Atrasentan: First Approval
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Published on: December 22, 2020
1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.
Abstract:
Atrasentan (VANRAFIA®), a potent, highly selective, orally administered endothelin type A (ETA) receptor antagonist, is in development by Novartis for the treatment of glomerular disease. In April 2025, atrasentan was approved in the USA (under accelerated approval based on a reduction in proteinuria) to reduce proteinuria in adults with primary IgA nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g. It has not been established whether atrasentan slows kidney function decline in patients with IgAN. This article summarizes the milestones in the development of atrasentan leading to this first approval for the reduction of proteinuria in adults with primary IgAN at risk of rapid disease progression.
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