VOYXACT (sibeprenlimab-szsi)
VOYXACT (sibeprenlimab-szsi) is indicated for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression. This indication received accelerated approval based on the drug's ability to reduce proteinuria, though its impact on long-term kidney function decline has not yet been established. Continued approval for this use may be contingent upon the verification of clinical benefit in confirmatory clinical trials.
How VOYXACT Works
VOYXACT is an antibody that binds to A Proliferation Inducing Ligand (APRIL), which blocks signaling at the B cell maturation antigen (BCMA) and TACI receptors. By inhibiting APRIL, the drug reduces serum levels of galactose-deficient immunoglobulin A1 (Gd-IgA1). This reduction is therapeutically relevant because Gd-IgA1 is a protein implicated in the pathogenesis of IgAN.
Details
- Status
- Prescription
- First Approved
- 2025-11-25
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
VOYXACT Approval History
What VOYXACT Treats
1 indicationsVOYXACT is approved for 1 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Immunoglobulin A Nephropathy
VOYXACT Target & Pathway
ProTarget
A protein highly expressed on malignant plasma cells in multiple myeloma. BCMA-targeted therapies, including CAR-T cells and bispecific antibodies, can eliminate myeloma cells while sparing most normal immune cells.
VOYXACT Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
VOYXACT FDA Label Details
Indications & Usage
FDA Label (PDF)VOYXACT is indicated for the treatment of Immunoglobulin A Nephropathy.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.