Novartis reported the final results of its Phase III ALIGN study for Vanrafia, an oral endothelin‑A receptor antagonist, in adults with IgA nephropathy. The study, which followed patients for 132 weeks and collected data through week 136, showed a clinically meaningful slowing of kidney function decline, with an estimated glomerular filtration rate (eGFR) change from baseline of 2.39 ml/min/1.73 m² versus placebo at week 136. In patients also receiving sodium‑glucose co‑transporter‑2 inhibitors, the improvement was 2.59 ml/min/1.73 m² at week 132.
The primary kidney‑function endpoint narrowly missed statistical significance, with a p‑value of 0.057. Despite this, the magnitude of the benefit and the consistency of safety outcomes—aligned with earlier trials—support Vanrafia’s potential as a foundational therapy that can be added to existing supportive care regimens without titration and without a risk‑evaluation and mitigation strategy (REMS).
Novartis has already secured accelerated approval in the United States and China in 2025 for proteinuria reduction in IgA nephropathy and plans to submit for traditional approval in 2026. “Progressive and complex diseases such as IgAN present an urgent need for medicines that can target the different drivers of the disease. Vanrafia can be seamlessly integrated into patients’ existing treatment plans, with a consistent safety profile. We are pleased with today’s Phase III ALIGN results, which add to the growing evidence of Vanrafia as a potential foundational therapy to slow kidney function decline,” said Ruchira Glaser, M.D., Global Head of Cardiovascular, Renal & Metabolic Development at Novartis.
The results reinforce Novartis’s broader kidney‑disease portfolio, which also includes Fabhalta (iptacopan) and zigakibart, and position the company to address a significant unmet need in a disease that affects an estimated 25 million people worldwide. The data provide a critical step toward a full regulatory approval that could expand the drug’s market potential and strengthen Novartis’s competitive stance in the emerging IgA nephropathy therapeutic space.
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