ABX464

Phase 3Small molecule

AAbivax S.A.

ABX464 is one of 81 small molecule programs targeting Acute Respiratory Failure. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Acute Respiratory FailureActive, not recruiting

Rheumatoid ArthritisActive, not recruiting

Ulcerative ColitisActive, not recruiting

Acute Respiratory FailurePhase 2/Phase 3

Active, not recruiting

Rheumatoid ArthritisPhase 2

Active, not recruiting

Ulcerative ColitisPhase 3

Active, not recruiting

Competition

Competitive Landscape

791 competitors in Rheumatoid Arthritis

#DrugCompanyPhaseTrials

Cimzia

UCB

Preclinical

30 2

ABX464

AAbivax S.A.

Phase 3

2 3

Simponi

Johnson & Johnson

Preclinical

19 4

Remicade

OOrganon and Co

Preclinical

43 5

Kevzara

AAzienda U.S.L. 1 di Massa e Carrara

Preclinical

14 6

Ilaris

Novartis

Preclinical

3 7

Cataflam

Rituxan

7 9

Velcade

SShilpa Grover, MD, MPH

Preclinical

2 10

Cimzia

UCB

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2030

Phase 3Active, not recruiting

Ulcerative Colitis

NCT05535946

Clinical

Trials by Indication[1]

Ulcerative Colitis8 trials

Study Evaluating the Long-term Safety and Efficacy of ABX464 in Active Ulcerative Colitis

Completed·AAbivax S.A.·Phase 2·NCT03368118·22 enrolled

ABTECT-2 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -2

Completed·AAbivax S.A.·Phase 3·NCT05507216·636 enrolled

ABTECT-1 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -1

Completed·AAbivax S.A.·Phase 3·NCT05507203·639 enrolled

Show 5 more trials

Efficacy and Safety Study of ABX464 as Maintenance Therapy in Patients With Moderate to Severe Ulcerative Colitis

Completed·AAbivax S.A.·Phase 2·NCT04023396·217 enrolled

Long-term Safety and Efficacy Profile of ABX464 in Subjects With Moderate to Severe Active Ulcerative Colitis

Active, not recruiting·AAbivax S.A.·Phase 2·NCT05177835·203 enrolled

Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative Colitis

Completed·AAbivax S.A.·Phase 2·NCT03760003·355 enrolled

ABX464 in Subjects With Moderate to Severe Active Ulcerative Colitis

Completed·AAbivax S.A.·Phase 2·NCT03093259·32 enrolled

A Randomized, Double-blind, Multicenter Phase III Study to Evaluate the Long-term Efficacy and Safety of ABX464 25 mg or 50 mg Once Daily as a Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis

Active, not recruiting·AAbivax S.A.·Phase 3·NCT05535946·1,116 enrolled

Rheumatoid Arthritis2 trials

Study Evaluating the Long-Term Safety and Efficacy of ABX464 in Patients With Moderate to Severe Rheumatoid Arthritis

Completed·AAbivax S.A.·Phase 2·NCT04049448·40 enrolled

Study of Two Doses of ABX464 in Participants With Moderate to Severe Rheumatoid Arthritis

Completed·AAbivax S.A.·Phase 2·NCT03813199·60 enrolled

Acute Respiratory Failure1 trial

ABX464 in Treating Inflammation and Preventing Acute Respiratory Failure in Patients With COVID-19

Terminated·AAbivax S.A.·Phase 2/3·NCT04393038·509 enrolled

Treatment1 trial

ABX464 in Fully Controlled HIV Infected Patients Treated With Boosted Protease Inhibitor Treatment

Completed·AAbivax S.A.·Phase 2·NCT02735863·30 enrolled

Crohn's Disease1 trial

Phase 2b/3 Study of ABX464 in Moderate to Severe Active Crohn's Disease Patients

Withdrawn·AAbivax S.A.·Phase 2/3·NCT03905109

6 more indications

First in Man Study1 trial

ABX464 First in Man Study

Completed·AAbivax S.A.·Phase 1·NCT02792686·24 enrolled

Interaction1 trial

Evaluation of the Potential CYP1A2-mediated Drug Drug Interaction Safety, and Tolerability of ABX464

Completed·AAbivax S.A.·Phase 1·NCT05121714·59 enrolled

Tics1 trial

Safety and Pharmacokinetics Study in Healthy Japanese Volunteers

Completed·AAbivax S.A.·Phase 1·NCT05032560·48 enrolled

HIV-11 trial

A Safety, Pharmacokinetics, and Pharmacodynamics Study of ABX464 in HIV-1 Seronegative and Seropositive Adults

Completed·AAbivax S.A.·Phase 1/2·NCT02990325·36 enrolled

HIV1 trial

Safety, PK and PD Study of ABX464 in Untreated HIV Patients

Completed·AAbivax S.A.·Phase 2·NCT02452242·70 enrolled

Unspecified1 trial

Food Effect on Pharmacokinetic Parameters of ABX464

Completed·AAbivax S.A.·Phase 1·NCT02731885·48 enrolled

Sources

References

[1]
ClinicalTrials.gov — 19 trial records for ABX464. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — ABX464 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for ABX464. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Abivax S.A. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: AAbivax S.A.

ABX464

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2030

Trials by Indication[1]

Ulcerative Colitis8 trials

Rheumatoid Arthritis2 trials

Acute Respiratory Failure1 trial

Treatment1 trial

Crohn's Disease1 trial

First in Man Study1 trial

Interaction1 trial

Tics1 trial

HIV-11 trial

HIV1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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