VOYXACT

(Sibeprenlimab)

Phase 3Monoclonal antibody

Otsuka

VOYXACT is one of 100 small molecule programs targeting IgA Nephropathy. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Iga NephropathyNot yet recruiting

Efficacy and SafetyActive, not recruiting

NephropathyEnrolling by invitation

Iga NephropathyPhase 3

Not yet recruiting

Efficacy and SafetyPhase 2

Active, not recruiting

NephropathyPhase 3

Enrolling by invitation

Competition

Competitive Landscape

242 competitors in Efficacy and Safety

#DrugCompanyPhaseTrials

Fludara

Sanofi

Phase 3

1 2

Tyvyt

Innovent Biologics (Suzhou) Co. Ltd.

Phase 3

3 3

BESREMI

PPharmaEssentia

Phase 3

2 4

Giapreza

LLa Jolla Pharmaceutical Company

Phase 3

1 5

Alka-Seltzer

AAbbott

Phase 3

1 6

Mitomycin C

GGynecologic Oncology Group

Phase 3

2 7

Becotatug Vedotin

FFudan University

Phase 3

1 8

Apatinib Mesylate

BBukwang Pharmaceutical

Phase 3

1 9

VOYXACT

Otsuka

Phase 3

1 10

Raphamin

MMateria Medica Holding

Phase 3

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

Timeline

Expected Milestones

Q1 2027

Phase 3Active, not recruiting

Immunoglobulin a Nephropathy

NCT05248646

Q2 2027

Phase 2Active, not recruiting

Efficacy and Safety

NCT06928142

Q2 2029

Phase 2Recruiting

Nephropathy

NCT06740526

Q1 2030

Phase 3Not yet recruiting

Iga Nephropathy

NCT07770815

Clinical

Trials by Indication[1]

Nephropathy2 trials

Phase 2/3 Open-Label Trial of Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy

Enrolling by invitation· Otsuka logo

Otsuka·Phase 2/3·NCT05248659·600 enrolled

Trial of the Impact of Sibeprenlimab on Immunoglobulin A Nephropathy Kidney Tissue

Recruiting· Otsuka logo

Otsuka·Phase 2·NCT06740526·25 enrolled

Efficacy and Safety1 trial

A Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Participants With Sjögren's

Active, not recruiting· Otsuka logo

Otsuka·Phase 2·NCT06928142·83 enrolled

IgA Nephropathy1 trial

A Phase 3, Open-label, Single-arm, Repeat-dose Trial to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Sibeprenlimab Administered Subcutaneously in Children and Adolescents With Immunoglobulin A Nephropathy

Not yet recruiting· Otsuka logo

Otsuka·Phase 3·NCT07770815·24 enrolled

Immunoglobulin A Nephropathy1 trial

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Subjects With Immunoglobulin A Nephropathy.

Active, not recruiting· Otsuka logo

Otsuka·Phase 3·NCT05248646·530 enrolled

Unspecified1 trial

Safety and Tolerability, and PK of Sibeprenlimab in Chinese Healthy Subject

Completed· Otsuka logo

Otsuka·Phase 1·NCT07105124·24 enrolled

Regulatory

FDA Approval Timeline[4]

Nov 25, 2025

VOYXACT

BLA BLA761434

Sources

References

[1]
ClinicalTrials.gov — 6 trial records for Sibeprenlimab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Sibeprenlimab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Sibeprenlimab. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA761434). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Otsuka company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: Otsuka

VOYXACT

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q2 2027

Q2 2029

Q1 2030

Trials by Indication[1]

Nephropathy2 trials

Efficacy and Safety1 trial

IgA Nephropathy1 trial

Immunoglobulin A Nephropathy1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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