib With Paclitaxel vs. Paclitaxel Alone in Metastatic or Locally Recurrent Breast Cancer

Completed·UUS Oncology Research·Phase 2·NCT02187991·169 enrolled

A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer

Recruiting·PPuma Biotechnology, Inc.·Phase 2·NCT06369285·150 enrolled

Small Cell Lung Cancer3 trials

A Study of Alisertib and Paclitaxel in Patients With Small Cell Lung Cancer (SCLC)

Not yet recruiting·PPuma Biotechnology, Inc.·Phase 2·NCT07465757·50 enrolled

A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer

Recruiting·PPuma Biotechnology, Inc.·Phase 2·NCT06095505·80 enrolled

Phase 2 Study of Alisertib (MLN8237) in Combination With Paclitaxel Versus Placebo in Combination With Paclitaxel as Second Line Therapy for Small Cell Lung Cancer (SCLC)

Completed· Takeda logo

Takeda·Phase 2·NCT02038647·178 enrolled

Advanced Solid Tumors2 trials

A Study of MLN8237, a Novel Aurora A Kinase Inhibitor, in Participants With Advanced Solid Tumors

Completed· Takeda logo

Takeda·Phase 1·NCT00500903·87 enrolled

Study of MLN8237 in Participants With Advanced Solid Tumors

Completed· Takeda logo

Takeda·Phase 1·NCT00962091·53 enrolled

Prostate Cancer2 trials

Alisertib, Abiraterone Acetate and Prednisone in Treating Patients With Hormone-Resistant Prostate Cancer

Completed·SSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·Phase 1/2·NCT01848067·9 enrolled

A Phase 1 Study of Alisertib Participants With Advanced Solid Tumors Including Castration-Resistant Prostate Cancer Receiving a Standard Docetaxel Regimen

Completed· Takeda logo

Takeda·Phase 1·NCT01094288·41 enrolled

30 more indications

Non-Small Cell Lung Cancer1 trial

Osimertinib in Combination With Alisertib or Sapanisertib for the Treatment of Osimertinib-Resistant EGFR Mutant Stage IIIB or IV Non-Small Cell Lung Cancer

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT04479306·37 enrolled

Metastatic Sarcoma1 trial

Alisertib in Treating Patients With Advanced or Metastatic Sarcoma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01653028·72 enrolled

Leukemia1 trial

Alisertib in Treating Young Patients With Recurrent or Refractory Solid Tumors or Leukemia

Completed·CChildren's Oncology Group·Phase 2·NCT01154816·118 enrolled

Acute Myeloid Leukemia1 trial

Alisertib for Acute Myeloid Leukemia

Completed·MMassachusetts General Hospital·Phase 1·NCT01779843·22 enrolled

Induction Chemotherapy1 trial

Phase II Trial of Alisertib With Induction Chemotherapy in High-risk AML

Completed·MMassachusetts General Hospital·Phase 2·NCT02560025·42 enrolled

Hematologic Malignancies1 trial

A Study MLN2480 in Combination With MLN0128 or Alisertib, or Paclitaxel, or Cetuximab, or Irinotecan in Adult Participants With Advanced Nonhematologic Malignancies

Completed· Takeda logo

Takeda·Phase 1·NCT02327169·81 enrolled

Papilloma1 trial

Alisertib and TAK-228 in Participants With Human Papilloma Virus (HPV) Associated Malignancies

Withdrawn·MM.D. Anderson Cancer Center·Phase 1·NCT02812056

Gastrointestinal Tumors1 trial

Alisertib and Combination Chemotherapy in Treating Patients With Gastrointestinal Tumors

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT02319018·14 enrolled

Myelodysplastic Syndrome1 trial

A Phase 2 Trial of MLN8237 in Adult Participants With Acute Myelogenous Leukemia and High-Grade Myelodysplastic Syndrome

Completed· Takeda logo

Takeda·Phase 2·NCT00830518·57 enrolled

Esophageal Adenocarcinoma1 trial

MLN1117 in Combination With Docetaxel, Paclitaxel, and Other Investigational Anticancer Agents to Treat Participants With Gastric and Gastroesophageal Adenocarcinoma

Terminated· Takeda logo

Takeda·Phase 1·NCT02551055·32 enrolled

Triple-Negative Breast Cancer1 trial

Phase I Study of MLN0128 and MLN8237 in Patients With Advanced Solid Tumors and Metastatic Triple-negative Breast Cancer

Completed·UUniversity of Colorado, Denver·Phase 1·NCT02719691·47 enrolled

Pancreatic Cancer1 trial

Alisertib and Gemcitabine Hydrochloride in Treating Patients With Solid Tumors or Pancreatic Cancer

Completed·EEdward Kim·Phase 1·NCT01924260·26 enrolled

Malignant Mesothelioma1 trial

Phase II Trial of Alisertib (MLN8237) in Salvage Malignant Mesothelioma

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT02293005·28 enrolled

Head and Neck Squamous Cell Cancer1 trial

Alisertib and Pembrolizumab for the Treatment of Patients With Rb-deficient Head and Neck Squamous Cell Cancer

Completed·MM.D. Anderson Cancer Center·Phase 1/2·NCT04555837·24 enrolled

Colorectal Cancer1 trial

Irinotecan and Alisertib in Treating Patients With Advanced Solid Tumors or Colorectal Cancer

Completed·UUniversity of California, Davis·Phase 1·NCT01923337·17 enrolled

Advanced Malignancies1 trial

A Phase I Clinical and Pharmacodynamic Study of MLN8237, A Novel Aurora A Kinase Inhibitor, in Participants With Advanced Malignancies

Completed· Takeda logo

Takeda·Phase 1·NCT00651664·59 enrolled

Hematological Malignancies1 trial

Study of MLN8237 in Participants With Advanced Hematological Malignancies

Completed· Takeda logo

Takeda·Phase 1·NCT00697346·58 enrolled

Peritoneal Carcinoma1 trial

MLN8237 for Treatment of Participants With Ovarian, Fallopian Tube, or Peritoneal Carcinoma

Completed· Takeda logo

Takeda·Phase 2·NCT00853307·31 enrolled

Glioma1 trial

Alisertib and Fractionated Stereotactic Radiosurgery in Treating Patients With Recurrent High Grade Gliomas

Completed·SSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·Phase 1·NCT02186509·17 enrolled

Patients With Advanced Solid Tumors1 trial

Alisertib (MLN8237) in Combination With Weekly Paclitaxel in East Asian Patients With Advanced Solid Tumors

Terminated· Takeda logo

Takeda·Phase 1·NCT02367352·9 enrolled

Myelofibrosis1 trial

Alisertib in Treating Patients With Myelofibrosis or Relapsed or Refractory Acute Megakaryoblastic Leukemia

Unknown status·NNorthwestern University·N/A·NCT02530619·26 enrolled

Lung Cancer1 trial

Alisertib in Combination With Osimertinib in Metastatic EGFR-mutant Lung Cancer

Recruiting·CCollin Blakely·Phase 1·NCT04085315·38 enrolled

Patients With Solid Tumors1 trial

Phase I Study of MLN8237 and Pazopanib in Patients With Solid Tumors

Completed·UUniversity of Illinois at Chicago·Phase 1·NCT01639911·28 enrolled

Metabolism1 trial

Mass Balance, Pharmacokinetics and Metabolism Study of Alisertib

Completed· Takeda logo

Takeda·Phase 1·NCT01714947·3 enrolled

T-cell non-Hodgkin lymphoma1 trial

Alisertib in Treating Patients With Relapsed or Refractory Peripheral T-Cell Non-Hodgkin Lymphoma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01466881·42 enrolled

Leiomyosarcoma1 trial

Alisertib in Treating Patients With Recurrent or Persistent Leiomyosarcoma of the Uterus

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01637961·23 enrolled

Urothelial Cancer1 trial

Alisertib in Chemotherapy-pretreated Urothelial Cancer

Completed·FFondazione IRCCS Istituto Nazionale dei Tumori, Milano·Phase 2·NCT02109328·22 enrolled

Rhabdoid Tumor1 trial

Phase 2 Study of Alisertib Therapy for Rhabdoid Tumors

Active, not recruiting·SSt. Jude Children's Research Hospital·Phase 2·NCT02114229·125 enrolled

Recurrent B-Cell Non-Hodgkin Lymphoma1 trial

A Phase I Study of MLN8237 in Combination With Bortezomib and Rituximab in Relapsed and Refractory Mantle Cell and Low Grade Non-Hodgkin Lymphoma

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT01695941·24 enrolled

Unspecified1 trial

Safety, Tolerability and Pharmacokinetic (PK) of Concomitant Esomeprazole and Rifampin, and QT Study on Single and Multiple-doses of Alisertib

Completed· Takeda logo

Takeda·Phase 1·NCT01844583·55 enrolled

Sources

References

[1]
ClinicalTrials.gov — 53 trial records for Alisertib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Alisertib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Alisertib. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Takeda company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Serine/threonine-Protein Kinase Aurora-a Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Takeda

Related News