Product Description
A second-generation, orally bioavailable, highly selective small molecule inhibitor of the serine/threonine protein kinase Aurora A kinase with potential antineoplastic activity. Alisertib binds to and inhibits Aurora A kinase, which may result in disruption of the assembly of the mitotic spindle apparatus, disruption of chromosome segregation, and inhibition of cell proliferation. Aurora A kinase localizes to the spindle poles and to spindle microtubules during mitosis, and is thought to regulate spindle assembly. Aberrant expression of Aurora kinases occurs in a wide variety of cancers, including colon and breast cancers. (Sourced from: https://www.cancer.gov/publications/dictionaries/cancer-drug/def/alisertib)
Mechanisms of Action: AURK Inhibitor
Novel Mechanism: Yes
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: Orphan Drug - Lung Cancer|Small Cell Lung Cancer *
Approval Status: Not Approved
Approved Countries: Slovenia
Approved Indications: None
Company: Puma Biotechnology
Company Location: Western America
Company Founding Year: 2010
Additional Commercial Interests: Takeda
Clinical Description
Countries in Clinic: Portugal, Spain, United States
Active Clinical Trial Count: 5
Recent & Upcoming Milestones
- Clinical Outcomes Expected - Puma Biotechnology announced they will present P2 Breast Cancer results in 4Q26 for Alisertib
- Clinical Outcomes Expected - Puma Biotechnology announced they will present P2 Non-Small-Cell Lung Cancer results in 2Q26 for Alisertib
- Clinical Outcomes Reported - Puma Biotechnology presented P2 Breast Cancer results on 2024-05-31 for Alisertib
Highest Development Phases
Phase 2: Breast Cancer|Small Cell Lung Cancer
Phase 1: Lung Cancer
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT04085315 |
NCI-2019-05913 | P1 |
Recruiting |
Lung Cancer |
2026-12-31 |
21% |
2024-06-11 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT06369285 |
ALISCA-Breast1 | P2 |
Recruiting |
Breast Cancer |
2027-06-30 |
12% |
2024-10-19 |
Primary Endpoints |
NCT06095505 |
ALISCA-Lung1 | P2 |
Recruiting |
Small Cell Lung Cancer |
2027-04-30 |
12% |
2025-07-02 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
2024-511497-79-00 |
PUMA-ALI-1201 | P2 |
Recruiting |
Breast Cancer |
2029-06-01 |
12% |
2025-05-02 |
Treatments |
NCT07465757 |
ALISCA-Lung2 | P2 |
Not yet recruiting |
Small Cell Lung Cancer |
2028-03-31 |
12% |
2026-03-13 |
Primary Endpoints|Treatments |