Bayer's KERENDIA Achieves Primary Endpoint in Phase III Trial for Type 1 Diabetes and Chronic Kidney Disease
Bayer AG announced that its KERENDIA® (finerenone) achieved a significant reduction in urine albumin-to-creatinine ratio (UACR) by 25% in a Phase III trial for adults with type 1 diabetes and chronic kidney disease. The results were presented at the ASN Kidney Week 2025, and Bayer plans to submit a supplemental New Drug Application to the U.S. FDA in 2026 based on these findings. Additionally, data from the Phase II CONFIDENCE trial will also be presented at the event.
Bayer AG has announced new Phase III investigational data from the pivotal FINE-ONE trial, demonstrating that KERENDIA® (finerenone) significantly reduced urine albumin-to-creatinine ratio (UACR) by 25% over six months compared to placebo in adults with type 1 diabetes (T1D) and chronic kidney disease (CKD) receiving standard of care. These late-breaking results were presented at the opening plenary session of the American Society of Nephrology (ASN) Kidney Week 2025. Bayer also plans to submit a supplemental New Drug Application (sNDA) to the U.S. FDA based on the FINE-ONE trial results in 2026. Additionally, data from the Phase II CONFIDENCE trial, which investigated the combination of finerenone and a sodium-glucose transport protein 2 inhibitor (SGLT2i) in patients with type 2 diabetes (T2D) and CKD, will be presented as two late-breaking analyses at ASN 2025. Previously announced CONFIDENCE results will also be featured in a session highlighting impactful kidney research articles from leading medical journals. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Bayer AG published the original content used to generate this news brief via Business Wire (Ref. ID: 20251106278975) on November 06, 2025, and is solely responsible for the information contained therein. © Copyright 2025 - Public Technologies (PUBT)
