On May 21, 2026, Bayer announced that the FDA granted Priority Review to a supplemental NDA for finerenone (Kerendia) in a new indication that has seen almost no meaningful pharmacological progress in over three decades. The drug itself is important. The pattern it represents is more important.
What Happened and Why It Took 30 Years
FINE-ONE is the first Phase III study since the 1990s to show positive results for patients with type 1 diabetes and chronic kidney disease. Since 2021, Kerendia has been approved to reduce cardiovascular death, hospitalization for heart failure, non-fatal myocardial infarction, sustained eGFR decline, and end-stage kidney disease in adults with CKD associated with type 2 diabetes. In July 2025, Kerendia received an additional FDA approval to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure with left ventricular ejection fraction of at least 40%.
Now the same molecule is seeking a third indication. On May 21, 2026, Bayer announced FDA acceptance and Priority Review designation for a supplemental New Drug Application for finerenone for the treatment of adults with type 1 diabetes and chronic kidney disease. The sNDA is supported by the Phase III FINE-ONE trial, which showed Kerendia significantly reduced urine albumin-to-creatinine ratio compared with placebo when used alongside standard of care in adults with T1D and CKD.
“The FDA’s acceptance of this application underscores the clinical importance of our ongoing program for Kerendia, and growing evidence base, across broad patient populations in cardiovascular and kidney diseases,” said Carolina Aldworth, MD, MSc, Executive Medical Director at Bayer. “With five Phase III trials now having achieved their primary endpoints, including FINE-ONE, which forms the basis of this submission, we’re proud that this milestone brings us one step closer to potentially addressing unmet needs among people living with type 1 diabetes and chronic kidney disease.”
The FINE-ONE Trial Data Pharmacists Need to Know
The FINE-ONE study enrolled 242 patients with type 1 diabetes, CKD with eGFR of 25 to less than 90 mL/min/1.73m², and albuminuria with UACR of 200 to less than 5,000 mg/g, all receiving treatment with an ACE inhibitor or ARB.
Finerenone significantly reduced UACR compared to placebo over six months, with a least-squares mean change of 0.75, 95% CI 0.65 to 0.87, P less than 0.001. This 25% reduction in UACR represents clinically meaningful kidney protection in a population that has had no approved nonsteroidal MRA option.
The eGFR signal requires clinical context. The change in eGFR at six months was negative 5.6 mL/min/1.73m² in the finerenone arm and negative 2.7 in the placebo arm. Following a 30-day washout period, eGFR values in the finerenone group approached baseline levels. This initial eGFR dip is consistent with the class effect seen with other cardiorenal agents and is expected to reverse off therapy, a finding that requires patient counseling up front to prevent premature discontinuation.
Safety findings were largely consistent with prior finerenone experience. The rate of treatment-emergent adverse events was 47.1% for finerenone versus 49.2% for placebo. Hyperkalemia, the adverse event of special interest, occurred in 10.1% of finerenone-treated patients versus 3.3% with placebo, with treatment discontinuation due to hyperkalemia at 1.7% versus 0%.
The hyperkalemia rate is the most pharmacist-relevant safety signal in the entire trial. One in ten T1D-CKD patients on finerenone will develop hyperkalemia, roughly three times the rate seen with placebo. Most won’t discontinue because of it, but all of them need monitoring.
The Pharmacist’s Clinical Essentials – Right Now
If approved under Priority Review, finerenone’s T1D-CKD indication will arrive on the clinical landscape within approximately six months of the PDUFA date. Pharmacists who build their clinical protocol now will be the ones their prescribers call when the first prescriptions arrive.
Potassium monitoring is the primary pharmacist intervention. Measure serum potassium and eGFR in all patients before initiation and dose accordingly. The prescribing information for the existing Kerendia indications requires this baseline assessment, and the same protocol will apply to the T1D-CKD indication.
The monitoring schedule: potassium should be checked at baseline, at one month after initiation or after any dose change, and then periodically during therapy. Any patient with potassium above 5.0 mEq/L at baseline should not initiate finerenone. Patients who develop potassium above 5.5 mEq/L during therapy should have finerenone withheld until potassium returns to below 5.0 mEq/L. This protocol is pharmacist-manageable under a collaborative practice agreement in most states.
CYP3A4 interaction surveillance is the second critical pharmacist function. Finerenone is primarily metabolized by CYP3A4, and the interaction profile requires active management in a T1D-CKD patient population that is often on complex multi-drug regimens.
Concomitant use with strong CYP3A4 inhibitors, including azole antifungals, certain antibiotics like clarithromycin, and HIV protease inhibitors, is contraindicated. Patients must also avoid grapefruit and grapefruit juice entirely. Concomitant use with moderate or weak CYP3A4 inhibitors warrants enhanced potassium monitoring. Concomitant use with strong or moderate CYP3A4 inducers, including rifampin, carbamazepine, and St. John’s Wort, should be avoided as it significantly reduces finerenone exposure.
In the T1D-CKD population, the likelihood of a CYP3A4 interaction is high. These patients are often on ACE inhibitors or ARBs for the renal protective effect already required by trial design. They may also be on statins, some of which have CYP3A4 liability. They may have comorbid cardiovascular conditions requiring additional agents. The pharmacist reviewing a complete medication profile for a T1D-CKD patient starting finerenone will catch interaction risks that no prescriber managing a single-disease specialty appointment will have time to identify systematically.
The Pattern This Drug Illustrates and Why It Matters for the Profession
Step back from the specific pharmacology and look at what finerenone’s approval trajectory represents.
2021: approved for CKD associated with type 2 diabetes. July 2025: approved for heart failure with LVEF at least 40%. 2026 under Priority Review: potentially approved for CKD associated with type 1 diabetes.
A single nonsteroidal MRA, titrated carefully across three overlapping cardiorenal indications, in a patient population where heart failure, T2D, T1D, and CKD frequently coexist in the same person.
The regulatory submission for the T1D-CKD indication is based primarily on albuminuria reduction data rather than kidney failure or cardiovascular outcomes in this population, reflecting the unmet need and the FDA’s willingness to use surrogate endpoints for a historically undertreated group.
The complexity this creates for patient management is exactly the complexity that defines the pharmacist’s future practice environment. A patient with T1D, CKD, heart failure, and hypertension may be on an ACE inhibitor or ARB, an SGLT2 inhibitor for renal protection, finerenone for cardiorenal benefit, insulin, a GLP-1 or dual agonist for metabolic management, and antihypertensives. Each of those drug classes carries its own potassium, renal, and interaction profile. The overlap between them, across all five simultaneously, creates monitoring demands that no prescriber’s quarterly visit can sustainably track.
The pharmacist reviewing the complete regimen at every refill touchpoint, flagging interaction risks as new medications are added, monitoring potassium trends as finerenone is initiated and titrated, and communicating proactively with the prescribing team, provides a clinical function that is both irreplaceable and increasingly documented as generating measurable outcomes.
The 2026 ADA Standards, covered in the previous issue of this newsletter, explicitly incorporated finerenone for heart failure with diabetes into the pharmacologic guidance. The growing evidence base across cardiovascular and kidney diseases that Bayer cites positions finerenone as a cardiorenal cornerstone therapy, not a niche agent. Pharmacists who understand the full indication landscape and monitoring requirements will be the clinical partners that cardiologists, nephrologists, and endocrinologists need as this drug scales.
The Approval Timeline and What to Do Before It Arrives
Priority Review designation typically reduces the FDA’s target review time from 12 months to six months. With FDA acceptance announced May 21, 2026, a potential PDUFA date lands in approximately November 2026, assuming standard Priority Review timelines.
That gives pharmacists roughly five months to build clinical fluency before the first T1D-CKD prescriptions arrive.
The preparatory work: review the FINE-ONE trial publication in the New England Journal of Medicine, March 2026, for the full efficacy and safety dataset. Review the FIDELIO-DKD and FIGARO-DKD trial results for the existing T2D-CKD indication to understand how the drug performs across a larger patient population over a longer timeframe. Review the current Kerendia prescribing information, specifically sections on drug interactions, contraindications, and the potassium monitoring protocol.
Then identify the T1D patients in your current panel who also carry a CKD diagnosis. For each one, note their current eGFR, their baseline potassium trend from recent labs, and their current medication list for CYP3A4 interaction risk. That preparation is not extra work. It is the clinical groundwork that allows a pharmacist to walk into the provider conversation already knowing what the prescriber will need to know.
The pharmacist who presents to the next provider meeting already fluent in finerenone’s three indications, its potassium monitoring protocol, and its interaction profile is the pharmacist who earns a permanent seat at the cardiorenal care table.
That seat is being set right now.
Sources: Bayer US Press Release (Kerendia Granted Priority Review for T1D and CKD, May 21, 2026), BioSpace (Bayer Priority Review Announcement), Renal and Urology News (FDA Grants Priority Review to Finerenone for T1D and CKD, May 21, 2026), HCPLive (Finerenone Gets FDA Priority Review for T1D With CKD), Endocrinology Advisor (FDA Priority Review for Finerenone T1D-CKD, May 21, 2026), Patient Care Online (Finerenone Gets FDA Priority Review for T1D and CKD; 5 FDA Decisions for Primary Care, May 2026), Bayer Press Release (FINE-ONE Phase III Primary Endpoint Met, November 2025), New England Journal of Medicine (Heerspink HJL et al. Finerenone in Type 1 Diabetes and Chronic Kidney Disease, published online March 4, 2026), DiabetesontheNet (2026 ADA Standards of Care Update), Guideline Central (2026 ADA Standards of Care Summary)
