vicadrostat (BI 690517) / Boehringer Ingelheim - LARVOL DELTA

Urine Extracellular Vesicle miRNA Changes Induced by Vicadrostat with/Without Empagliflozin in Patients with Chronic Kidney Disease. (PubMed, Int J Mol Sci) - "Vicadrostat plus empagliflozin altered uEV miRNAs involved in immunomodulatory and fibrotic pathways irrespective of participant diabetes status. Regulation of miRNAs may provide insights into synergistic mechanisms of vicadrostat and empagliflozin in CKD treatment."

Journal • Chronic Kidney Disease • Diabetes • Fibrosis • Metabolic Disorders • Nephrology • Renal Disease • MIR192 • MIR194 • MIR199B • MIR27A • MIR381 • MIR513A1

Urine Exosomal miRNA Alterations Induced by Vicadrostat and Empagliflozin in Patients with CKD (KIDNEY WEEK 2025) - P2 | "Conclusion VicaEmpa or VICA alone altered various uEV miRNAs involved in immunomodulatory and fibrotic pathways irrespective of diabetes status. Regulation of miRNAs in the kidney provides insights into mechanisms of action for VICA in CKD."

Clinical • Chronic Kidney Disease • Diabetes • Diabetic Nephropathy • Fibrosis • Metabolic Disorders • Nephrology • Renal Disease

Selectivity of Vicadrostat for Aldosterone Synthase Inhibition: Findings from a Phase 2 Trial in CKD (KIDNEY WEEK 2025) - P2, P3 | "Conclusion Vicadrostat, with or without empagliflozin, selectively suppressed aldosterone levels, without any meaningful effects on cortisol. These findings will be explored further in EASi-HF Preserved™ (NCT06424288), EASi-HF Reduced™ (NCT06935370) and EASi-Kidney™ (NCT06531824) phase 3 trials."

P2 data • Chronic Kidney Disease

Evaluating Aldosterone Synthase Inhibitors in Hypertension: A Meta-Analysis of Efficacy, Safety, and Subgroup Outcomes Across Novel Agents (AHA 2025) - "Four different ASIs - lorundrostat, osilodrostat, baxdrostat, and vicadrostat- were evaluated across the included trials. ASIs appear to be effective and well-tolerated antihypertensive agents, offering significant BP reduction across diverse patient groups, with lorundrostat demonstrating the strongest efficacy. These findings support further large-scale head-to-head trials to better define their role in hypertension management."

Retrospective data • Cardiovascular • Chronic Kidney Disease • Hypertension

EASi-PROTKT Clinical Trail (ChiCTR) - P3 | N=11674 | Not yet recruiting | Sponsor: Peking University Third Hospital; Peking University Third Hospital

Head-to-Head • New P3 trial • Cardiovascular • Diabetes • Hypertension • Metabolic Disorders • Type 2 Diabetes Mellitus

A Study in Healthy People to Test How 2 Different Formulations of a Combination Treatment (Vicadrostat and Empagliflozin) Are Taken up in the Body and How Food Influences the Amount of the Medicines in the Blood (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: Boehringer Ingelheim | Active, not recruiting ➔ Completed

Trial completion

A Study in Healthy People to Test How 2 Different Formulations of a Combination Treatment (Vicadrostat and Empagliflozin) Are Taken up in the Body and How Food Influences the Amount of the Medicines in the Blood (clinicaltrials.gov) - P1 | N=32 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Recruiting ➔ Active, not recruiting

Enrollment closed

A Study in Healthy People to Test How 2 Different Formulations of a Combination Treatment (Vicadrostat and Empagliflozin) Are Taken up in the Body and How Food Influences the Amount of the Medicines in the Blood (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: Boehringer Ingelheim | Not yet recruiting ➔ Recruiting

Enrollment open

The Emerging Role of Aldosterone Synthase Inhibitors in Overcoming Renin-Angiotensin-Aldosterone System Therapy Limitations: A Narrative Review. (PubMed, Card Fail Rev) - "Early clinical trials of ASIs (baxdrostat, lorundrostat, vicadrostat, dexfadrostat phosphate, JX09) report significant reductions in aldosterone, blood pressure and albuminuria, with promising safety. Challenges include ensuring high selectivity, mitigating hyperkalaemia and establishing long-term benefits. Ongoing Phase III trials will clarify their efficacy, safety and synergy with additional therapies - including sodium-glucose cotransporter 2 inhibitors - and clinical outcomes, positioning ASIs as an important advance in renin-angiotensin-aldosterone system modulation."

Journal • Review • Cardiovascular • Hypertension • Renal Disease

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

Enrollment open • Chronic Kidney Disease • Nephrology • Renal Disease

A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People With Type 2 Diabetes, High Blood Pressure, and Cardiovascular Disease (clinicaltrials.gov) - P3 | N=11800 | Not yet recruiting | Sponsor: Boehringer Ingelheim

Head-to-Head • New P3 trial • Cardiovascular • Congestive Heart Failure • Diabetes • Hypertension • Metabolic Disorders • Type 2 Diabetes Mellitus

A Study in Healthy People to Test How 2 Different Formulations of a Combination Treatment (Vicadrostat and Empagliflozin) Are Taken up in the Body and How Food Influences the Amount of the Medicines in the Blood (clinicaltrials.gov) - P1 | N=32 | Not yet recruiting | Sponsor: Boehringer Ingelheim

New P1 trial

A Study in Healthy Men to Compare the Amount of Vicadrostat and Empagliflozin in the Blood When Taken Separately and Together (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: Boehringer Ingelheim | Not yet recruiting ➔ Recruiting

Enrollment open

A Study in Healthy Men to Compare the Amount of Vicadrostat and Empagliflozin in the Blood When Taken Separately and Together (clinicaltrials.gov) - P1 | N=15 | Completed | Sponsor: Boehringer Ingelheim | Active, not recruiting ➔ Completed

Trial completion

A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People With Type 2 Diabetes, High Blood Pressure, and Cardiovascular Disease (clinicaltrials.gov) - P3 | N=11800 | Recruiting | Sponsor: Boehringer Ingelheim | Not yet recruiting ➔ Recruiting

Enrollment open • Head-to-Head • Cardiovascular • Congestive Heart Failure • Diabetes • Hypertension • Metabolic Disorders • Type 2 Diabetes Mellitus

A Study in Healthy Men to Compare the Amount of Vicadrostat and Empagliflozin in the Blood When Taken Separately and Together (clinicaltrials.gov) - P1 | N=15 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Recruiting ➔ Active, not recruiting

Enrollment closed

Pharmacodynamic effects of highly selective aldosterone synthase inhibitor vicadrostat in cynomolgus monkeys: Contrasting effects of once versus twice daily dosing. (PubMed, J Pharmacol Exp Ther) - "Here, the study describes key preclinical studies with the novel aldosterone synthase inhibitor vicadrostat that were instrumental in the design of early clinical studies and provide insight into predicted and unpredicted pharmacodynamic effects. These observations will inform further development of vicadrostat and related drugs for the treatment of kidney disease and other metabolic disease-related morbidities."

Journal • PK/PD data • Cardiovascular • Chronic Kidney Disease • Congestive Heart Failure • Heart Failure • Hypertension • Metabolic Disorders • Nephrology • Renal Disease • CYP11B1

Blood Pressure-Lowering Effects of Aldosterone Synthase Inhibitors-A Systematic Review. (PubMed, Basic Clin Pharmacol Toxicol) - "A significant suppression of cortisol production was found for LCI699 (osilodrostat) but not for baxdrostat, lorundrostat, BI 690517 (vicadrostat) or dexfadrostat. We conclude that ASIs have promising BP-lowering effects with very limited effects on cortisol production and offer reno-protective effects in chronic kidney disease. Studies on hypertensive target organ damage and cardiovascular outcomes are, however, lacking."

Journal • Review • Cardiovascular • Chronic Kidney Disease • Fibrosis • Hypertension • Immunology • Nephrology • Novel Coronavirus Disease • Renal Disease

A Study in Healthy Men to Compare the Amount of Vicadrostat and Empagliflozin in the Blood When Taken Separately and Together (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Boehringer Ingelheim

New P1 trial

A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure (clinicaltrials.gov) - P3 | N=6000 | Recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Nov 2027 ➔ May 2028 | Trial primary completion date: Nov 2027 ➔ May 2028

Head-to-Head • Trial completion date • Trial primary completion date • Cardiovascular • Congestive Heart Failure • Heart Failure

Vicadrostat with and without empagliflozin reduces albuminuria across KDIGO risk class in chronic kidney disease (ERA 2025) - P2, P3 | "Vicadrostat with and without empagliflozin reduced albuminuria across KDIGO risk class in chronic kidney disease. Vicadrostat given in combination with empagliflozin shows promise as a potential treatment option for patients with CKD that will undergo further testing in a Phase 3 trial program (EASi-KIDNEYTM, NCT06531824)."

Chronic Kidney Disease • Diabetes • Diabetic Nephropathy • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

Effects of vicadrostat with and without empagliflozin in people with chronic kidney disease by baseline BMI (ERA 2025) - P2, P3 | "Vicadrostat with or without empagliflozin reduced albuminuria irrespective of baseline BMI dichotomized at 30 kg/m2 in participants with CKD and with or without type 2 diabetes. Vicadrostat given in combination with empagliflozin shows promise as a potential treatment option for patients with CKD that will undergo further testing in a phase 3 trial program (EASi-KIDNEYTM, NCT06531824)."

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

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

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 | Recruiting | Sponsor: Boehringer Ingelheim | Not yet recruiting ➔ Recruiting

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

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

Clinical • P2 data • Cardiovascular