TheraRadar
Data updated: May 26, 2026

EMPAGLIFLOZIN

Metabolic Approved 2022-08-03
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
3
Years on Market

Details

Status
None (Tentative Approval)
First Approved
2022-08-03
Routes
ORAL
Dosage Forms
TABLET

Companies

ALKEM LABS LTD AJANTA PHARMA LTD LAURUS GENERICS INC Sun Pharma ANNORA PHARMA ZYDUS PHARMS AIZANT
Active Ingredient: EMPAGLIFLOZIN

EMPAGLIFLOZIN Approval History

2023
2024
2025
2026
Original
New Indication
New Form
Label Update
2 FDA actions from 2022 to 2022
Aug 2022 ORIGINAL
Update
FDA Letter

What EMPAGLIFLOZIN Treats

1 FDA approvals

Originally approved for its first indication in 2022 .

  • Other (1)
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Clinical Trial Registry

121 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 active not recruiting 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 active not 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 121 trials

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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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 FDA Label Details

Looking for the branded version?

GLYXAMBI

Full clinical data, patents, trials, and competitive landscape for empagliflozin.

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Data Sources

FDA Approval: ANDA212382 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.