Tucatinib clinical trials
Tucatinib is named as an intervention in 23 current clinical trials in our USA, South Korea, Canada, France, UK, Spain, Italy, Japan, Germany, Taiwan, Belgium, Australia, China, Israel, Netherlands, Poland, Austria, Brazil, Mexico, Switzerland, Portugal, Norway, Turkey, Czechia, Ireland, India, Sweden, Denmark, Singapore and Egypt registers. 9 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Seagen, a wholly owned subsidiary of Pfizer (6). The most-studied condition is Breast Cancer.
Where Tucatinib is approved
All regulators →Of the three regulators tracked here, the first to approve Tucatinib was the US, on 17 Apr 2020. 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.
Tucatinib patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Tucatinib, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 7 listed patents; the last listed expires 27 Apr 2038 (US 11666572).
- Latest patent on the drug substance itself: 17 Apr 2034 (US 8648087).
- Exclusivity ODE-422: Orphan drug exclusivity: treatment of adult patients with ras wild-type, HER2-positive unresectable or metastatic colorectal cancer that ha…, until 19 Jan 2030.
- Exclusivity ODE-309: Orphan drug exclusivity: indicated for use in combination with trastuzumab and capecitabine for treatment of adult patients with metastatic…, until 17 Apr 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 Tucatinib
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 Tucatinib works
All drug targets →- Receptor protein-tyrosine kinase erbB-2 inhibitor InhibitorTarget: ERBB2 erb-b2 receptor tyrosine kinase 2✓ In ChEMBL and the Guide to Pharmacology
- Colorectal cancerPhase 3
- Non-small cell lung carcinomaPhase 3
- Gastric adenocarcinomaPhase 2/3
- Gastroesophageal junction adenocarcinomaPhase 2/3
- Biliary tract cancerPhase 2
- CancerPhase 2
- Cervical cancerPhase 2
- Colon carcinomaPhase 2
- Gastric cancerPhase 2
- Leptomeningeal metastasisPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL3989868, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 9922, 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 Tucatinib
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 1 technology appraisal of Tucatinib. 1 is current, and 1 of it recommends it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Tucatinib with trastuzumab and capecitabine for treating HER2-positive advanced breast cancer after 2 or more anti-HER2 therapies NICE TA786 | Recommended | 27 Apr 2022 | 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 Tucatinib
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 2 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: TukysaEMA 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 Tucatinib
- ChEMBL
- CHEMBL3989868
- DrugBank
- DB11652
- PubChem CID
- 51039094
- CAS number
- 937263-43-9
- FDA UNII
- 234248D0HH
- Wikidata
- Q25100690
- Wikipedia
- Tucatinib
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 Tucatinib
23 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.
Tucatinib 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)
2 single-substance products containing Tucatinib on the HPRA medicines list.
- TUKYSA 150 mg film-coated tabletsPfizer Europe MA EEIG · EU/1/20/1526/002
- TUKYSA 50 mg film-coated tabletsPfizer Europe MA EEIG · EU/1/20/1526/001
Supply shortages
No entry for Tucatinib in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Tucatinib
38 conditionsAll 38 conditions
| Condition (as registered) | Trials |
|---|---|
| Breast Cancer | 5 |
| Breast Neoplasms | 3 |
| HER2-positive Breast Cancer | 3 |
| Advanced Solid Tumors | 3 |
| HER2-positive Metastatic Breast Cancer | 2 |
| Lymphoma, Non-Hodgkin | 2 |
| Multiple Myeloma | 2 |
| Colorectal Neoplasms | 1 |
| Uterine Neoplasms | 1 |
| Uterine Cervical Neoplasms | 1 |
| Biliary Tract Neoplasms | 1 |
| Urologic Neoplasms | 1 |
| Gastroesophageal Junction Adenocarcinoma | 1 |
| HER2 Low Breast Neoplasms | 1 |
| HER2 Positive Breast Neoplasms | 1 |
| Metastatic Breast Cancer | 1 |
| HER2 Positive Breast Cancer | 1 |
| Advanced Cancer | 1 |
| PI3K Gene Mutation | 1 |
| Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Cancer | 1 |
| Colorectal Carcinoma | 1 |
| Gastric Adenocarcinoma | 1 |
| GEJ Adenocarcinoma | 1 |
| Esophageal Adenocarcinoma | 1 |
| HER2-positive Gastric Cancer | 1 |
| Metastatic HER2+ Advanced Breast Cancer | 1 |
| Gastric or Gastroesophageal Junction Adenocarcinoma (GEC) | 1 |
| Colorectal Cancer | 1 |
| Metastatic Breast Cancer ( HER2 Negative) | 1 |
| Unresectable Breast Cancer | 1 |
| Metastatic Breast Cancer With a Isolated Brain Progression | 1 |
| Leptomeningeal Metastasis | 1 |
| Leptomeningeal Disease | 1 |
| LMD | 1 |
| Anatomic Stage II Breast Cancer AJCC v8 | 1 |
| Anatomic Stage III Breast Cancer AJCC v8 | 1 |
| HER2 Positive Breast Carcinoma | 1 |
| Invasive Breast Carcinoma | 1 |
Sponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Seagen, a wholly owned subsidiary of Pfizer | 6 |
| Criterium, Inc | 2 |
| Pfizer | 2 |
| UNICANCER | 2 |
| AstraZeneca | 1 |
| Hoffmann-La Roche | 1 |
| Merck Sharp & Dohme LLC | 1 |
| OnKure, Inc | 1 |
| Pieris Pharmaceuticals, Inc | 1 |
| Institut Curie | 1 |
| The Netherlands Cancer Institute | 1 |
| American Society of Clinical Oncology | 1 |
| Canadian Cancer Trials Group | 1 |
| Sunnybrook Health Sciences Centre | 1 |
| Alliance for Clinical Trials in Oncology | 1 |
By country register
A trial with sites in more than one country appears in each of those registers.
Related compounds
Questions about Tucatinib trials
How many clinical trials are testing Tucatinib?
23 current trials in our USA, South Korea, Canada, France, UK, Spain, Italy, Japan, Germany, Taiwan, Belgium, Australia, China, Israel, Netherlands, Poland, Austria, Brazil, Mexico, Switzerland, Portugal, Norway, Turkey, Czechia, Ireland, India, Sweden, Denmark, Singapore and Egypt registers name Tucatinib (also registered as ONT-380) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Tucatinib trials recruiting patients?
Yes. 9 of the 23 trials are recruiting: 3 with sites in USA, 3 with sites in South Korea, 5 with sites in Canada, 4 with sites in France, 3 with sites in UK, 2 with sites in Spain, 2 with sites in Italy, 2 with sites in Japan, 2 with sites in Germany, 2 with sites in Taiwan, 2 with sites in Belgium, 2 with sites in Australia, 2 with sites in China, 2 with sites in Israel, 2 with sites in Netherlands, 2 with sites in Poland, 2 with sites in Austria, 2 with sites in Brazil, 1 with sites in Mexico, 1 with sites in Switzerland, 2 with sites in Portugal, 2 with sites in Norway, 1 with sites in Turkey, 1 with sites in Czechia and 1 with sites in Ireland. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Tucatinib clinical trials?
Seagen, a wholly owned subsidiary of Pfizer (6), Criterium, Inc (2), Pfizer (2) and UNICANCER (2), among 15 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Are there Tucatinib 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 Tucatinib licensed in Ireland?
Yes. The HPRA medicines list includes 2 single-substance products containing Tucatinib, for example TUKYSA 150 mg film-coated tablets (Pfizer Europe MA EEIG). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Tucatinib shortage?
Not in the lists we track: Tucatinib 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 Tucatinib 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 Tucatinib 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 Tucatinib (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.