Prescription medicine
Sibeprenlimab Brand names: Voyxact
Sibeprenlimab (Voyxact) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the sibeprenlimab FDA label on DailyMed (effective March 17, 2026); every sibeprenlimab label on DailyMed.
Highlights of the record
FDA label of March 17, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageVOYXACT is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression.
Forms and strengths
- 200 mg/ml
Injection.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 302 through July 30, 2026
What is sibeprenlimab used for?
From the label: indications and usageVOYXACT 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. […]
Source: FDA drug label (VOYXACT), Otsuka America Pharmaceutical, Inc., effective March 17, 2026 (SPL set c8a93b32-0676-4704-86dc-cb65f425c6e5), via openFDA; the full label on DailyMed
Is there a generic for sibeprenlimab (Voyxact)?
No generic sibeprenlimab is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for sibeprenlimab?
The FDA Adverse Event Reporting System holds 302 reports that list sibeprenlimab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 26 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Sibeprenlimab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other