BLAINJECTIONINJECTABLEPriority Review
Approved
Nov 2025
Lifecycle
Launch
Competitive Pressure
30/100
Clinical Trials
7
Data completeness
2/8 — Basic
Priority Review
Drug data last refreshed 8h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VOYXACT (sibeprenlimab) is a Biologics License Application (BLA) product approved by Otsuka on November 25, 2025, currently in launch phase. The specific indication, mechanism of action, and therapeutic class are not yet publicly detailed in available data. The drug is administered via injection.
Launch
Early-stage launch presents opportunity for commercial team expansion, though competitive pressure at 30% suggests a moderately crowded indication with established players.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (7)
A Study to Evaluate the Effectiveness and Safety of Sibeprenlimab in Participants With Primary Membranous Nephropathy, Immune-mediated Focal Segmental Glomerulosclerosis, and Minimal Change Disease
Started Dec 2026
20 enrolled
Primary Membranous NephropathyMinimal Change DiseaseFocal Segmental Glomerulosclerosis
Trial of Sibeprenlimab in Children and Adolescents With Immunoglobulin A Nephropathy (IgAN)
Started Oct 2026
24 enrolled
IgA Nephropathy
A Phase 3b Study of Participant Experience on Povetacicept Administered Via Autoinjector as Compared to Sibeprenlimab Administered Via Prefilled Syringe
Started Oct 2026
40 enrolled
Immunoglobulin A Nephropathy
A Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Participants With Sjögren's
Started Apr 2025
83 enrolled
Sjogren Disease
Safety and Tolerability, and PK of Sibeprenlimab in Chinese Healthy Subject
Started Oct 2022
24 enrolled
Healthy Subjects (HS)
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.