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Obefazimod - Abivax

Drug Profile

Obefazimod - Abivax

Alternative Names: ABX-464; SPL-464

Latest Information Update: 08 May 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

  • 29 Apr 2025 Abivax completes enrolment in the phase III ABTECT-2 trial for 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)
  • 29 Apr 2025 Abivax completes enrolment in the phase-III ABTECT Maintenance trial for Ulcerative colitis (In adolescents, In adults, In the elderly, Treatment-experienced) in Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Croatia, Czech Republic, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Portugal, Romania, Serbia, Slovakia, South Korea, Spain, Switzerland, Turkey, United Kingdom (PO) (NCT05535946)
  • 09 Jan 2025 Abivax announces intention to submit NDA application to the US FDA for Obefazimod in the second-half of 2026

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