Epcoritamab clinical trials
Epcoritamab is named as an intervention in 27 current clinical trials in our France, Australia, USA, Netherlands, Spain, Israel, Germany, Denmark, Belgium, Japan, South Korea, Italy, UK, China, Czechia, Poland, Turkey, Canada, Taiwan, Sweden, Mexico, Austria, Brazil, Portugal, Singapore, Switzerland, Norway and Ireland registers. 11 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Genmab (14). The most-studied condition is Diffuse Large B-Cell Lymphoma. The EU clinical trials register (CTIS) separately lists 5 authorised or ongoing trials, 2 with a site in Ireland.
Where Epcoritamab is approved
All regulators →Of the three regulators tracked here, the first to approve Epcoritamab was the US, on 19 May 2023. It is approved in 3 of the 3 regulators tracked here.
- 2 EU orphan designations, most recently for treatment of follicular lymphoma (21 Jun 2022, withdrawn)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.
What health systems spend on Epcoritamab
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 Epcoritamab works
All drug targets →- B-lymphocyte antigen CD20 binding agent Binding agentTarget: MS4A1 membrane spanning 4-domains A1✓ In ChEMBL and the Guide to Pharmacology
- T cell surface glycoprotein CD3 binding agent Binding agentTarget: T cell surface glycoprotein CD3✓ In ChEMBL and the Guide to Pharmacology
- B-cell chronic lymphocytic leukemiaPhase 2
- Waldenstrom macroglobulinemiaPhase 2
- Diffuse large B-cell lymphoma of the central nervous systemPhase 2
- Mantle cell lymphomaPhase 2
- Marginal zone lymphomaPhase 2
- Non-Hodgkin lymphomaPhase 2
- Richter transformationPhase 1/2
- High grade B-cell lymphomaPhase 1/2
- Burkitt lymphomaPhase 1
- Neoplasm of mature B-cellsPhase 1
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL4650393, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 11442, 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 Epcoritamab
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 2 technology appraisals of Epcoritamab. 2 are current, and 2 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Epcoritamab for treating relapsed or refractory follicular lymphoma after 2 or more lines of systemic treatment NICE TA1139 | Optimised | 11 Mar 2026 | Current |
| Epcoritamab for treating relapsed or refractory diffuse large B-cell lymphoma after 2 or more systemic treatments NICE TA954 | Optimised | 6 Mar 2024 | 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 Epcoritamab
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: TepkinlyEMA 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 Epcoritamab
27 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.
Epcoritamab in the EU trials register (CTIS)
5 trials · 2 in IrelandAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Epcoritamab. 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.
Epcoritamab 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 Epcoritamab on the HPRA medicines list.
- Tepkinly 4 mg/0.8 ml solution for injectionAbbVie Deutschland GmbH & Co. KG · EU/1/23/1759/001
- Tepkinly 48 mg solution for injectionAbbVie Deutschland GmbH & Co. KG · EU/1/23/1759/002
Supply shortages
No entry for Epcoritamab in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Epcoritamab
40 conditionsAll 40 conditions
| Condition (as registered) | Trials |
|---|---|
| Diffuse Large B-Cell Lymphoma | 5 |
| Follicular Lymphoma | 4 |
| Follicular Lymphoma (FL) | 2 |
| Small Lymphocytic Lymphoma | 2 |
| High-grade B-cell Lymphoma | 2 |
| Richter Transformation | 1 |
| Diffuse Large B-cell Lymphoma | 1 |
| Relapsed/Refractory Non-Hodgkin Lymphoma | 1 |
| DLBCL | 1 |
| High-grade B-cell Lymphoma (HGBCL) | 1 |
| Primary Mediastinal Large B-cell Lymphoma (PMBCL) | 1 |
| FL | 1 |
| Relapsed/Refractory Chronic Lymphocytic Leukemia | 1 |
| Richter's Syndrome | 1 |
| Treatment-naïve High Risk Chronic Lymphocytic Leukemia | 1 |
| Classic Follicular Lymphoma | 1 |
| Non-Hodgkin Lymphoma | 1 |
| Non-hodgkin Lymphoma | 1 |
| B-Cell Non-Hodgkin Lymphoma | 1 |
| CLL/SLL | 1 |
| Chronic Lymphocytic Leukemia | 1 |
| Refractory Diffuse Large B-Cell Lymphoma (DLBCL) | 1 |
| Refractory Large B-cell Lymphoma (LBCL) | 1 |
| Refractory T-cell/Histiocyte-rich Large B-cell Lymphoma | 1 |
| Refractory Transformed Follicular Lymphoma | 1 |
| Primary CNS Lymphoma (PCNSL) | 1 |
| Large B Cell Lymphoma | 1 |
| Relapsed/Refractory Diffuse Large B Cell Lymphoma | 1 |
| Diffuse Large B Cell Lymphoma | 1 |
| Primary Mediastinal Large B Cell Lymphoma | 1 |
| DLBCL - Diffuse Large B Cell Lymphoma | 1 |
| High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements | 1 |
| DLBCL, Nos Genetic Subtypes | 1 |
| Relapsed/Refractory Large B-cell Lymphoma | 1 |
| Waldenstrom Macroglobulinemia | 1 |
| B-Cell Lymphoproliferative Disorder | 1 |
| Lymphoma | 1 |
| Lymphoma,Non-Hodgkin | 1 |
| Lymphoma, Non-Hodgkin's, Adult | 1 |
| Low Grade Non-Hodgkin's Lymphoma, Adult | 1 |
Sponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Genmab | 14 |
| The Lymphoma Academic Research Organisation | 3 |
| German CLL Study Group | 1 |
| Bristol-Myers Squibb | 1 |
| Stichting Hemato-Oncologie voor Volwassenen Nederland | 1 |
| Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea | 1 |
| Hospital Universitario Dr. Jose E. Gonzalez | 1 |
| Australasian Leukaemia and Lymphoma Group | 1 |
| Peter MacCallum Cancer Centre, Australia | 1 |
| Gottfried von Keudell, MD PhD | 1 |
| Beth Israel Deaconess Medical Center | 1 |
| Reid Merryman, MD | 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 Epcoritamab trials
How many clinical trials are testing Epcoritamab?
27 current trials in our France, Australia, USA, Netherlands, Spain, Israel, Germany, Denmark, Belgium, Japan, South Korea, Italy, UK, China, Czechia, Poland, Turkey, Canada, Taiwan, Sweden, Mexico, Austria, Brazil, Portugal, Singapore, Switzerland, Norway and Ireland registers name Epcoritamab (also registered as GEN3013) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Epcoritamab trials recruiting patients?
Yes. 11 of the 27 trials are recruiting: 2 with sites in France, 4 with sites in Australia, 1 with sites in USA, 2 with sites in Netherlands, 2 with sites in Spain, 3 with sites in Israel, 3 with sites in Germany, 2 with sites in Denmark, 1 with sites in Belgium, 1 with sites in Japan, 1 with sites in South Korea, 1 with sites in Italy, 1 with sites in UK, 1 with sites in China, 1 with sites in Turkey, 1 with sites in Mexico, 1 with sites in Austria, 1 with sites in Switzerland 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 Epcoritamab clinical trials?
Genmab (14), The Lymphoma Academic Research Organisation (3), German CLL Study Group (1) and Bristol-Myers Squibb (1), among 12 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Are there Epcoritamab clinical trials in Ireland?
Yes. 1 trial in our Ireland register (ClinicalTrials.gov), and 2 trials in the EU register (CTIS) list a site in Ireland. Some may be the same study registered in both. See the Irish clinical trials register for sites and contacts.
Is Epcoritamab licensed in Ireland?
Yes. The HPRA medicines list includes 2 single-substance products containing Epcoritamab, for example Tepkinly 4 mg/0.8 ml solution for injection (AbbVie Deutschland GmbH & Co. KG). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Epcoritamab shortage?
Not in the lists we track: Epcoritamab 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 Epcoritamab 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 Epcoritamab 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 Epcoritamab (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.