Larotrectinib clinical trials
Larotrectinib is named as an intervention in 13 current clinical trials in our China, Canada, Australia, Germany, USA, France, Spain, Italy, Sweden, Switzerland, Japan, South Korea, Israel, Norway, Ireland, UK, Netherlands, Denmark, Poland, Czechia, Turkey, Belgium, Austria, Mexico and Egypt registers. 6 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Bayer (3). The most-studied condition is Advanced Malignant Solid Neoplasm. The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial.
Where Larotrectinib is approved
All regulators →Of the three regulators tracked here, the first to approve Larotrectinib was the US, on 26 Nov 2018. It is approved in 3 of the 3 regulators tracked here.
- 3 EU orphan designations, most recently for treatment of papillary thyroid cancer (19 Nov 2018, withdrawn)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.
Larotrectinib patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Larotrectinib, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 20 listed patents; the last listed expires 16 May 2037 (US 11337967).
- Latest patent on the drug substance itself: 15 Aug 2036 (US 10799505).
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 Larotrectinib
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 Larotrectinib works
All drug targets →- Neurotrophic tyrosine kinase receptor inhibitor InhibitorTarget: Neurotrophic tyrosine kinase receptor✓ In ChEMBL and the Guide to Pharmacology
- Acute leukemiaPhase 2
- Breast cancerPhase 2
- Colorectal cancerPhase 2
- Congenital fibrosarcomaPhase 2
- Differentiated thyroid carcinomaPhase 2
- FibrosarcomaPhase 2
- LymphomaPhase 2
- Medullary thyroid gland carcinomaPhase 2
- Non-small cell lung carcinomaPhase 2
- Plasma cell myelomaPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL3889654, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 8909, 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 Larotrectinib
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 1 technology appraisal of Larotrectinib. 1 is current.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Larotrectinib for treating NTRK fusion-positive solid tumours NICE TA630 | Recommended (Cancer Drugs Fund) | 27 May 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 Larotrectinib
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 1 product on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: VitrakviEMA 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.
Trials by status
Trials by phase
Clinical trials of Larotrectinib
13 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.
Larotrectinib in the EU trials register (CTIS)
1 trialAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Larotrectinib. 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 |
|---|---|---|---|---|
|
TAILOR-PANC: Molecularly Tailored Therapy versus Standard Care in Advanced Pancreatic Cancer (DPCG-02)
2025-522431-34-00 · CTIS ↗ · Neoplasms
|
Phase 2 | Authorised | Region Hovedstaden | Denmark |
Larotrectinib 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)
1 single-substance product containing Larotrectinib on the HPRA medicines list.
- VITRAKVI 20 mg/ml Oral solutionBayer AG · EU/1/19/1385/003-004
Supply shortages
No entry for Larotrectinib in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Larotrectinib
24 conditionsAll 24 conditions
| Condition (as registered) | Trials |
|---|---|
| Advanced Malignant Solid Neoplasm | 2 |
| Solid Tumors Harboring NTRK Fusion | 1 |
| Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion | 1 |
| Lung Cancer Stage III | 1 |
| Mutation | 1 |
| Advanced Thyroid Cancer Patients Who Received Target Therapy | 1 |
| Locally Advanced Thyroid Gland Carcinoma | 1 |
| Thyroid Neoplasms | 1 |
| High Grade Glioma | 1 |
| Diffuse Intrinsic Pontine Glioma | 1 |
| Metastatic Colorectal Cancer | 1 |
| Advanced Lymphoma | 1 |
| Bladder Carcinoma | 1 |
| Breast Carcinoma | 1 |
| Advanced or Recurrent Solid Tumor Harboring an NTRK Gene Fusion | 1 |
| IDH Wildtype Glioblastoma | 1 |
| Glioblastoma (GBM) | 1 |
| Ann Arbor Stage III Non-Hodgkin Lymphoma | 1 |
| Ann Arbor Stage IV Non-Hodgkin Lymphoma | 1 |
| Histiocytic Sarcoma | 1 |
| Central Nervous System Neoplasm | 1 |
| Infantile Fibrosarcoma | 1 |
| Recurrent Acute Leukemia | 1 |
| Refractory Acute Leukemia | 1 |
Sponsors
lead sponsor per trialBy country register
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 Larotrectinib trials
How many clinical trials are testing Larotrectinib?
13 current trials in our China, Canada, Australia, Germany, USA, France, Spain, Italy, Sweden, Switzerland, Japan, South Korea, Israel, Norway, Ireland, UK, Netherlands, Denmark, Poland, Czechia, Turkey, Belgium, Austria, Mexico and Egypt registers name Larotrectinib (also registered as Vitrakvi, BAY2757556) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Larotrectinib trials recruiting patients?
Yes. 6 of the 13 trials are recruiting: 3 with sites in China, 1 with sites in Canada, 1 with sites in Australia, 1 with sites in Germany, 1 with sites in Japan 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 Larotrectinib clinical trials?
Bayer (3), National Cancer Institute (NCI) (2), Sun Yat-sen University (1) and Fudan University (1), among 10 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Are there Larotrectinib clinical trials in Ireland?
Yes. 1 trial in our Ireland register (ClinicalTrials.gov). Some may be the same study registered in both. See the Irish clinical trials register for sites and contacts.
Is Larotrectinib licensed in Ireland?
Yes. The HPRA medicines list includes 1 single-substance product containing Larotrectinib, for example VITRAKVI 20 mg/ml Oral solution (Bayer AG). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Larotrectinib shortage?
Not in the lists we track: Larotrectinib 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 Larotrectinib 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 Larotrectinib 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 Larotrectinib (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.