Kanarb (fimasartan) / Boryung Group, R-Pharm, Zuellig - LARVOL DELTA

Efficacy and Safety of Fimasartan, Atorvastatin, and Ezetimibe Combination Therapy in Patients With Hypertension and Dyslipidemia: A Randomized, Double-Blind, Multicenter, Therapeutic Confirmatory, Phase III Clinical Trial. (PubMed, Clin Ther) - "Triple combination therapy with FMS + ATO/EZE was superior to dual therapy or monotherapy in reducing both BP and LDL-C levels in patients with essential hypertension accompanied by primary hypercholesterolemia. The safety profile was comparable with that of the individual components, confirming the tolerability and safety of FMS + ATO/EZE therapy. However, the 8-week follow-up period and enrollment of an exclusively Korean cohort may limit the assessment of long-term effects and generalizability to other ethnic populations."

Clinical • Journal • P3 data • Cardiovascular • Dyslipidemia • Hypertension • Metabolic Disorders

Letter to the Editor: Fimasartan-Induced Liver Injury and Update on Hepatotoxicity Risks. (PubMed, J Korean Med Sci) - No abstract available

Journal • Hepatology • Liver Failure

Eco-friendly Nano-scale Bio-analytical Insights for Spectrofluorimetric Estimation of Fimasartan Using Integrated Approach of Enhanced Microwave-assisted Hantzsch Reaction and Multicolored Analytical Chemistry. (PubMed, J Fluoresc) - "By successfully combining analytical quality, environmental sustainability, and cost-effectiveness, this new spectrofluorimetric method presents a valuable tool for researchers and pharmaceutical professionals in the analysis of fimasartan. Its ability to provide accurate measurements at very small nano-scale concentrations while maintaining eco-friendly practices makes it a significant advancement in pharmaceutical analysis techniques."

Journal

Angiotensin receptor blockers and drug-induced liver injury: a cohort study using electronic-health records-based common data model database (EASL 2025) - "In this study, patients were designated to treatment groups according to the ARB prescribed at cohort entry, i.e., azilsartan, eprosartan, telmisartan, fimasartan, valsartan, olmesartan, losartan, irbesartan, or candesartan. Our findings provide insights to the methods for detecting DILI using real-world data and enhance understanding of the variations in risk of DILI among individuals using different ARBs."

Hepatology • Liver Failure

Fimasartan Optimal Reduction Targeting Elevated Blood Pressure: the FORTE Study (clinicaltrials.gov) - P=N/A | N=3554 | Completed | Sponsor: Boryung Pharmaceutical Co., Ltd | Unknown status ➔ Completed

Trial completion • Cardiovascular • Hypertension

A Study to Evaluate the Efficacy and Safety of BR1015 Combination Therapy (clinicaltrials.gov) - P3 | N=248 | Completed | Sponsor: Boryung Pharmaceutical Co., Ltd | Recruiting ➔ Completed

Monotherapy • Trial completion • Cardiovascular • Hypertension

A Study to Evaluate the Efficacy and Safety of BR1017A and BR1017B Combination Therapy in Essential Hypertension Patients With Primary Hypercholesterolemia (clinicaltrials.gov) - P3 | N=148 | Completed | Sponsor: Boryung Pharmaceutical Co., Ltd | Recruiting ➔ Completed

Combination therapy • Trial completion • Cardiovascular • Dyslipidemia • Hypertension • Metabolic Disorders

Novel Fimasartan Fluidized Solid Dispersion and Its Tablet: Preparation, Crystallinity, Solubility, Dissolution, and Pharmacokinetics in Beagle Dogs. (PubMed, Eur J Drug Metab Pharmacokinet) - "This novel FFSD tablet could be a potential oral pharmaceutical product with the improved oral bioavailability of fimasartan."

Journal • PK/PD data

Real-world efficacy of fimasartan vs. other angiotensin receptor blockers in combination with calcium channel blockers: a nationwide cohort study. (PubMed, Clin Hypertens) - "Fimasartan is associated with a lower need for additional antihypertensive drugs compared to other ARBs. This implies its greater effectiveness in hypertension management, potentially enhancing cardiovascular outcomes, and minimizing polypharmacy."

Combination therapy • Journal • Real-world • Real-world effectiveness • Real-world evidence • Cardiovascular • Congestive Heart Failure • Diabetes • Dyslipidemia • Heart Failure • Hypertension • Metabolic Disorders • Oncology

Blood pressure control in diabetic kidney disease: a post-hoc analysis of the FANTASTIC trial. (PubMed, Clin Hypertens) - P3 | "In patients with DKD, targeting a SBP of less than 130 mmHg, as compared with less than 140 mmHg, did not reduce the rate of a composite of cardiovascular and renal events. Achieved SBP of 130-139 mmHg was associated with a decreased risk for the primary outcome in patients with DKD."

Journal • Retrospective data • Cardiovascular • Chronic Kidney Disease • Diabetic Nephropathy • Nephrology • Renal Disease

A Study to Evaluate the Efficacy and Safety of BR1017A and BR1017B Combination Therapy in Essential Hypertension Patients With Primary Hypercholesterolemia (clinicaltrials.gov) - P3 | N=156 | Recruiting | Sponsor: Boryung Pharmaceutical Co., Ltd | Trial completion date: Jun 2024 ➔ Sep 2024 | Trial primary completion date: Jun 2024 ➔ Sep 2024

Combination therapy • Trial completion date • Trial primary completion date • Cardiovascular • Dyslipidemia • Hypertension • Metabolic Disorders

Solidification of deep eutectic solvent containing fimasartan through wet impregnation and exploration of flow attributes by modified SeDeM-SLA expert system. (PubMed, Eur J Pharm Biopharm) - "Furthermore, excellent stability, i.e., a shelf life of 28.44 months, reported by SDES-FS (A) in accelerated stability studies, suggests better formulation perspectives. In a nutshell, the present study evokes the potentiality of performing solidification through wet impregnation and successful implementation of the SeDeM-SLA expert model, which could find wide applications in pharmaceutical science."

Journal

Angiotensin Receptor Blockers and Drug-Induced Liver Injury: A Cohort Study Using Common Data Model (APASL 2024) - "In this study, patients were designated to treatment groups according to the ARB prescribed at cohort entry, i.e., azilsartan, eprosartan, telmisartan, fimasartan, valsartan, olmesartan, losartan, irbesartan, or candesartan. In overall, the risk was significantly lower in olmesartan users compared to valsartan users (HR: 0.73 [95% confidence interval (CI): 0.55-0.96]). In patients receiving monotherapy, the risk was significantly higher in azilsartan users compared to valsartan users (HR: 6.55 [95% CI: 5.28-8.12])."

Hepatology • Liver Failure

Podocyte disease following treatment with intravenous ibandronate in an older patient. (PubMed, Ann Geriatr Med Res) - "While renal toxicity is common with pamidronate and zoledronate, few ibandronate-related cases are reported...She was treated with diuretics, tacrolimus, and fimasartan...This case emphasizes the importance of careful monitoring of proteinuria and renal function during ibandronate treatment. In older adult patients, kidney biopsy and immunosuppressive treatment may be considered based on physical activity and underlying diseases."

Journal • Focal Segmental Glomerulosclerosis • Glomerulonephritis • Nephrology • Osteoporosis • Renal Disease • Rheumatology

Towards improved predictions of pharmacokinetics of transported drugs in hepatic impairment: insights from the extended clearance model. (PubMed, CPT Pharmacometrics Syst Pharmacol) - "However, there was a trend towards underprediction of the AUCR of the dual OATP/CYP3A4 substrates fimasartan and atorvastatin. These predictions improved when the sinusoidal efflux CL of these two drugs was increased in healthy volunteers (i.e., before incorporating the effect of HI), and by modifying the directionality of its modulation by HI (i.e., increase or decrease). To accurately predict the effect of HI on AUC of hepatobiliary cleared drugs it is important to accurately predict all hepatobiliary pathways, including sinusoidal efflux CL."

Journal • PK/PD data • Hepatology • CYP3A4

A Study to Evaluate the Efficacy and Safety of BR1017A and BR1017B Combination Therapy in Essential Hypertension Patients With Primary Hypercholesterolemia (clinicaltrials.gov) - P3 | N=150 | Recruiting | Sponsor: Boryung Pharmaceutical Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Dyslipidemia • Hypertension • Metabolic Disorders

FINALE: An Observation Study to Evaluate the Renoprotective Effect of Fimasartan in Patients With DKD and Proteinuria (clinicaltrials.gov) - P=N/A | N=360 | Completed | Sponsor: Boryung Pharmaceutical Co., Ltd | Active, not recruiting ➔ Completed

Trial completion • Cardiovascular • Diabetic Nephropathy • Hypertension • Nephrology • Renal Disease

Efficacy of fimaSartan on arTerIal stiFFness iN patiEntS With HypertenSion (clinicaltrials.gov) - P=N/A | N=90 | Completed | Sponsor: Boryung Pharmaceutical Co., Ltd | Unknown status ➔ Completed

Trial completion • Cardiovascular • Hypertension

A Study to Evaluate the Efficacy and Safety of BR1017A and BR1017B Combination Therapy in Essential Hypertension Patients With Primary Hypercholesterolemia (clinicaltrials.gov) - P3 | N=150 | Not yet recruiting | Sponsor: Boryung Pharmaceutical Co., Ltd

Combination therapy • New P3 trial • Cardiovascular • Dyslipidemia • Hypertension • Metabolic Disorders

Comparison Between Fimasartan Versus Other Angiotensin Receptor Blockers in Patients With Heart Failure After Acute Myocardial Infarction. (PubMed, J Korean Med Sci) - "In this nationwide cohort, fimasartan, compared with other ARBs, had comparable treatment effects for a composite of all-cause death, recurrent MI, hospitalization for heart failure, and stroke in patients with heart failure after MI."

Journal • Cardiovascular • Congestive Heart Failure • Heart Failure • Myocardial Infarction

A CASE OF PODOCYTE DISEASE WITH AZOTEMIA FOLLOWING TREATMENT WITH INTRAVENOUS IBANDRONATE (ERA-EDTA 2023) - "The patient was treated with tacrolimus and fimasartan. Compared to pamidronate and zoledronate, ibandronate is more highly protein-bound with a significantly shorter renal tissue half life, which might explain the rarity of ibandronate-related nephrotoxicity. Contrary to the trend of other bisphosphonates nephropathies, our case showed simultaneous podocyte disease and tubule damage. We recommend close monitoring of proteinuria and renal function for prompt nephrotoxicity detection in patients treated with ibandronate."

Clinical • Cardiovascular • Chronic Kidney Disease • Diabetes • Diabetic Nephropathy • Fibrosis • Focal Segmental Glomerulosclerosis • Glomerulonephritis • Hypertension • Immunology • Metabolic Disorders • Nephrology • Osteoporosis • Renal Disease • Rheumatology

FIMARO: Fimasartan and Rosuvastatin for Hypertension and Dyslipidemia Control (clinicaltrials.gov) - P=N/A | N=541 | Completed | Sponsor: Boryung Pharmaceutical Co., Ltd | Unknown status ➔ Completed | N=1056 ➔ 541

Enrollment change • Trial completion • Cardiovascular • Dyslipidemia • Hypertension • Metabolic Disorders

Antiproliferative and apoptotic effects of telmisartan in human glioma cells. (PubMed, Cancer Cell Int) - "In this study, we assessed the effects of three ARBs with the ability to cross the blood brain barrier (telmisartan, valsartan and fimasartan) on cell proliferation in three glioblastoma multiforme (GBM) cell lines. Telmisartan also suppressed tumor growth in vivo in an orthotopic transplant mouse model. Therefore, telmisartan is a potential treatment for human GBM."

Journal • Brain Cancer • Cardiovascular • CNS Tumor • Glioblastoma • Glioma • Hypertension • Oncology • Solid Tumor • Transplantation • SOX9

FINALE: An Observation Study to Evaluate the Renoprotective Effect of Fimasartan in Patients With DKD and Proteinuria (clinicaltrials.gov) - P=N/A | N=360 | Active, not recruiting | Sponsor: Boryung Pharmaceutical Co., Ltd | Recruiting ➔ Active, not recruiting | Trial completion date: Feb 2024 ➔ Jun 2023

Enrollment closed • Trial completion date • Cardiovascular • Diabetic Nephropathy • Hypertension • Nephrology • Renal Disease

A Study to Evaluate the Efficacy and Safety of BR1015 Combination Therapy (clinicaltrials.gov) - P3 | N=244 | Recruiting | Sponsor: Boryung Pharmaceutical Co., Ltd

Combination therapy • Monotherapy • New P3 trial • Cardiovascular • Hypertension