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

Enavogliflozin alleviates motor deficits in rotenone-induced Parkinson's disease mice via attenuation of oxidative stress and neuroinflammation as well as activation of the SIRT1/PINK1/Parkin pathway. (PubMed, Neuropharmacology) - "In conclusion, enavogliflozin ameliorates motor dysfunction in rotenone-induced Parkinson's disease mice by attenuating oxidative stress, inhibiting neuroinflammation, and activating SIRT1/PINK1/Parkin pathway. These findings support a neuroprotective and preventive role for enavogliflozin in Parkinson's disease."

Journal • Preclinical • CNS Disorders • Inflammation • Movement Disorders • Parkinson's Disease • IL6 • TNFA

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 | Trial completion date: Apr 2027 ➔ Apr 2029 | Trial primary completion date: Dec 2026 ➔ Dec 2028

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

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

Enrollment open • Cardiac Amyloidosis • Cardiomyopathy • Cardiovascular

Comparative Effects of Enavogliflozin Versus Dapagliflozin on Adipokines and Leptin Sensitivity in Patients with Type 2 Diabetes: A Pooled Analysis of Phase 3 Trials (ENDO 2026) - "Enavogliflozin demonstrated a superior reduction in serum leptin levels and a trend toward improved leptin sensitivity compared with dapagliflozin in patients with T2DM."

P3 data • Retrospective data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus • LEP

Enavogliflozin Improves Non-invasive Hepatic Steatosis Indices in Patients With Type 2 Diabetes: A Pooled Analysis of Three Randomised Trials. (PubMed, Diabetes Obes Metab) - No abstract available

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

To Evaluate the Efficacy and Safety of Initial Combination Therapy With DWP16001 and DWC202518 Compared to DWP16001 Monotherapy and DWC202518 Monotherapy in Patients With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P3 | N=510 | Not yet recruiting | Sponsor: Daewoong Pharmaceutical Co. LTD.

Monotherapy • New P3 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Daewoong Pharmaceutical's Diabetes Drug Envlo Wins Mexico Approval (Seoul Economic Daily) - Daewoong Pharmaceutical announced in a regulatory filing...that it recently obtained product approval for Envlo Tablets 0.3mg, a treatment for type 2 diabetes, from Mexico's Federal Commission for the Protection against Sanitary Risks (COFEPRIS).

Approval • Type 2 Diabetes Mellitus

Effect of Enavogliflozin on Adipokines and Leptin Sensitivity in Patients with Type 2 Diabetes: A Post-hoc Analysis of a Randomized, Placebo-Controlled Phase 3 Trial (ECO 2026) - "Enavogliflozin significantly improved adipokine profiles and leptin sensitivity compared with placebo in patients with T2DM, which was associated with increased blood ketone levels. Conflicts of Interest & Funding: Hansol Lee is an employee of Daewoong Pharmaceutical Co., Ltd., the sponsor of the clinical trial analyzed in this manuscript. All other authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper."

Clinical • P3 data • Retrospective data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus • LEP

ENAVO-AF: Effect of Enavogliflozin on Recurrence of Atrial Fibrillation After Catheter Ablation (clinicaltrials.gov) - P4 | N=390 | Recruiting | Sponsor: Yonsei University | Trial completion date: Aug 2026 ➔ May 2027 | Trial primary completion date: Aug 2026 ➔ May 2027 | Not yet recruiting ➔ Recruiting

Enrollment open • Trial completion date • Trial primary completion date • Atrial Fibrillation • Cardiovascular • Congestive Heart Failure • Heart Failure

Enavogliflozin vs. Pioglitazone on Glucose and Atherosclerosis (clinicaltrials.gov) - P4 | N=120 | Recruiting | Sponsor: Seoul National University Bundang Hospital | Trial completion date: Dec 2026 ➔ Dec 2027 | Trial primary completion date: Jun 2026 ➔ Dec 2026

Trial completion date • Trial primary completion date • Atherosclerosis • Cardiovascular • 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

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

Trial completion

Pharmacokinetic comparison between fixed-dose combination and loose combination of enavogliflozin 0.3 mg and metformin HCl 1000 mg in healthy subjects under fasting and fed conditions. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "The FDC of enavogliflozin 0.3 mg and metformin HCl and the corresponding loose combination were pharmacokinetically equivalent without safety concerns in fasting and high-fat-fed states. The FDC can be an alternative option for combination therapy with enavogliflozin and metformin HCl with improved compliance."

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

EVENT: Enavogliflozin Outcome Trial in Functional Tricuspid Regurgitation (clinicaltrials.gov) - P3 | N=541 | Active, not recruiting | Sponsor: Asan Medical Center | Recruiting ➔ Active, not recruiting | Trial primary completion date: Dec 2026 ➔ Jun 2027

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

Evaluation of formulation on the pharmacokinetics, safety, and tolerability of enavogliflozin in healthy Korean adults. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "This study demonstrated that three tablets of 0.1 mg enavogliflozin had PK characteristics similar to those of one tablet of 0.3 mg enavogliflozin. Furthermore, the two high-strength formulations showed bioequivalence and were well tolerated."

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

Daewoong Pharmaceutical announced on December 24 that its internally developed type 2 diabetes treatment 'Envlo (enavogliflozin)' has received final marketing approval from Indonesia’s drug regulatory authority, Badan Pengawas Obat dan Makanan (BPOM) (KoreaTimes) - "In phase 3 clinical trials, a once-daily low dose of 0.3 mg demonstrated glucose-lowering efficacy comparable to dapagliflozin, an existing SGLT-2 inhibitor. Clinical results, including data from Asian patient populations, showed a glycated hemoglobin (HbA1c) target achievement rate of 78.1 percent, compared with 65.7 percent for dapagliflozin."

Approval • Type 2 Diabetes Mellitus

Efficacy and Safety of Enavogliflozin as Add-on in Adults with Type 2 Diabetes Mellitus Inadequately Controlled with Insulin or Insulin with Other Antidiabetic Drugs. (PubMed, Diabetes Metab J) - P3 | "No significant increase in treatment-related AEs was observed for enavogliflozin. Enavogliflozin 0.3 mg/day is an efficacious and safe add-on treatment option in T2DM patients controlled inadequately with insulin alone or combined with OADs."

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

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