12 unknown, 8 recruiting, 7 completed, 3 not yet recruiting. 13 Phase 1, 9 Phase 3, 7 Phase 4, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 13 | Unknown 8, Completed 4, Not yet recruiting 1 |
| Phase 3 | 9 | Completed 3, Unknown 3, Not yet recruiting 2, Active not recruiting 1 |
| Phase 4 | 7 | Recruiting 7 |
| Phase 2 | 1 | Unknown 1 |
Follow this drug Literature Review of Enavogliflozin trials Research Report on Enavogliflozin
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| 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 DWP16001, DWC202518, Placebo of DWP16001 - T2DM (Type 2 Diabetes Mellitus) | Phase 3 | Not yet recruiting | Daewoong Pharmaceutical Co. LTD. | 510 | 2026-06-01 | 2026-06-02 |
| Enavogliflozin for the Management of Patients With Amyloid CardiomyopaThy Enavogliflozin 0.3mg, Placebo - Amyloid Cardiomyopathy | Phase 4 | Recruiting | Seoul St. Mary's Hospital | 68 | 2026-01-06 | 2026-06-18 |
| Drug-Drug Interaction Study to Evaluate the Effect of DWC202511 or DWC202512 With DWP16001 in Healthy Adults DWP16001, DWC202511, DWC202512 - Healthy | Phase 1 | Completed | Daewoong Pharmaceutical Co. LTD. | 18 | 2025-11-09 | 2026-02-11 |
| Effect of Enavogliflozin on Recurrence of Atrial Fibrillation After Catheter Ablation Enavogliflozin, Placebo - Atrial Fibrillation | Phase 4 | Recruiting | Yonsei University | 390 | 2025-04-03 | 2026-05-12 |
| Effects of Enavogliflozin on Coronary Microvascular and Cardiac Function in Obesity Enavogliflozin, Placebo - Obesity and Type 2 Diabetes | Phase 4 | Recruiting | Korea University Anam Hospital | 30 | 2025-01-20 | 2025-09-02 |
| ENAVOgliflozin Outcome Trial in Patients With Severe Aortic Stenosis After Transcatheter Aortic Valve Replacement Enavogliflozin, Standard-of-Care - Aortic Valve Stenosis, Heart Failure | Phase 4 | Recruiting | Duk-Woo Park, MD | 1040 | 2024-12-18 | 2026-06-29 |
| Evaluation of Enavogliflozin's Efficacy and Safety in Type II Diabetes With Hypertension or Dyslipidemia Envlo Tablet, Envlomet SR Tablet - Diabetes Mellitus, Type 2 | Recruiting | Daewoong Pharmaceutical Co. LTD. | 12000 | 2024-12-03 | 2025-01-23 | |
| Phase 1 Study of Drug-Drug Interactions Between DWP16001, DWC202407, and DWC202408 in Healthy Adults DWP16001 0.3mg, DWC202407 1,000mg, DWC202408 2mg - Healthy | Phase 1 | Not yet recruiting | Daewoong Pharmaceutical Co. LTD. | 34 | 2024-10-26 | 2024-10-16 |
| ENavogliflozin DElivering Alleviation of Ventricular Diastolic Dysfunction in nonObstRuctive Hypertrophic CardioMyopathy enavogliflozin 0.3mg, enavogliflozin Placebo - Nonobstructive Hypertrophic Cardiomyopathy | Phase 4 | Recruiting | Yonsei University | 200 | 2024-10-15 | 2024-11-08 |
| Evaluate the Efficacy and Safety of DWP16001 in Type 2 Diabetic Nephropathy with Moderate Renal Impairment Patients DWP16001 Placebo, DWP16001 0.3mg - Type 2 Diabetic Nephropathy | Phase 3 | Not yet recruiting | Daewoong Pharmaceutical Co. LTD. | 348 | 2024-09-23 | 2024-09-20 |
| Enavogliflozin vs. Pioglitazone on Glucose and Atherosclerosis Enavogliflozin, Pioglitazone - Type 2 Diabetes | Phase 4 | Recruiting | Seoul National University Bundang Hospital | 120 | 2024-02-01 | 2026-05-05 |
| A Prospective Trial of Enavogliflozin to Evaluate Cardio-renal Outcome in Type 2 Diabetes Mellitus Patients Enavogliflozin, Dapagliflozin or Empagliflozin - Diabetes Mellitus, Type 2, Cardiovascular Diseases | Phase 4 | Recruiting | Yonsei University | 2862 | 2024-01-22 | 2024-10-15 |
| Study to Evaluate the Long Term Safety and Efficacy of DWP16001 in Patients With Type 2 Diabetes Mellitus DWP16001 0.3 mg - T2DM (Type 2 Diabetes Mellitus) | Phase 3 | Unknown | Daewoong Pharmaceutical Co. LTD. | 134 | 2023-12-01 | 2023-11-21 |
| Enavogliflozin Outcome Trial in Functional Tricuspid Regurgitation Enavogliflozin, Placebo - Tricuspid Regurgitation, Heart Failure With Preserved Ejection Fraction | Phase 3 | Active not recruiting | Asan Medical Center | 541 | 2023-10-25 | 2025-12-29 |
| To Evaluate the Efficacy and Safety of Envlo Tablet or Envlomet SR Tablet in Patients With Type II Diabetes Mellitus Enavogliflozin - Diabetes Mellitus, Type 2 | Active not recruiting | Daewoong Pharmaceutical Co. LTD. | 15000 | 2023-09-21 | 2025-09-02 | |
| To Compare the Safety and PK/PD Characteristics of Subjects With Between Hepatic Impairment and Normal Hepatic Function DWP16001 - Diabetes Mellitus, Type 2 | Phase 1 | Unknown | Daewoong Pharmaceutical Co. LTD. | 24 | 2023-04-13 | 2024-04-08 |
| A Study to Investigate the Effect of DWP16001 as add-on Therapy to Drug A in Patients With Type 2 Diabetes Mellitus DWP16001 0.3mg, DWP16001 Placebo - Type 2 Diabetes Mellitus | Phase 3 | Unknown | Daewoong Pharmaceutical Co. LTD. | 240 | 2023-03-17 | 2024-04-08 |
| To Evaluate the Effect of Food on the Safety and PK Characteristics of DWP16001 in Healthy Adult Volunteers DWP16001 - Healthy | Phase 1 | Unknown | Daewoong Pharmaceutical Co. LTD. | 32 | 2023-03-09 | 2023-04-04 |
| To Compare the Pharmacokinetic Characteristics of the Fixed-dose Combination Compared to the Loose Combination DWC202213, DWJ1563, DWP16001 - FDC, Diabetes Mellitus, Type 2 | Phase 1 | Unknown | Daewoong Pharmaceutical Co. LTD. | 40 | 2023-01-25 | 2023-02-21 |
| The Efficacy and Safety of DWP16001 in Combination With Metformin in T2DM Patients Inadequately Controlled on Metformin DWP16001, Dapagliflozin, DWP16001 Placebo - Diabetes Mellitus, Diabetes Mellitus, Type 2 | Phase 3 | Unknown | Daewoong Pharmaceutical Co. LTD. | 340 | 2022-09-28 | 2024-04-04 |
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Diabetes Mellitus, Type 2 (15) · Diabetes Mellitus (2) · Amyloid Neuropathies, Familial (1) · Aortic Valve Stenosis (1) · Atrial Fibrillation (1) · Cardiomyopathy, Hypertrophic (1) · Cardiovascular Diseases (1) · Endocrine System Diseases (1) · Glucose Metabolism Disorders (1) · Heart Failure (1) · Kidney Diseases (1) · Metabolic Diseases (1) · Obesity (1) · Tricuspid Valve Insufficiency (1)
Daewoong Pharmaceutical Co. LTD. (24) · Yonsei University (3) · Asan Medical Center (1) · Duk-Woo Park, MD (1) · Korea University Anam Hospital (1) · Seoul National University Bundang Hospital (1) · Seoul St. Mary's Hospital (1)
South Korea (27) · China (1)
In-Cheol Kim, MD (1) · Jang-Won Son, MD (1) · Jiwon Seo, MD (1) · Jong-Chan Youn, MD, PhD (1) · Linong Ji, Dr. (1) · Sang Hoon Moon (1) · Seong-Mi Park, M.D., Ph.D. (1) · Seung-jung Park, MD (1) · Soo Lim, M.D. Ph.D. (1) · Soo Lim, MD, PH.D (1)
PMID 38456558, PMID 36756676, PMID 37593838, PMID 37621153, PMID 38618974, PMID 38866445, PMID 39054871, PMID 41397686