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Fianlimab - Regeneron Pharmaceuticals

Drug Profile

Fianlimab - Regeneron Pharmaceuticals

Alternative Names: Anti-LAG-3 antibody - Regeneron Pharmaceuticals; REGN-3767

Latest Information Update: 21 Nov 2025

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At a glance

  • Originator Regeneron Pharmaceuticals
  • Class Antineoplastics; Immunotherapies; Monoclonal antibodies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; CD223 antigen inhibitors; T lymphocyte stimulants
  • Orphan Drug Status

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

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Malignant melanoma
  • Phase II/III Non-small cell lung cancer
  • Phase II Bladder cancer; Colorectal cancer; Solid tumours
  • Phase I Haematological malignancies

Most Recent Events

  • 21 Nov 2025 Regeneron plans a phase II trial for Malignant mesothelioma (Combination therapy, Inoperable/Unresectable) (CTIS2024-519208-29-00)
  • 03 Nov 2025 Regeneron Pharmaceuticals plans the phase II NACho trial for Colon cancer (Neo-adjuvant therapy, Combination therapy) (IV), in January 2026 (NCT07224022)
  • 03 Nov 2025 Regeneron Pharmaceuticals plans the phase II LAG-BOOST trial for Brain metastases (Combination therapy) in USA (IV) in December 2025 (NCT07223541)

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