Alisertib
As of the edition of 20 October 2026, Alisertib is a small molecule: in active development; acts on AURKA.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Active, 2026
- Kind
- Small molecule
- Registered trials
- 65, 8 stopped early
- Disease areas
- Cancer; Blood and lymph; Immune system; Lungs and airways; Skin and connective tissue; Urinary and reproductive
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Companies that need a new molecule because of this drug
1 company on route A because of this drug.
Companies on route A for this drug
In the product1 company is on route A because of Alisertib.
See the 1 company on route A for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| AURKA | Aurora kinase A | O14965 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 0 | 0 | 0 |
| Phase 1 | 34 | 27 | 1 | 6 |
| Phase 2 | 28 | 21 | 5 | 2 |
| Phase 3 | 1 | 1 | 0 | 0 |
| All trials | 65 |
Who ran its trials
| Company | Role | Years |
|---|---|---|
| Takeda | Lead sponsor of trials | 2007 to now |
| US Oncology | Lead sponsor of trials | 2015 to now |
| Puma Biotechnology | Lead sponsor of trials | 2024 to now |