Bayer heads to regulators with nondiabetic kidney disease trial win for Kerendia

With a fresh phase 3 win for Kerendia, Bayer is one step closer to pushing the ascendant drug into a much broader population of patients with chronic kidney disease (CKD). 

Kerendia, also known as finerenone, met the mark in Bayer’s late-stage Find-CKD study in adult patients with CKD who don’t have diabetes, allowing the study to hit its primary endpoint, the company said Monday. 

In the trial, Bayer’s drug helped patients chart a statistically significant and clinically meaningful reduction in kidney function decline compared to placebo, as measured by the estimated glomerular filtration rate (eGFR) slope, which is used as a surrogate endpoint for clinical kidney outcomes and a predictor for the risk of kidney failure. Patients in both trial arms received standard of care in addition to placebo or Kerendia.

Bayer did not divulge fine details around Kerendia’s performance but noted that it plans to present the data at an upcoming medical conference and submit them to regulators in hopes of expanding Kerendia into the nondiabetic CKD population. 

Kerendia first emerged on the U.S. scene in 2021 with an FDA nod to curb the risk of kidney function decline, kidney failure, cardiovascular death, nonfatal heart attacks and hospitalization in patients with CKD associated with Type 2 diabetes. 

In addition, the mineralocorticoid receptor antagonist last year picked up a green light for two types of heart failure—either with preserved ejection fraction or mildly reduced ejection fraction—and has become, alongside Nubeqa, a key piece in Bayer’s strategy to navigate the decline of older products Xarelto and Eylea. 

Of the roughly 850 million people estimated to have CKD worldwide, “more than half” have nondiabetic CKD, according to Bayer. That version of the condition can stem from multiple sources, but the most common are hypertension and glomerulonephritis, with the latter referring to the inflammation of the tiny filters in the kidneys dubbed glomeruli, the company explained. 

Hypertension-linked CKD is the second most common cause of kidney failure, according to Bayer, which also noted that patients with the nondiabetic incarnation of the disease face a roughly 2.6 times higher risk of a fatal cardiovascular event than the general population without CKD. 

“The positive results of the Phase III FIND-CKD study represent an important advancement in the area of non-diabetic chronic kidney disease, regardless of the underlying cause,” Christian Rommel, global head of R&D at Bayer’s pharma division, said in a statement. 

Kerendia and its continued growth—both in terms of its sales and label—will be essential to Bayer’s execution in the coming months and years.

The German conglomerate continues to grapple with generic competition against blood thinner Xarelto, which suffered (PDF) a 33% sales decline to 2.34 billion euros ($2.6 billion) last year, plus the recent entry of biosimilars to the Regeneron-partnered eye med Eylea, which experienced a 6% annual sales slide in 2025. 

The Eylea decline is expected to pick up pace in 2026, Bayer said in its earnings report earlier this month. 

Still, Kerendia and other newer drugs in Bayer’s roster are picking up steam. 

For all of last year, Kerendia’s sales soared a staggering 79%—and an even more impressive 93% in the fourth quarter specifically—to reach 829 million euros ($936 million) across 2025, coming close to but not quite breaching the blockbuster sales threshold. 

“We’re well set for our next wave of growth, right into the next decade, driven by significant, sustained Nubeqa and Kerendia sales,” Bayer’s pharma president Stefan Oelrich told analysts on a conference call in early March, highlighting the company’s fast-growing prostate cancer treatment alongside Kerendia.