Lusefi (luseogliflozin) / Taisho - LARVOL DELTA

Association of Sodium-Glucose Cotransporter-2 Inhibitors With Fournier Gangrene: A Disproportionality Analysis Using the Japanese Adverse Drug Event Report Database. (PubMed, Am J Ther) - "All 5 SGLT2 inhibitors were associated with FG, with empagliflozin carrying the highest risk. Male patients exhibited elevated susceptibility. Continuous monitoring throughout treatment is essential. Further clinical trials are warranted to clarify causal relationships."

Adverse events • Journal • Genetic Disorders • Obesity

Comparison of effects of luseogliflozin with dulaglutide on coronary atherosclerotic plaques in patients with acute coronary syndrome and type 2 diabetes: open-label, randomised controlled trial (EASD 2026) - "Both groups showed a significant reduction in plaque volume to a similar extent. Similarly, both groups showed a significant decrease in HbA1c and LDL-C to a comparable degree. However, regarding the effects on blood pressure and inflammatory markers, differences were observed between the two groups, suggesting that plaque regression in each group may have been contributed to by different mechanisms."

Clinical • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus • CRP • IL18 • IL6

Efficacy and Safety of Luseogliflozin (TS-071) in Japanese Children and Adolescents with Type 2 Diabetes Mellitus: A Multicenter, Randomized, Double-masked, Placebo-controlled Phase 3 Study. (PubMed, Horm Res Paediatr) - "Luseogliflozin significantly improved glycemic control and was well tolerated, supporting its potential as an effective and safe treatment option for children and adolescents with T2D."

Journal • P3 data • Diabetes • Hypoglycemia • Infectious Disease • Metabolic Disorders • Type 2 Diabetes Mellitus

Impact of diabetes treatment choice on MASH: a randomised trial of adding the SGLT2 inhibitor luseogliflozin to semaglutide at antidiabetic doses (EASD 2026) - "Selection of antidiabetic therapy, specifically combining a GLP-1 receptor agonist with an SGLT2 inhibitor, may improve MASH histology without disease-specific treatment. Optimizing routine diabetes management may represent a practical and scalable strategy for improving liver disease in patients with MASH and type 2 diabetes."

Clinical • Diabetes • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • Type 2 Diabetes Mellitus

BALLAST: a multicentre randomised trial evaluating the efficacy and safety of luseogliflozin in older adults with type 2 diabetes receiving amino acid supplementation and structured exercise (EASD 2026) - "In older Japanese T2D adults receiving LEAAS and structured exercise, luseogliflozin achieved sustained improvements in glycemic control and body weight over 52 weeks without clinically meaningful deterioration in muscle mass, strength, or physical function."

Clinical • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Effects of SGLT2 inhibitors on anti-VEGF treatment burden in diabetic macular oedema according to renal function (EASD 2026) - "Materials and We condacted a post hoc subgroup analysis of the COMET randomized trial, comparing luseogliflozin (SGLT2i) and sulfonylurea (SU) in patients with type 2 diabetes and DME receiving anti-vascular endothelial growth factor (VEGF) therapy... SGLT2i may reduce the burden of anti-VEGF treatment burden in patients with lower albuminuria (UACR <300 mg/g), but not in those with advanced nephropathy (UACR ≥300 mg/g). These results suggest that earlier initiation of SGLT2i may be beneficial for DME management. Further studies are needed to confirm these results."

Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Effects of luseogliflozin on arterial stiffness and body composition: A 48-week analysis using cardio-ankle vascular index and bioelectrical impedance analysis (EASD 2026) - "Therefore, we compared the effects of the SGLT2 inhibitor luseogliflozin versus glimepiride on arterial stiffness and body composition. In addition to its hypoglycemic effects and preventive effect on diabetic macular edema, luseogliflozin may improve arterial stiffness, promote weight loss, improve uric acid levels, and protect renal function."

Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Exercise and SGLT2 inhibition, but not insulin, attenuate MASLD in db/db mice via glycaemia-independent modulation of hepatic mitochondrial dynamics (EASD 2026) - "Materials and Ten-week-old male db/db mice were assigned to control, exercise (treadmill 10-15 m/min, 30 min, 5 days/week), luseogliflozin (10 mg/kg/day), or insulin glargine (10 U/body/day) for 4 weeks... . Our findings highlight mitochondrial dynamics as a central cellular mechanism linking metabolism and inflammation, and demonstrate that diabetes therapies differentially modulate this axis. Targeting mitochondrial dynamics may therefore represent a novel therapeutic strategy for MASLD beyond glycaemic control."

Preclinical • Diabetes • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Type 2 Diabetes Mellitus • MFN2 • TNFA

Ophthalmic factors affecting SGLT2 inhibitor efficacy in diabetic macular oedema: post-hoc COMET trial analysis (EASD 2026) - "Materials and Sixty patients with DME requiring anti-VEGF therapy were randomized to receive either luseogliflozin (S) or glimepiride (G). This post-hoc analysis suggests that the therapeutic efficacy of SGLT2 inhibitors in DME varies depending on ophthalmic background, and that optimal patient selection is crucial. Combining SGLT2 inhibitors with anti-VEGF therapy in appropriately selected cases may enable more precise and effective treatment strategies."

Clinical • Retrospective data • Diabetes • Metabolic Disorders

Efficacy of Luseogliflozin Added to Semaglutide in Patients With Metabolic Dysfunction-Associated Steatohepatitis and Type 2 Diabetes Mellitus: A Randomised, Open-Label Trial. (PubMed, Diabetes Obes Metab) - "In the pre-specified full analysis set, combination therapy at antidiabetic doses did not significantly improve pre-specified histological endpoints compared with monotherapy. In the pre-specified per-protocol analysis, a nominal improvement in the NAS was observed. Combination therapy improved body weight, glycemic control, aminotransferase levels and liver stiffness, with no new safety concerns identified."

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

Cost-effectiveness of luseogliflozin for the management of type 2 diabetes mellitus in Vietnam: a Markov model analysis from the Vietnam social health insurance perspective. (PubMed, Cost Eff Resour Alloc) - "From the VSHI perspective, luseogliflozin was cost-effective compared with SoC, and the results remained robust across all sensitivity and scenario analyses. As the first economic evaluation of luseogliflozin in Vietnam, these findings provide locally relevant evidence to inform reimbursement policy for diabetes treatment."

HEOR • Journal • Reimbursement • US reimbursement • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Luseogliflozin restores GIP responsiveness in diabetic male mice with preserved β-cell function. (PubMed, Physiol Rep) - "Ex vivo analyses using isolated islets further showed that chronic luseogliflozin treatment altered incretin-stimulated insulin secretion, including attenuation of enhanced GLP-1 responsiveness under diabetic conditions. These findings suggest that luseogliflozin may partially normalize aberrant β-cell incretin signaling and restore GIP responsiveness when sufficient β-cell function remains."

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

Luseogliflozin efficacy in MAFLD with type 2 diabetes: a 6-month randomized double-blinded controlled trial of biochemical and imaging outcomes (IDDF 2026) - "Ultrasound and SWE confirmed a reduction in hepatic steatosis and fibrosis progression. Larger, longer-term trials with histological endpoints are warranted.View this table:View inline View popup Abstract IDDF2026-ABS-0196 Table 1 Biochemical and imaging outcomes at 3,6 months"

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

Effect of Luseogliflozin on Myocardial Flow Reserve in Patients with Type 2 Diabetes Mellitus (LUCENT-J Study) (ADA 2026) - "This study showed that MFR didn't increase by luseogliflozin."

Clinical • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

When Antidiabetic Therapy Affects the Skin – case report and literature review. (EADV-Sp 2026) - "Initial dermatological management included systemic antihistamines and topical triamcinolone combined with tetracycline spray...The patient was maintained on metformin monotherapy...This drug class includes canagliflozin, dapagliflozin, empagliflozin, ipragliflozin, luseogliflozin, and tofogliflozin [3]...Conclusions In the present case, blistering lesions developed after more than one year of empagliflozin therapy and showed partial remission following drug substitution and complete resolution after discontinuation of SGLT2 inhibitor treatment , suggesting a possible association with a non-autoimmune bullous reaction. This observation highlights the importance of considering SGLT2 inhibitors (flozins) in the in the differential diagnosis of bullous or blistering skin eruptions in patients with type 2 diabetes mellitus."

Case report • Clinical • Review • Bullous Pemphigoid • Cardiovascular • Dermatopathology • Diabetes • Hypotension • Immunology • Infectious Disease • Metabolic Disorders • Nephrology • Pruritus • Psoriasis • Type 2 Diabetes Mellitus

Sodium-glucose cotransporter 2 inhibition and injection burden in mild diabetic macular edema: An exploratory post hoc analysis of the COMET trial. (PubMed, J Diabetes Investig) - "In this exploratory analysis, SGLT2 inhibition was associated with fewer intravitreal injections in patients meeting the CRT-based mild criteria. These findings are hypothesis-generating and warrant confirmation in future prospective studies."

Journal • Retrospective data • Diabetic Macular Edema • Ophthalmology

POLUS: Description of the Effectiveness and Tolerability of Luseogliflozin in Patients With Type 2 Diabetes. (clinicaltrials.gov) - P=N/A | N=300 | Recruiting | Sponsor: Servier Russia | Not yet recruiting ➔ Recruiting

Enrollment open • Real-world evidence • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Do SGLT2 Inhibitors Influence Parkinson’s Disease Risk? A Meta-analysis of Randomized Trials (AAN 2026) - "No eligible data were found for ertugliflozin, enavogliflozin, henagliflozin, ipragliflozin, luseogliflozin, or tofogliflozin...Subgroup analyses showed no significant effect for individual agents: empagliflozin 10 mg (OR 0.64, 95% CI 0.17–2.43), empagliflozin 25 mg (OR 0.33, 95% CI 0.01–8.15), dapagliflozin 10 mg (OR 0.33, 95% CI 0.09–1.23), sotagliflozin (OR 0.25, 95% CI 0.03–2.24), canagliflozin 100 mg (OR 3.00, 95% CI 0.31–28.81), and bexagliflozin (OR 1.50, 95% CI 0.06–36.99)...Conclusions SGLT2 inhibitors do not significantly alter the risk of PD. These findings support their neurological safety, though longer follow-up and dedicated neurodegenerative outcome trials are warranted."

Retrospective data • Cardiovascular • Chronic Kidney Disease • CNS Disorders • Congestive Heart Failure • Diabetes • Heart Failure • Metabolic Disorders • Movement Disorders • Nephrology • Parkinson's Disease • Renal Disease • Type 2 Diabetes Mellitus

Pharmacokinetics, Pharmacodynamics, and Safety of Single-Dose Luseogliflozin (TS-071) in Japanese Children and Adolescents With Type 2 Diabetes: A Multicenter, Open-Label, Parallel-Group Phase 1 Study. (PubMed, Clin Pharmacol Drug Dev) - "Luseogliflozin demonstrated favorable pharmacokinetic, pharmacodynamic, and safety profiles in pediatric patients, consistent with adult findings. These results support the selection of 2.5- and 5-mg doses for a future Phase 3 pediatric study."

Journal • P1 data • PK/PD data • Diabetes • Metabolic Disorders • Pediatrics • Type 2 Diabetes Mellitus

Effects of individual sodium-glucose cotransporter-2 inhibitors on all-cause mortality in patients with diabetic kidney disease. (PubMed, Clin Exp Nephrol) - "Comparable effects of SGLT2is on all-cause mortality risk were observed in patients with DKD using the Asian real-world data. This apparent class effect on all-cause mortality suggests that different agents may confer comparable short-term mortality benefits when selected according to patient characteristics."

Journal • Diabetic Nephropathy • Nephrology • Renal Disease

EFFICACY OF SODIUM-GLUCOSE COTRANSPORTER 2 INHIBITORS IN PATIENTS WITH DIABETIC MACULAR OEDEMA AND HYPERTENSION: POST HOC SUBGROUP ANALYSIS OF THE COMET TRIAL (ATTD 2026) - "Participants were randomized to receive either SGLT2 inhibitor (luseogliflozin) or sulfonylurea (SU, glimepiride). The primary outcome was the treatment burden, quantified by the total number of intravitreal ranibizumab injections (IVRs) over 48 weeks. Within the OSBP ≥140 mmHg subgroup, 14 patients received SGLT2 inhibitor and 15 received SU... SGLT2 inhibitor may help reduce the treatment burden of IVRs in patients with DMO and elevated OSBP. The improvements in blood pressure and visual acuity, despite fewer injections, indicate a potential synergistic effect of SGLT2 inhibitor in managing hypertensive DMO. Further investigation is warranted to validate its efficacy as a non-invasive therapeutic option."

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

Efficacy of luseogliflozin in elderly patients with type 2 diabetes and metabolic dysfunction associated steatotic liver disease (EASL-SLD 2026) - "Conclusion Luseogliflozin improved ALT levels in elderly patients as well as in non-elderly patients. These findings suggest that luseogliflozin may represent a therapeutic option for elderly patients with type 2 diabetes and MASLD."

Clinical • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease

POLUS: Description of the Effectiveness and Tolerability of Luseogliflozin in Patients With Type 2 Diabetes. (clinicaltrials.gov) - P=N/A | N=300 | Not yet recruiting | Sponsor: Servier Russia

New trial • Real-world evidence • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

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