Bayer is looking to expand the use case of its non-steroidal chronic kidney disease (CKD) drug, Kerendia (finerenone), to non-diabetic patients, after the company posted a win in this population during a late-stage trial.
In the Phase III FIND-CKD study (NCT05047263), Kerendia plus standard of care (SoC) significantly reduced kidney function decline over placebo plus SoC in patients with non-diabetic CKD – meeting the trial’s primary endpoint. This was determined by the improved annual rate of change in estimated glomerular filtration compared with placebo at month 32.
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SoC in this context was a stable and maximum tolerated labelled dose of either an angiotensin-converting enzyme inhibitor (ACEI) or angiotension receptor blocker (ARB), as per ClinicalTrials.gov.
Patients also tolerated the selective mineralocorticoid receptor antagonist well tolerated in this study, while the drug’s safety profile remained consistent with previous studies. Bayer plans to present more data from the FIND-CKD study at an upcoming scientific conference.
Following the positive outcome of the FIND-CKD study, Bayer is planning to submit these data to health authorities, which could see Kerendia’s market reach expand to the non-diabetic patient subset. According to the German pharma company, this group constitutes more than half of the global CKD patient population, with the most common causes of non-diabetic CKD being high blood pressure and inflammation of the glomeruli.
The CKD treatment landscape shift
Previously, the CKD treatment landscape primarily centred around blood pressure management, which saw treatments like ARBs and calcium channel blockers dominate the market.
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By GlobalDataHowever, the CKD treatment paradigm is currently undergoing a notable shift. This comes as physicians increasingly use disease-modifying therapies (DMTs) that slow progression and diminish the risk of kidney failure to manage the condition.
This includes drugs like Kerendia, as well as sodium-glucose co-transporter 2 (SGLT2) inhibitors such as AstraZeneca’s Forxiga (dapagliflozin) and Boehringer Ingelheim & Eli Lilly’s Jardiance (empagliflozin).
According to a forecast from analysts GlobalData, parent company of Clinical Trials Arena, Kerendia will become a blockbuster seller for Bayer in 2026, with sales of the drug expected to peak at $2.6bn in 2031.
Meanwhile, GlobalData forecasts declining sales for Forixga and Jardiance due to their upcoming loss of market exclusivity, with each medication expected to bring in $2.7bn and $873m, respectively, in 2031.
There are also several drugs in late-stage development for CKD. According to GlobalData’s Pharmaceutical Intelligence Center, there are 95 Phase III trials currently ongoing across the indication.
Of the drugs in clinical development, endothelin receptor agonists (ERAs) are garnering attention, as a recent meta-analysis published in the Clinical Journal of the American Society of Nephrology highlighted their disease-modifying potential in CKD.
