Trastuzumab deruxtecan clinical trials
Trastuzumab deruxtecan is named as an intervention in 91 current clinical trials in our China, USA, Spain, Italy, South Korea, France, Germany, Japan, Taiwan, UK, Canada, Belgium, Poland, Brazil, Australia, Netherlands, Israel, Turkey, Austria, India, Portugal, Denmark, Sweden, Mexico, Czechia, Ireland, Norway, Singapore and Switzerland registers. 55 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is AstraZeneca (23). The most-studied condition is Breast Cancer. The EU clinical trials register (CTIS) separately lists 4 authorised or ongoing trials.
Where Trastuzumab deruxtecan is approved
All regulators →Of the three regulators tracked here, the first to approve Trastuzumab deruxtecan was the EU, on 18 Jan 2021. It is approved in 2 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.
What health systems spend on Trastuzumab deruxtecan
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 Trastuzumab deruxtecan works
All drug targets →- Receptor protein-tyrosine kinase erbB-2 binding agent Binding agentTarget: ERBB2 erb-b2 receptor tyrosine kinase 2ChEMBL only
- DNA topoisomerase I inhibitor InhibitorTarget: TOP1 DNA topoisomerase IChEMBL only
- Biliary tract cancerPhase 3
- CancerPhase 3
- Endometrial cancerPhase 3
- Gastric adenocarcinomaPhase 3
- Gastric cancerPhase 3
- Gastroesophageal junction adenocarcinomaPhase 3
- Non-small cell lung carcinomaPhase 3
- Paget diseasePhase 2
- AnemiaPhase 2
- Bladder transitional cell carcinomaPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL4297844, CC BY-SA 3.0. The Guide to Pharmacology has no record of this medicine, so its targets rest on ChEMBL alone. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Trastuzumab deruxtecan
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 6 technology appraisals of Trastuzumab deruxtecan. 6 are 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 Trastuzumab deruxtecan
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: EnhertuEMA 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 Trastuzumab deruxtecan
91 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.
Trastuzumab deruxtecan in the EU trials register (CTIS)
4 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Trastuzumab deruxtecan. 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.
Trastuzumab deruxtecan 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 Trastuzumab deruxtecan on the HPRA medicines list.
- Enhertu 100 mg powder for concentrate for solution for infusionDaiichi Sankyo Europe GmbH · EU/1/20/1508/001
Supply shortages
No entry for Trastuzumab deruxtecan in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Trastuzumab deruxtecan
105 conditionsAll 105 conditions
| Condition (as registered) | Trials |
|---|---|
| Breast Cancer | 17 |
| Metastatic Breast Cancer | 11 |
| HER2-positive Breast Cancer | 6 |
| Advanced Solid Tumor | 5 |
| Advanced Breast Cancer | 5 |
| Gastroesophageal Junction Adenocarcinoma | 4 |
| Ovarian Cancer | 4 |
| Endometrial Cancer | 3 |
| Gastric Cancer | 2 |
| Breast Neoplasms | 2 |
| HER2-positive Gastric Cancer | 2 |
| HER2-positive Early Breast Cancer | 2 |
| Locally Advanced or Metastatic Non-Small Cell Lung Cancer | 2 |
| HER2 + Breast Cancer | 2 |
| Breast Cancer With Brain Metastasis | 2 |
| HER2-low Expressing Breast Cancer | 2 |
| HER2-negative Breast Cancer | 2 |
| HER2-low Breast Cancer | 2 |
| Advanced Cancer | 2 |
| Colorectal Cancer | 2 |
| Breast Cancer Stage IV | 2 |
| Gastric Cancer, Adenocarcinoma | 1 |
| Gastroesophageal Junction Cancer | 1 |
| Triple Negative Breast Neoplasms | 1 |
| Urinary Bladder Neoplasms | 1 |
| Neoplasm Metastasis | 1 |
| Ureteral Neoplasms | 1 |
| Non-small Cell Lung Cancer | 1 |
| Part 1: Bladder, Biliary Tract, Cervical, Endometrial, Ovarian, Pancreatic Cancer, Rare Tumors, Any Tumor Type Excluding Breast, Gastric, Colorectal Cancer | 1 |
| Part 2: HER2 Expressing/Amplified Solid Tumors Excluding Breast, Gastric, Colorectal Cancer | 1 |
| Metastatic Gastric Adenocarcinoma | 1 |
| Esophageal Adenocarcinoma | 1 |
| Breast Cancer; HER2-positive; Metastatic | 1 |
| Advanced or Metastatic Breast Cancer | 1 |
| Gastroesophageal Adenocarcinoma | 1 |
| Non-small Cell Lung Carcinoma | 1 |
| Biliary Tract Cancer | 1 |
| Advanced Solid Malignancies | 1 |
| Hormone Receptor Positive | 1 |
| HER2-low or HER2-ultralow | 1 |
| Unresectable or Metastatic Breast Cancer | 1 |
| Homologous Recombination Deficiency | 1 |
| HRR Deficiency | 1 |
| Advanced Solid Tumors With HER2 Mutation,eg:Colorectal,Urothelial,Gastric, Hepatobiliary,Endometrial,Melanoma,Ovarian,Cervical,Salivary Gland,Pancreatic,Breast | 1 |
| Recurrent or Metastatic Solid Tumors | 1 |
| Non-Small Cell Lung Cancer | 1 |
| HER2 Positive | 1 |
| HR Positive | 1 |
| Metastatic Solid Tumor | 1 |
| Soft Tissue Sarcoma (STS) | 1 |
| Platinum-resistant Ovarian Cancer (PROC) | 1 |
| Advanced Solid Tumors | 1 |
| Cholangiocarcinoma | 1 |
| Adenocarcinoma (NOS) | 1 |
| Anal Cancer | 1 |
| Bladder Cancer | 1 |
| Cervical Cancer | 1 |
| BREAST CANCER | 1 |
| HER2-mutant Non-Small Cell Lung Cancer | 1 |
| Advanced/Metastatic Breast Cancer | 1 |
| HER2+, Low, or Ultralow Advanced/Metastatic Breast Cancer | 1 |
| HER2-low Hormone Receptor Positive Breast Cancer | 1 |
| Advanced Solid Tumors (Excluding Gastric Cancer and Breast Cancer) | 1 |
| Unresectable Locally Recurrent Breast Cancer | 1 |
| Unresectable Locally Metastatic Breast Cancer | 1 |
| Advanced or Metastatic Pancreatic Adenocarcinoma | 1 |
| Advanced or Metastatic Breast Cancer (BC) | 1 |
| HER2-positive Gastroesophageal Junction | 1 |
| Solid Cancer | 1 |
| Advanced Breast Carcinoma | 1 |
| Hormone Receptor Positive Breast Carcinoma | 1 |
| Esophagogastric Adenocarcinoma | 1 |
| Colorectal Adenocarcinoma | 1 |
| Rectal Adenocarcinoma | 1 |
| Rectal Cancer, Adenocarcinoma | 1 |
| HER2-positive Advanced Gastric Cancer | 1 |
| HER2-positive Gastroesophageal Junction Adenocarcinoma | 1 |
| Unresectable Breast Cancer | 1 |
| HER2-(Ultra)Low Expressing Breast Cancer | 1 |
| Drug-Related Side Effects and Adverse Reactions | 1 |
| Pharmacogenetic Variant | 1 |
| Resectable Colorectal Carcinoma | 1 |
| Radiomic | 1 |
| Radiomics | 1 |
| Breast Cancer Metastatic | 1 |
| Metastatic Salivary Gland Carcinoma | 1 |
| Recurrent Salivary Gland Carcinoma | 1 |
| Stage III Major Salivary Gland Cancer AJCC v8 | 1 |
| Stage IV Major Salivary Gland Cancer AJCC v8 | 1 |
| Stomach Neoplasm | 1 |
| Non Small Cell Lung Cancer | 1 |
| Stomach Neoplasms | 1 |
| Pancreatic Cancer | 1 |
| Prostate Cancer | 1 |
| Metastatic Cancer | 1 |
| HER2 Mutant Non-small Cell Lung Cancer | 1 |
| HER2-positive Metastatic Breast Cancer | 1 |
| HER2 Gene Mutation | 1 |
| HER2 Amplification | 1 |
| Ovarian Carcinoma, Recurrent | 1 |
| Ovarian Cancer Metastatic Recurrent | 1 |
| Ovarian Cancer (OvCa) | 1 |
| Gastric Adenocarcinoma | 1 |
| HER2-Positive Primary Breast Cancer | 1 |
| Residual Invasive Breast Cancer | 1 |
Sponsors
lead sponsor per trial+ 25 more sponsors in the trial list above.
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 Trastuzumab deruxtecan trials
How many clinical trials are testing Trastuzumab deruxtecan?
91 current trials in our China, USA, Spain, Italy, South Korea, France, Germany, Japan, Taiwan, UK, Canada, Belgium, Poland, Brazil, Australia, Netherlands, Israel, Turkey, Austria, India, Portugal, Denmark, Sweden, Mexico, Czechia, Ireland, Norway, Singapore and Switzerland registers name Trastuzumab deruxtecan (also registered as DS-8201a) as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Trastuzumab deruxtecan trials recruiting patients?
Yes. 55 of the 91 trials are recruiting: 29 with sites in China, 24 with sites in USA, 24 with sites in Spain, 20 with sites in Italy, 20 with sites in South Korea, 20 with sites in France, 17 with sites in Germany, 17 with sites in Japan, 15 with sites in Taiwan, 12 with sites in UK, 9 with sites in Canada, 12 with sites in Belgium, 11 with sites in Poland, 11 with sites in Brazil, 12 with sites in Australia, 9 with sites in Netherlands, 9 with sites in Israel, 8 with sites in Turkey, 7 with sites in Austria, 4 with sites in India, 6 with sites in Portugal, 3 with sites in Denmark, 5 with sites in Sweden, 3 with sites in Mexico, 3 with sites in Czechia, 1 with sites in Ireland, 4 with sites in Norway, 2 with sites in Singapore and 2 with sites in Switzerland. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Trastuzumab deruxtecan clinical trials?
AstraZeneca (23), Daiichi Sankyo (16), Fudan University (7) and MedSIR (3), among 40 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Are there Trastuzumab deruxtecan clinical trials in Ireland?
Yes. 5 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 Trastuzumab deruxtecan licensed in Ireland?
Yes. The HPRA medicines list includes 1 single-substance product containing Trastuzumab deruxtecan, for example Enhertu 100 mg powder for concentrate for solution for infusion (Daiichi Sankyo Europe GmbH). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Trastuzumab deruxtecan shortage?
Not in the lists we track: Trastuzumab deruxtecan 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 Trastuzumab deruxtecan 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 Trastuzumab deruxtecan 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 Trastuzumab deruxtecan (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 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.