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Alisertib · PB-8237, MLN-8237

Small molecule · Inhibitor of Aurora A kinase (AURKA) · developed by Millennium Pharmaceuticals

Phase 2 Most advanced trial

1 Registered trials

What is Alisertib?

Alisertib is an orally bioavailable small molecule inhibitor of Aurora A kinase. It binds to and inhibits Aurora A, disrupting mitotic spindle assembly and chromosome segregation to inhibit cell proliferation. It is studied in hormone receptor positive, HER-2 negative breast cancer and metastatic breast cancer.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as: PB-8237, MLN-8237
Drug type: Small molecule
Targets: Aurora A kinase (AURKA)
Mechanism: Inhibitor of Aurora A kinase (AURKA)
Pathways: mitotic spindle assembly, chromosome segregation, cell proliferation
Therapy area: Oncology
Developer: Millennium Pharmaceuticals, Inc.
In trials of: PBYI
FDA status: Investigational, not approved in the US. Most advanced trial: Phase 2
UNII: T66ES73M18

🧪 Clinical trials

Trial	Phase	Condition	Status	Sponsor
NCT06369285	Phase 2	Hormone Receptor Positive HER-2 Negative Breast Cancer	Recruiting	PBYI

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Hormone Receptor Positive HER-2 Negative Breast CancerMetastatic Breast CancerRecurrent Breast Cancer

Sources

Updated Oct 3, 2026.

Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z