Data updated: Jun 28, 2026
EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE (empagliflozin) · ZYDUS PHARMS
Metabolic
Approved 2022-07-07
1
Indication
--
Phase 3 Trials
4
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2022-07-07
- Routes
- ORAL
- Dosage Forms
- TABLET, TABLET, EXTENDED RELEASE
Companies
Website: ↗
EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE Approval History
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
8 FDA actions from 2022 to 2024
Aug 2024 SUPPL
Label · Labeling
What EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE Treats
1 FDA approvalsOriginally approved for its first indication in 2022 .
- Other (1)
Other
(1 approval)- • Approved indication (Jul 2022)Letter
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Clinical Trial Registry
122 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07064473 | 1378-0041 U1111-1319-9064, 2025-521188-11-00 | Ph 3 | recruiting | EASi-PROTKT™ - A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People With Type 2 Diabetes, High Blood Pressure, and Cardiovascular Disease |
| NCT06935370 | 1378-0018 2024-519525-38-00, U1111-1317-0692 | Ph 3 | recruiting | A Study to Test Whether Vicadrostat (BI 690517) in Combination With Empagliflozin Helps People With Heart Failure and a Weak Pumping Function of the Left Side of the Heart |
| NCT06424288 | 1378-0020 2023-509706-30-00, U1111-1302-4422 | Ph 3 | recruiting | A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure |
| NCT06844669 | 202502113 | Ph 2 | terminated | HER2HEART-US: Prevention of Cardiotoxicity in Breast Cancer Patients Receiving HER2-directed Therapy |
| NCT06926660 | 1378-0023 2024-518457-42-00, U1111-1314-0083 | Ph 2 | active not recruiting | A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Chronic Kidney Disease |
| NCT05510115 | 22-0616 1R01DK131755-01A1 | Ph 2 | active not recruiting | Feasibility of Study of Empagliflozin in Patients With Autosomal Dominant Polycystic Kidney Disease |
| NCT06618976 SOTATHROMBUS | STUDY-24-00304 | Ph 4 | completed | Antithrombotic Activities of Sotagliflozin vs. Empagliflozin |
| NCT06531824 | 1378-0006 2024-511025-63-00, U1111-1306-5049 | Ph 3 | recruiting | EASi-KIDNEY™ (The Studies of Heart & Kidney Protection With BI 690517 in Combination With Empagliflozin) |
| NCT07107945 | 1245-0256 2024-512577-27-00, U1111-1312-1389 | Ph 3 | recruiting | A Study to Find Out How EMPAgliflozin is Tolerated and if it Helps Children and Adolescents With Chronic KIDNEY Disease (EMPA-KIDNEY® Kids) |
| NCT06171802 EMPAVR | 2023-504731-40-01 | Ph 4 | completed | EMPagliflozin After Aortic Valve Replacement |
| NCT04381936 RECOVERY | NDPHRECOVERY 2020-001113-21, ISRCTN50189673 | Ph 3 | recruiting | Randomised Evaluation of COVID-19 Therapy |
| NCT06013865 SEKTR | NEPH-008-22F CSR&D | Ph 4 | recruiting | Empagliflozin Treatment in Kidney Transplant Recipients |
| NCT07541456 EMPA-BP | SIMC-IM-EMPA-BP-RCT-2025-01 | Ph 4 | completed | Empagliflozin Versus Non-SGLT2 Oral Drugs for Blood Pressure in Type 2 Diabetes |
| NCT03424005 Morpheus-panBC | CO40115 2017-002038-21, 2023-503629-20-00 | Ph 1, Ph 2 | recruiting | A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer |
| NCT06762314 | Tanta 145 | Ph 2 | recruiting | Efficacy and Safety of Empagliflozin or Semaglutide in Overweight/Obese Patients With Type 1 Diabetes |
| NCT05174507 Hypo-PrEA | 2020-01287; me20Donath | Ph 2 | withdrawn | Empagliflozin and Anakinra for the Treatment of Postprandial Hypoglycemia in Patients With Prediabetes |
| NCT05669742 | EMPA2022 | Ph 3 | recruiting | Empagliflozin Addition in Modulating Metabolic Disturbances Associated With Olanzapine in Schizophrenia Patients |
| NCT07372040 | Acute Heart Failure 2026 | Ph 2 | recruiting | Add-on Diuretics in Acute Decompensated Heart Failure |
| NCT05426525 | OregonSU | Ph 4 | active not recruiting | Use of Empagliflozin to Treat Prediabetes |
| NCT05164263 EASE | GTZ-DM-003-21 | Ph 4 | recruiting | Real World Safety & Efficacy Experience of Empagliflozin With or Without Metformin in T2DM Patients - EASE Study |
| NCT06625073 | NEPH-004-24S | Ph 4 | recruiting | Randomized Trial of SGLT2i in Heart Transplant Recipients |
| NCT07214818 SGLT2-NS | MS.25.08.3285 | Ph 2, Ph 3 | recruiting | SGLT2 Inhibitors in Adult Primary Nephrotic Syndrome |
| NCT06149793 | MED-2023-31645 | Ph 2, Ph 3 | active not recruiting | SGLT2 Inhibitor Therapy in Cystic Fibrosis-related Diabetes |
| NCT07331389 | HDM1002-111 | Ph 1 | recruiting | A Drug-Drug Interaction Study of HDM1002 and Metformin, Empagliflozin, Midazolam, Valsartan, and Warfarin |
| NCT06528405 ESS-AKD | 202404095MINE | Ph 2 | recruiting | The Efficacy and Safety of Sodium-glucose Cotransporter 2 Inhibitors in Patients With Acute Kidney Disease |
| NCT05028140 PIEMONTE | EMS1020 - PIEMONTE | Ph 3 | recruiting | Efficacy and Safety of Piemonte Association in the Treatment of Type II Diabetes Mellitus |
| NCT04602754 | EMS1019 - Berlim 25/20 | Ph 3 | recruiting | Efficacy and Safety of Berlim 25/20 Association in the Treatment of Type II Diabetes Mellitus and Dyslipidemia. |
| NCT05757791 | 23-00027 | Ph 2 | recruiting | Sodium-Glucose Cotransporter-2 Inhibitor (SGLT2) in Major Depressive Disorder (MDD) |
| NCT06571591 CT-L03 | CT-L03-301 CT-L03 | Ph 3 | completed | Efficacy and Safety of Pioglitazone Combination Therapy in Type 2 Diabetes Patients on a Background of Empagliflozin With Metformin |
| NCT06745063 EMPA | CARB-015-24S 2107866 | Ph 2 | recruiting | Arterial Destiffening Effects of SGLT2 Inhibition in Veterans With Obesity |
| NCT07180745 | FMBSUREC/01092024 | Ph 4 | not yet recruiting | Empagliflozin Versus Statins in Non-Alcoholic Fatty Liver Disease |
| NCT06962826 | 1245-0358 2025-520813-29-00, U1111-1313-4642 | Ph 1 | completed | A Study in Healthy People to Test How Empagliflozin is Taken up in the Body When Taken as a Whole Tablet or Dissolved in Water and Mixed With Food |
| NCT06570473 CRAVE | CRAVE-01 | Ph 2 | recruiting | Feasibility Trial for a Right Ventricular Failure Platform Trial |
| NCT06435858 SIDIA | 2024-00070 | Ph 2 | recruiting | Short-term Effects of an SGLT2 Inhibitor on Divalent Ions in Autosomal Dominant Polycystic Kidney Disease |
| NCT05282121 results posted | 1366-0029 2021-005171-40, 2023-504257-12-00 | Ph 2 | terminated | A Study to Test Whether BI 685509 Alone or in Combination With Empagliflozin Helps People With Liver Cirrhosis Caused by Viral Hepatitis or Non-alcoholic Steatohepatitis (NASH) Who Have High Blood Pressure in the Portal Vein (Main Vessel Going to the Liver) |
| NCT05373680 | 34976/10/21 | Ph 2, Ph 3 | completed | Efficacy and Safety of Metformin Versus Empagliflozin on Chronic Kidney Disease Progression |
| NCT05614115 | IRB_00155825 1R01DK131265 | Ph 1 | completed | Safety, Tolerability, and Feasibility of Empagliflozin Therapy in Dialysis-dependent ESKD |
| NCT07093476 | CT-L02-301 | Ph 3 | recruiting | Efficacy and Safety of Add-On Therapy With Empagliflozin in Patients With Type 2 Diabetes on a Background of Alogliptin and Metformin |
| NCT03594110 results posted | 1245-0137 2017-002971-24 | Ph 3 | completed | EMPA-KIDNEY (The Study of Heart and Kidney Protection With Empagliflozin) |
| NCT07060417 EMPA-CKD | NEPH-006-24F | Ph 2 | not yet recruiting | Vascular Effects of SGLT2i in Non-diabetic CKD |
| NCT05078879 | 10000236 000236-I | Ph 1 | completed | Empagliflozin as a Treatment for Severe Congenital Neutropenia Due to G6PC3 Deficiency |
| NCT04345796 PROVE | 2020-0127 | Ph 3 | completed | Pharmacological Reduction of Right Ventricular Enlargement |
| NCT03790787 | HMM0112 | Ph 1 | completed | Drug Interaction Study Between Dorzagliatin and Empagliflozin |
| NCT05254002 CONFIDENCE | 21839 2023-506981-30-00, 2021-003037-11 | Ph 2 | completed | A Study to Learn How Well the Treatment Combination of Finerenone and Empagliflozin Works and How Safe it is Compared to Each Treatment Alone in Adult Participants With Long-term Kidney Disease (Chronic Kidney Disease) and Type 2 Diabetes |
| NCT06024746 CONFIRMATION | 202303CPC | Ph 3 | recruiting | A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients with Heart Failure (CONFIRMATION-HF) |
| NCT03646292 | 4-2018-0655 | Ph 4 | completed | Antidiabetic Drugs for Steatotic Liver Disease |
| NCT06339788 | HD-MP-106 | Ph 1 | completed | Pharmacokinetics of HD-P023 and Co-administration of Teneligliptin and Empagliflozin High in Healthy Volunteers |
| NCT04509674 results posted | 1245-0202 2019-001037-13 | Ph 3 | completed | EMPACT-MI: A Study to Test Whether Empagliflozin Can Lower the Risk of Heart Failure and Death in People Who Had a Heart Attack (Myocardial Infarction) |
| NCT06683053 ADDEMFEP | CMEP | Ph 3 | active not recruiting | Evaluation of the Use of Empagliflozin in Patients with HF with PEF in a Cardiology Outpatient Department |
| NCT05182840 results posted | 1378.5 2021-001434-19, 1378-0005 | Ph 2 | completed | A Study to Test Whether Different Doses of BI 690517 Alone or in Combination With Empagliflozin Improve Kidney Function in People With Chronic Kidney Disease |
Showing 50 of 122 trials
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.