aBLA Filing Intelligence & Biosimilar Opportunity

Voyxact

Sibeprenlimab-Szsi

Immunomodulator

Injection

Voyxact® (sibeprenlimab-szsi) is an FDA-approved prescription medicine used to reduce proteinuria (protein in the urine) in adults with primary IgA nephropathy (IgAN) who are at risk of disease progression. This approval is under the FDA’s accelerated approval pathway, based on the reduction of proteinuria. Its long-term impact on slowing kidney function decline is still being studied in confirmatory trials.

Approval Date

25-Nov-25

Data Exclusivity Expiry

25-Nov-29

Market Exclusivity Expiry

25-Nov-37

Commercial snapshot

Market performance & projections

Revenue ($M)

CAGR (%)

5.4826

Projected sales, 2026–2032 ($M)

Analyst projection, $M per year

2026

245

2027

703

2028

1289

2029

1766

2030

2258

2031

2765

2032

3255

Molecule profile

Details & specifications

Molecule

Sibeprenlimab-Szsi

Innovator

OTSUKA PHARM CO LTD

Dosage Form

Injection

Strength

400 mg/2 mL (200 mg/mL)

Therapeutic Category

Immunomodulator

Usage

To reduce proteinuria in primary immunoglobulin a nephropathy in adults at risk for disease progression

Good to know

Frequently asked questions

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