Azilva (azilsartan) / Takeda - LARVOL DELTA

Multidisciplinary intervention for adverse events associated with ATZ + BEV therapy: a case report. (PubMed, J Pharm Health Care Sci) - "The pathophysiology of irAE-induced peripheral neuropathy associated with immune checkpoint inhibitors remains poorly understood. This case underscores the challenges of managing irAE-related neuropathy, which may exhibit limited responsiveness to conventional treatments. Early detection, timely intervention, and multidisciplinary approaches are crucial for optimizing patient outcomes and mitigating the impact of severe side effects."

Adverse events • Journal • Cardiovascular • Hepatocellular Cancer • Hypertension • Oncology • Pain • Solid Tumor

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

Azilsartan Confers Protection Against Kainic Acid-Induced Hippocampal Neuron Damage by Upregulating Sirt3/Sod2 Pathway. (PubMed, Dev Neurobiol) - "Besides, Azilsartan administration activated Sirt3 and Sod2 expression in KA-stimulated HT-22 cells, and Sirt3 depletion partially blocked the impacts of Azilsartan on Sirt3/Sod2 pathway, mitochondrial damage, viability, and apoptosis in HT-22 cells exposed to KA. Collectively, Azilsartan might act as a neuroprotective agent in treating epilepsy through the activation of Sirt3/Sod2 pathway."

Journal • CNS Disorders • Epilepsy • SIRT3 • SOD2

Angiotensin II Promotes Osteocyte RANKL Expression via AT1R Activation. (PubMed, Biomedicines) - "These effects were abrogated by azilsartan, a blocker targeting Ang II type 1 receptors (AT1R). p38 and ERK1/2 in the MAPK pathway were also activated by Ang II. Ang II enhances osteocyte-mediated osteoclastogenesis via AT1R activation, highlighting its potential as a therapeutic target for bone diseases."

Journal • Cardiovascular • Hypertension • Orthopedics • CSF1 • TNFSF11

ACUTE KIDNEY INJURY FROM MONONUCLEAR CELL-PREDOMINATED INTERSTITIAL NEPHRITIS AFTER THE INTRODUCTION OF GLUCAGON-LIKE PEPTIDE-1 AGONISTS: A CASE REPORT (ISN-WCN 2025) - "Results A 63-year-old female with diabetic kidney disease in stage 3b and depressive disorder was prescribed dulaglutide 0.75 mg per week subcutaneously in August 2023 due to persistent albuminuria despite the maximum tolerated dose of azilsartan...Azilsartan and chlorthalidone could be successfully rechallenged after almost complete recovery of kidney function...Nevertheless, this does not prevent the prescription of GLP-1 RAs to alleviate the DKD progression in indicated patients. This abstract was also submitted for the Nephrology Society of Thailand Annual Meeting 2024 congress."

Case report • Clinical • Acute Kidney Injury • Chronic Kidney Disease • CNS Disorders • Depression • Diabetes • Diabetic Nephropathy • Infectious Disease • Metabolic Disorders • Nephrology • Psychiatry • Renal Disease

In silico and in vitro assessments of the mutagenicity of the azilsartan photoproduct. (PubMed, Mutat Res Genet Toxicol Environ Mutagen) - "However, APP was not mutagenic in the Ames test. Density functional theory (DFT) calculations showed that APP cannot intercalate into DNA, due to its nonplanar structure, resulting from steric hindrance of its phenanthridine and benzimidazole moieties."

Journal • Preclinical

Efficacy and safety of azilsartan in the treatment of OSAS-related hypertension combined with coronary artery disease: a randomized controlled double-blind clinical trial (ChiCTR) - P4 | N=280 | Not yet recruiting | Sponsor: Southern Medical University Southern Hospital; Southern Medical University Southern Hospital

New P4 trial • Cardiovascular • Coronary Artery Disease • Hypertension

A Bioequivalence Study of Azilsartan in Healthy Chinese Subjects. (PubMed, Clin Pharmacol Drug Dev) - "No serious adverse events or unexpected adverse drug reactions were observed. In conclusion, the test and reference preparations of azilsartan tablets demonstrate bioequivalence and good safety in healthy Chinese subjects under fasting and postprandial conditions."

Journal • Cardiovascular • Congestive Heart Failure • Diabetic Nephropathy • Heart Failure • Hypertension • Nephrology • Renal Disease

Patient Adherence and Duration of Continuous Treatment With Various Arbs in Patients With Uncomplicated Arterial Hypertension in the USA Based on The Analysis of the Truven Health Analytics MarketScan Database. (PubMed, Kardiologiia) - "The study provided data for comparing the adherence of patients with uncomplicated AH to the therapy with different ARBs. Further study of adherence to treatment will provide additional data that will allow an optimal selection of drugs for the treatment of AH in patients with potentially poor adherence."

Adherence • Journal • Cardiovascular • Congestive Heart Failure • Heart Failure • Hypertension • Pulmonary Arterial Hypertension

A Study of Azilsartan in Children from 6 to Less Than 16 Years Old with High Blood Pressure (clinicaltrials.gov) - P=N/A | N=5 | Completed | Sponsor: Takeda | Active, not recruiting ➔ Completed

Trial completion • Cardiovascular • Hypertension • Pediatrics

Accurate determination of three new antihypertensive drugs illegally added to food using ultra-high performance liquid chromatography-tandem mass spectrometry (PubMed, Se Pu) - "In this study, a novel ultra-high performance liquid chromatography-triple-quadrupole mass spectrometry (UHPLC-MS/MS) method was developed for the simultaneous determination of three antihypertensive drugs (azilsartan, candesartan cilexetil, and lacidipine) in 12 food matrices (pressed candies, solid beverages, alternative teas, tea drinks, biscuits, jellies, mixed liquors, oral liquids, medicinal teas, tablets, hard capsules, and soft capsules). Overall, the newly developed method is simple, rapid, sensitive, accurate, and suitable for the qualitative and quantitative determination of antihypertensive drugs in different food matrices. This work could provide technical support for food safety agencies in implementing measures against the illegal addition of antihypertensive drugs to food."

Journal

The relationship between CYP2C9 gene polymorphisms and azilsartan metabolism in vitro. (PubMed, Expert Opin Drug Metab Toxicol) - "Thisassessment revealed the effect of CYP2C9 gene polymorphisms on azilsartanmetabolism, establishing a theoretical basis for further in-vivo studies andclinical applications. This study will help expand the database of CYP2C9gene-drug pairs and identify appropriate treatment strategies for azilsartan,contributing to the field of precision medicine."

Journal • Preclinical • CYP2C9

Cardioprotective efficacy of combined therapy with azilsartan, indapamide, and nitrendipine in patients with essential hypertension (ESC 2024) - "Achieving target blood pressure levels provided high cardioprotective efficacy of combined therapy with azilsartan, indapamide, and nitrendipine with improvement in LV echo geometry in both groups."

Clinical • Cardiovascular • Hypertension

Azilsartan as a preventive agent against cyclophosphamide-induced testicular injury in male rats. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "Azilsartan's mitigation of CP's effects suggests it can prevent male rats' reproductive damage caused by CP. One possible explanation for AZ's protective effects is that it inhibits lipid peroxidation and has antioxidant properties."

Journal • Preclinical • Infertility • Oncology • Sexual Disorders

Sex-based differences in left ventricular mass reduction across angiotensin II receptor blockers in patients with heart failure with preserved or mildly reduced ejection fraction. (PubMed, Heart Vessels) - "In patients with HF, the effectiveness of either azilsartan or candesartan in achieving > 10% LV mass reduction depends on sex. Male is more sensitive to azilsartan than candesartan to achieve cardiac hypertrophy in HF patients."

Journal • Cardiovascular • Congestive Heart Failure • Heart Failure

Retrospective analysis of neoplasms in patients using angiotensin receptor blockers. (PubMed, Sci Rep) - "The EVDAS database contained 68,522 safety reports related to ARBs (including Azilsartan, Candesartan, Irbesartan, Olmesartan, Losartan, Valsartan, and Telmisartan), among which 3,396 (5%) cases were associated with neoplasms. Our study identifies a possible signal of an association between ARBs, particularly valsartan, and the risk of neoplasms. However, further observational and analytical studies are necessary to confirm these findings and elucidate the underlying mechanisms."

Journal • Retrospective data • Cardiovascular • Hypertension • Oncology • ROR1

A Study of Azilsartan in Children From 6 to Less Than 16 Years Old With High Blood Pressure (clinicaltrials.gov) - P=N/A | N=5 | Active, not recruiting | Sponsor: Teva takeda | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Hypertension • Pediatrics

Light chain only variant of proliferative glomerulonephritis with monoclonal immunoglobulin deposits: a case report (ERA-EDTA 2024) - "Case presentation: We present the case of a 73-year-old female with a past medical history of rheumatoid arthritis and hypertension, under methotrexate 10mg per week, prednisone 2.5mg per day, amlodipine, nebivolol, azilsartan, and a recurrent naproxen intake...The patient was started on Bortezomib, cyclophosphamide and dexamethasone... This case highlights the rare occurrence of a PGNMID with light chains only deposition (without C3 co-deposition) as a complication of small lymphocytic lymphoma. This contributes to the growing body of evidence surrounding this entity, with the particularity being that C3 was not detected. The authors hypothesized some pathophysiologic mechanisms to justify the absence of C3 co-deposition."

Case report • Clinical • Acute Kidney Injury • Anorexia • Cardiovascular • Fatigue • Glomerulonephritis • Hematological Malignancies • Hypertension • Inflammatory Arthritis • Lupus Nephritis • Lymphoma • Nephrology • Non-Hodgkin’s Lymphoma • Oncology • Rheumatoid Arthritis • Rheumatology • Small Lymphocytic Lymphoma

Efficacy and Safety of Combinations of Azilsartan- Medoximil/Chlorthalidone Versus Olmesartan-medoximil/Hydrochlorothiazide Among Hypertensive Patients: A Meta- Analysis (ATS 2024) - "AZI-M/CT is more effective in lowering the blood pressure albeit its more adverse outcomes compared to OLM/HCTZ in hypertensive patients. However, further studies are necessary to investigate the clinical relevance of these results."

Clinical • Cardiovascular • Hypertension

Changing Concepts About Optimal Target Blood Pressure and the Therapeutic Advantages of Azilsartan for Achieving it (PubMed, Kardiologiia) - "This systematic review will provide comprehensive information on a possible role of using the angiotensin II receptor blocker azilsartan as a basic drug for the treatment of a wide range of patients with high BP. Most of the studies included in the systematic review assessed the effectiveness of combination therapy including azilsartan."

Journal • Review • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension

Gastrodin regulates the expression of renin-angiotensin system-SIRT3 and proinflammatory mediators in reactive astrocytes via activated microglia. (PubMed, Eur J Neurosci) - "Additionally, azilsartan (a specific inhibitor of AT1) inhibited the expression of C3 and S100A10, which remained unaffected in gastrodin and azilsartan combination treatment. These findings provide evidence that gastrodin may have a therapeutic effect via regulating RAS-SIRT3."

Journal • BDNF • IGF1 • S100A10 • SIRT3

Relationship between 2nd-generation angiotensin receptor blockers and the risk of hypotension in COVID-19 patients admitted to hospital. (PubMed, Hypertens Res) - "ARB were divided into 1st- and 2nd-generations based on their approval for use (before 2000 and after 2001), with the former consisting of losartan, candesartan, and valsartan, and the latter of telmisartan, olmesartan, irbesartan, and azilsartan. These results suggest that patients taking 2nd-generation ARB may be at a higher risk of hypotension than those taking 1st-generation ARB and also that careful observations are needed. Further studies are continuously needed to support decisions to adjust medications for co-morbidities."

Journal • Critical care • Hypotension • Infectious Disease • Novel Coronavirus Disease

Azilsartan improves doxorubicin-induced cardiotoxicity via inhibiting oxidative stress, proinflammatory pathway, and apoptosis. (PubMed, J Med Life) - "Additionally, MDA significantly decreased in the cardiac tissue, although TAC was significantly increased when comparing the azilsartan group to the group receiving doxorubicin-only. These results suggest that azilsartan effectively reduced doxorubicin-induced cardiotoxicity, likely by mitigating apoptosis, inflammation, and oxidative stress in cardiac tissues."

Journal • Cardiomyopathy • Cardiovascular • Inflammation • BCL2 • CASP3 • IL1B • TNFA

Angiotensin II Is Involved in MLKL Activation During the Development of Heart Failure Following Myocardial Infarction in Rats. (PubMed, Biol Pharm Bull) - "We found that administration of azilsartan, an angiotensin II AT1 receptor blocker, or trandolapril, an angiotensin-converting enzyme inhibitor, to rats from the 2nd to the 8th week after myocardial infarction resulted in preservation of cardiac function and attenuation of mixed lineage kinase domain-like (MLKL) activation. Pretreatment with azilsartan also prevented the conditioned medium-induced increase in activated MLKL. These results suggest that angiotensin II contributes to the induction of myocardial necroptosis during the development of heart failure."

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

Angiotensin Receptor Blockers and the Risk of Suspected Drug-Induced Liver Injury: A Retrospective Cohort Study Using Electronic Health Record-Based Common Data Model in South Korea. (PubMed, Drug Saf) - "We found a significantly higher risk of suspected DILI in patients receiving azilsartan monotherapy compared with valsartan monotherapy. Our findings emphasize the utility of real-world evidence in advancing our understanding of adverse drug reactions in clinical practice."

Journal • Retrospective data • Hepatology • Liver Failure