vicadrostat (BI 690517) / Boehringer Ingelheim - LARVOL DELTA

Vicadrostat with and without empagliflozin reduces albuminuria across KDIGO risk class in chronic kidney disease (ERA 2025) - No abstract available

Chronic Kidney Disease • Nephrology • Renal Disease

Effects of vicadrostat with and without empagliflozin in people with chronic kidney disease by baseline BMI (ERA 2025) - No abstract available

Chronic Kidney Disease • Nephrology • Renal Disease

ISS1.3 Reducing aldosterone: can we protect kidneys and hearts? (ERA 2025) - "The second segment presents phase 2 data from the combined treatment of vicadrostat and empagliflozin, demonstrating a significant reduction in aldosterone levels and the urinary albumin-to-creatinine ratio (UACR) in patients with Chronic Kidney Disease (CKD). The final part underscores the interconnectedness of heart and kidney diseases, proposing that reducing aldosterone synthesis could also benefit patients with Heart Failure (HF).The session advocates for a collaborative approach among specialties to effectively address these diseases. The symposium concludes by emphasizing the centrality of the patient in these discussions, reinforcing the need for patient-centric strategies in disease management"

Cardiovascular • Chronic Kidney Disease • Congestive Heart Failure • Fibrosis • Heart Failure • Hypertension • Immunology • Inflammation • Nephrology • Renal Disease

Insights from the vicadrostat phase 2 study and implications for further clinical development (HEART FAILURE 2025) - "Sponsored by Boehringer Ingelheim"

Clinical • P2 data • Cardiovascular

New Therapies for the Management of Chronic Kidney Disease. (PubMed, Cureus) - "Aldosterone synthase inhibitors (ASIs), such as vicadrostat, may represent a new horizon in selectively inhibiting aldosterone synthesis while preserving cortisol production. Early-phase trials have shown reductions in albuminuria and a potential for renal protection. The question is, could ASIs emerge as a fifth pillar in CKD management and help curb the progression?"

Journal • Review • Cardiovascular • Chronic Kidney Disease • Diabetes • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

Exploring the Potential Health Economic Value of the Aldosterone Synthase inhibitor and Sodium Glucose Transporter 2 inhibitor Combination in Chronic Kidney Disease (ISPOR 2025) - P2, P3 | "The simulation modeling suggests the vicadrostat+empagliflozin combination may offer a promising new option in CKD treatment with meaningful cost savings for health systems through improved patient outcomes and avoidance of complications. Clinical outcomes of the ongoing phase 3 trial (EASi-KIDNEY™, NCT06531824) will be essential to confirm these findings."

HEOR • Chronic Kidney Disease • Nephrology • Renal Disease

A Study to Test Whether Vicadrostat (BI 690517) in Combination With Empagliflozin Helps People With Heart Failure and a Weak Pumping Function of the Left Side of the Heart (clinicaltrials.gov) - P3 | N=4200 | Not yet recruiting | Sponsor: Boehringer Ingelheim

Head-to-Head • New P3 trial • Cardiovascular • Congestive Heart Failure • Heart Failure

A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Chronic Kidney Disease (clinicaltrials.gov) - P2 | N=416 | Not yet recruiting | Sponsor: Boehringer Ingelheim

New P2 trial • Chronic Kidney Disease • Nephrology • Renal Disease

Targeting aldosterone to improve cardiorenal outcomes: from nonsteroidal mineralocorticoid receptor antagonists to aldosterone synthase inhibitors. (PubMed, Curr Opin Nephrol Hypertens) - "In the coming years, nonsteroidal MR antagonists and aldosterone synthase inhibitors are likely to play an increasingly large role in routine medical practice to help improve cardiovascular and kidney outcomes."

Journal • Cardiovascular • Chronic Kidney Disease • Hypertension • Nephrology • Renal Disease

EASi-KIDNEY™ (The Studies of Heart & Kidney Protection With BI 690517 in Combination With Empagliflozin) (clinicaltrials.gov) - P3 | N=11000 | Recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Jan 2029 ➔ Aug 2028 | Trial primary completion date: Jan 2029 ➔ Aug 2028

Trial completion date • Trial primary completion date • Chronic Kidney Disease • Congestive Heart Failure • Nephrology • Renal Disease

Aldosterone Synthase Inhibitor BI 690517: Specificity for Mineralocorticoid Receptor. (PubMed, Cardiol Rev) - "A new class of drugs to consider are the aldosterone synthase inhibitors, which inhibit salt and water reabsorption and decrease sympathetic stimulation. The ideal candidate drug must be capable of inhibiting the MR while sparing the glucocorticoid receptor, a challenge given the 95% homology of these receptors."

Journal • Cardiovascular • Congestive Heart Failure • Heart Failure • Hypertension • Nephrology

EASi-KIDNEY™ (The Studies of Heart & Kidney Protection With BI 690517 in Combination With Empagliflozin) (clinicaltrials.gov) - P3 | N=11000 | Recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Aug 2028 ➔ Jan 2029 | Trial primary completion date: Aug 2028 ➔ Jan 2029

Trial completion date • Trial primary completion date • Chronic Kidney Disease • Congestive Heart Failure • Nephrology • Renal Disease

Phase 1 studies of the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 690517 (vicadrostat), a novel aldosterone synthase inhibitor, in healthy male volunteers. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "BI 690517 was well tolerated and demonstrated dose-dependent inhibition of aldosterone synthesis. Larger studies are warranted to confirm these findings."

Journal • P1 data • PK/PD data • Chronic Kidney Disease • Hypotension • Nephrology • Renal Disease

CUMULATIVE EFFECTS OF THE ALDOSTERONE SYNTHASE INHIBITOR VICADROSTAT COMBINED WITH EMPAGLIFLOZIN ON ALBUMINURIA IN PEOPLE WITH CKD (ISN-WCN 2025) - P3 | "Combination of an ASi with an SGLT2 inhibitor is a promising, novel therapy strategy that may afford superior benefits over aldosterone synthase or SGLT2 inhibition alone and will be tested further in a phase III clinical trial (EASi-KIDNEY,NCT06531824). This abstract was also submitted to theASN 2024congress as ' Cumulative effects of aldosterone synthase and SGLT2 inhibition on albuminuria in people with CKD' ."

Chronic Kidney Disease • Nephrology • Renal Disease

A Study in Healthy People to Test How 2 Different Formulations of BI 690517 Are Taken up in the Body and How Probenecid Influences the Amount of BI 690517 in the Blood (clinicaltrials.gov) - P1 | N=15 | Completed | Sponsor: Boehringer Ingelheim | Active, not recruiting ➔ Completed

Trial completion

Aldosterone synthase inhibitor vicadrostat (BI 690517) ± empagliflozin in a CKD phase II trial: Effects on albuminuria and SBP in patients with/without T2D (CVCT USA 2024) - No abstract available

Clinical • P2 data • Chronic Kidney Disease • Renal Disease • Type 2 Diabetes Mellitus

A Study in Healthy People to Test How 2 Different Formulations of BI 690517 Are Taken up in the Body and How Probenecid Influences the Amount of BI 690517 in the Blood (clinicaltrials.gov) - P1 | N=15 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Recruiting ➔ Active, not recruiting

Enrollment closed

The potential for improving cardio-renal outcomes in chronic kidney disease with the aldosterone synthase inhibitor vicadrostat (BI 690517): a rationale for the EASi-KIDNEY trial. (PubMed, Nephrol Dial Transplant) - P3 | "The EASi-KIDNEY (NCT06531824) double-blind placebo-controlled trial will test this approach by assessing the safety and cardiorenal efficacy of vicadrostat in combination with empagliflozin in ∼11,000 patients with CKD. It will be sufficiently large to assess effects in patients with and without diabetes separately."

Journal • Cardiovascular • Chronic Kidney Disease • Congestive Heart Failure • Diabetic Nephropathy • Heart Failure • Metabolic Disorders • Nephrology • Renal Disease

A Study in Healthy People to Test How 2 Different Formulations of BI 690517 Are Taken up in the Body and How Probenecid Influences the Amount of BI 690517 in the Blood (clinicaltrials.gov) - P1 | N=15 | Recruiting | Sponsor: Boehringer Ingelheim | Not yet recruiting ➔ Recruiting

Enrollment open

Cumulative Effects of Aldosterone Synthase and SGLT2 Inhibition on Albuminuria in People with CKD (KIDNEY WEEK 2024) - "Funding: Commercial Support - Boehringer Ingelheim Background: A phase II trial reported efficacy and safety of the aldosterone synthase inhibitor (ASi) BI 690517 in chronic kidney disease (CKD) showing significant albuminuria reduction with or without empagliflozin (EMPA) in the Background. Meaningfully larger UACR reductions across all ASi doses were achieved in participants with CKD who received both active components of EMPA+ASi compared to treatment with either ASi or EMPA alone. Combination of ASi with SGLT2 inhibitors is a promising, novel therapy strategy that may afford superior benefits over AS or SGLT2 inhibition alone and will be tested further in a phase III clinical trial."

Chronic Kidney Disease • Nephrology • Renal Disease

A Study in Healthy People to Test How 2 Different Formulations of BI 690517 Are Taken up in the Body and How Probenecid Influences the Amount of BI 690517 in the Blood (clinicaltrials.gov) - P1 | N=15 | Not yet recruiting | Sponsor: Boehringer Ingelheim

New P1 trial

New trial to test potential treatment for chronic kidney disease (University of Oxford) - "The EASi-KIDNEY trial will evaluate whether vicadrostat, also known as BI 690517, improves clinical outcomes in a large group of people living with CKD when it is given in combination with existing treatments...The trial will run in 15-20 countries around the world, with around 11,000 people expected to participate. The first participants have been recruited in Oxford...The EASi-KIDNEY trial will investigate whether the combination of vicadrostat (BI 690517) and empagliflozin reduces the risk of kidney disease progression, hospitalisation for heart failure, or death from cardiovascular disease in people with CKD compared with empagliflozin, when added on top of standard medical care....Participants are asked to stay in the study for three-four years and it is hoped that full results will be available in 2028/2029."

Enrollment open • P3 data • Cardiovascular • Chronic Kidney Disease • Heart Failure • Renal Disease

EASi-KIDNEY™ (The Studies of Heart & Kidney Protection With BI 690517 in Combination With Empagliflozin) (clinicaltrials.gov) - P3 | N=11000 | Recruiting | Sponsor: Boehringer Ingelheim | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Chronic Kidney Disease • Congestive Heart Failure • Nephrology • Renal Disease

EASi-KIDNEY™ (The Studies of Heart & Kidney Protection With BI 690517 in Combination With Empagliflozin) (clinicaltrials.gov) - P3 | N=11000 | Not yet recruiting | Sponsor: Boehringer Ingelheim

Combination therapy • New P3 trial • Chronic Kidney Disease • Congestive Heart Failure • Nephrology • Renal Disease

A Study to Test Whether BI 690517 in Combination With Empagliflozin Helps People With Heart Failure (clinicaltrials.gov) - P3 | N=6000 | Recruiting | Sponsor: Boehringer Ingelheim | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Head-to-Head • Cardiovascular • Congestive Heart Failure • Heart Failure