Obefazimod - Abivax
Alternative Names: ABX-464; SPL-464Latest Information Update: 08 May 2025
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
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- 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