Odronextamab
REGENERON PHARMACEUTICALS, INC. REGN · Follicular Lymphoma (FL); B-Cell Non-Hodgkin Lymphoma (B-NHL); Diffuse Large B-cell Lymphoma (DLBCL); Relapsed/Refractory Follicular Lymphoma; Relapsed/Refractory Marginal Zone Lymphoma (R/R MZL)
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Phase 3
Not recorded
Linked trials
5
From ClinicalTrials.gov
Latest FDA action
None on record
From Drugs@FDA
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- REGENERON PHARMACEUTICALS, INC. REGN Source: Company record for REGENERON PHARMACEUTICALS, INC. (opens in a new tab)
- Indications
- Follicular Lymphoma (FL); B-Cell Non-Hodgkin Lymphoma (B-NHL); Diffuse Large B-cell Lymphoma (DLBCL); Relapsed/Refractory Follicular Lymphoma; Relapsed/Refractory Marginal Zone Lymphoma (R/R MZL) Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 Completed
- Phase 3 Current stageFirst trial start 14 Nov 20235 linked trials
- Filed Not yet
- Approved Not yet
Overview
- Mechanism
- Not recorded
- Route
- Not recorded
- Modality
- Not recorded
- Specialties
- Not recorded
Overview text is written by HealthTrade editors.
Key dates
No catalysts yet. Editors add each date together with its source.
FDA designations
No FDA designations are on record for Odronextamab. Editors add each one with its source.
Filed application
No filed application is on record for Odronextamab. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Odronextamab.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT06230224ClinicalTrials.gov record for NCT06230224 (opens in a new tab)OLYMPIA-4 | A Trial to Learn How Effective and Safe Odronextamab is Compared to Standard of Care for Adult Participants With Previously Treated Aggressive B-cell Non-Hodgkin Lymphoma | Phase 3 | Active, not recruiting | 216 (actual) | 29 May 2028 (estimated) | No |
| NCT06149286ClinicalTrials.gov record for NCT06149286 (opens in a new tab)OLYMPIA-5 | A Trial to Find Out if Odronextamab Combined With Lenalidomide is Safe and Works Better Than Rituximab Combined With Lenalidomide in Adult Participants With Follicular Lymphoma and Marginal Zone Lymphoma | Phase 3 | Recruiting | 580 (estimated) | 30 Apr 2031 (estimated) | No |
| NCT06091865ClinicalTrials.gov record for NCT06091865 (opens in a new tab)OLYMPIA-3 | A Study to Compare How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Against Rituximab Combined With Chemotherapy, in Adult Patients With Previously Untreated Diffuse Large B-cell Lymphoma | Phase 3 | Recruiting | 904 (estimated) | 30 Mar 2028 (estimated) | No |
| NCT06091254ClinicalTrials.gov record for NCT06091254 (opens in a new tab)OLYMPIA-1 | A Trial to Learn if Odronextamab is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Chemotherapy for Adult Participants With Previously Untreated Follicular Lymphoma | Phase 3 | Recruiting | 822 (estimated) | 7 Feb 2028 (estimated) | No |
| NCT06097364ClinicalTrials.gov record for NCT06097364 (opens in a new tab)OLYMPIA-2 | A Trial to Learn if Odronextamab Combined With Chemotherapy is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Chemotherapy for Adult Participants With Follicular Lymphoma | Phase 3 | Active, not recruiting | 733 (estimated) | 29 Jul 2029 (estimated) | No |
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.
Trial quality
About CT-VCALoading trial quality…
FDA actions
No FDA approvals on record for this drug.
FDA recalls load here.
FDA drug shortages load here.
Orange Book patents load here.
FAERS adverse event counts load here.
Papers and preprints load here.
Community discussion loads here.
EU status (EMA)
AuthorisedOrphan medicineConditional
Ordspono (EMEA/H/C/006215)
- Authorised
- Therapeutic area
- Lymphoma, Follicular
- Marketing authorisation holder
- Regeneron Ireland Designated Activity Company (DAC)
- Active substance (INN)
- odronextamab
- ATC code
- Not yet assigned
- Latest EMA decision
Matched by active substance: EMA's INN or active substance equals this drug's name.
EMA page for Ordspono (opens in a new tab)EMA medicine data (opens in a new tab)
Source: European Medicines Agency (EMA), medicines data download. Licence: EMA re-use with acknowledgement. EMA medicines report 2026-10-26.
Related news
No recent headlines mention this drug.
Sources
- ClinicalTrials.gov NCT06149286 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT06097364 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT06230224 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT06091865 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT06091254 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.