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非奈利酮用于慢性肾病合并2型糖尿病患者获批上市!

Author: Medicalhalo
Release time: 2025-10-19 11:44:20

Chronic kidney disease is a common and potentially fatal disease that develops in up to 40% of people with type 2 diabetes. On July 9, 2021, the U.S. Food and Drug Administration (FDA) approved the market. The drug was developed and produced by the Bayer Group. It can be used to reduce the risk of sustained decline in eGFR, non-fatal myocardial infarction, end-stage renal disease, cardiovascular death, and hospitalization for heart failure in adult patients with chronic kidney disease and type 2 diabetes.

Fenelidone is the first non-steroidal selective mineralocorticoid receptor antagonist. The pivotal Phase III clinical FIDELIO-DKD study evaluated the efficacy and safety of Fenelidone compared with placebo. After a median follow-up of 2.6 years, fenelidone significantly reduced the composite risk of first renal failure, sustained reduction in estimated glomerular filtration rate (eGFR) from baseline by ≥40% for at least 4 weeks, and renal death by 18% compared with placebo. At 36 months, the number needed to treat to prevent one primary composite endpoint event was 29. The results showed that compared with placebo, fenelinone significantly reduced the risk of the composite primary endpoint of CKD progression, renal failure, and renal death.

Finelidone can effectively block the excessive activation of MR caused by aldosterone, thereby delaying the damage to kidney structure and function. It is a third-generation potent, highly selective, non-steroidal mineralocorticoid receptor antagonist (MRA). Hyperkalemia, hypotension, and hyponatremia are relatively common side effects of fenelinone. It is recommended that patients pay attention to their own reactions during treatment. If they are intolerant, they should contact their doctor in time to adopt a new treatment plan.

Note: The above information comes from the Internet and is compiled and edited by Medical Companion Travel (please correct me if there are any errors or omissions). It is only to provide information on the latest drugs on the market in the world and help Chinese patients understand the latest international new drug trends. It is only for internal discussion among medical staff and does not serve as any basis for medication. For specific medication guidelines, please consult the attending physician.

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