Zigakibart
An investigational treatment for IgA Nephropathy.
The same compound appears under different names depending on the context. Here is how to identify Zigakibart wherever you encounter it, plus the key facts at a glance.
- Generic name
- Zigakibart
- Development codes
- BION-1301, FUB523
- Drug class
- APRIL antagonist
- Manufacturer
- Novartis
- How it's taken
- Given as a subcutaneous (under the skin) injection of 600 mg from a prefilled syringe every 2 weeks in the BEYOND trial.
An anti-APRIL antibody in Phase 3 trials for IgA nephropathy. Zigakibart blocks the APRIL immune signal that drives production of the defective antibodies responsible for kidney damage.
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How Zigakibart works
Zigakibart is a monoclonal antibody that binds to and neutralizes APRIL, a protein that drives your immune cells to produce the defective IgA1 antibodies that damage your kidneys. By blocking APRIL, zigakibart reduces production of these harmful antibodies at the source.
Mechanism: Humanized monoclonal antibody targeting APRIL to block APRIL-driven Gd-IgA1 production
Side effects and safety
Novartis reported no new safety signals in long-term data from the Phase 1/2 study through week 124. Phase 3 safety results from the BEYOND trial have not been released yet. BEYOND leaves out people whose IgG antibody level is below 6 g/L at screening.
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Zigakibart
Given as a subcutaneous (under the skin) injection of 600 mg from a prefilled syringe every 2 weeks in the BEYOND trial.
Clinical trial results
The Phase 3 BEYOND trial (NCT05852938) enrolled 383 adults in a double-blind, placebo-controlled study over 104 weeks. Its registered primary endpoint is the change in kidney function (eGFR) at week 104. Long-term Phase 1/2 data showed lasting drops in Gd-IgA1 and IgA through week 124, along with lower urine protein and stable eGFR, according to Novartis. Novartis expects BEYOND results in the first half of 2027.
Main registered trial: NCT05852938 on ClinicalTrials.gov. Check it for the current status, sites and contacts before asking about enrollment.
Development history
Zigakibart, first known as BION-1301, came to Novartis when it completed its purchase of Chinook Therapeutics on August 11, 2023, a month after the Phase 3 trial began. Novartis develops it under the code FUB523. BEYOND is one of several late-stage IgAN programs targeting the APRIL/BAFF pathway.
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Common questions about Zigakibart
▸What is Zigakibart?
An anti-APRIL antibody in Phase 3 trials for IgA nephropathy. Zigakibart blocks the APRIL immune signal that drives production of the defective antibodies responsible for kidney damage.
▸How does Zigakibart work?
Zigakibart is a monoclonal antibody that binds to and neutralizes APRIL, a protein that drives your immune cells to produce the defective IgA1 antibodies that damage your kidneys. By blocking APRIL, zigakibart reduces production of these harmful antibodies at the source.
▸What are the side effects of Zigakibart?
Novartis reported no new safety signals in long-term data from the Phase 1/2 study through week 124. Phase 3 safety results from the BEYOND trial have not been released yet. BEYOND leaves out people whose IgG antibody level is below 6 g/L at screening.
▸How is Zigakibart taken?
Given as a subcutaneous (under the skin) injection of 600 mg from a prefilled syringe every 2 weeks in the BEYOND trial.
▸Is Zigakibart FDA approved?
Zigakibart is currently in phase 3 clinical trials for IgA Nephropathy. It has not yet received FDA approval.
▸What is APRIL and why target it for IgAN?
APRIL (A Proliferation-Inducing Ligand) is a cytokine that drives B cells to produce galactose-deficient IgA1, the harmful antibody that causes kidney damage in IgA nephropathy. Blocking APRIL reduces production of these pathogenic antibodies at the source.
▸What is the current development status of zigakibart?
Zigakibart is in Phase 3 development. The BEYOND trial enrolled 383 patients in a double-blind, placebo-controlled study over 104 weeks, and Novartis expects results in the first half of 2027.
▸How is zigakibart administered?
In the BEYOND trial, zigakibart is given as a 600 mg injection under the skin from a prefilled syringe every 2 weeks for 104 weeks.
▸What development codes is zigakibart known by?
Zigakibart was first known as BION-1301 at Chinook Therapeutics. Novartis bought Chinook in August 2023 and develops it under the code FUB523.
▸How does zigakibart differ from atacicept?
Zigakibart selectively blocks only APRIL, while atacicept blocks both BAFF and APRIL. No trial has compared the 2. Atacicept was FDA-approved as Trutakna in July 2026; zigakibart is still in Phase 3 and not yet approved.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- ClinicalTrials.gov. A Study of Zigakibart in Adults With IgA Nephropathy (BEYOND). https://clinicaltrials.gov/study/NCT05852938
- Novartis · 2026-07-21. Novartis Q2 2026 results media release. https://www.novartis.com/sites/novartis_com/files/q2-2026-media-release-en.pdf
- Novartis · 2023-08-11. Novartis completes acquisition of Chinook Therapeutics. https://www.novartis.com/news/media-releases/novartis-completes-acquisition-chinook-therapeutics