Clinical Trials

Numerous clinical trials sponsored by Abivax S.A. evaluate ABX464 across Phase 1, Phase 2, and Phase 3 studies to assess safety, pharmacokinetics, drug interactions, and therapeutic efficacy. These investigations target conditions such as ulcerative colitis, Crohn's disease, rheumatoid arthritis, COVID-19, and HIV infections, alongside studies in healthy volunteers. Portfolio recruitment statuses range from completed and active not recruiting to terminated, withdrawn, and unknown status.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05177835 ACTIVE_NOT_RECRUITING
Ulcerative Colitis
Abivax S.A.
 2021-12-03 PHASE2
NCT05535946 ACTIVE_NOT_RECRUITING
Ulcerative Colitis
Abivax S.A.
 2023-01-16 PHASE3
NCT05507203 COMPLETED
Ulcerative Colitis
Abivax S.A.
 2022-10-10 PHASE3
NCT05507216 COMPLETED
Ulcerative Colitis
Abivax S.A.
 2022-12-21 PHASE3
NCT04023396 COMPLETED
Ulcerative Colitis
Abivax S.A.
 2020-01-13 PHASE2
NCT04049448 COMPLETED
Rheumatoid Arthritis
Abivax S.A.
 2019-10-25 PHASE2
NCT03905109 WITHDRAWN
Crohn Disease
Abivax S.A.
 2022-09-19 PHASE2; PHASE3
NCT03368118 COMPLETED
Ulcerative Colitis
Abivax S.A.
 2018-01-20 PHASE2
NCT05032560 COMPLETED
Healthy Volunteers
Abivax S.A.
 2021-09-27 PHASE1
NCT05177835 Active not recruiting
Ulcerative Colitis
Abivax S.A.
 2021-12-03 Phase 2
NCT05121714 COMPLETED
Healthy
Abivax S.A.
 2020-12-17 PHASE1
NCT03813199 COMPLETED
Rheumatoid Arthritis
Abivax S.A.
 2019-07-04 PHASE2
NCT03760003 COMPLETED
Ulcerative Colitis
Abivax S.A.
 2019-08-13 PHASE2
NCT04393038 TERMINATED
COVID-19
Abivax S.A.
 2020-07-01 PHASE2; PHASE3
NCT05121714 Completed
Healthy
Abivax S.A.
 2020-12-17 Phase 1
NCT03905109 Unknown status
Crohn Disease
Abivax S.A.
 2020-04-15 Phase 2
NCT04023396 Unknown status
Ulcerative Colitis
Abivax S.A.
 2020-01-13 Phase 2
NCT04049448 Completed
Rheumatoid Arthritis
Abivax S.A.
 2019-10-24 Phase 2
NCT02990325 COMPLETED
HIV Infections; Health Volunteers
Abivax S.A.
 2017-03-27 PHASE1; PHASE2
NCT03093259 COMPLETED
Ulcerative Colitis
Abivax S.A.
 2017-11-16 PHASE2
NCT02735863 COMPLETED
HIV Infection
Abivax S.A.
 2016-05 PHASE2
NCT02452242 COMPLETED
Human Immunodeficiency Virus Infections
Abivax S.A.
 2015-01 PHASE2
NCT02731885 COMPLETED
Healthy Volunteers
Abivax S.A.
 2014-09 PHASE1
NCT02792686 COMPLETED
Healthy Volunteers
Abivax S.A.
 2014-03 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-04-27)

Check the ABX464 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

ABX464 selectively targets and binds the cap-binding complex to modulate precursor RNA splicing, thereby blocking downstream viral transcript generation and cellular pro-inflammatory mediator production in immune cells. This targeted inhibition suppresses viral replication and downstream inflammatory cascades, providing clinical relevance for treating chronic inflammatory conditions such as ulcerative colitis and Crohn's disease as well as HIV-1 infection.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.