Empagliflozin: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Empagliflozin appears in the FDA drug-label database. Marketed as JARDIANCE.
- Drug class
- Sodium-Glucose Cotransporter 2 Inhibitor (FDA established pharmacologic class)
- Mechanism of action
- Sodium-Glucose Transporter 2 Inhibitors (as stated on the FDA label)
FDA-approved use
JARDIANCE is indicated: to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure. to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease. as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. JARDIANCE is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated: To reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure. ( 1 ) To reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease. ( 1 ) As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitations of Use: Not recommended in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients. ( 1 ) Not recommended for use to improve glycemic control in adults with type 2 diabetes mellitus with an eGFR less than 30 mL/min/1.73 m 2 ( 1 ) Limitations of Use JARDIANCE is not recommended in patients with type 1 diabetes mellitus. It may increase the r…
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| Cross Contamination With Other Products: — Boehringer Ingelheim Pharmaceuticals, Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2018-09-04 |
| Labeling: Label Mix-up — Boehringer Ingelheim Pharmaceuticals, Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2023-03-09 |
| CGMP Deviations: Intermittent exposure to temperature excursion during storage. — Cardinal Health Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2021-03-15 |
| CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. — CARDINAL HEALTHCARE | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2022-01-26 |
Phase breakdown
Conditions being studied
Recruiting trials involving Empagliflozin
- A Drug-Drug Interaction Study of HDM1002 and Metformin, Empagliflozin, Midazolam, Valsartan, and Warfarin
- A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
- A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients With Heart Failure (CONFIRMATION-HF)
- A Study to Find Out How EMPAgliflozin is Tolerated and if it Helps Children and Adolescents With Chronic KIDNEY Disease (EMPA-KIDNEY® Kids)
- 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
- A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure
- Add-on Diuretics in Acute Decompensated Heart Failure
- Arterial Destiffening Effects of SGLT2 Inhibition in Veterans With Obesity
- EASi-KIDNEY™ (The Studies of Heart & Kidney Protection With BI 690517 in Combination With Empagliflozin)
- 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
- Effect of Empagliflozin on Left Atrial Function in Adults at Risk for Heart Failure
- Efficacy and Safety of Add-On Therapy With Empagliflozin in Patients With Type 2 Diabetes on a Background of Alogliptin and Metformin
- Efficacy and Safety of Berlim 25/20 Association in the Treatment of Type II Diabetes Mellitus and Dyslipidemia.
- Efficacy and Safety of Empagliflozin or Semaglutide in Overweight/Obese Patients With Type 1 Diabetes
- Efficacy and Safety of Piemonte Association in the Treatment of Type II Diabetes Mellitus
- Empagliflozin Addition in Modulating Metabolic Disturbances Associated With Olanzapine in Schizophrenia Patients
- Empagliflozin Treatment in Kidney Transplant Recipients
- Evaluate the Possible Efficacy and Safety of Empagliflozin in Patient With Ulcerative Colitis
- Feasibility Trial for a Right Ventricular Failure Platform Trial
- Real World Safety & Efficacy Experience of Empagliflozin With or Without Metformin in T2DM Patients - EASE Study
- Sodium-Glucose Cotransporter-2 Inhibitor (SGLT2) in Major Depressive Disorder (MDD)
Common questions
Is Empagliflozin FDA-approved?
Yes, marketed as JARDIANCE.
How many recruiting trials involve Empagliflozin?
21 recruiting trials across 15 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.