Product Description
ABX464 (Abivax, Paris, France) is a novel, first-in-class, orally administered small molecule for treatment of ulcerative colitis (UC). ABX464 interacts with the cap binding complex, allowing specific splicing of anti-inflammatory miR-124 (microRNA-124), leading to a cascade dextran sulfate sodium of modulating proinflammatory cytokines.1 Additionally, ABX464 demonstrated a dual mechanism of action in HIV—generating miR-124 and splicing viral RNA— warranting further exploration in inflammatory bowel disease. (Sourced from: https://www.gastrojournal.org/article/S0016-5085(21)00459-5/fulltext)
Mechanisms of Action: MiR-124 Inhibitor
Novel Mechanism: Yes
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Abivax
Company Location:
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belarus, Belgium, Bosnia, Brazil, Bulgaria, Canada, China, Croatia, Czech Republic, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Lithuania, Mexico, Netherlands, New Zealand, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, South Korea, Spain, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 16
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Abivax presented P3 Colitis, Ulcerative results on 2025-11-03 for Obefazimod
- Clinical Outcomes Reported - Abivax presented P3 Colitis, Ulcerative results on 2025-10-06 for Obefazimod
- Clinical Outcomes Reported - Abivax presented P3 Colitis, Ulcerative results on 2025-10-05 for Obefazimod
Highest Development Phases
Phase 3: Colitis, Ulcerative
Phase 2: Arthritis, Rheumatoid|Crohn Disease
Phase 1: COVID-19
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| 2006-7041-83/hah | P1 |
Not yet recruiting |
COVID-19 |
2020-09-30 |
|||
| ENHANCE-CD | P2 |
Recruiting |
Crohn Disease |
2026-12-01 |
2% |
2025-02-19 |
Primary Endpoints |
| ABX464-108 | P2 |
Active, not recruiting |
Colitis, Ulcerative |
2026-03-01 |
2% |
2025-09-05 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
| 2019-001578-27 | P2 |
Completed |
Arthritis, Rheumatoid |
2023-01-23 |
2022-03-13 |
Treatments |
|
| ABX464-202 | P2 |
Recruiting |
Crohn Disease |
2028-07-12 |
2025-05-02 |
Treatments |
|
| ABX464-108 | P2 |
Active, not recruiting |
Colitis, Ulcerative |
2026-03-31 |
2025-05-02 |
Treatments |
|
| ABX464-104 | P2 |
Completed |
Colitis, Ulcerative |
2023-02-23 |
54% |
2025-04-30 |
|
| 2019-000733-39 | P2 |
Completed |
Colitis, Ulcerative |
2023-02-23 |
2025-07-05 |
Treatments |
|
| ABX464-107 | P3 |
Active, not recruiting |
Colitis, Ulcerative |
2026-04-01 |
33% |
2025-10-28 |
Primary Endpoints |
| ABX464-107 | P3 |
Recruiting |
Colitis, Ulcerative |
2025-10-31 |
2025-05-02 |
Treatments |
|
| ABX464-106 | P3 |
Completed |
Colitis, Ulcerative |
2025-06-24 |
17% |
2025-08-07 |
Primary Endpoints |
| ABX464-105 | P3 |
Completed |
Colitis, Ulcerative |
2025-06-24 |
17% |
2025-08-07 |
|
| jRCT2031230081 | P3 |
Recruiting |
Colitis, Ulcerative |
2025-04-20 |
|||
| ABX464-105 | P3 |
Recruiting |
Colitis, Ulcerative |
2025-04-11 |
2025-05-02 |
Treatments |
|
| ABX464-106 | P3 |
Recruiting |
Colitis, Ulcerative |
2025-04-11 |
2025-05-02 |
Treatments |
|
| jRCT2031230257 | P3 |
Recruiting |
Colitis, Ulcerative |
1970-01-01 |