Brigatinib clinical trials
Brigatinib is named as an intervention in 8 current clinical trials in our China, France, Netherlands, Spain, Canada and Japan registers. 5 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Hunan Province Tumor Hospital (2). The most-studied condition is Non-small Cell Lung Cancer (NSCLC). The EU clinical trials register (CTIS) separately lists 2 authorised or ongoing trials.
Where Brigatinib is approved
All regulators →Of the three regulators tracked here, the first to approve Brigatinib was the US, on 28 Apr 2017. It is approved in 3 of the 3 regulators tracked here.
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.
Brigatinib patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Brigatinib, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 4 listed patents; the last listed expires 10 Nov 2035 (US 10385078).
- Latest patent on the drug substance itself: 10 Nov 2035 (US 10385078).
- Exclusivity ODE-300: Orphan drug exclusivity: for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung …, until 22 May 2027.
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.
What health systems spend on Brigatinib
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Brigatinib works
All drug targets →- ALK tyrosine kinase receptor inhibitor InhibitorTarget: ALK ALK receptor tyrosine kinase✓ In ChEMBL and the Guide to Pharmacology
- Epidermal growth factor receptor erbB1 inhibitor InhibitorTarget: EGFR epidermal growth factor receptor✓ In ChEMBL and the Guide to Pharmacology
- Acoustic neuromaPhase 2
- Breast cancerPhase 2
- Digestive system neoplasmPhase 2
- EpendymomaPhase 2
- Malignant pancreatic neoplasmPhase 2
- Mature T-cell and NK-cell non-Hodgkin lymphomaPhase 2
- MeningiomaPhase 2
- Pancreatic neoplasmPhase 2
- Inflammatory myofibroblastic tumorPhase 1/2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL3545311, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 7741, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Brigatinib
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 2 technology appraisals of Brigatinib. 2 are current, and 2 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Brigatinib for ALK-positive advanced non-small-cell lung cancer that has not been previously treated with an ALK inhibitor NICE TA670 | Recommended | 27 Jan 2021 | Current |
| Brigatinib for treating ALK-positive advanced non-small-cell lung cancer after crizotinib NICE TA571 | Recommended | 20 Mar 2019 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Brigatinib
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 3 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: AlunbrigEMA product information: package leaflet and summary of product characteristics in every EU language.
- 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 Brigatinib
- ChEMBL
- CHEMBL3545311
- DrugBank
- DB12267
- PubChem CID
- 68165256
- CAS number
- 1197953-54-0
- FDA UNII
- HYW8DB273J
- Wikidata
- Q27456393
- Wikipedia
- Brigatinib
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 Brigatinib
8 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.
Brigatinib in the EU trials register (CTIS)
2 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Brigatinib. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
DYNAMIC ” IDentifY the best therapeutic sequeNcing strAtegy in oncogene addICted NSCLC:”
“A multi-arms prospective, randomized phase II study to evaluate the best sequential
therapeutic strategis in patients with metastatic non-small cell lung cancer harboring
targetable genomic driver alterations”
2026-525268-16-00 · CTIS ↗ · Neoplasms
|
Phase 3 | Authorised | Universita' Degli Studi Di Torino | Italy |
|
Randomized study evaluating the impact of an innovative and cooperative pathway integrating oncogeriatric, pharmaceutical and pharmacological follow-up in elderly patients (>70 years old) presenting with cancer and treated with oral therapy _ POG
2025-523610-83-00 · Immune System Diseases
|
Phase 4 | Authorised | Institut Gustave Roussy | France |
Brigatinib across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
3 single-substance products containing Brigatinib on the HPRA medicines list.
- Alunbrig 180 mg film-coated tabletsTakeda Pharma A/S · EU/1/18/1264/009-010
- Alunbrig 30 mg film-coated tabletsTakeda Pharma A/S · EU/1/18/1264/001-004
- Alunbrig 90 mg film-coated tabletsTakeda Pharma A/S · EU/1/18/1264/005-008
Supply shortages
No entry for Brigatinib in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Brigatinib
16 conditionsAll 16 conditions
| Condition (as registered) | Trials |
|---|---|
| Non-small Cell Lung Cancer (NSCLC) | 2 |
| Non Small Cell Lung Cancer | 2 |
| ALK Gene Mutation | 2 |
| Non-small Cell Lung Cancer | 1 |
| EGFR Gene Mutation | 1 |
| ROS1 Gene Mutation | 1 |
| Anaplastic Large Cell Lymphoma, ALK-Positive | 1 |
| Inflammatory Myofibroblastic Tumor | 1 |
| Other Solid Tumor | 1 |
| Lung Cancer | 1 |
| NSCLC | 1 |
| NSCLC Stage IIIB | 1 |
| NSCLC Stage IV | 1 |
| Pancreatic Ductal Carcinoma | 1 |
| Advanced Cancer | 1 |
| Epithelial Tumor | 1 |
Sponsors
lead sponsor per trialBy country register
| Register | Trials | Recruiting |
|---|---|---|
| Clinical trials in China | 3 | 2 |
| Clinical trials in France | 2 | 1 |
| Clinical trials in Netherlands | 1 | 1 |
| Clinical trials in Spain | 1 | 0 |
| Clinical trials in Canada | 1 | 1 |
| Clinical trials in Japan | 1 | 1 |
| EU register (CTIS) | 2 | — |
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Brigatinib trials
How many clinical trials are testing Brigatinib?
8 current trials in our China, France, Netherlands, Spain, Canada and Japan registers name Brigatinib (also registered as AP26113) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Brigatinib trials recruiting patients?
Yes. 5 of the 8 trials are recruiting: 2 with sites in China, 1 with sites in France, 1 with sites in Netherlands, 1 with sites in Canada and 1 with sites in Japan. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Brigatinib clinical trials?
Hunan Province Tumor Hospital (2), Takeda (2), Princess Maxima Center for Pediatric Oncology (1) and Intergroupe Francophone de Cancerologie Thoracique (1), among 6 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Brigatinib licensed in Ireland?
Yes. The HPRA medicines list includes 3 single-substance products containing Brigatinib, for example Alunbrig 180 mg film-coated tablets (Takeda Pharma A/S). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Brigatinib shortage?
Not in the lists we track: Brigatinib has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
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 Brigatinib 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 Brigatinib 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 Brigatinib (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.