Enblo (enavogliflozin) / Daewoong Pharma, GC Biopharma, M8 Pharma - LARVOL DELTA

Efficacy and safety of enavogliflozin as add-on in adults with type 2 diabetes inadequately controlled with insulin or insulin with other antidiabetic drugs (EASD 2025) - P3 | "Enavogliflozin appears an efficacious and safe add-on treatment option in patients whose T2DM is controlled inadequately with insulin alone or combined with other antidiabetic agents."

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

Comparative Effects of Enavogliflozin vs. Dapagliflozin on Adipokines in Patients with Type 2 Diabetes Mellitus (ADA 2025) - "Enavogliflozin improved adipokines and showed more leptin reduction than dapagliflozin in patients with T2DM."

Clinical • Late-breaking abstract • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus • LEP

Enavogliflozin, an SGLT2 Inhibitor, Improves Nonalcoholic Steatohepatitis Induced by High-Fat, High-Cholesterol Diet. (PubMed, Diabetes Metab J) - "The potential pathway through which enavogliflozin attenuated liver fibrosis development may be associated with the transforming growth factor β1/Smad signaling pathway. Our results suggest that enavogliflozin is effective in a mouse model of MASH by attenuating hepatic steatosis, suppressing inflammation, and improving liver fibrosis."

Journal • Fibrosis • Gastroenterology • Hepatocellular Cancer • Hepatology • Immunology • Liver Cirrhosis • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • Oncology • Solid Tumor • TGFB1

Effect of enavogliflozin on the improvement of hepatic steatosis in patients with type 2 diabetes mellitus: A pooled analysis of three randomized controlled trials (ECO 2025) - "Enavogliflozin demonstrated significant efficacy in reducing hepatic steatosis in patients with T2DM, comparable to dapagliflozin. However, its effect on hepatic fibrosis was neutral. The potent SGLT2 inhibitors like enavogliflozin represents an attractive therapeutic option for patients with both T2DM and hepatic steatosis."

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

Anti-Senescence Effect of Inhibiting Sodium-Glucose Cotransporter 2 and α-Glucosidase in a Type 2 Diabetes Mellitus Animal Model. (PubMed, Diabetes Metab J) - "As canagliflozin and acarbose have been shown to increase lifespan in mice, we investigated the effect of sodium-glucose cotransporter 2 (SGLT2) inhibitor, α-glucosidase inhibitor or both on the cellular senescence of β-cells in a T2DM mouse model. The combined administration of enavogliflozin and acarbose significantly reduced blood glucose, improved β-cell function, and reduced senescent β-cells in db/db mice. This combination therapy holds potential as a senotherapeutic strategy for managing T2DM."

Journal • Preclinical • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus • CDKN1A

SGLT2 Inhibition by Enavogliflozin Significantly Reduces Aβ Pathology and Restores Cognitive Function via Upregulation of Microglial AMPK Signaling in 5XFAD Mouse Model of Alzheimer's Disease. (PubMed, Aging Cell) - "These findings highlight the multifaceted neuroprotective effects of SGLT2 inhibition in AD, demonstrating its potential to mitigate pathology and improve cognitive function. By uncovering its impact on neuroinflammation and microglial function, this study establishes SGLT2 inhibition as a promising therapeutic avenue for AD and other neurodegenerative disorders."

Journal • Preclinical • Alzheimer's Disease • CNS Disorders • Diabetes • Inflammation • Metabolic Disorders • Type 2 Diabetes Mellitus • AMPK

Daewoong files diabetes drug Envlo in 7 additional countries (Korea Biomedical Review) - "According to the company, Envlo applications have been submitted in Costa Rica, Honduras, the Dominican Republic, Panama, El Salvador, and Guatemala, along with Russia. These filings bring the total number of countries where Envlo has entered or is in the process of entering to 19."

Filing • Diabetes

ENVY: Effects of Enavogliflozin on Coronary Microvascular and Cardiac Function in Obesity (clinicaltrials.gov) - P4 | N=30 | Recruiting | Sponsor: Korea University Anam Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Study Design and Protocol for a Randomized Controlled Trial of Enavogliflozin to Evaluate Cardiorenal Outcomes in Type 2 Diabetes (ENVELOP). (PubMed, Diabetes Metab J) - "This trial will determine whether enavogliflozin is non-inferior to dapagliflozin or empagliflozin in terms of cardiorenal outcomes in patients with T2DM and cardiovascular risk factors. This study will elucidate the role of enavogliflozin in preventing vascular complications in patients with T2DM."

Clinical • Clinical protocol • Journal • Cardiovascular • Diabetes • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

ADIPONECTIN/LEPTIN RATIO INCREASE AFTER ENAVOGLIFLOZIN TREATMENT IN PATIENTS WITH TYPE 2 DIABETES (ATTD 2025) - "However, changes in adiponectin levels and the ALR remained not statistically significant after adjusting for weight loss.Conclusions Enavogliflozin treatment significantly increased the ALR in patients with type 2 diabetes over 24 weeks, suggesting improved adipocyte dysfunction. These results highlight enavogliflozin's potential beyond glycemic control, offering additional benefits."

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

Daewoong Pharm marks record-breaking performance driven by new drugs and global expansion plan (Korea Biomedical Review) - "Fexuclu, Korea's 34th homegrown new drug, surpassed 1 trillion won in global and domestic cumulative sales within just three years of launch, earning blockbuster status...Envlo, Korea’s 36th new drug, achieved annual sales exceeding 10 billion won for the first time last year, solidifying its presence in the SGLT-2 inhibitor market with strong blood sugar-lowering effects...Ursosan, a drug that treats liver diseases such as primary biliary cirrhosis (PBC), primary sclerosing cholangitis (PSC), and cystic fibrosis (CF)-related cholestasis, generated 96.2 billion won in revenue and is expected to reach the 1 trillion won milestone this year....In 2024, Nabota recorded 186.4 billion won in sales, marking 27 percent compared to the previous year. Export sales accounted for approximately 84 percent of the total revenue."

Sales • Gastroesophageal Reflux Disease • Migraine • Overactive Bladder • Primary Biliary Cholangitis • Type 2 Diabetes Mellitus

Evaluation of Enavogliflozin's Efficacy and Safety in Type II Diabetes With Hypertension or Dyslipidemia (clinicaltrials.gov) - P=N/A | N=12000 | Recruiting | Sponsor: Daewoong Pharmaceutical Co. LTD. | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Diabetes • Dyslipidemia • Hypertension • Metabolic Disorders • Type 2 Diabetes Mellitus

To Evaluate the Efficacy and Safety of Envlo Tablet or Envlomet SR Tablet in Patients With Type II Diabetes Mellitus (clinicaltrials.gov) - P=N/A | N=15000 | Active, not recruiting | Sponsor: Daewoong Pharmaceutical Co. LTD. | Recruiting ➔ Active, not recruiting

Enrollment closed • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

An anonymized, de-identified registry study protocol to determine the effectiveness and safety of weight loss with enavogliflozin in patients with type 2 diabetes mellitus. (PubMed, PLoS One) - "Eligible participants are adults aged 19 to 80 with T2D and a body mass index (BMI) of ≥23 kg/m2 who are currently receiving treatment with Envlo (enavogliflozin) or Envlomet (enavogliflozin/metformin) tablets or planning to start treatment. For safety outcomes, the trial will prioritize the monitoring of adverse drug reactions and specific events of interest such as hypoglycemia, urinary tract infections, genital infections, polyuria, and polydipsia. This study design enables us to evaluate the effectiveness and safety of enavogliflozin for weight loss in a real-world setting while exploring its potential positive effects on cardiac function and metabolic risk factors in overweight or obese patients with T2D."

Journal • Observational data • Diabetes • Hypoglycemia • Infectious Disease • Metabolic Disorders • Nephrology • Obesity • Type 2 Diabetes Mellitus

ENVY: Effects of Enavogliflozin on Coronary Microvascular and Cardiac Function in Obesity (clinicaltrials.gov) - P4 | N=30 | Not yet recruiting | Sponsor: Korea University Anam Hospital

New P4 trial • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

ENAVO-TAVR: ENAVOgliflozin Outcome Trial in Patients With Severe Aortic Stenosis After Transcatheter Aortic Valve Replacement (clinicaltrials.gov) - P4 | N=1040 | Recruiting | Sponsor: Duk-Woo Park, MD | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Congestive Heart Failure • Heart Failure

EVENT: Enavogliflozin Outcome Trial in Functional Tricuspid Regurgitation (clinicaltrials.gov) - P3 | N=540 | Recruiting | Sponsor: Asan Medical Center | Trial primary completion date: Apr 2026 ➔ Dec 2026

Trial primary completion date • Cardiovascular • Congestive Heart Failure • Heart Failure

ENVELOP: A Prospective Trial of Enavogliflozin to Evaluate Cardio-renal Outcome in Type 2 Diabetes Mellitus Patients (clinicaltrials.gov) - P4 | N=2862 | Recruiting | Sponsor: Yonsei University

New P4 trial • Cardiovascular • Diabetes • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

The Impact of the Novel Sodium-Dependent Glucose Cotransporter 2 Inhibitor, Enavogliflozin, on Cardiac Reverse Remodeling in Heart Failure Patients With Type 2 Diabetes Mellitus: A Case Series. (PubMed, Int J Heart Fail) - No abstract available

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

ARNI-TAVI: ENAVOgliflozin Outcome Trial in Patients with Severe Aortic Stenosis After Transcatheter Aortic Valve Replacement (clinicaltrials.gov) - P4 | N=1040 | Not yet recruiting | Sponsor: Duk-Woo Park, MD | Trial completion date: Apr 2026 ➔ Apr 2027 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Cardiovascular • Congestive Heart Failure • Heart Failure

Adiponectin/Leptin Ratio Increase After Enavogliflozin Treatment in Patients with Type 2 Diabetes (OBESITY WEEK 2024) - "Enavogliflozin treatment significantly increased the ALR in patients with type 2 diabetes over 24 weeks, suggesting improved adipocyte dysfunction. These results highlight enavogliflozin's potential beyond glycemic control, offering additional benefits in managing metabolic dysregulation associated with type 2 diabetes."

Clinical • Diabetes • Inflammation • Metabolic Disorders • Type 2 Diabetes Mellitus • LEP

To Evaluate the Efficacy and Safety of Enavogliflozin in Patients With Type II Diabetes Mellitus Accompanied by Hypertension or Dyslipidemia (clinicaltrials.gov) - P=N/A | N=12000 | Not yet recruiting | Sponsor: Daewoong Pharmaceutical Co. LTD.

New trial • Cardiovascular • Diabetes • Dyslipidemia • Hypertension • Metabolic Disorders • Type 2 Diabetes Mellitus

ENDEAVOR-HCM: ENavogliflozin DElivering Alleviation of Ventricular Diastolic Dysfunction in nonObstRuctive Hypertrophic CardioMyopathy (clinicaltrials.gov) - P4 | N=200 | Recruiting | Sponsor: Yonsei University | Initiation date: May 2024 ➔ Oct 2024

Trial initiation date • Cardiomyopathy • Cardiovascular • Hypertrophic Cardiomyopathy • Non-obstructive Hypertrophic Cardiomyopathy

DW_DWP16001112: Phase 1 Study of Drug-Drug Interactions Between DWP16001, DWC202407, and DWC202408 in Healthy Adults (clinicaltrials.gov) - P1 | N=34 | Not yet recruiting | Sponsor: Daewoong Pharmaceutical Co. LTD.

New P1 trial

Evaluate the Efficacy and Safety of DWP16001 in Type 2 Diabetic Nephropathy with Moderate Renal Impairment Patients (clinicaltrials.gov) - P3 | N=348 | Not yet recruiting | Sponsor: Daewoong Pharmaceutical Co. LTD.

New P3 trial • Chronic Kidney Disease • Diabetes • Diabetic Nephropathy • Nephrology • Renal Disease • Type 2 Diabetes Mellitus