Atrasentan Impurities—A Critical Quality Control Factor in IgA Nephropathy Treatment

In August 2025, atrasentan  hydrochloride  tablets were officially approved by China‘s National Medical Products Administration (NMPA) for the reduction of proteinuria in adult patients with primary immunoglobulin A nephropathy (IgA nephropathy) who are at risk of rapid disease progression.

IgA nephropathy is a common primary glomerular disease. Current pharmacological treatments often include renin–angiotensin system inhibitors, such as angiotensin-converting enzyme inhibitors, as well as other conventional immunosuppressive agents.

Atrasetan is a specific endothelin receptor antagonist. As the first non-immunosuppressive foundational therapy for IgA nephropathy approved in China, it potently inhibits the binding of endothelin-1 (ET-1) to the ETA receptor. By suppressing the overactivation of the endothelin system, it blocks key pathological pathways in IgA nephropathy, reduces glomerular inflammation and injury, and thereby lowers proteinuria levels, slows disease progression, and improves long-term outcomes.

Drug impurity control is essential to medication safety and a critical factor in drug registration and development. With the expanding use of atrasentan in IgA nephropathy treatment and ongoing research into its potential applications for other indications, the standards for impurity profiling of atrasentan are expected to become increasingly stringent.

SZEB supplies a comprehensive portfolio of atrasentan impurity reference standards, including isomer impurities, oxidative degradation impurities, and more. We provide end-to-end impurity research solutions for pharmaceutical R&D institutions and enterprises, supporting rigorous quality control of atrasentan-based medications.

For more details, visit our website: www.ex-biotech.cn .Contact us by e-mail:sales@ex-biotech.cn .