Odronextamab clinical trials
Odronextamab is named as an intervention in 10 current clinical trials in our Spain, USA, France, Taiwan, Australia, Israel, UK, Germany, South Korea, Italy, Belgium, Poland, Austria, Turkey, Brazil, Czechia, Singapore, Netherlands, Canada, Ireland, Switzerland, China, Japan and Sweden registers. 7 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Regeneron Pharmaceuticals (8). The most-studied condition is Follicular Lymphoma (FL).
Where Odronextamab is approved
All regulators →Of the three regulators tracked here, the first to approve Odronextamab was the EU, on 22 Aug 2024.
- 2 EU orphan designations, most recently for treatment of diffuse large B-cell lymphoma (18 Jul 2022, withdrawn)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.
How Odronextamab 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 CD3ChEMBL only
- Diffuse large B-cell lymphomaPhase 3
- Marginal zone lymphomaPhase 3
- Non-Hodgkin lymphomaPhase 3
- B-cell non-Hodgkin lymphomaPhase 2/3
- B-cell chronic lymphocytic leukemiaPhase 1
- Richter transformationPhase 1
- Lupus nephritisPhase 1
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL4298084, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 12690, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Odronextamab
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 3 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: OrdsponoEMA 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 Odronextamab
10 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.
Odronextamab 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)
3 single-substance products containing Odronextamab on the HPRA medicines list.
- Ordspono 2 mg Concentrate for solution for infusionRegeneron Ireland Designated Activity Company · EU/1/24/1843/001
- Ordspono 320 mg Concentrate for solution for infusionRegeneron Ireland Designated Activity Company · EU/1/24/1843/003
- Ordspono 80 mg Concentrate for solution for infusionRegeneron Ireland Designated Activity Company · EU/1/24/1843/002
Supply shortages
No entry for Odronextamab in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Odronextamab
11 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Regeneron Pharmaceuticals | 8 |
| University of Birmingham | 1 |
| Gottfried von Keudell, MD PhD | 1 |
By country register
A trial with sites in more than one country appears in each of those registers.
Related compounds
Questions about Odronextamab trials
How many clinical trials are testing Odronextamab?
10 current trials in our Spain, USA, France, Taiwan, Australia, Israel, UK, Germany, South Korea, Italy, Belgium, Poland, Austria, Turkey, Brazil, Czechia, Singapore, Netherlands, Canada, Ireland, Switzerland, China, Japan and Sweden registers name Odronextamab (also registered as REGN1979) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Odronextamab trials recruiting patients?
Yes. 7 of the 10 trials are recruiting: 5 with sites in Spain, 5 with sites in USA, 5 with sites in France, 4 with sites in Taiwan, 4 with sites in Australia, 5 with sites in Israel, 4 with sites in UK, 4 with sites in Germany, 4 with sites in South Korea, 3 with sites in Italy, 4 with sites in Belgium, 3 with sites in Poland, 4 with sites in Austria, 3 with sites in Turkey, 3 with sites in Brazil, 3 with sites in Czechia, 1 with sites in Singapore, 2 with sites in Netherlands, 1 with sites in Canada, 1 with sites in Ireland, 1 with sites in Switzerland and 1 with sites in Sweden. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Odronextamab clinical trials?
Regeneron Pharmaceuticals (8), University of Birmingham (1) and Gottfried von Keudell, MD PhD (1). The number in brackets is how many trials each organisation leads.
Are there Odronextamab 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 Odronextamab licensed in Ireland?
Yes. The HPRA medicines list includes 3 single-substance products containing Odronextamab, for example Ordspono 2 mg Concentrate for solution for infusion (Regeneron Ireland Designated Activity Company). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Odronextamab shortage?
Not in the lists we track: Odronextamab 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 Odronextamab 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 Odronextamab 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 Odronextamab (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.