With Kerendia’s new Phase 3 victory, Bayer is one step closer to bringing this powerful drug to a wider range of chronic kidney disease (CKD) patients.
Kelendia, also known as Filenone, met criteria in Bayer’s late-stage FIND-CKD study in nondiabetic adults with CKD, enabling the study to meet its primary endpoint, the company announced Monday.
In this trial, Bayer’s drug helped patients chart a statistically significant and clinically meaningful reduction in renal function decline compared to placebo, as measured by the slope of estimated glomerular filtration rate (eGFR), which is used as a surrogate endpoint for clinical renal outcomes and a predictor of renal failure risk. Patients in both study groups received standard treatment in addition to a placebo or Kerendia.
Bayer did not provide details about Kerendia’s performance, but said it plans to present data at an upcoming medical conference and submit it to regulatory authorities in hopes of expanding Kerendia to non-diabetic CKD patients.
Kerendia first appeared on the U.S. scene in 2021 and received FDA approval to reduce the risk of kidney function decline, kidney failure, cardiovascular death, non-fatal heart attack, and hospitalization in patients with CKD associated with type 2 diabetes.
Additionally, the mineralocorticoid receptor agonist was given the green light last year for two types of heart failure: preserved ejection fraction or mildly reduced ejection fraction, and, along with Nubeca, is a key part of Bayer’s strategy to overcome the decline of older products Xarelto and Eylea.
Of the approximately 850 million people estimated to have CKD worldwide, “more than half” have non-diabetic CKD, according to Bayer. The company explained that this version of the condition can be caused by multiple causes, but the most common is high blood pressure, the latter referring to inflammation of the kidney’s tiny filters called glomeruli.
Bayer notes that hypertension-related CKD is the second most common cause of kidney failure, and that patients with non-diabetic manifestations of the disease have an approximately 2.6 times higher risk of fatal cardiovascular events than the general population without CKD.
“The positive results of the Phase III FIND-CKD study represent an important advance in the field of non-diabetic chronic kidney disease, regardless of the underlying cause,” Christian Rommel, global head of research and development at Bayer Pharmaceuticals, said in a statement.
The continued growth of both Calendia and its sales and labels will be essential to Bayer’s operations in the coming months and years.
The German conglomerate continues to grapple with generic competition from blood thinner Exarelto, and sales fell 33% to 2.34 billion euros ($2.6 billion) last year (PDF) (PDF). In addition, the recent entry of a biosimilar to the eye drug Eylea, in partnership with Regeneron, reduced annual sales by 6% in 2025.
Bayer said in its earnings call earlier this month that the pace of Eyrie’s decline is expected to accelerate in 2026.
Still, Kerendia and Bayer’s other new drugs are gaining traction.
Over the whole of last year, Kerendia’s sales grew by an impressive 79%, with an even more impressive 93% especially in the fourth quarter, reaching €829 million ($936 million) for all of 2025, approaching but not quite exceeding the blockbuster sales threshold.
“With strong and sustained sales of Nubeca and Kerendia, we are poised for the next wave of growth into the next decade,” Bayer Pharmaceuticals President Stefan Orlich told analysts on a conference call in early March, highlighting the rapid growth of the company’s prostate cancer drugs alongside Kerendia.
