Otsuka adds Phase 3 support for Voyxact in IgA nephropathy
CURRENT BRIEF VERSION: Otsuka said new Phase 3 VISIONARY data continue to support Voyxact (sibeprenlimab-szsi) in adults with primary IgA nephropathy, building on the interim results that helped the drug win FDA accelerated approval in the U.S. in November 2025. In Otsuka’s prior disclosures, the ongoing global, randomized, placebo-controlled trial enrolled 510 adults on optimized background therapy, and the pre-specified interim analysis showed a 51% placebo-adjusted reduction in proteinuria at nine months. Later 12-month data, presented at ASN Kidney Week 2025 and published in The New England Journal of Medicine, showed a 54.3% placebo-adjusted reduction in 24-hour urine protein-to-creatinine ratio, with the study continuing in a blinded fashion to assess kidney function decline over 24 months. (otsuka-us.com)
Why it matters: For clinicians, the key issue is whether early proteinuria reduction with APRIL inhibition will translate into durable preservation of kidney function. FDA’s accelerated approval was based on proteinuria as a surrogate endpoint, and continued approval depends on confirmatory evidence from the ongoing VISIONARY trial’s eGFR readout. The data also matter because Voyxact entered an increasingly competitive IgA nephropathy market that already includes approved options such as sparsentan and budesonide, while also landing as Otsuka broadens its pipeline more broadly, including a planned roughly $1.225 billion acquisition of Transcend Therapeutics to add the Phase 3-ready PTSD candidate TSND-201 (methylone) and related prodrug programs in psychiatry and neurology. (otsuka.co.jp)
What to watch: Watch for the 24-month eGFR results from VISIONARY, expected in 2026, because those data are likely to determine whether Voyxact converts from accelerated to traditional approval. Separately, Otsuka has said its Transcend acquisition is expected to close in Q2 2026, offering another signal of how aggressively the company is deploying capital across specialty and CNS growth areas. (otsuka.co.jp)