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Molecule

Sibeprenlimab

Available on requestBiologicCold chain
Presentations
1
Brands
1
Manufacturers
1
Available from stock
0

Sibeprenlimab is a prescription medicine indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. It is available as injection for subcutaneous use. MedsAcross supplies Sibeprenlimab for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

US FDA first approval
25 November 2025
EU status
Not recorded
Orphan designation
Not recorded
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Subcutaneous
Dosage forms
Injection
Biologic
Yes
Identifiers
UNII GHX28QZ7DD

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

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.

Source: US FDA prescribing information

How it works

VOYXACT binds to APRIL with a dissociation constant (K D ) of 0.95 pM, which blocks signaling at the B cell maturation antigen (BCMA) and transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI) receptors. Inhibition of APRIL results in reduced levels of serum galactose-deficient immunoglobulin A1 (Gd-IgA1), which is implicated in the pathogenesis of IgAN.

Source: US FDA prescribing information

Dosing overview

Recommended dosage: 400 mg injected subcutaneously once every 4 weeks. Recommended Dosage The recommended dosage of VOYXACT is 400 mg administered by subcutaneous injection once every 4 weeks.

Source: US FDA prescribing information

Contraindications

VOYXACT is contraindicated in patients with serious hypersensitivity to sibeprenlimab-szsi or any of the excipients of VOYXACT. Serious hypersensitivity to sibeprenlimab-szsi or any excipients in VOYXACT.

Source: US FDA prescribing information

Warnings and precautions

Immunosuppression and Increased Risk of Infections: Before initiating VOYXACT, assess for active infections. During treatment, monitor for signs and symptoms of infection. Immunosuppression and Immunization Risks: Live vaccines not recommended within 30 days prior to initiation of VOYXACT or during treatment.

Source: US FDA prescribing information

Side effects

The following clinically significant adverse reactions are described elsewhere in the labeling: Immunosuppression and Increased Risk of Infections Immunosuppression and Immunization Risks Most common adverse reactions are upper respiratory tract infection and injection site erythema.

Source: US FDA prescribing information

Storage

Store VOYXACT in a refrigerator at 36°F to 46°F (2°C to 8°C). Do not freeze. Once VOYXACT prefilled syringe has reached room temperature, do not return it to the refrigerator. Do not use VOYXACT if it has been at room temperature for 7 days or longer. Do not shake.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

1 presentations of Sibeprenlimab, sorted by availability.

MedicineManufacturerRegisterAvailability
Voyxact 400 mg/2 mL injectionSubcutaneous Cold chainOtsuka America PharmaceuticalUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Voyxact

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 25 November 2025Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Sibeprenlimab available for export from India?

Yes, on request. MedsAcross lists 1 presentations of Sibeprenlimab and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Sibeprenlimab have?

The catalogue lists 1 brand names for Sibeprenlimab, including Voyxact.

Is Sibeprenlimab approved by the US FDA?

Yes. The US FDA first approved Sibeprenlimab on 25 November 2025, according to Drugs@FDA.

Does Sibeprenlimab need cold chain shipping?

At least one listed presentation of Sibeprenlimab must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.

References

  1. VOYXACT prescribing information (Otsuka America Pharmaceutical). U.S. National Library of Medicine, DailyMed. Retrieved 17 March 2026

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