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Atrasentan: First Approval
1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.
Drugs
|August 5, 2025
Summary
Atrasentan is a new treatment approved for reducing proteinuria in adults with IgA nephropathy. This oral endothelin receptor antagonist offers a potential option for patients at risk of rapid kidney disease progression.
Area of Science:
- Nephrology
- Pharmacology
- Glomerular Diseases
Background:
- Atrasentan is an orally administered, selective endothelin type A (ETA) receptor antagonist developed by Novartis.
- It is being investigated for the treatment of various glomerular diseases.
Purpose of the Study:
- To summarize the development milestones of atrasentan.
- To highlight its recent US approval for reducing proteinuria in primary IgA nephropathy (IgAN).
Main Methods:
- Review of atrasentan's development pathway.
- Analysis of the basis for its accelerated approval.
Main Results:
- Atrasentan received accelerated approval in the USA in April 2025.
- Approval was based on demonstrated reduction in proteinuria (urine protein-to-creatinine ratio [UPCR] ≥ 1.5 g/g).
- Indicated for adults with primary IgAN at risk of rapid disease progression.
Conclusions:
- Atrasentan represents a significant advancement in managing proteinuria in IgAN.
- Further studies are needed to confirm its effect on slowing kidney function decline in IgAN patients.
- This approval marks a key milestone for atrasentan in treating glomerular disease.
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