Alisertib clinical trials
Alisertib is named as an intervention in 3 current clinical trials in our USA, Spain, Portugal, Israel and France registers. 3 are recruiting patients now. All registered phases are Phase 2. The lead sponsor is Puma Biotechnology, Inc. The most-studied condition is Hormone Receptor Positive HER-2 Negative Breast Cancer.
Where Alisertib is approved
All regulators →- 2 EU orphan designations, most recently for treatment of peripheral T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated) (6 Dec 2012, withdrawn)
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
How Alisertib works
All drug targets →- Serine/threonine-protein kinase Aurora-A inhibitor InhibitorTarget: AURKA aurora kinase A✓ In ChEMBL and the Guide to Pharmacology
- Mature T-cell and NK-cell non-Hodgkin lymphomaPhase 3
- Burkitt lymphomaPhase 2
- Ewing sarcomaPhase 2
- Wilms tumorPhase 2
- Acute lymphoblastic leukemiaPhase 2
- Acute myeloid leukemiaPhase 2
- AngiosarcomaPhase 2
- Atypical teratoid rhabdoid tumorPhase 2
- Breast cancerPhase 2
- Dedifferentiated chondrosarcomaPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL483158, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 7790, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Alisertib
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Alisertib
- ChEMBL
- CHEMBL483158
- DrugBank
- DB05220
- PubChem CID
- 24771867
- CAS number
- 1028486-01-2
- FDA UNII
- T66ES73M18
- Wikidata
- Q15633917
- Wikipedia
- Alisertib
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Alisertib
3 trials| Study | Phase | Status | Lead sponsor | Registers |
|---|---|---|---|---|
|
A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
NCT06095505 · Small Cell Lung Cancer
|
Phase 2 | Recruiting | Puma Biotechnology, Inc | USA, Israel |
|
A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer
NCT06369285 · ClinicalTrials.gov ↗ · Hormone Receptor Positive HER-2 Negative Breast Cancer, Metastatic Breast Cancer, Recurrent Breast Cancer
|
Phase 2 | Recruiting | Puma Biotechnology, Inc | USA, Spain, Portugal |
|
A Study of Alisertib and Paclitaxel in Patients With Small Cell Lung Cancer (SCLC)
NCT07465757 · ClinicalTrials.gov ↗ · Small Cell Lung Cancer ( SCLC )
|
Phase 2 | Recruiting | Puma Biotechnology, Inc | USA, France, Spain |
Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Conditions studied with Alisertib
5 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Puma Biotechnology, Inc | 3 |
By country register
| Register | Trials | Recruiting |
|---|---|---|
| Clinical trials in USA | 3 | 3 |
| Clinical trials in Spain | 2 | 2 |
| Clinical trials in Portugal | 1 | 1 |
| Clinical trials in Israel | 1 | 1 |
| Clinical trials in France | 1 | 1 |
A trial with sites in more than one country appears in each of those registers.
Related compounds
Questions about Alisertib trials
How many clinical trials are testing Alisertib?
3 current trials in our USA, Spain, Portugal, Israel and France registers name Alisertib (also registered as PB-8237) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Alisertib trials recruiting patients?
Yes. 3 of the 3 trials are recruiting: 3 with sites in USA, 2 with sites in Spain, 1 with sites in Portugal, 1 with sites in Israel and 1 with sites in France. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Alisertib clinical trials?
The lead sponsor is Puma Biotechnology, Inc. The number in brackets is how many trials each organisation leads.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Alisertib works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Alisertib works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Alisertib (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.