Ensartinib clinical trials
Ensartinib is named as an intervention in 11 current clinical trials in our China, Canada, Australia, UK, USA, Germany, France, Spain, Italy, Netherlands, Belgium, Poland, Czechia, Turkey, Brazil, South Korea and Israel registers. 5 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Sun Yat-sen University (2). The most-studied condition is Non-small Cell Lung Cancer.
Where Ensartinib is approved
All regulators →Of the three regulators tracked here, the first to approve Ensartinib was the US, on 18 Dec 2024.
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.
Ensartinib patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Ensartinib, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 4 listed patents; the last listed expires 1 Jun 2037 (US 10899744).
- Latest patent on the drug substance itself: 1 Jun 2037 (US 10899744).
- Exclusivity NCE: New chemical entity, until 18 Dec 2029.
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
How Ensartinib works
All drug targets →- ALK tyrosine kinase receptor inhibitor InhibitorTarget: ALK ALK receptor tyrosine kinase✓ In ChEMBL and the Guide to Pharmacology
- Non-small cell lung carcinomaPhase 3
- MelanomaPhase 2
- Non-Hodgkin lymphomaPhase 2
- Lung adenocarcinomaPhase 1/2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL4113131, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 8959, 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 Ensartinib
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.
Trials by status
Trials by phase
Clinical trials of Ensartinib
11 trialsRegisters 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 Ensartinib
21 conditionsAll 21 conditions
| Condition (as registered) | Trials |
|---|---|
| Non-small Cell Lung Cancer | 2 |
| Advanced Malignant Solid Neoplasm | 2 |
| Lung Cancer Stage III | 1 |
| Mutation | 1 |
| Malignant Solid Neoplasm | 1 |
| Recurrent Ependymoma | 1 |
| Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor | 1 |
| Ann Arbor Stage III Non-Hodgkin Lymphoma | 1 |
| Ann Arbor Stage IV Non-Hodgkin Lymphoma | 1 |
| Histiocytic Sarcoma | 1 |
| ALK-positive Advanced NSCLC | 1 |
| ALK-positive Non-small Cell Lung Cancer (NSCLC) | 1 |
| MPR | 1 |
| Neoadjuvant Therapy | 1 |
| Solid Advanced Tumor | 1 |
| Non-Small Cell Lung Cancer | 1 |
| NSCLC (Non-small Cell Lung Cancer) | 1 |
| Carcinoma, Non-Small-Cell Lung | 1 |
| Anaplastic Lymphoma Kinase I1171N | 1 |
| Ensartinib | 1 |
| NSCLC, Stage I, II, IIIA, IIIB | 1 |
Sponsors
lead sponsor per trialBy country register
A trial with sites in more than one country appears in each of those registers.
Related compounds
Questions about Ensartinib trials
How many clinical trials are testing Ensartinib?
11 current trials in our China, Canada, Australia, UK, USA, Germany, France, Spain, Italy, Netherlands, Belgium, Poland, Czechia, Turkey, Brazil, South Korea and Israel registers name Ensartinib (also registered as X-396) as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Ensartinib trials recruiting patients?
Yes. 5 of the 11 trials are recruiting: 5 with sites in China. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Ensartinib clinical trials?
Sun Yat-sen University (2), National Cancer Institute (NCI) (2), Xcovery Holdings, Inc (1) and Hebei Medical University Fourth Hospital (1), among 9 lead sponsors in total. 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 Ensartinib 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 Ensartinib 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 Ensartinib (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 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.