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

EMPACT: Enavogliflozin for the Management of Patients With Amyloid CardiomyopaThy (clinicaltrials.gov) - P4 | N=68 | Not yet recruiting | Sponsor: Seoul St. Mary's Hospital

New P4 trial • Cardiac Amyloidosis • Cardiomyopathy • Cardiovascular

Enavogliflozin Improves Metabolic Markers in Chinese Patients With Type 2 Diabetes (OBESITY WEEK 2025) - " A total of 340 Chinese patients with T2DM inadequately controlled on metformin (HbA1c 7 to 10.5%) were randomized (1:1) to receive either enavogliflozin 0.3 mg/day or dapagliflozin 10 mg/day for 24 weeks (mean [SD] age 54.40 [10.80] years; BMI 26.18 [3.57] kg/m2). Both treatments demonstrated comparable weight reduction, enavogliflozin showed a greater reduction trend in weight loss at all visits. These findings indicate that enavogliflozin may provide unique metabolic benefits beyond glycemic control, potentially influencing long-term energy balance and insulin efficiency."

Clinical • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Physiologically-based pharmacokinetic modeling of enavogliflozin ophthalmic solution for starting dose selection in diabetic retinopathy treatment. (PubMed, Biomed Pharmacother) - "The optimized starting dose for once-daily dosing simulation was determined to range from 0.0092 to 0.0293 mg. These findings provide a scientific basis for further clinical studies of ophthalmic enavogliflozin as a noninvasive therapeutic formulation for diabetic retinopathy."

Journal • PK/PD data • Diabetic Retinopathy • Gastrointestinal Disorder • Ophthalmology • Retinal Disorders

Drug-Drug Interaction Study to Evaluate the Effect of DWC202511 or DWC202512 With DWP16001 in Healthy Adults (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: Daewoong Pharmaceutical Co. LTD.

New P1 trial

Pharmacokinetics and Safety of Fixed-Dose Versus Separate Enavogliflozin/Gemigliptin Combinations, and Food Effect on Enavogliflozin in Healthy Korean Subjects. (PubMed, Clin Transl Sci) - "The FDC of enavogliflozin and gemigliptin demonstrated pharmacokinetic equivalence and comparable safety to their co-administration as separate agents. Furthermore, the systemic exposure of enavogliflozin was not affected by food intake, supporting its potential for flexible, meal-independent use in clinical settings."

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

A Novel Presentation of Euglycemic Diabetic Ketoacidosis Associated with SGLT2 Inhibitor and Weekly GLP-1 Agonist: Case Report. (PubMed, Healthcare (Basel)) - "One week prior, she had started metformin and enavogliflozin, a selective SGLT2 inhibitor. This case highlights the importance of recognizing euDKA in patients using SGLT2 inhibitors and GLP-1RAs, particularly those with fasting or gastrointestinal symptoms. Clinicians should suspect euDKA even without significant hyperglycemia to enable prompt diagnosis and management, thereby preventing complications."

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

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

Weight-independent amelioration of adipokine profile by enavogliflozin, a selective SGLT2 inhibitor, in patients with type 2 diabetes. (PubMed, Cardiovasc Diabetol) - "Enavogliflozin treatment decreased leptin over 24 weeks in patients with type 2 diabetes, and this effect remained significant after adjusting for weight change, suggesting an improved adipokine profile. Reductions in leptin were also associated with improvements in insulin resistance and increases in serum ketone levels. These results highlight enavogliflozin as a potential treatment beyond glycemic control, offering additional benefits in managing metabolic dysregulation associated with type 2 diabetes."

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

Registry Study to Determine the Effectiveness and Safety of Weight Loss With Enavogliflozin in Patients With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P=N/A | N=200 | Active, not recruiting | Sponsor: Daewoong Pharmaceutical Co. LTD. | Recruiting ➔ Active, not recruiting

Enrollment closed • Diabetes • 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. | Trial completion date: Jun 2025 ➔ Dec 2025

Trial completion date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Differential glycemic effects of DWP16001 in diabetic dogs according to baseline glycemic status: a multicenter randomized controlled trial. (PubMed, BMC Vet Res) - "DWP16001 is a safe and effective adjunct to insulin therapy for diabetic dogs, especially those with suboptimal glycemic control. It demonstrated insulin-sparing effects and favorable metabolic safety, necessitating further evaluation in long-term clinical studies."

Clinical • Journal • Diabetes • Hematological Disorders • Hypoglycemia • Metabolic Disorders

Reverse translational approach to clarify the strong potency of enavogliflozin, a novel sodium-glucose cotransporter 2 inhibitor. (PubMed, J Pharmacol Exp Ther) - "The dihydrobenzofuran moiety of enavogliflozin is key to its distinctive inhibitory profile, contributing to its rigid conformation and optimal spatial orientation for effective π-π stacking interactions with Phe98, thereby enhancing its inhibitory potency. This structural feature distinguishes enavogliflozin from other SGLT2 inhibitors such as dapagliflozin and empagliflozin."

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Impact of the Wellcheck Smartphone App Linked to Electronic Health Records on Clinical Outcomes in Patients With Type 2 Diabetes: Study Protocol for Primary Care-Based, Prospective, Multicenter, Cluster-Randomized, Pragmatic Clinical Trials (ENDO 2025) - "Eligible participants include adults aged 19-80 with T2D who are treated with or planning to be treated with Envlo (enavogliflozin) or Envlomet (enavogliflozin/metformin). This study aims to explore the effectiveness of "WellCheck" in improving glycemic control and metabolic outcomes, providing valuable insights into its potential as a digital tool for managing T2D. The wide age range of participants and cluster randomization of primary care centers into the intervention and control groups enhance the generalizability and robustness of the study, reducing bias and enabling a meaningful comparison of outcomes in diverse healthcare settings."

Clinical • Clinical data • Cardiovascular • Diabetes • Dyslipidemia • Genetic Disorders • Hypertension • Metabolic Disorders • Obesity • 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