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UB-421

Phase 3Biologic

UUnited BioPharma

UB-421 is one of 56 biologic programs targeting Chidamide. It is currently in Phase 3.

2

Indications

10

Total Trials

2

Active Trials

55

Competitors

Pipeline

Status by Indication[3][1]

Indication

ChidamideNot yet recruiting

HIV-1 InfectionNot yet recruiting

ChidamidePhase 2

Not yet recruiting

HIV-1 InfectionPhase 3

Not yet recruiting

Competition

Competitive Landscape

66 competitors in HIV-1 Infection

#DrugCompanyPhaseTrials

Tybost

Emtriva

Istodax

Renvela

Ziagen

Bayer Aspirin

Crestor

Oncovin

Epidiolex

Jazz Pharmaceuticals

Niacor

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

Timeline

Expected Milestones

Q4 2027

Phase 2Not yet recruiting

Chidamide

NCT04985890

Clinical

Trials by Indication[1]

HIV-1 infection3 trials

UB-421 Combine With Optimized Background Therapy Regimen in Multi-Drug Resistant HIV-1 Infection Patients

Unknown status·UUnited BioPharma·Phase 2·NCT03164447·10 enrolled

A Trial of Anti-CD4 Antibody UB-421 in Combination With Optimized Background Antiretroviral Therapy in Patients With Multi-Drug Resistant HIV-1 Infection

Withdrawn·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT05582694

UB-421 in Combination With Optimized Background Regimen in Patients With Multi-drug Resistant HIV-1 Infection

Not yet recruiting·UUnited BioPharma·Phase 3·NCT04406727·50 enrolled

Safety and Efficacy2 trials

To Investigate the Safety and Efficacy of UB-421 Monotherapy in HIV Infected Adults

Completed·UUnited BioPharma·Phase 2·NCT02369146·29 enrolled

A Proof-of-concept Trial to Evaluate the Safety and Efficacy of UB-421 Plus Chidamide in Changing HIV Reservoirs

Completed·UUnited BioPharma·Phase 2·NCT05056974·11 enrolled

Function2 trials

The HIV Functional Cure Potential of UB-421 in ART Stabilized HIV-1 Patients

Unknown status·UUBP Greater China (Shanghai) Co., Ltd·Phase 2·NCT04404049·39 enrolled

The HIV Functional Cure Potential of UB-421 in ART Stabilized HIV-1 Patients

Completed·UUnited BioPharma·Phase 2·NCT03743376·31 enrolled

Chidamide1 trial

A Proof of Concept Study to Evaluate the Effect of UB-421 in Combination With Chidamide on HIV Viral Reservoir

Not yet recruiting·UUBP Greater China (Shanghai) Co., Ltd·Phase 2·NCT04985890·20 enrolled

Efficacy and Safety1 trial

To Investigate the Efficacy and Safety of UB-421 Monotherapy in HIV-1 Infected Adults

Withdrawn·UUnited BioPharma·Phase 3·NCT03149211

1 more indication

Efficacy1 trial

the Study to Evaluate the Safety of UB-421 in Combination With Antiretroviral Therapy (ART) and the Efficacy in Reduction of HIV Viral Load and Proviral DNA as Compared to ART Alone in ART-experienced Viremic HIV-1 Patients

Withdrawn·UUnited BioPharma·Phase 2·NCT04041362

Sources

References

[1]
ClinicalTrials.gov — 10 trial records for UB-421. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — UB-421 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for UB-421. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — United BioPharma company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Biologic[2]
Highest Phase: Phase 3[1]
Company: UUnited BioPharma

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