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Obefazimod - Abivax

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Drug Profile

Obefazimod - Abivax

Alternative Names: ABX-464; Obefazimod Minitablet - Abivax; SPL-464

Latest Information Update: 12 Aug 2026

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At a glance

  • Originator Splicos
  • Developer Abivax
  • Class Amines; Anti-inflammatories; Antirheumatics; Antivirals; Chlorobenzenes; Fluorobenzenes; Quinolines; Small molecules
  • Mechanism of Action MiRNA-124 expression stimulants; RNA cap-binding protein modulators
  • 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 Ulcerative colitis
  • Phase II/III COVID 2019 infections
  • Phase II Crohn's disease; Rheumatoid arthritis
  • Preclinical Inflammatory bowel diseases
  • Discontinued HIV infections

Most Recent Events

  • 31 Jul 2026 Abivax completes a positive pre-New Drug Application (NDA) interaction with the US FDA for obefazimod for the treatment Ulcerative colitis and received constructive FDA feedback
  • 01 Jul 2026 Efficacy data from the phase III ABTECT maintenance trial in Ulcerative colitis released by Abivax
  • 03 Jun 2026 Efficacy and adverse event data from the phase III ABTECT maintenance trial in Ulcerative colitis released by Abivax

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