Sibeprenlimab Injection 400 mg Suppliers & Bulk Manufacturers

Available Forms: Pre-filled syringe (subcutaneous)

Available Strengths: 400 mg

Reference Brands: Voyxact

Sibeprenlimab (Voyxact, Otsuka) is an antibody against APRIL, injected every four weeks to reduce proteinuria in IgA nephropathy. The US FDA granted accelerated approval in November 2025. PharmaTradz handles enquiries for authorised supply of the originator product (named-patient and import-permit orders), and connects developers and licensees preparing for patent and exclusivity expiry.

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Product Description:

Sibeprenlimab is a monoclonal antibody that blocks APRIL (a proliferation-inducing ligand), a signal that drives B cells to make the abnormal, poorly galactosylated IgA1 at the root of IgA nephropathy. That IgA1 forms immune complexes that lodge in the kidney's filters. Blocking APRIL lowers the abnormal IgA and the protein leaking into the urine.

The US FDA granted sibeprenlimab accelerated approval as Voyxact in November 2025 to reduce proteinuria in adults with primary IgA nephropathy at risk of disease progression. It is given as a 400 mg subcutaneous injection every four weeks. Continued approval depends on confirmation of benefit on kidney function.

Sourcing and licensing notes. Sibeprenlimab is patented and there is no biosimilar. Other IgA nephropathy treatments on PharmaTradz include sparsentan, iptacopan and the BAFF/APRIL blocker atacicept. We confirm registration status for each destination before quoting.

How Sibeprenlimab Injection is supplied today, and licensing ahead of patent expiry

Sibeprenlimab Injection is a patented innovator medicine. Where its patents are in force, which today includes most major markets, it can only be supplied by the originator or its licensees, through the routes below. Patents do expire, though, and generic development and licensing deals for post-patent markets start years in advance. If you are developing Sibeprenlimab Injection, hold a dossier for it or want to license it, talk to us.

Where sibeprenlimab is approved

Checked 3 Oct 2026

Market	Status	Brand · regulator · date
United States	Approved	Voyxact · FDA · Nov 2025 (accelerated)
Generic / biosimilar	None	None approved as of the check date

Not approved in your country? A hospital or doctor can often still import it for a named patient, through a special-access, import-permit or compassionate-use route. We confirm which route applies in your country and the documents needed before quoting. Ask about named-patient supply →

Named-patient import Where a patient needs the product in a market where it is not registered, named-patient import is the lawful route. It requires the treating physician's documentation and authorisation from the destination regulator. We handle this pathway. Named-patient access

Authorised distribution For registered markets, supply runs through the manufacturer's authorised distribution channel. We can identify the authorised route for your market and tell you whether the product is registered there at all. Innovator sourcing

A genericised alternative Where the clinical requirement is the drug class rather than this specific molecule, there is often an off-patent alternative that is faster to register and materially cheaper. Tell us the indication and target market and we will say plainly whether one exists. Discuss alternatives

Licensing and generic development Patents expire country by country, and in many countries development and dossier filing can start before expiry under research and regulatory-review exemptions. We connect manufacturers developing this molecule, dossier holders, licensees and tech-transfer partners for markets where it is, or will become, off-patent. Partner on this molecule

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