Kerendia Could Double Reach in Non-Diabetic CKD as Bayer Pursues Regulatory Approval

Bayer has achieved a major milestone with Kerendia, moving closer to expanding its use in patients with chronic kidney disease (CKD) who do not have diabetes. This comes after the drug delivered positive results in the late-stage Find-CKD study, which tested its effectiveness in adults with nondiabetic CKD.

Successful Phase 3 Trial

In the trial, Kerendia demonstrated a statistically significant and clinically meaningful reduction in the decline of kidney function compared to placebo. Researchers measured kidney performance using the estimated glomerular filtration rate (eGFR) slope, a recognized predictor for kidney failure. Importantly, patients in both the treatment and placebo groups received standard-of-care therapies, ensuring robust results.

Regulatory Submission Planned

Bayer intends to present the trial data at an upcoming medical conference. Following this, the company plans to submit the results to regulators, seeking approval to expand Kerendia’s label to include the nondiabetic CKD population.

Addressing a Large Unmet Need

Globally, approximately 850 million people have CKD, and more than half suffer from nondiabetic forms of the disease, according to Bayer. Common causes include hypertension and glomerulonephritis, with hypertension-linked CKD ranking as the second leading cause of kidney failure. Patients with nondiabetic CKD also face a 2.6 times higher risk of fatal cardiovascular events compared to the general population.

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Strategic Importance for Bayer

Kerendia first entered the U.S. market in 2021 for CKD patients with Type 2 diabetes. It has since gained approval for certain heart failure conditions, positioning it alongside Bayer’s Nubeqa as a key growth driver amid declining sales of older products like Xarelto and Eylea. As per Fierce Pharma, Kerendia’s sales surged 79% in 2025, reaching €829 million ($936 million), highlighting its expanding role in Bayer’s portfolio.

Looking Ahead

Bayer anticipates that Kerendia, combined with other newer therapies, will fuel sustained growth in the coming years. The drug’s continued success will be central to Bayer’s strategy for navigating competitive pressures and maintaining market momentum.