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Drug

Odronextamab

Approved · EMA
Late-stage development
RxNorm2540150UNII8R5CM46UIO
13
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Dose Escalation Study Investigating Bispecific Antibody Therapy in Patients With Lupus Nephritis

Clinical trial2026-07-09Results expected Q3 2029 · ClinicalTrials.gov

A Phase 2 Study of Odronextamab in Relapsed/ Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) Before and After Chimeric Antigen Receptor (CAR) T-Cell Therapy

Clinical trial2026-07-08Results expected Q4 2028 · ClinicalTrials.gov

A Phase 3, Open Label, Randomized Study Comparing the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 × Anti-CD3 Bispecific Antibody, in Combination With CHOP (ODRO-CHOP) Versus Rituximab in Combination With CHOP (R-CHOP) in Previously Untreated Participants With Diffuse Large B-cell Lymphoma (DLBCL) (OLYMPIA-3)

Clinical trial2026-07-08Results expected Q1 2028 · ClinicalTrials.gov

An Open-Label Study to Assess the Anti-Tumor Activity and Safety of REGN1979, an Anti-CD20 x Anti-CD3 Bispecific Antibody, in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

Clinical trial2026-07-06Primary completion · ClinicalTrials.gov

A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 X Anti-CD3 Bispecific Antibody Versus Investigator's Choice in Previously Untreated Participants With Follicular Lymphoma (OLYMPIA-1)

Clinical trial2026-06-24Results expected Q1 2028 · ClinicalTrials.gov

A Phase 1 Study to Assess Safety and Tolerability of REGN5837, an Anti-CD22 x Anti-CD28 Costimulatory Bispecific Monoclonal Antibody, in Combination With Odronextamab, an Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody, in Patients With Aggressive B-Cell Non-Hodgkin Lymphomas (ATHENA-1)

Clinical trial2026-05-19Results expected Q1 2029 · ClinicalTrials.gov

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 Therapy in Participants With Relapsed/Refractory Aggressive B-cell Non-Hodgkin Lymphoma (OLYMPIA-4)

Clinical trial2026-05-11Results expected Q2 2028 · ClinicalTrials.gov

A Phase 3, Open Label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 x Anti-CD3 Bispecific Antibody, in Combination With Lenalidomide Versus Rituximab in Combination With Lenalidomide in Relapsed/Refractory Participants With Follicular Lymphoma and Marginal Zone Lymphoma (OLYMPIA-5)

Clinical trial2026-05-06Results expected Q1 2029 · ClinicalTrials.gov

Odronextamab for Relapsed/Refractory Large B-Cell Lymphomas Before Definitive Lymphoma-Directed Therapies

Clinical trial2026-05-06Results expected Q2 2028 · ClinicalTrials.gov

A Phase 1 Study to Assess Safety and Tolerability of Odronextamab (REGN1979) an Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody, and Cemiplimab (REGN2810), an Anti-Programmed Death-1 Monoclonal Antibody in Patients With B-Cell Malignancies (CLIO-1)

Clinical trial2026-04-29Completed · ClinicalTrials.gov

A Phase II Study of Odronextamab in Treatment Naïve Patients With Low Tumor Volume Advanced Stage Follicular Lymphoma

Clinical trial2026-03-13Results expected Q1 2027 · ClinicalTrials.gov

Approval: Ordspono (EMA)

Regulatory2024-08-22EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Odronextamab
RxNorm CUI
2540150
UNII
8R5CM46UIO
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2024-08-22
Latest approval
2024-08-22
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2024-08-22Approval
Approval: Ordspono (EMA)
Indication: Ordspono as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (r/r FL) after two or more lines of systemic therapy.… Show full indication

Ordspono as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (r/r FL) after two or more lines of systemic therapy. Ordspono as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) after two or more lines of systemic therapy.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

14 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
14
registered trials across all phases
LATEST COMPLETION 2026
13
Active studies
10
Recruiting
6
Late-stage (III+)
1
Completed
PHASE DISTRIBUTIONn = 14
Phase 14Phase 24Phase 2 / 31Phase 35

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Global Study of Novel Agents in Paediatric and Adolescent Relapsed and Refractory B-cell Non-Hodgkin Lymphoma

RecruitingPH II/IIIUniversity of Birminghamn=2102033

A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 X Anti-CD3 Bispecific Antibody Versus Investigator's Choice in Previously Untreated Participants With Follicular Lymphoma (OLYMPIA-1)

RecruitingPH IIIRegeneron Pharmaceuticalsn=8222029

A Phase 3, Open Label, Randomized Study Comparing the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 × Anti-CD3 Bispecific Antibody, in Combination With CHOP (ODRO-CHOP) Versus Rituximab in Combination With CHOP (R-CHOP) in Previously Untreated Participants With Diffuse Large B-cell Lymphoma (DLBCL) (OLYMPIA-3)

RecruitingPH IIIRegeneron Pharmaceuticalsn=9042029

A Phase 3, Open-Label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20x Anti-CD3 Bispecific Antibody, Combined With Chemotherapy Versus Rituximab Combined With Chemotherapy in Previously Untreated Participants With Follicular Lymphoma (OLYMPIA-2)

Active, not recruitingPH IIIRegeneron Pharmaceuticalsn=7332029

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 Therapy in Participants With Relapsed/Refractory Aggressive B-cell Non-Hodgkin Lymphoma (OLYMPIA-4)

Active, not recruitingPH IIIRegeneron Pharmaceuticalsn=2162029
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.