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FDA Medication Tracker

← All approvals · Kidney, liver & lung · 2025

Voyxact (sibeprenlimab-szsi)

The FDA approved Voyxact (sibeprenlimab-szsi) on November 25, 2025 to reduce proteinuria in primary immunoglobulin A nephropathy in adults at risk for disease progression.
Brand name
Voyxact
Generic name
sibeprenlimab-szsi
FDA approval date
November 25, 2025
Approved use (FDA wording)
To reduce proteinuria in primary immunoglobulin A nephropathy in adults at risk for disease progression
Company
Otsuka Pharm Co Ltd
Application
BLA761434
Dosage form / route
INJECTABLE · INJECTION
Boxed warning on label
Not listed
Category on this site
Kidney, liver & lung

Indications and usage, from the FDA label

VOYXACT is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. This indication is approved under accelerated approval based on reduction of proteinuria. It has not been established whether VOYXACT slows kidney function decline over the long-term in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial. VOYXACT is an A Proliferation Inducing Ligand (APRIL) blocker, indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. ( 1 ) This indication is ap…

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.