Ryan Livingston joined the MJH Life Sciences team in March of 2025, shortly after graduating from TCNJ with a bachelor’s degree in English. He enjoys creative writing, reading, and scuba diving. He can be reached at rlivingston@mjhlifesciences.com.

Image Credit: US Food and Drug Administration

On May 21, 2026, Bayer announced that the 

 had accepted a supplemental New Drug Application (sNDA) and granted Priority Review for finerenone (Kerendia) for adults with 

, which is supported by the phase 3 FINE-ONE trial.

The regulatory submission is based primarily on albuminuria reduction data rather than kidney failure or cardiovascular outcomes in this population.

“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,” Carolina Aldworth, MD, MSc, executive medical director at Bayer, said in a statement. “With 5 Phase 3 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.”

FDA Priority Review for Finerenone in T1D and CKD

The proposed indication would expand finerenone beyond its current US approvals. Finerenone is already indicated to reduce the risk of sustained estimated glomerular filtration rate decline, end-stage kidney disease, cardiovascular death, nonfatal myocardial infarction, and hospitalization for heart failure in adults with CKD associated with T2D. It is also approved to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure and left ventricular ejection fraction of ≥40%.

Finerenone is a nonsteroidal mineralocorticoid receptor antagonist. The drug blocks mineralocorticoid receptor overactivation, a pathway implicated in inflammatory and fibrotic processes in the heart and kidneys. In the T1D setting, the sNDA remains under FDA review, and the currently approved label does not include CKD associated with T1D.

FINE-ONE was a pivotal, global, randomized, prospective, double-blind, multicenter phase 3 trial enrolling 242 adults with T1D and CKD. Participants received finerenone 10 mg or 20 mg, or placebo once daily, added to standard of care. The trial’s primary objective was to determine whether finerenone was superior to placebo for reducing urine albumin-to-creatinine ratio (UACR) over 6 months.

According to Bayer, finerenone significantly reduced UACR compared with placebo over the 6-month study period, with a least-squares mean change of 0.75 (95% CI, 0.65-0.87; P < .001). Detailed trial results were presented at the American Society of Nephrology Kidney Week 2025 and published in the New England Journal of Medicine.

UACR is commonly used as a marker of kidney disease progression and cardiovascular risk, but the reported FINE-ONE data are not a direct demonstration of reduced kidney failure, cardiovascular events, or mortality in adults with T1D and CKD. The sNDA was also supported by pooled phase 3 data from FIDELIO-DKD and FIGARO-DKD, which studied adults with CKD associated with 

Safety Findings and Remaining Questions for Clinicians

Safety findings in FINE-ONE were generally consistent with the established safety profile of finerenone in CKD associated with T2D, according to Bayer. Treatment-emergent adverse events occurred in 47.1% of participants receiving finerenone and 49.2% receiving placebo. Treatment-emergent serious adverse events were reported in 11.8% and 11.5%, respectively.

Hyperkalemia, a known adverse event of interest with mineralocorticoid receptor antagonism, was more frequent with finerenone than placebo in FINE-ONE, occurring in 10.1% vs 3.3% of participants. Discontinuation due to hyperkalemia occurred in 1.7% of finerenone-treated participants and 0% of placebo-treated participants.

The current prescribing information lists contraindications including hypersensitivity to any product component, concomitant use with strong CYP3A4 inhibitors, and adrenal insufficiency. It also recommends potassium and eGFR assessment before initiation and periodic monitoring during treatment because hyperkalemia risk increases with lower kidney function and higher baseline potassium levels.

The regulatory decision, if favorable, would address a population with fewer disease-modifying kidney therapies than patients with T2D and CKD. However, the available announcement centers on 6-month UACR reduction and safety, leaving longer-term clinical outcomes in T1D and CKD as an important area for continued evaluation.

Bayer. Bayer’s KERENDIA® (finerenone) granted Priority Review of supplemental New Drug Application by U.S. FDA for treatment of adults with type 1 diabetes and chronic kidney disease. Published May 21, 2026. Accessed May 21, 2026. 

https://www.bayer.com/en/us/news-stories/kerendiar-granted-priority-review

KERENDIA (finerenone) [prescribing information]. Bayer HealthCare Pharmaceuticals Inc. August 2025. Accessed May 21, 2026. 

https://labeling.bayerhealthcare.com/html/products/pi/Kerendia_PI.pdf

Heerspink HJL, Birkenfeld AL, Cherney DZI, et al. Finerenone in type 1 diabetes and chronic kidney disease. 

Articles

Bayer’s sNDA for finerenone received FDA acceptance and Priority Review for adults with type 1 diabetes and CKD, potentially positioning it as the first MRA labeled for this population. The submission is primarily supported by FINE-ONE, a phase 3, randomized, double-blind trial (n=242) showing significant 6-month UACR reduction versus placebo on background standard of care. Safety was broadly consistent with prior experience in type 2 diabetes–associated CKD, although hyperkalemia occurred more frequently with finerenone. Long-term renal and cardiovascular outcome evidence in type 1 diabetes remains limited.

The FDA accepted Bayer’s sNDA for finerenone in adults with type 1 diabetes and CKD based on albuminuria data from FINE-ONE.

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Chronic Kidney Disease

FDA Grants Priority Review to Finerenone for Type 1 Diabetes and CKD

Ania Jastreboff, MD, PhD | Image Credit: Yale School of Medicine

Eli Lilly has reported topline phase 3 results for retatrutide in adults with 

 or overweight and ≥1 weight-related comorbidity, with all tested doses meeting the primary and key secondary endpoints for weight reduction at 80 weeks, according to a May 21, 2026 announcement.

“TRIUMPH-1 highlights the importance of options and the potential for retatrutide to help people across various stages of their obesity journey,” Kenneth Custer, PhD, executive vice president and president of Lilly Cardiometabolic Health, said in a statement. “From the 4 mg dose, reaching nearly 20% weight loss with 1 escalation step, to the 12 mg dose that delivered a level of weight loss associated with bariatric surgery, retatrutide offers the potential for a patient-centric approach to obesity.”

The company-reported data come from TRIUMPH-1, a randomized, double-blind, placebo-controlled phase 3 trial evaluating once-weekly retatrutide, a triple agonist targeting glucose-dependent insulinotropic polypeptide, glucagon-like peptide-1, and glucagon receptors. The reported analysis included adults without diabetes, a clinically relevant distinction given ongoing development programs for obesity both with and without 

Retatrutide: GIP/GLP-1/glucagon agonist  

Population: obesity/overweight, no diabetes  

TRIUMPH-1 randomized 2339 participants in a 1:1:1:1 ratio to retatrutide 4 mg, 9 mg, 12 mg, or placebo. Participants initiated retatrutide at 2 mg once weekly and escalated every 4 weeks to target doses. The mean baseline body weight was 112.7 kg (248.5 lb), with a mean BMI of 40.0 kg/m2.

For the efficacy endpoint at 80 weeks, mean body weight reduction was 19.0% with retatrutide 4 mg, 25.9% with 9 mg, and 28.3% with 12 mg, compared with 2.2% with placebo. In absolute terms, the corresponding reductions were 21.4 kg, 29.2 kg, and 31.9 kg vs 2.5 kg with placebo.

Several categorical weight-loss thresholds also favored retatrutide. At 80 weeks, 62.5% of participants receiving 12 mg achieved ≥25% weight loss, 45.3% achieved ≥30% weight loss, and 27.2% achieved ≥35% weight loss. In the placebo group, those proportions were 2.2%, 0.5%, and 0.3%, respectively. Investigators also reported reductions in waist circumference and improvements from baseline in selected cardiometabolic measures, including non-HDL cholesterol, triglycerides, systolic blood pressure, and high-sensitivity C-reactive protein.

A pre-specified blinded extension enrolled 532 participants with baseline BMI ≥35 kg/m2 who completed the 80-week study and tolerated assigned treatment. At 104 weeks, participants initially assigned to retatrutide 12 mg and escalated to maximum tolerated dose had a mean weight loss of 30.3%, or 38.5 kg.

Safety Findings Reported With Retatrutide

Adverse events reported with retatrutide were generally consistent with other incretin-based therapies. The most common events were gastrointestinal. Nausea occurred in 28.6%, 38.4%, and 42.4% of participants assigned to retatrutide 4 mg, 9 mg, and 12 mg, respectively, compared with 14.8% with placebo. Diarrhea occurred in 25.2%, 34.1%, and 32.0% vs 13.5%; constipation in 23.8%, 25.9%, and 26.1% vs 10.9%; and vomiting in 10.6%, 22.8%, and 25.3% vs 4.8%.

The company also reported dysesthesia in 5.1%, 12.3%, and 12.5% of participants receiving retatrutide 4 mg, 9 mg, and 12 mg, respectively, compared with 0.9% receiving placebo. Urinary tract infection occurred in 7.5%, 8.8%, and 8.4% of retatrutide-treated participants vs 5.3% with placebo. Most of these events were characterized as mild to moderate, and most participants continued treatment. Discontinuation due to adverse events occurred in 4.1% of participants receiving retatrutide 4 mg, 6.9% receiving 9 mg, and 11.3% receiving 12 mg, compared with 4.9% receiving placebo.

Retatrutide Mechanism, Development, and Next Steps

Retatrutide is designed as a once-weekly agonist of GIP, GLP-1, and glucagon receptors. Earlier phase 2 data published in 2023 supported additional study of the molecule in obesity.

The broader TRIUMPH program is evaluating retatrutide across multiple obesity-related settings, including obesity or overweight with T2D, established cardiovascular disease, knee osteoarthritis pain, moderate to severe obstructive sleep apnea, chronic low back pain, cardiovascular and renal outcomes, and metabolic dysfunction-associated steatotic liver disease. The company stated additional TRIUMPH-1 results will be presented at the 86th annual American Diabetes Association Scientific Sessions, with more detailed results expected at future medical meetings and in peer-reviewed publications.

Lilly also indicated results from TRIUMPH-2, evaluating retatrutide in adults with obesity or overweight and T2D, and TRIUMPH-3, evaluating adults with obesity or overweight and established cardiovascular disease, are expected later this year. Until regulatory review is complete, retatrutide remains legally available only to clinical trial participants.

“Obesity is a chronic disease, and people living with obesity deserve treatment options that match the complex biology of their neurometabolic disease,” Ania Jastreboff, MD, PhD, professor of medicine and pediatrics at the Yale School of Medicine, director of the Yale Obesity Research Center, and lead investigator of TRIUMPH-1, said in a statement. “For patients I see in clinic, retatrutide may potentially be a highly impactful future tool to treat their obesity and transform their health trajectory.”

Eli Lilly and Company. Lilly’s triple agonist, retatrutide, delivered powerful weight loss in pivotal Phase 3 obesity trial. News release. May 21, 2026. Accessed May 21, 2026. 

https://investor.lilly.com/news-releases/news-release-details/lillys-triple-agonist-retatrutide-delivered-powerful-weight-loss

Eli Lilly and Company. A Study of Retatrutide (LY3437943) in Participants Who Have Obesity and Overweight (TRIUMPH-1). ClinicalTrials.gov Identifier: NCT05929066. Updated April 18, 2025. Accessed May 21, 2026. 

https://clinicaltrials.gov/study/NCT05929066

Jastreboff AM, Kaplan LM, Frias JP, et al. Triple-hormone-receptor agonist retatrutide for obesity—a phase 2 trial. N Engl J Med. 2023;389(6):514-526. 

Eli Lilly reported positive topline phase 3 TRIUMPH-1 results for once-weekly retatrutide, a GIP/GLP-1/glucagon triple agonist, in adults with obesity or overweight without diabetes. Across 4 mg, 9 mg, and 12 mg doses, mean weight loss at 80 weeks reached 19.0%, 25.9%, and 28.3% versus 2.2% with placebo, with high proportions achieving ≥25%–35% loss at 12 mg. Safety was predominantly gastrointestinal, with dose-related discontinuations and notable dysesthesia rates.

Retatrutide successfully reduced body weight versus placebo in adults with obesity or overweight in topline phase 3 TRIUMPH-1 results.

Obesity Management

Obesity Management condition center page, resources on the topics of medical news and expert insight into clinical weight management can be found. Content includes articles, interviews, videos, podcasts, and breaking news on obesity research, treatment, and drug development.

Retatrutide Meets Weight Loss Endpoints in Phase 3 Obesity Trial

Klaus F. Rabe, MD, PhD, from LungenClinic Grosshansdorf GmbH. 

Mixed AERIFY Data May Delay Itepekimab Approval Pathway in COPD, With Klaus F. Rabe, MD, PhD

2026 American Thoracic Society (ATS) International Conference

, Klaus Friedrich Rabe, MD, PhD, of LungenClinic Grosshansdorf GmbH further discussed with 

 the implications of the phase 3 AERIFY program evaluating itepekimab in former smokers with chronic obstructive pulmonary disease (COPD), emphasizing both the scientific promise of IL-33 inhibition and the uncertainty surrounding the drug’s future regulatory pathway.

The AERIFY-1 and AERIFY-2 trials evaluated itepekimab, an anti–IL-33 monoclonal antibody, as add-on therapy in patients with COPD despite dual or triple inhaler therapy. While AERIFY-1 met its primary endpoint with significant reductions in moderate or severe exacerbations, AERIFY-2 failed to replicate those findings despite nearly identical trial designs.

During his interview, Rabe addressed additional questions surrounding the studies’ lung function findings, eosinophil-independent design, and next steps for the investigational therapy.

Discussing forced expiratory volume in 1 second (FEV1) outcomes, Rabe acknowledged the data were difficult to interpret. AERIFY-1 demonstrated reductions in exacerbations but minimal improvement in lung function, whereas AERIFY-2 showed more substantial FEV1 signals despite failing on exacerbation endpoints. He cautioned clinicians against overinterpreting the lung function data at this stage, noting the inconsistent dose-response patterns across the studies.

Rabe emphasized itepekimab remains in the development phase and is unlikely to become clinically available in the near term. According to Rabe, had both phase 3 studies produced concordant positive results, sponsors likely would have pursued immediate regulatory submission to the FDA. Instead, he suggested additional clinical evidence may now be required before potential approval.

He also highlighted the rationale behind enrolling patients regardless of baseline eosinophil count. Unlike currently approved biologic therapies for COPD, which primarily benefit patients with type 2 inflammation and elevated eosinophils, anti-alarmin therapies such as itepekimab are being developed for broader COPD populations. Rabe noted the trials intentionally included a wide range of eosinophil levels and that analyses did not demonstrate a clear efficacy signal tied to eosinophil counts, supporting the hypothesis that IL-33 inhibition may work independently of traditional type 2 biomarkers.

Looking ahead, Rabe pointed to ongoing extension data from AERIFY-1 and AERIFY-2, as well as additional mechanistic findings expected from the AERIFY-3 biopsy study later this year. Although he personally anticipates regulators may require another confirmatory study, he stressed the broader importance of IL-33 as an emerging therapeutic target in COPD.

Despite the mixed trial results, Rabe said the overall findings reinforce growing interest in anti-alarmin therapies and suggest IL-33 inhibition may ultimately provide a treatment option for a wider spectrum of patients with COPD beyond eosinophilic disease.

Rabe K, Martinez F, Mouded M, et al. Efficacy and Safety of Itepekimab in Former Smokers With Chronic Obstructive Pulmonary Disease: AERIFY-1 and AERIFY-2 Trials. Poster presented at ATS 2026 on May 17.

Rabe K. AERIFY: Phase 3 Data Reveal Challenges, Potential of Itepekimab in COPD. HCPLive. May 20, 2026. Accessed May 21, 2026. 

https://www.hcplive.com/view/aerify-phase-3-data-reveal-challenges-potential-itepekimab-copd

Videos

Klaus Friedrich Rabe, MD, PhD, spoke at ATS about the mixed phase 3 AERIFY trial findings on itepekimab, an anti–IL-33 monoclonal antibody, in COPD.

COPD

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Real-World Evidence and Strategies for Long-Term Adherence in Wilson Disease

In this episode, 'Real-World Evidence and Strategies for Long-Term Adherence in Wilson Disease,' the experts explore the complexities of maintaining treatment compliance in a lifelong chronic condition. Dr. Rima Fawaz addresses the "grave and irreversible" consequences of non-adherence, particularly for patients with neurological presentations. She notes a unique challenge in hepatic-focused cases, where a lack of daily symptoms can lead to a false sense of security, resulting in treatment gaps that may eventually trigger acute liver failure or decompensation. The panel specifically identifies the "desire to be normal" as a major hurdle for pediatric and adolescent patients, who often struggle with dietary restrictions and the social stigma of frequent medication.

The discussion shifts to a review of data from the AASLD Liver Meeting, which demonstrated a high medication adherence rate (84% of days covered) for patients treated with trientine tetrahydrochloride. Dr. Peter Hedera emphasizes that these findings are "data-driven" evidence that convenience directly correlates with clinical success. He highlights that removing technical barriers—such as the need for refrigeration or the shift from thrice-daily to twice-daily dosing—provides tangible benefits for students and active adults.

Concluding the segment, the panelists reflect on the psychological components of adherence, noting that even patients with medical backgrounds can relapse if they stop treatment because they "feel okay." The experts agree that while clinical trials establish efficacy, real-world evidence is essential for understanding how subtle changes in drug formulation can lead to profound improvements in long-term patient stability and quality of life.

The next episode in this series, 'The Multidisciplinary Approach to Patient Counseling and Care Transitions in Wilson Disease,' features the panelists advancing their conversation on Wilson disease and focusing on the essential role of longitudinal education. The experts discuss tailored counseling strategies to combat treatment burnout, the logistical hurdles of transitioning from pediatric to adult care, and how center-of-excellence models utilize multidisciplinary teams to prevent patients from falling through the cracks.

New ATP7B gene therapies aim to normalize copper in Wilson’s disease, reducing chelation needs while raising durability and patient-selection questions.

Video Series

Gene Therapy as an Emerging Treatment Approach in Wilson Disease

This episode, titled 'Gene Therapy as an Emerging Treatment Approach in Wilson Disease,' features panelists discussing the revolutionary potential of UX701 and other AAV-based gene therapies. Dr. Peter Hedera explains that because carriers of a single ATP7B mutation are asymptomatic, a treatment does not need to achieve 100% expression to restore functional copper homeostasis. However, he raises critical questions regarding the durability of these benefits, noting that because hepatocytes are dividing cells, there is a risk of losing the genetic construct over time. Furthermore, the immunogenicity of adeno-associated viruses (AAV) typically limits patients to a single "one-shot" treatment, making durability the primary focus of current clinical trials.

The conversation expands into next-generation technologies like CRISPR-Cas9 and prime editing. While these tools offer the possibility of permanent genetic correction, the experts acknowledge the immense challenge posed by the high number of unique ATP7B mutations. The panelists emphasize that the future of Wilson disease management will likely move away from a "one size fits all" model toward a highly individualized approach. This could involve tailoring choices between traditional chelation, once-daily salts, or gene therapy based on a patient's lifestyle, their ability to adhere to complex regimens, and their willingness to undergo short-term immunosuppression for long-term freedom from daily pills.

As the segment concludes, the panel highlights that while current trials often focus on stable patients, future research may investigate whether gene therapy can accelerate recovery in acutely ill or non-compliant populations. The experts look forward to real-world evidence to determine if these emerging therapies will act as standalone cures or be integrated into hybrid treatment plans, marking an era of unprecedented granular control in medical genetics.

In the next episode, 'Real-World Evidence and Strategies for Long-Term Adherence in Wilson Disease,' panelists will continue their discussion on Wilson disease and highlight the critical barriers to lifelong medication compliance. The experts examine recent real-world data regarding treatment discontinuation and discuss how practical factors—such as dosing frequency and storage requirements—significantly influence clinical outcomes and disease progression.

In the final episode, each panelist synthesizes their top recommendations for advancing EPI care.

Closing the Loop: Key Recommendations and Future Directions for EPI

At ATS, Klaus Friedrich Rabe, MD, PhD, discussed phase 3 data on itepekimab in former smokers with chronic obstructive pulmonary disease (COPD).

AERIFY: Phase 3 Data Reveal Challenges, Potential of Itepekimab in COPD

Diana Isaacs, PharmD, is an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic.

Diabetes Dialogue cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, cover more of the upcoming news releases announced for ADA 2026.

Type 2 Diabetes

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Strategic Alliance Partnership

Rapid Evolution in GLP-1s and Therapeutics at ADA 2026

Victoria Johnson joined MJH Life Sciences in 2020 and has written for NeurologyLive, CGTLive, and is now an assistant managing editor for HCPLive and RheumatologyLive. She doesn’t have enough time for her numerous hobbies. You can reach her at vjohnson@mjhlifesciences.com.

Experts unpack new asthma/COPD biologics, eosinophil+FeNO targeting, twice-yearly depemokimab switching, and payer hurdles in 2026 care.

Asthma

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Not Everything That Wheezes Is Asthma: Comorbidities, Mimickers, and the Right Time to Escalate

Deepak Bhatt, MD, MPH, MBA, discusses his recent presentation at the ASPC 2026 Virtual Imaging Symposium and how plaque imaging can change the MI landscape.

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Atherosclerotic Cardiovascular Disease

Plaque Imaging and the TRANSFORM Trial in Myocardial Infarction

Vallerie McLaughlin, MD, is a professor of medicine and director of the Pulmonary Hypertension Program in the Division of Cardiovascular Medicine at the University of Michigan.

At ATS 2026, Vallerie McLaughlin, MD discusses ADVANCE OUTCOMES showing ralinepag reduced PAH clinical worsening risk by 55% in pretreated patients.

Ralinepag Achieves 55% Risk Reduction in PAH, With Vallerie McLaughlin, MD

Patrick J. Strollo, MD, from the University of Pittsburgh Medical Center

This interview at ATS highlights key takeaways regarding new phase 3 data on AD109 for obstructive sleep apnea (OSA).

Obstructive Sleep Apnea

What the Phase 3 AD109 Data Mean for Sleep Apnea, With Patrick John Strollo, MD 

Chelsie Derman is an associate editor for 

who covers allergy and  psychiatry. She joined MJH Life Sciences in September 2023 after graduating from The College of New Jersey with a bachelor’s degree in journalism and professional writing. In her free time, she enjoys creative writing and reading.

Results from the phase 3 TETON-1 study presented at ATS 2026 showed inhaled treprostinil preserved lung function and reduced clinical worsening risk in IPF.

Pulmonary Fibrosis

TETON-1: Treprostinil Preserved Lung Function in Idiopathic Pulmonary Fibrosis

Gerard Criner, MD, is chair and professor of thoracic medicine and surgery at Lewis Katz School of Medicine at Temple University and director of the Temple Lung Center.

At ATS 2026, pooled phase 3 data showed mepolizumab reduced COPD exacerbations and hospitalizations in patients with blood eosinophil counts starting at 150 cells/µL.

Mepolizumab Reduced COPD Exacerbations, With Gerard Criner, MD

Diabetes Dialogue cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss the presentations that they’re looking forward to at ADA 2026.

Latest News

FDA Grants Priority Review to Finerenone for Type 1 Diabetes and CKD

Retatrutide Meets Weight Loss Endpoints in Phase 3 Obesity Trial

Mixed AERIFY Data May Delay Itepekimab Approval Pathway in COPD, With Klaus F. Rabe, MD, PhD

Real-World Evidence and Strategies for Long-Term Adherence in Wilson Disease

Gene Therapy as an Emerging Treatment Approach in Wilson Disease