On August 20, Novartis announcedAtrasentan (brand name Nourida) has been approved by the National Medical Products Administration for reducing proteinuria in adult patients with primary immunoglobulin A nephropathy (IgA nephropathy) who are at risk of rapid disease progression. The drug isChina's First Approved Non-immunological Therapy for Treating IgA Nephropathy, is domesticallyThe first and currently only highly selective endothelin A (ETA) receptor antagonist for this indication, is expected to reshape the cornerstone of IgA nephropathy treatment. This also followsIpsenatide Hydrochloride Capsules(Product Name:Fei He Da) The second nephrology product approved by Novartis in China after receiving approval for its nephrology indication.
In primary glomerulonephritis, IgA nephropathy is the most common type, with approximately 4 million patients in China. IgA nephropathy predominantly affects young adults, with a peak incidence between the ages of 20 and 30. Studies have shown that up to 50% of IgA nephropathy patients with persistent proteinuria may progress to renal failure within 10 to 20 years after diagnosis, requiring lifelong dialysis or kidney transplantation. IgA nephropathy progresses rapidly, and due to the limited availability of targeted treatment options, patients often face significant therapeutic challenges and management difficulties.The progression of IgA nephropathy is relatively insidious. If not detected and treated early, the condition can easily deteriorate into renal failure once it worsens. For patients with IgA nephropathy, even if proteinuria is at a lower level, the disease may still progress rapidly.The endothelin system ensures smooth renal blood flow and filtration by regulating vasoconstriction, and can lead to inflammation infiltration, renal fibrosis, and podocyte reduction, mediating the occurrence and development of chronic kidney disease. Its excessive activation is one of the key driving factors in the progression of IgA nephropathy.AtrasentanAs a highly selective endothelin A receptor antagonist (ERA), it provides multiple renal protective functions by precisely blocking this key pathological pathway, reducing glomerular hypertension, decreasing proteinuria, inhibiting inflammatory responses, and improving renal tissue fibrosis. This offers the potential to slow disease progression and improve long-term outcomes.AtrasentanData from the Phase III ALIGN study showed that patients in the treatment group experienced a reduction in urinary total protein-to-creatinine ratio (UPCR) as early as Week 6, with a 36.1% decrease in 24-hour UPCR compared to the placebo group at Week 36 (P<0.0001).AtrasentanThe treatment demonstrated good safety and tolerability.To date, Novartis has received approvals for renal products covering C3 glomerulopathy (C3G) and IgA nephropathy indications. In April 2025, Atrasentan Hydrochloride Tablets received accelerated approval from the U.S. FDA to reduce proteinuria in adult patients with primary IgA nephropathy who are at risk of rapid progression.Scan the WeChat QR code to add.Medicine Space-TimeEditorPlease indicate: Name + Research Direction!
