Lusefi (luseogliflozin) / Taisho - LARVOL DELTA

Impact of luseogliflozin on metabolic health, lipid profiles, and cardiovascular outcomes in patients with type II diabetes: A systematic review and network meta-analysis. (PubMed, Diabetes Obes Metab) - No abstract available

Journal • Retrospective data • Cardiovascular • Diabetes • Dyslipidemia • Metabolic Disorders • Type 2 Diabetes Mellitus

BALLAST study: A multicentre, open-label, randomized-controlled, 52-week clinical trial of the efficacy and safety of luseogliflozin in older Japanese adults with type 2 diabetes receiving leucine-enriched amino acid supplementation and physical exercise programme. (PubMed, Diabetes Obes Metab) - No abstract available

Journal • Diabetes • Metabolic Disorders • Sarcopenia • Type 2 Diabetes Mellitus

SGLT2 inhibitor-induced glycosuria improves steatotic liver disease in parallel with enhanced ureagenesis in ob/ob mice. (PubMed, J Pharmacol Sci) - "Our data suggest that enhanced hepatic ureagenesis as a compensatory water conservation mechanism for glycosuria-induced fluid loss may be associated with amelioration of steatotic liver disease in SGLT2 inhibitor-treated ob/ob mice."

Journal • Preclinical • Hepatology

Basic Science and Pathogenesis. (PubMed, Alzheimers Dement) - "These results indicate that SGLT2 inhibition protects cognitive function in AD by enhancing cerebral blood flow autoregulation, highlighting a mechanism that involves improved cerebrovascular function rather than glucose regulation. Our study opens new avenues for targeting cerebral perfusion as a treatment strategy for AD/ADRD."

Journal • Cardiovascular • Congestive Heart Failure • Diabetes • Heart Failure • Metabolic Disorders • Type 2 Diabetes Mellitus

Sodium-glucose cotransporter-2 inhibitors and risk of diabetic retinopathy in type 2 diabetes: a network meta-analysis of randomised clinical trials. (PubMed, Int J Clin Pharm) - "SGLT‑2 inhibitors showed a neutral effect on the incidence of diabetic retinopathy. Baseline diabetic retinopathy risk appears to moderate relative effects, and no dose-response was evident for diabetic retinopathy. Choice among agents should be driven by overall efficacy, safety and patient factors rather than retinal risk; dedicated trials with prespecified ophthalmic endpoints are warranted."

Journal • Retrospective data • Review • Diabetes • Diabetic Retinopathy • Metabolic Disorders • Ophthalmology • Retinal Disorders • Type 2 Diabetes Mellitus

Blood Pressure Status Modulates the Therapeutic Response to Sodium-Glucose Cotransporter 2 Inhibitors in Diabetic Macular Edema: A Post Hoc Subgroup Analysis of the COMET Trial. (PubMed, J Diabetes) - "SGLT2i may help reduce the treatment burden of IVRs in patients with DME and elevated OSBP. The improvements in blood pressure and visual acuity, despite fewer injections, indicate a potential synergistic effect of SGLT2i in managing DME with hypertension. Further investigation is warranted to validate its efficacy as a potential systemic adjunct."

Clinical • Journal • Retrospective data • Cardiovascular • Diabetic Macular Edema • Hypertension • Ophthalmology

Relationship between changes in uric acid levels and renal function during 12 months of treatment with luseogliflozin. (PubMed, Diabetol Int) - "Changes in eGFR after luseogliflozin administration were significantly correlated with baseline eGFR, uACR, and changes in uric acid levels (Δ uric acid). The change in uric acid levels following SGLT2 inhibitor treatment was associated with metabolic parameters such as blood pressure and albuminuria, suggesting that it may function as a surrogate marker reflecting renal metabolic processes."

Journal • Cardiovascular • Chronic Kidney Disease • Congestive Heart Failure • Diabetes • Heart Failure • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

Efficacy and Safety of Luseogliflozin in Patients with Type 2 Diabetes Mellitus: An Umbrella Review of Systematic Reviews. (PubMed, Diabetes Metab Syndr Obes) - "These findings suggest that luseogliflozin is an effective and safe treatment for T2DM, offering substantial benefits in glycemic control, weight management, blood pressure lowering, and metabolic parameters, with a favorable safety profile regarding hypoglycemia. Further long-term studies are warranted to establish its definitive role in clinical practice and support broader regulatory approvals."

Journal • Review • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Luseogliflozin Suppresses Late-Night Basal Glycemic Variability in Type 2 Diabetes: A Retrospective Observational Study. (PubMed, Cureus) - " This is the first study to demonstrate that an SGLT2 inhibitor can suppress nocturnal basal GV immediately after initiation. Given that GV has been associated with sympathetic activation and vascular injury, these results suggest that reducing basal GV with SGLT2 inhibitors may contribute to vascular protection. Further studies with larger sample sizes and longer follow-up are warranted to confirm these observations."

Journal • Observational data • Retrospective data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Sodium-glucose cotransporter 2 inhibitors-but not insulin-enhance renal branched-chain amino acid catabolism. (PubMed, Front Endocrinol (Lausanne)) - "We conducted a prospective, single-center, open-label, nonrandomized, controlled clinical study in patients with type 2 diabetes stably treated with insulin, who were assigned to dapagliflozin (5 mg/day with dose-reduced insulin; n=8/9 completed) or insulin dose-up (n=5/8 completed)...To explore mechanisms, 10-week-old db/db mice received luseogliflozin (10 mg/kg/day, p.o.) or insulin glargine (10 U/day, s.c.) for 4 weeks; renal histology, mRNA and protein expression of key enzymes involved in BCAA catabolism, including branched-chain aminotransferase 2 (BCAT2), branched-chain ketoacid dehydrogenase (BCKDH), and BCKD kinase (BCKDK), were assessed...These findings provide mechanistic, translational evidence that SGLT2i modulate BCAA flux independently of glucose lowering, suggesting BCAA catabolism as a therapeutic axis in diabetic kidney disease. https://rctportal.mhlw.go.jp/en/detail?trial_id=UMIN000052955, identifier UMIN000052955."

Journal • Diabetes • Diabetic Nephropathy • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus • COL1A1 • TGFB1

LUSEOGLIFLOZIN EFFICACY IN MAFLD WITH TYPE 2 DIABETES: A 6-MONTH RANDOMIZED DOUBLE-BLINDED CONTROLLED TRIAL OF BIOCHEMICAL AND IMAGING OUTCOMES [WITHDRAWN] (UEGW 2025) - "Over 6 months, luseogliflozin when added to standard therapy in MAFLD patients with T2DM significantly improved Fib-4 index, AST, HbA1c, and lipid profiles versus conventional therapy. Conventional ultrasound and shear wave elastography confirmed reductions in steatosis and fibrosis progression.. Future studies with larger cohorts, longer duration, and incorporation of biopsy data are warranted to validate and extend these findings."

Clinical • Diabetes • Fibrosis • Hepatology • Immunology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Type 2 Diabetes Mellitus

Efficacy of luseogliflozin for renal function preservation in patients with type 2 diabetes mellitus and impaired renal function: A randomized open-label clinical trial (RESOLUTION study). (PubMed, J Diabetes Investig) - "Although the primary endpoint did not reach statistical significance, luseogliflozin may provide renoprotective benefits in patients with type 2 diabetes mellitus and moderate-to-severe renal impairment, potentially by slowing eGFRcreat decline post-initial decline."

Clinical • Journal • Diabetes • Diabetic Nephropathy • Glomerulonephritis • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

LUSEOGLIFLOZIN REDUCED CVD RISK BY IMPROVING BLOOD PRESSURE AND HDL CHOLESTEROL LEVELS IN DIABETIC PATIENTS WITH MASLD: A POOLED META-ANALYSIS OF PHASE III CLINICAL TRIALS USING A CAUSAL INFERENCE ANALYSIS (AASLD 2025) - "This pooled meta-analysis demonstrated that 24-week treatment with luseogliflozin improved FRS in diabetic patients with MASLD. Furthermore, the improvement in CVD risk was directly caused by the improvement of blood pressure as well as HDL-cholesterol levels. Thus, luseogliflozin may be useful for reducing CVD risk through the improvement of circulatory dynamics and lipid metabolism in diabetic patients with MASLD."

P3 data • Retrospective data • Cardiovascular • Diabetes • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease

Efficacy of sodium-glucose cotransporter 2 inhibitor in mild diabetic macular edema: a sub-analysis from the COMET trial (EASD 2025) - "Patients in the COMET Trial were assigned to receive either the SGLT2i luseogliflozin or sulfonylurea (SU) as control, based on factors such as HbA1c, urinary albumin, and BCVA... Our findings demonstrated a significant reduction in IVR frequency in the SGLT2i group among cases with CRT <375 μm and relatively mild DME. However, in the BCVA favorable group, which included cases with pronounced CRT thickening, no significant reduction in IVR was noted. These results suggest that incorporating SGLT2 inhibitors could be a valuable strategy for treating early-stage DME in cases with mild CRT."

Clinical • Diabetes • Metabolic Disorders

SGLT2 inhibition mitigates glucotoxicity and suppresses m6A RNA methylation defects in pancreatic islets in diabetic mice (EASD 2025) - "Luseogliflozin administration to db/db mice, preventing glucotoxicity, preserved high m6A methylation in pancreatic islets. Methylation defects decreased mRNA stability of key genes involved in insulin biosynthesis and secretion, such as MafA and Glut2. These findings suggest that methylation defects in pancreatic islets contribute to type 2 diabetes progression."

Preclinical • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus • ALKBH5 • CCND2 • CDK4 • CDKN1A • HES1 • METTL14 • METTL3 • NEUROD1 • PDX1 • YTHDF2

Sodium-glucose co-transporter 2 inhibitors reduce the intravitreal anti-VEGF treatment necessity in eyes with early diabetic macular oedema: A post-hoc analysis focusing on the fellow eye of the COMET trial. (PubMed, Diabetes Obes Metab) - "Systemic SGLT2i therapy reduced the need for intravitreal anti-VEGF treatment in eyes with early and mild DMO. These results suggest that SGLT2i may be effective in preventing the progression of early and mild DMO."

Journal • Retrospective data • Diabetic Macular Edema • Diabetic Retinopathy • Macular Edema • Ophthalmology • Retinal Disorders

SGLT2 inhibitor administration to two patients with diabetes mellitus with ascites due to cirrhosis. (PubMed, Endocrinol Diabetes Metab Case Rep) - "Luseogliflozin administration reduced ascites in patients with diabetes mellitus. Caution is warranted, as discontinuation of sodium-glucose cotransporter 2 inhibitors might lead to an increase in ascites."

Journal • Colorectal Cancer • Diabetes • Fibrosis • Immunology • Metabolic Disorders • Oncology • Solid Tumor

Letter to the Editor in response to the article "Effect of luseogliflozin on liver fibrosis differs depending on alcohol consumption in patients with type 2 diabetes". (PubMed, J Diabetes Investig) - No abstract available

Journal • Diabetes • Fibrosis • Hepatology • Immunology • Liver Cirrhosis • Metabolic Disorders • Type 2 Diabetes Mellitus

Clinical efficacy and safety of sodium-glucose cotransporter protein-2 (SGLT-2) inhibitor, glucagon-like peptide-1 (GLP-1) receptor agonist, and Finerenone in type 2 diabetes mellitus with non-dialysis chronic kidney disease: a network meta-analysis of randomized clinical trials. (PubMed, Front Pharmacol) - "According to the SUCRA based relative ranking of treatments, Empagliflozin was the most effective in reducing HbA1c and DBP...Liraglutide was the most effective in reducing LDL-C. Bexagliflozin, Canagliflozin were the most effective in reducing SBP and body weight. Finerenone had the lowest incidence of urinary tract infection, Hypoglycemia was the lowest in the Luseogliflozin group. Ertugliflozin was the least likely to cause acute kidney injury...SGLT-2 inhibitors had a preferential glucose-lowering and weight-loss function, GLP-1 receptor agonists had a preferential lowering of LDL-C and blood glucose, and Finereone significantly reduced SBP compared with PBO. Systematic Review Registration: PROSPERO, CRD42024571544."

Clinical • Journal • Retrospective data • Review • Acute Kidney Injury • Chronic Kidney Disease • Diabetes • Diabetic Nephropathy • Dyslipidemia • Hypoglycemia • Infectious Disease • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

VASCULAR PROTECTIVE EFFECTS OF SGLT2 INHIBITION IN AD/ADRD (ADPD 2025) - " TgF344-AD rats were orally admin istered luseogliflozin (20 mg/kg/day) for 3 months... These findings suggest that SGLT2 inhibition is a promising therapeutic approach for addressing vascular dysfunction in AD."

Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Diabetes • Metabolic Disorders

Effect of luseogliflozin on liver fibrosis differs depending on alcohol consumption in patients with type 2 diabetes. (PubMed, J Diabetes Investig) - "HbA1c levels and body weight decreased in patients with type 2 diabetes after initiating luseogliflozin therapy, regardless of drinking habits. However, it is desirable to limit alcohol consumption when considering its effects on liver fibrosis."

Journal • Diabetes • Fibrosis • Hepatology • Immunology • Liver Cirrhosis • Metabolic Disorders • Type 2 Diabetes Mellitus

Luseogliflozin Persistently Lowers Glycemia and Body Weight Over a Period of Two Years in Patients With Type 2 Diabetes. (PubMed, Cureus) - "The effects of luseogliflozin on glucose and BW reduction were sustained for at least two years, indicating similarity to other SGLT2 inhibitors."

Journal • Cardiovascular • Congestive Heart Failure • Diabetes • Heart Failure • Metabolic Disorders • Type 2 Diabetes Mellitus

Ranibizumab with luseogliflozin in type 2 diabetes with diabetic macular oedema: A randomised clinical trial. (PubMed, Diabetes Obes Metab) - "Although the overall number of anti-VEGF injections in the target eye showed no significant difference, some patients responded favourably to SGLT2i and required fewer injections. The reduction in fellow eye injections suggests SGLT2i's efficacy in treating early-stage DMO."

Journal • Diabetes • Diabetic Macular Edema • Diabetic Retinopathy • Macular Edema • Metabolic Disorders • Ophthalmology • Retinal Disorders • Type 2 Diabetes Mellitus

Long-term renoprotective effect of luseogliflozin in type 2 diabetes patients: CHikushi Anti-diabetes mellitus Trial-Lusefi (CHAT-Lu). (PubMed, Drug Discov Ther) - "There were four adverse events, but no serious adverse events closely related to luseogliflozin treatment. In type 2 diabetes patients, 2-year treatment with luseogliflozin provided beneficial metabolic effects and improved the rate of decline in eGFR, suggesting a renal protective effect."

Journal • Observational data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Expanding access to sodium-glucose cotransporter 2 inhibitors (SGLT2i) in the Ministry of Health Malaysia - a multiple HTA approach. (PubMed, Int J Technol Assess Health Care) - "The multiple HTA approach guided the complex decision-making process by providing a holistic understanding of the decision's impact."

Journal • Review • Cardiovascular