Entrectinib clinical trials
Entrectinib is named as an intervention in 17 current clinical trials in our China, France, Mexico, South Korea, USA, Germany, Italy, UK, Belgium, Poland, Japan, Taiwan, Spain, Brazil, Canada, Singapore, Australia, Netherlands, Israel, Sweden, Turkey, Denmark, Switzerland, Portugal, Egypt, India and Norway registers. 9 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Hoffmann-La Roche (7). The most-studied condition is Cancer.
Where Entrectinib is approved
All regulators →Of the three regulators tracked here, the first to approve Entrectinib was the US, on 15 Aug 2019. 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.
Entrectinib patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Entrectinib, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 14 listed patents; the last listed expires 18 Jul 2038 (US 11253515).
- Latest patent on the drug substance itself: 18 May 2037 (US 10738037).
- Exclusivity ODE-448: Orphan drug exclusivity: treatment of pediatric patients older than 1 month up to 12 years of age with solid tumors that have a neurotrophi…, until 20 Oct 2030.
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 Entrectinib
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 Entrectinib works
All drug targets →- Neurotrophic tyrosine kinase receptor inhibitor InhibitorTarget: Neurotrophic tyrosine kinase receptorChEMBL only
- Proto-oncogene tyrosine-protein kinase ROS inhibitor InhibitorTarget: ROS1 ROS proto-oncogene 1, receptor tyrosine kinaseChEMBL only
- ALK tyrosine kinase receptor inhibitor InhibitorTarget: ALK ALK receptor tyrosine kinaseChEMBL only
- Childhood malignant neoplasmPhase 2/3
- AdenocarcinomaPhase 2
- Breast cancerPhase 2
- Central nervous system cancerPhase 2
- Central nervous system neoplasmPhase 2
- Colorectal cancerPhase 2
- Digestive system neoplasmPhase 2
- Invasive lobular breast carcinomaPhase 2
- Lung cancerPhase 2
- Malignant gliomaPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1983268, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 8290, 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 Entrectinib
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 3 technology appraisals of Entrectinib. 2 are current, and 1 of these recommend it for at least some patients. 1 older appraisal was replaced or withdrawn.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Entrectinib for treating NTRK fusion-positive solid tumours in people 12 years and over (terminated appraisal) NICE TA1118 | Terminated (no company submission) | 7 Jan 2026 | Current |
| Entrectinib for treating ROS1-positive advanced non-small-cell lung cancer NICE TA643 | Recommended | 12 Aug 2020 | 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 Entrectinib
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: RozlytrekEMA 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 Entrectinib
- ChEMBL
- CHEMBL1983268
- DrugBank
- DB11986
- PubChem CID
- 25141092
- CAS number
- 1108743-60-7
- FDA UNII
- L5ORF0AN1I
- Wikidata
- Q25323953
- Wikipedia
- Entrectinib
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 Entrectinib
17 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.
Entrectinib 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 Entrectinib on the HPRA medicines list.
- Rozlytrek 100 mg hard capsulesRoche Registration GmbH · EU/1/20/1460/001
- Rozlytrek 200 mg hard capsulesRoche Registration GmbH · EU/1/20/1460/002
- Rozlytrek 50 mg film-coated granules in sachetRoche Registration GmbH · EU/1/20/1460/003
Supply shortages
No entry for Entrectinib in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Entrectinib
30 conditionsAll 30 conditions
| Condition (as registered) | Trials |
|---|---|
| Cancer | 2 |
| Solid Tumors | 2 |
| Non-Small Cell Lung Cancer | 2 |
| Non Small Cell Lung Cancer | 2 |
| CNS Tumors | 1 |
| Breast Cancer | 1 |
| Cholangiocarcinoma | 1 |
| Colorectal Cancer | 1 |
| Head and Neck Neoplasms | 1 |
| Non-small Cell Lung Cancer | 1 |
| Carcinoma, Non-Small-Cell Lung | 1 |
| Advanced Thyroid Cancer Patients Who Received Target Therapy | 1 |
| Locally Advanced Thyroid Gland Carcinoma | 1 |
| ROS1 Fusion Positive | 1 |
| EGFR Gene Mutation | 1 |
| ALK Gene Mutation | 1 |
| ROS1 Gene Mutation | 1 |
| Tumors | 1 |
| Neoplasm | 1 |
| Neoplasia | 1 |
| Cancer Metastatic | 1 |
| High Grade Glioma | 1 |
| CNS Tumor | 1 |
| CDK Gene Mutation | 1 |
| Metastatic Malignant Neoplasm in the Brain | 1 |
| Metastatic Malignant Solid Neoplasm | 1 |
| NTRK Family Gene Mutation | 1 |
| Solid Tumor | 1 |
| Advanced Solid Tumor | 1 |
| Metastatic Cancer | 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 Entrectinib trials
How many clinical trials are testing Entrectinib?
17 current trials in our China, France, Mexico, South Korea, USA, Germany, Italy, UK, Belgium, Poland, Japan, Taiwan, Spain, Brazil, Canada, Singapore, Australia, Netherlands, Israel, Sweden, Turkey, Denmark, Switzerland, Portugal, Egypt, India and Norway registers name Entrectinib (also registered as RO7102122) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Entrectinib trials recruiting patients?
Yes. 9 of the 17 trials are recruiting: 5 with sites in China, 1 with sites in France, 1 with sites in Mexico, 1 with sites in South Korea, 1 with sites in USA, 1 with sites in UK, 1 with sites in Belgium, 1 with sites in Poland, 1 with sites in Japan, 1 with sites in Taiwan, 1 with sites in Brazil, 1 with sites in Canada, 1 with sites in Netherlands and 1 with sites in Norway. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Entrectinib clinical trials?
Hoffmann-La Roche (7), Fudan University (2), Genentech, Inc (1) and West China Hospital (1), among 10 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Entrectinib licensed in Ireland?
Yes. The HPRA medicines list includes 3 single-substance products containing Entrectinib, for example Rozlytrek 100 mg hard capsules (Roche Registration GmbH). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Entrectinib shortage?
Not in the lists we track: Entrectinib 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 Entrectinib 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 Entrectinib 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 Entrectinib (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.