Zanidatamab clinical trials
Zanidatamab is named as an intervention in 14 current clinical trials in our Germany, France, Spain, USA, China, Italy, Belgium, Canada, South Korea, UK, Japan, Brazil, India, Poland, Portugal, Turkey, Mexico, Taiwan, Australia, Ireland, Netherlands, Singapore, Sweden, Czechia, Israel and Austria registers. 11 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Jazz Pharmaceuticals (6). The most-studied condition is Gastroesophageal Adenocarcinoma. The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial.
Where Zanidatamab is approved
All regulators →Of the three regulators tracked here, the first to approve Zanidatamab was the US, on 20 Nov 2024. It is approved in 3 of the 3 regulators tracked here.
- 4 EU orphan designations, most recently for treatment of oesophageal cancer (21 Nov 2025, positive)
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.
Zanidatamab patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Zanidatamab, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- Ziihera for treatment of biliary tract cancer: until 30 Jun 2035. Union Register
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 Zanidatamab
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 Zanidatamab works
All drug targets →- Receptor protein-tyrosine kinase erbB-2 inhibitor InhibitorTarget: ERBB2 erb-b2 receptor tyrosine kinase 2ChEMBL only
- Biliary tract cancerPhase 3
- Breast cancerPhase 3
- CancerPhase 3
- Gastric adenocarcinomaPhase 3
- CarcinosarcomaPhase 2
- Colorectal cancerPhase 2
- Endometrial cancerPhase 2
- Endometrial carcinomaPhase 2
- Esophageal cancerPhase 2
- Gallbladder cancerPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL4650256, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 13627, 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 Zanidatamab
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 1 technology appraisal of Zanidatamab. 1 is current, and 1 of it recommends it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Zanidatamab for treating HER2-positive advanced biliary tract cancer after 1 or more lines of systemic treatment NICE TA1153 | Recommended | 7 May 2026 | 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 Zanidatamab
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: ZiiheraEMA 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 Zanidatamab
14 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.
Zanidatamab in the EU trials register (CTIS)
1 trialAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Zanidatamab. 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 |
|---|---|---|---|---|
|
Perioperative zanidatamab combined with chemotherapy in HER2-positive locally advanced operable gastroesophageal adenocarcinoma (GEA): a Phase 1b/2a single-arm trial
2025-523483-20-00 · Neoplasms
|
Phase 1 | Authorised | UZ Leuven | Belgium |
Zanidatamab 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 Zanidatamab on the HPRA medicines list.
- Ziihera 300 mg powder for concentrate for solution for infusionJazz Pharmaceuticals Ireland Limited · EU/1/25/1931/001-002
Supply shortages
No entry for Zanidatamab in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Zanidatamab
25 conditionsAll 25 conditions
| Condition (as registered) | Trials |
|---|---|
| Gastroesophageal Adenocarcinoma | 4 |
| Esophageal Adenocarcinoma | 2 |
| Gastroesophageal Junction Adenocarcinoma | 2 |
| Breast Cancer | 2 |
| Esophageal Cancer | 2 |
| HER2-positive Gastric Cancer | 2 |
| Gastric Cancer | 2 |
| Gastric Neoplasms | 1 |
| Metastatic Breast Cancer | 1 |
| Metastatic Gastric Adenocarcinoma | 1 |
| Biliary Tract Cancer | 1 |
| Metastatic HER2-positive Breast Cancer | 1 |
| HER2-positive Breast Cancer | 1 |
| GastroEsophageal Cancer | 1 |
| Gastroesophageal-junction Cancer | 1 |
| Gastroesophageal Cancer | 1 |
| Muscle Invasive Bladder Cancer (MIBC) | 1 |
| First Line Therapy | 1 |
| HER2 + Gastric Cancer | 1 |
| PDL-1 | 1 |
| Non-Small Cell Lung Cancer | 1 |
| Sarcoma | 1 |
| Head &Amp; Neck Cancer | 1 |
| Colorectal Carcinoma | 1 |
| Biliary Tract Neoplasms | 1 |
Sponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Jazz Pharmaceuticals | 6 |
| UNICANCER | 2 |
| Boehringer Ingelheim | 1 |
| Zhifeng Zhao, PhD | 1 |
| Fujian Medical University Union Hospital | 1 |
| Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | 1 |
| Canadian Cancer Trials Group | 1 |
| American Association for Cancer Research | 1 |
By 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 Zanidatamab trials
How many clinical trials are testing Zanidatamab?
14 current trials in our Germany, France, Spain, USA, China, Italy, Belgium, Canada, South Korea, UK, Japan, Brazil, India, Poland, Portugal, Turkey, Mexico, Taiwan, Australia, Ireland, Netherlands, Singapore, Sweden, Czechia, Israel and Austria registers name Zanidatamab (also registered as ZW25) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Zanidatamab trials recruiting patients?
Yes. 11 of the 14 trials are recruiting: 5 with sites in Germany, 5 with sites in France, 5 with sites in Spain, 5 with sites in USA, 3 with sites in China, 4 with sites in Italy, 4 with sites in Belgium, 4 with sites in Canada, 4 with sites in South Korea, 3 with sites in UK, 3 with sites in Japan, 2 with sites in Brazil, 1 with sites in India, 1 with sites in Poland, 1 with sites in Portugal, 1 with sites in Turkey, 1 with sites in Mexico, 1 with sites in Taiwan, 1 with sites in Australia, 1 with sites in Sweden, 1 with sites in Czechia, 1 with sites in Israel and 1 with sites in Austria. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Zanidatamab clinical trials?
Jazz Pharmaceuticals (6), UNICANCER (2), Boehringer Ingelheim (1) and Zhifeng Zhao, PhD (1), among 8 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Are there Zanidatamab 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 Zanidatamab licensed in Ireland?
Yes. The HPRA medicines list includes 1 single-substance product containing Zanidatamab, for example Ziihera 300 mg powder for concentrate for solution for infusion (Jazz Pharmaceuticals Ireland Limited). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Zanidatamab shortage?
Not in the lists we track: Zanidatamab 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 Zanidatamab 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 Zanidatamab 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 Zanidatamab (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.