SYNJARDY (empagliflozin)
Synjardy is a combination of empagliflozin (an SGLT2 inhibitor) and metformin (a biguanide) indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. In adults with type 2 diabetes, the empagliflozin component is further indicated to reduce the risk of cardiovascular death in patients with established cardiovascular disease, reduce the risk of cardiovascular death and hospitalization in patients with heart failure, and slow the progression of chronic kidney disease (including risk of sustained eGFR decline and end-stage kidney disease). It is not recommended for patients with type 1 diabetes due to the risk of diabetic ketoacidosis.
How SYNJARDY Works
Synjardy utilizes two synergistic mechanisms to manage glucose levels. Empagliflozin inhibits the sodium-glucose co-transporter 2 (SGLT2) in the proximal renal tubules, reducing the reabsorption of filtered glucose and lowering the renal threshold for glucose, thereby increasing urinary glucose excretion. Metformin improves glucose tolerance by decreasing hepatic glucose production (gluconeogenesis), decreasing the intestinal absorption of glucose, and improving insulin sensitivity by increasing peripheral glucose uptake and utilization.
Details
- Status
- Prescription
- First Approved
- 2015-08-26
- Patent Cliff
- 2034
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
SYNJARDY Approval History
What SYNJARDY Treats
3 indicationsSYNJARDY is approved for 3 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Type 2 Diabetes
- Heart Failure
- Chronic Kidney Disease
SYNJARDY Boxed Warning
LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (>5 mmol/Liter), anion gap acidosis (without evidence of ketonuri...
WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (>5 mmol/Liter), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio; and metformin plasma levels generally >5 mcg/mL [see Warnings and Precautions (5.1) ] . Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g., carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, and hepatic impairment. Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided in the full prescribing information [see Dosage and Administration (2.1) , Contraindications (4) , Warnings and Precautions (5.1) , Drug Interactions (7) , and Use in Specific Populations (8.6 , 8.7) ]. If metformin-associated lactic acidosis is suspected, immediately discontinue SYNJARDY or SYNJARDY XR and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended [see Warnings and Precautions (5.1) ]. WARNING: LACTIC ACIDOSIS See full prescribing information for complete boxed warning. Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. Symptoms included malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Laboratory abnormalities included elevated blood lactate levels, anion gap acidosis, increase
SYNJARDY Target & Pathway
ProTarget
A transporter in the kidney that reabsorbs glucose back into the bloodstream. Blocking SGLT2 causes excess glucose to be excreted in urine, lowering blood sugar. These drugs also provide cardiovascular and kidney protection beyond glucose control.
SYNJARDY Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in SYNJARDY's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications SYNJARDY treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to SYNJARDY
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
SYNJARDY FDA Label Details
Indications & Usage
FDA Label (PDF)SYNJARDY is indicated for the treatment of Type 2 Diabetes; Heart Failure; Chronic Kidney Disease.
WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias...
SYNJARDY Patents & Exclusivity
Patents (25 active)
Exclusivity
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Revenue Insights
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Patent Timeline
- • Cliff: 2034
- • 480 active patents
Trial Analysis
- • Clinical trial tracking
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Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.