Zolbetuximab clinical trials
Zolbetuximab is named as an intervention in 14 current clinical trials in our South Korea, USA, Japan, China, Taiwan, France, Spain, Italy, Canada, Turkey, Brazil, Mexico, Australia, UK, Belgium, Netherlands, Germany, Poland, Ireland, Portugal, Czechia, Israel, India and Austria registers. 8 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Astellas Pharma Global Development, Inc (6). The most-studied condition is Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer.
Where Zolbetuximab is approved
All regulators →Of the three regulators tracked here, the first to approve Zolbetuximab was the EU, on 19 Sep 2024. 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.
Zolbetuximab patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Zolbetuximab, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- Vyloy for treatment of gastric cancer: until 25 Sep 2034. 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 Zolbetuximab
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 Zolbetuximab works
All drug targets →- Claudin-18 binding agent Binding agentTarget: CLDN18 claudin 18✓ In ChEMBL and the Guide to Pharmacology
- Esophageal cancerPhase 2/3
- Esophageal adenocarcinomaPhase 2
- Malignant pancreatic neoplasmPhase 2
- Pancreatic adenocarcinomaPhase 2
- Pancreatic neoplasmPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL2109427, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 9209, 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 Zolbetuximab
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 1 technology appraisal of Zolbetuximab. 1 is current.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Zolbetuximab with chemotherapy for untreated claudin-18.2-positive HER2-negative unresectable advanced gastric or gastro-oesophageal junction adenocarcinoma NICE TA1046 | Not recommended | 12 Mar 2025 | 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 Zolbetuximab
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: VyloyEMA 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 Zolbetuximab
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.
Zolbetuximab 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 Zolbetuximab on the HPRA medicines list.
- Vyloy 100 mg powder for concentrate for solution for infusion.Astellas Pharma Europe B.V. · EU/1/24/1856/001-002
Supply shortages
No entry for Zolbetuximab in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Zolbetuximab
21 conditionsAll 21 conditions
| Condition (as registered) | Trials |
|---|---|
| Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer | 5 |
| Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer | 5 |
| Metastatic Gastric Adenocarcinoma or Cancer | 5 |
| Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma | 5 |
| Gastric Cancer | 3 |
| Metastatic Pancreatic Adenocarcinoma | 2 |
| Pancreatic Cancer | 1 |
| Metastatic Pancreatic Cancer | 1 |
| Gastroesophageal Junction Adenocarcinoma | 1 |
| Esophageal Cancer | 1 |
| Pharmacokinetics of Zolbetuximab | 1 |
| Gastro-esophageal Junction (GEJ) Cancer | 1 |
| Pharmacokinetics of Oxaliplatin | 1 |
| GastroEsophageal Cancer | 1 |
| Gastric Cancer Adenocarcinoma Metastatic | 1 |
| Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma | 1 |
| Gastroesophageal Adenocarcinoma | 1 |
| CLDN18.2-Positive Gastric Cancer | 1 |
| CLDN18.2-Positive Gastroesophageal Junction Adenocarcinoma | 1 |
| Stomach Neoplasm | 1 |
| Gastric (Stomach) Cancer | 1 |
Sponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Astellas Pharma Global Development, Inc | 6 |
| AstraZeneca | 1 |
| Shanghai Zhongshan Hospital | 1 |
| Universitaire Ziekenhuizen KU Leuven | 1 |
| American Association for Cancer Research | 1 |
| National Cancer Center, Japan | 1 |
| Astellas Pharma Korea, Inc | 1 |
| Asan Medical Center | 1 |
| Astellas Pharma Europe Ltd | 1 |
By country register
A trial with sites in more than one country appears in each of those registers.
Related compounds
Questions about Zolbetuximab trials
How many clinical trials are testing Zolbetuximab?
14 current trials in our South Korea, USA, Japan, China, Taiwan, France, Spain, Italy, Canada, Turkey, Brazil, Mexico, Australia, UK, Belgium, Netherlands, Germany, Poland, Ireland, Portugal, Czechia, Israel, India and Austria registers name Zolbetuximab (also registered as IMAB362) as a drug or biological intervention, as of the registry sync on 11 November 2026. Completed and withdrawn studies are not counted.
Are Zolbetuximab trials recruiting patients?
Yes. 8 of the 14 trials are recruiting: 4 with sites in South Korea, 2 with sites in USA, 3 with sites in Japan, 3 with sites in China, 2 with sites in Taiwan, 2 with sites in France, 2 with sites in Spain, 2 with sites in Italy, 2 with sites in Canada, 2 with sites in Turkey, 2 with sites in Brazil, 1 with sites in Mexico, 2 with sites in Australia, 2 with sites in UK, 3 with sites in Belgium, 2 with sites in Netherlands, 2 with sites in Germany, 2 with sites in Poland, 1 with sites in Portugal, 1 with sites in Czechia, 1 with sites in India 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 Zolbetuximab clinical trials?
Astellas Pharma Global Development, Inc (6), AstraZeneca (1), Shanghai Zhongshan Hospital (1) and Universitaire Ziekenhuizen KU Leuven (1), among 9 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Are there Zolbetuximab clinical trials in Ireland?
Yes. 2 trials 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 Zolbetuximab licensed in Ireland?
Yes. The HPRA medicines list includes 1 single-substance product containing Zolbetuximab, for example Vyloy 100 mg powder for concentrate for solution for infusion. (Astellas Pharma Europe B.V.). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Zolbetuximab shortage?
Not in the lists we track: Zolbetuximab 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 Zolbetuximab 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 Zolbetuximab 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 Zolbetuximab (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 11 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.