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Odronextamab - Regeneron Pharmaceuticals

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Drug Profile

Odronextamab - Regeneron Pharmaceuticals

Alternative Names: CD20xCD3 bispecific antibody - Regeneron Pharmaceuticals; Ordspono; REGN-1979; ZL-1307

Latest Information Update: 09 Apr 2026

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At a glance

  • Originator Regeneron Pharmaceuticals
  • Class Antineoplastics; Bispecific antibodies; Immunotherapies; Urologics
  • Mechanism of Action Antibody-dependent cell cytotoxicity; T lymphocyte stimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Diffuse large B cell lymphoma; Follicular lymphoma
  • New Molecular Entity Yes

Highest Development Phases

  • Registered Diffuse large B cell lymphoma; Follicular lymphoma
  • Phase III Marginal zone B-cell lymphoma; Non-Hodgkin's lymphoma
  • Phase II B-cell lymphoma
  • Phase I Lupus nephritis
  • No development reported Chronic lymphocytic leukaemia

Most Recent Events

  • 22 Dec 2025 Phase-I clinical trials in Lupus nephritis (Treatment-resistant) in USA, Germany, South Korea, Taiwan (Parenteral) (NCT06975787)
  • 06 Dec 2025 Efficacy, pharmacodynamic and adverse event data from a phase III OLYMPIA-2 trial in Follicular lymphoma presented at the 67th American Society of Hematology Annual Meeting and Exposition (ASH 2025)
  • 06 Dec 2025 Efficacy and adverse events data from the phase II ELM-2 trial in Non-Hodgkin's lymphoma presented at the 67th American Society of Hematology Annual Meeting and Exposition (ASH-Hem-2025)

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