Drugs / Odronextamab
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved · conditional | EU (EMA) | Ordspono | — | 2024-08-22 | europa.eu ↗ |
Trials 15 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT06975787 | Dec 2025 → Sep 2029 expected | lupus nephritis | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 1 | NCT06735664 | Aug 2025 → Dec 2027 expected | Richter transformation | City of Hope Medical Center | Recruiting | No outcome recorded |
| Phase 1 | NCT05685173 | Apr 2023 → Feb 2029 expected | aggressive B-cell non-Hodgkin lymphoma | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 1 | NCT02651662 | Jan 2016 → Apr 2026 | aggressive B-cell non-Hodgkin lymphoma | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02290951 | Jan 2015 → Aug 2025 | chronic lymphocytic leukemia/small lymphocytic lymphoma | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT07128641 | Sep 2025 → Jan 2027 expected | follicular lymphoma | Gottfried von Keudell, MD PhD | Recruiting | No outcome recorded |
| Phase 2 | NCT06784726 | Sep 2025 → Apr 2028 expected | high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma | University of Washington | Recruiting | No outcome recorded |
| Phase 2 | NCT06854159 | Aug 2025 → Oct 2028 expected | diffuse large B-cell lymphoma | University of California, Davis | Recruiting | No outcome recorded |
| Phase 2 | NCT03888105 | Nov 2019 → Jul 2026 overdue | B-cell non-Hodgkin lymphoma | Regeneron Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT05991388 | May 2024 → May 2031 expected | B-cell non-Hodgkin lymphoma | University of Birmingham | Recruiting | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT06230224 | Feb 2024 → May 2028 expected | aggressive B-cell non-Hodgkin lymphoma | Regeneron Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06149286 | Dec 2023 → Jan 2029 expected | marginal zone lymphoma | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT06091865 | Dec 2023 → Mar 2028 expected | diffuse large B-cell lymphoma | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT06091254 | Dec 2023 → Feb 2028 expected | follicular lymphoma | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT06097364 | Nov 2023 → Jul 2029 expected | follicular lymphoma | Regeneron Pharmaceuticals | Active not recruiting | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| — | NCT05619367 Background | — | high grade B-cell lymphoma | Regeneron Pharmaceuticals | Available | No outcome recorded |
Press releases naming this drug 15 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-02-26 | Regeneron Pharmaceuticals | Odronextamab BLA Accepted for FDA Review for the Treatment of Relapsed/Refractory Follicular Lymphoma regeneron.com ↗ |
| 2024-12-09 | Regeneron Pharmaceuticals | Odronextamab ASH Presentations Underscore Impressive Potential in Earlier Lines of Treatment and Additional Types of Lymphoma regeneron.com ↗ |
| 2024-08-26 | Regeneron Pharmaceuticals | Ordspono™ (odronextamab) Approved in the European Union for the Treatment of Relapsed/Refractory Follicular Lymphoma and Diffuse Large B-cell Lymphoma regeneron.com ↗ |
| 2024-06-28 | Regeneron Pharmaceuticals | Odronextamab Recommended for EU Approval by the CHMP to Treat Relapsed/Refractory Follicular Lymphoma and Diffuse Large B-cell Lymphoma regeneron.com ↗ |
| 2024-03-25 | Regeneron Pharmaceuticals | Regeneron Provides Update on Biologics License Application for Odronextamab regeneron.com ↗ |
| 2023-12-10 | Regeneron Pharmaceuticals | Updated Odronextamab Data from Relapsed/Refractory Diffuse Large B-cell Lymphoma Pivotal Trial Showed Deep and Durable Responses and the Potential of ctDNA To Predict Long-term Outcomes regeneron.com ↗ |
| 2023-12-10 | Regeneron Pharmaceuticals | Latest Odronextamab Data in Relapsed/Refractory Follicular Lymphoma Showed Compelling Responses and Overall Maintenance of Patient-Reported Outcomes regeneron.com ↗ |
| 2023-09-29 | Regeneron Pharmaceuticals | Odronextamab BLA for Treatment of Relapsed/Refractory Follicular Lymphoma (FL) and Diffuse Large B-cell Lymphoma (DLBCL) Accepted for FDA Priority Review regeneron.com ↗ |
| 2023-08-17 | Regeneron Pharmaceuticals | Odronextamab Receives EMA Filing Acceptance for Treatment of Relapsed/Refractory Follicular Lymphoma and Diffuse Large B-cell Lymphoma regeneron.com ↗ |
| 2022-12-12 | Regeneron Pharmaceuticals | Odronextamab (CD20xCD3) Demonstrates High and Durable Complete Response Rate among Patients with Relapsed/Refractory Follicular Lymphoma in Pivotal Phase 2 Trial regeneron.com ↗ |
| 2022-12-11 | Regeneron Pharmaceuticals | Pivotal Odronextamab (CD20xCD3) Phase 2 Data in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma Debut at ASH regeneron.com ↗ |
| 2020-04-08 | Regeneron Pharmaceuticals | Regeneron and Zai Lab Announce Regional Strategic Collaboration for REGN1979 (CD20xCD3 Bispecific Antibody) regeneron.com ↗ |
| 2019-06-14 | Regeneron Pharmaceuticals | Regeneron CD20xCD3 Bispecific REGN1979 Shows Positive Results in Patients with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma, including in CAR-T Failures regeneron.com ↗ |
| 2018-12-01 | Regeneron Pharmaceuticals | Regeneron Presents Positive Data at ASH for REGN1979 CD20xCD3 Bispecific Antibody in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma regeneron.com ↗ |
| 2017-11-01 | Regeneron Pharmaceuticals | Regeneron to Share Clinical Progress of REGN1979 and Cemiplimab (REGN2810) in B-Cell Lymphomas at the 2017 ASH Annual Meeting regeneron.com ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 18 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Odronextamab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07128641 ↗ |
| Known as | REGN1979 | “A Phase 3, Randomized, Open Label Study Evaluating the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 x Anti-CD3 Bispecific Antibody, Versus Standard of Care...” NCT06230224 ↗ |
| Action | Deplete | “triggering T-cell-mediated cytotoxicity independent of T-cell-receptor recognition” PMID 34997701 ↗ Jan 2022 |
| Modality | Monoclonal antibody | “Odronextamab is a fully-human IgG4-based CD20xCD3 bispecific antibody” PMID 34997701 ↗ Jan 2022 |
| Route | Intravenous | “Administered by intravenous (IV) infusion” NCT02290951 ↗ |
| Target | MS4A1 | “B-lymphocyte antigen CD20 binding agent” CHEMBL4298084 ↗ |