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Obefazimod - Abivax

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Drug Profile

Obefazimod - Abivax

Alternative Names: ABX-464; SPL-464

Latest Information Update: 17 Sep 2025

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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

  • 22 Jul 2025 Abivax announces intention to submit NDA application to the US FDA and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for obefazimod in the second-half of 2026
  • 22 Jul 2025 Efficacy and adverse event data from the phase III ABTECT-1 and ABTECT-2 trial in Ulcerative colitis released by Abivax
  • 15 Jul 2025 Abivax completes the phase III ABTECT-2 trial in Ulcerative colitis (In adolescents, In adults, In the elderly, Treatment-experienced) in USA, Belgium, Croatia, India, Israel, Japan, Lithuania, Mexico, New Zealand, Brazil, Bulgaria, Romania, United Kingdom, Spain, Slovakia, Serbia, Poland, Ireland, Italy, Hungary, Germany, France, Czech Republic, Canada, Belgium, Argentina (PO) (NCT05507216)

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