BLAINJECTIONINJECTABLEPriority Review
Approved
Nov 2025
Lifecycle
Launch
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
2/8 — Basic
Priority Review
Drug data last refreshed 2h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VOYXACT (sibeprenlimab) is a biologic injectable approved by the FDA in November 2025. The mechanism of action and specific indications are not yet publicly detailed in available sources. This launch-stage product represents Otsuka's entry into a new therapeutic area.
Growth
As a newly launched injectable biologic, VOYXACT will require rapid field team expansion and intensive market education during its first 12-24 months.
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 (5)
A Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Participants With Sjögren's
Started Apr 2025
83 enrolled
Sjogren Disease
Trial of the Impact of Sibeprenlimab on Immunoglobulin A Nephropathy Kidney Tissue
Started Nov 2024
25 enrolled
IgA Nephropathy
Safety and Tolerability, and PK of Sibeprenlimab in Chinese Healthy Subject
Started Oct 2022
24 enrolled
Healthy Subjects (HS)
Trial of Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy (IgAN)
Started Apr 2022
600 enrolled
Immunoglobulin A Nephropathy
Trial of Sibeprenlimab in the Treatment of A Nephropathy (IgAN)
Started Mar 2022
530 enrolled
Immunoglobulin A Nephropathy
Worked on VOYXACT at Otsuka? Share your interview experience or compensation data (+7 days Pro)
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.