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:
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, Ghana, Greece, Hungary, India, Indonesia, Israel, Italy, Japan, Jordan, Korea, Malaysia, Mexico, Nepal, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, Vietnam
Active Clinical Trial Count: 44
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|Kidney Diseases|Kidney Failure, Chronic|Myocardial Infarction|Severe Acute Respiratory Syndrome|Shock, Cardiogenic|Tricuspid Valve Insufficiency|Type 2 Diabetes
Phase 2: Kidney Calculi|Liver Cirrhosis|Liver Failure|Nephrolithiasis
Phase 1: General Diabetes|Healthy Volunteers
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| EMPACT-MI | P3 |
Completed |
Myocardial Infarction |
2023-11-05 |
53% |
2025-07-09 |
Treatments |
| U1111-1313-4642 | P1 |
Active, not recruiting |
Healthy Volunteers |
2025-06-26 |
69% |
2025-07-02 |
Primary Endpoints|Start Date|Treatments|Trial Status |
| 24-VIN-0556 | P1 |
Completed |
Type 2 Diabetes |
2025-05-14 |
2025-06-27 |
Primary Endpoints|Treatments |
|
| 24-VIN-0555 | P1 |
Completed |
Type 2 Diabetes |
2025-03-07 |
2025-04-18 |
Primary Endpoints|Treatments |
|
| U1111-1314-0083 | P2 |
Not yet recruiting |
Kidney Failure, Chronic |
2027-01-08 |
12% |
2025-04-15 |
Primary Endpoints |
| SEED | P2 |
Recruiting |
Kidney Failure, Chronic |
2026-12-30 |
50% |
2025-02-04 |
Primary Completion Date|Primary Endpoints |
| EMPA Liver | P2 |
Recruiting |
Liver Failure|Liver Cirrhosis |
2025-09-01 |
2% |
2024-04-05 |
|
| CONFIDENCE | P2 |
Completed |
Type 2 Diabetes|Kidney Failure, Chronic |
2025-03-14 |
50% |
2025-03-19 |
|
| 21839 | P2 |
Completed |
Kidney Diseases|Type 2 Diabetes |
2025-02-26 |
50% |
2025-05-02 |
Treatments |
| U1111-1317-0692 | P3 |
Recruiting |
Heart Failure |
2029-02-04 |
31% |
2025-06-05 |
Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status |
| U1111-1306-5049 | P3 |
Recruiting |
Kidney Failure, Chronic |
2028-08-30 |
36% |
2025-02-28 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
| 1378-0006 | P3 |
Recruiting |
Kidney Diseases |
2028-07-01 |
36% |
2025-05-02 |
Treatments |
| U1111-1302-4422 | P3 |
Recruiting |
Heart Failure |
2028-05-22 |
31% |
2025-06-12 |
|
| EMPA-HEART-3 | P3 |
Not yet recruiting |
Congenital Heart Defects |
2027-12-01 |
2025-05-03 |
||
| 1378-0020 | P3 |
Recruiting |
Heart Failure |
2027-11-05 |
31% |
2025-05-02 |
Treatments |
| 2021PI218 | P3 |
Recruiting |
Shock, Cardiogenic |
2026-08-01 |
2025-05-02 |
Treatments |
|
| CONFIRMATION | P3 |
Recruiting |
Heart Failure |
2026-07-01 |
17% |
2025-03-12 |
Primary Endpoints |
| RECOVERY | P3 |
Recruiting |
COVID-19|Severe Acute Respiratory Syndrome |
2026-06-30 |
2024-01-06 |
||
| CT-L03-301 | P3 |
Recruiting |
Type 2 Diabetes |
2026-05-31 |
2025-05-02 |
Treatments |
|
| CT-L03-301 | P3 |
Recruiting |
Type 2 Diabetes |
2026-05-01 |
18% |
2024-08-27 |
Primary Endpoints|Treatments |
| EMS1019 - Berlim 25/20 | P3 |
Recruiting |
Dyslipidemia|Type 2 Diabetes |
2025-04-01 |
7% |
2025-02-07 |
|
| EMS0919 - Berlim 25/10 | P3 |
Not yet recruiting |
Dyslipidemia|Type 2 Diabetes |
2025-04-01 |
28% |
2025-02-07 |
Primary Endpoints|Treatments |
| EMPA-AHF | P3 |
Recruiting |
Heart Failure, Acute |
2025-03-31 |
5% |
2024-08-07 |
Patient Enrollment|Primary Endpoints|Study Completion Date |
| U1111-1313-3279 | P1 |
Not yet recruiting |
Healthy Volunteers |
2025-08-07 |
69% |
2025-06-26 |
Primary Endpoints |
| EMPA post-GDM | P3 |
Completed |
Diabetes, Gestational |
2024-12-31 |
23% |
2025-03-08 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |