Product Description
Empagliflozin is an orally available competitive inhibitor of sodium-glucose co-transporter 2 (SGLT2; SLC5A2) with antihyperglycemic activity. Upon oral administration, empagliflozin selectively and potently inhibits SGLT2 in the kidneys, thereby suppressing the reabsorption of glucose in the proximal tubule.
Mechanisms of Action: SGLT2 Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Canada | Chile | China | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Mexico | Netherlands | New Zealand | Norway | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: None
Known Adverse Events: None
Company: Boehringer Ingelheim
Company Location: Europe
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Ghana, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Latvia, Lithuania, Malaysia, Mexico, Nepal, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, Unknown Location, Vietnam
Active Clinical Trial Count: 61
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Inventiva Pharma presented P2 Non-alcoholic Steatohepatitis results on 2024-11-15 for Empagliflozin
Highest Development Phases
Phase 3: COVID-19|Congenital Heart Defects|Diabetes, Gestational|Dyslipidemia|Heart Failure|Heart Failure, Acute|Hypertension|Kidney Diseases|Kidney Failure, Chronic|Myocardial Infarction|Severe Acute Respiratory Syndrome|Shock, Cardiogenic|Tricuspid Valve Insufficiency|Type 2 Diabetes
Phase 2: Breast Cancer|Kidney Calculi|Liver Cirrhosis|Liver Failure|Nephrolithiasis
Phase 1: General Diabetes|Healthy Volunteers|Overweight
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT07331389 |
HDM1002-111 | P1 |
Recruiting |
Overweight |
2026-01-12 |
50% |
2026-01-10 |
Primary Endpoints |
NCT06450262 |
NCT06450262 | P1 |
Completed |
Healthy Volunteers|General Diabetes |
2024-01-16 |
2024-06-11 |
Primary Endpoints|Treatments |
|
NCT03424005 |
Morpheus-panBC | P2 |
Recruiting |
Breast Cancer |
2030-09-30 |
12% |
2025-11-29 |
|
2024-518457-42-00 |
1378-0023 | P2 |
Not yet recruiting |
Kidney Diseases |
2027-01-08 |
12% |
||
NCT05786443 |
SEED | P2 |
Recruiting |
Kidney Failure, Chronic |
2026-12-30 |
50% |
2025-02-04 |
Primary Completion Date|Primary Endpoints |
NCT05726032 |
EMPA Liver | P2 |
Recruiting |
Liver Failure|Liver Cirrhosis |
2025-12-01 |
2% |
2025-10-08 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT04911660 |
SWEETSTONE | P2 |
Completed |
Nephrolithiasis|Kidney Calculi |
2023-03-30 |
50% |
2023-06-16 |
|
NCT07064473 |
U1111-1319-9064 | P3 |
Recruiting |
Type 2 Diabetes|Hypertension |
2029-12-14 |
25% |
2025-07-30 |
|
NCT06955260 |
EMPA-HEART-3 | P3 |
Not yet recruiting |
Congenital Heart Defects |
2027-12-01 |
2025-05-03 |
||
2023-503602-37-00 |
2021PI218 | P3 |
Recruiting |
Shock, Cardiogenic |
2026-08-01 |
2025-05-02 |
Treatments |
|
NCT06024746 |
CONFIRMATION | P3 |
Recruiting |
Heart Failure |
2026-07-01 |
32% |
2025-03-12 |
Primary Endpoints |
NCT04381936 |
RECOVERY | P3 |
Recruiting |
COVID-19|Severe Acute Respiratory Syndrome |
2026-06-30 |
2024-01-06 |
||
NCT04602754 |
EMS1019 - Berlim 25/20 | P3 |
Recruiting |
Dyslipidemia|Type 2 Diabetes |
2026-05-01 |
18% |
2025-12-11 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT06571591 |
CT-L03 | P3 |
Active, not recruiting |
Type 2 Diabetes |
2026-05-01 |
18% |
2025-11-20 |
Primary Endpoints |
NCT05392764 |
EMPA-AHF | P3 |
Recruiting |
Heart Failure, Acute |
2025-03-31 |
13% |
2024-08-07 |
Patient Enrollment|Primary Endpoints|Study Completion Date |
NCT03215069 |
EMPA post-GDM | P3 |
Completed |
Diabetes, Gestational |
2024-12-31 |
38% |
2025-03-08 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT04345796 |
PROVE | P3 |
Completed |
Tricuspid Valve Insufficiency |
2024-06-03 |
2025-03-27 |
Patient Enrollment|Primary Endpoints |
|
NCT04509674 |
EMPACT-MI | P3 |
Completed |
Heart Failure|Myocardial Infarction |
2023-11-05 |
53% |
2025-01-08 |
Primary Endpoints |
jRCT2031250347 |
jRCT2031250347 | P3 |
Not yet recruiting |
Hypertension |
2029-12-31 |
|||
2025-521188-11-00 |
1378-0041 | P3 |
Not yet recruiting |
Hypertension|Type 2 Diabetes |
2029-10-12 |
25% |
||
2024-512577-27-00 |
1245-0256 | P3 |
Not yet recruiting |
Kidney Diseases |
2029-06-25 |
12% |
||
jRCT2031250295 |
jRCT2031250295 | P3 |
Not yet recruiting |
Kidney Diseases |
2029-05-31 |
|||
NCT06935370 |
U1111-1317-0692 | P3 |
Recruiting |
Heart Failure |
2029-02-04 |
25% |
2025-09-25 |
Primary Endpoints|Start Date|Treatments |
NCT06531824 |
U1111-1306-5049 | P3 |
Recruiting |
Kidney Failure, Chronic |
2028-08-30 |
70% |
2025-02-28 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
2024-511025-63-00 |
1378-0006 | P3 |
Recruiting |
Kidney Diseases |
2028-07-01 |
70% |
2025-05-02 |
Treatments |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
12/08/2025 |
News Article |
Wellgistics Health Announces Launch of Diabetes Drug Brenzavvy(R) to Wellgistics Pharmacy Network |
|
11/20/2025 |
News Article |
Anti-Obesity Drug Market to Reach USD 82.55 Billion in 2032, Exclusive Report by Coherent Market Insights |
|
11/06/2025 |
News Article |
KERENDIA® (finerenone) Meets Primary Endpoint in Phase III Clinical Trial for Adults with Type 1 Diabetes and Chronic Kidney Disease |
|
11/05/2025 |
News Article |
Thryv Therapeutics to Present at the 2025 American Heart Association Scientific Sessions in New Orleans, LA |