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Frexalimab - ImmuNext/Sanofi

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Drug Profile

Frexalimab - ImmuNext/Sanofi

Alternative Names: INX 021; SAR-441344

Latest Information Update: 25 Feb 2026

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At a glance

  • Originator ImmuNext
  • Developer Sanofi
  • Class Antihyperglycaemics; Monoclonal antibodies
  • Mechanism of Action CD40 ligand inhibitors
  • 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 Multiple sclerosis
  • Phase II Focal segmental glomerulosclerosis; Lipoid nephrosis; Type 1 diabetes mellitus
  • Discontinued Sjogren's syndrome; Systemic lupus erythematosus

Most Recent Events

  • 17 Feb 2026 Sanofi plans a phase II/III FREXERA trial for Renal transplant rejection (SC/IV) in March 2026 (NCT07412470)
  • 14 Jan 2026 Sanofi imitates a phase III trial for Multiple sclerosis in USA (IV, SC) (NCT07325292) (CTIS2024-519304-28)
  • 01 Jan 2026 Sanofi plans a phase III trial for Multiple sclerosis in January 2025 (IV, SC) (NCT07325292) (CTIS2024-519304-28)

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