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Synjardy (Empagliflozin (SGLT2i))
Empagliflozin is a SGLT2 inhibitor and biguanide combination that targets Type 2 Diabetes Mellitus and cardiovascular disease.
Empagliflozin, developed by Hotel Dieu de France Hospital, is a SGLT2 inhibitor and biguanide combination. It targets Type 2 Diabetes Mellitus, cardiovascular death, and heart failure. Empagliflozin's mechanism involves inhibiting SGLT2, reducing glucose reabsorption, and increasing urinary glucose excretion. This leads to improved glucose tolerance and reduced hepatic glucose production. The drug's clinical differentiation lies in its unique mechanism of action and efficacy in cardiovascular and kidney disease. Empagliflozin's commercial significance is evident in its market presence and revenue. Pipeline developments are not mentioned.
At a glance
| Generic name | Empagliflozin (SGLT2i) |
|---|---|
| Sponsor | Hotel Dieu de France Hospital |
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 2015 |
Mechanism of action
Empagliflozin works by inhibiting SGLT2, the predominant transporter responsible for glucose reabsorption in the kidneys. This leads to a reduction in glucose reabsorption and an increase in urinary glucose excretion. As a result, empagliflozin lowers the renal threshold for glucose and improves glucose tolerance in patients with type 2 diabetes mellitus. Additionally, empagliflozin reduces sodium reabsorption and increases the delivery of sodium to the distal tubule, which may influence several physiological functions.
Approved indications
- Type 2 Diabetes Mellitus
- Cardiovascular (CV) Death in Adults with Established CV Disease
- CV Death and Hospitalization for Heart Failure in Adults with Heart Failure
- Sustained Decline in eGFR, End-Stage Kidney Disease, CV Death, and Hospitalization in Adults with Chronic Kidney Disease at Risk of Progression
Boxed warnings
- 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
Common side effects
- Urinary tract infection
- Female genital mycotic infections
- Upper respiratory tract infection
- Increased urination
- Dyslipidemia
- Arthralgia
- Male genital mycotic infections
- Nausea
- Volume Depletion
- Hypotension
- Hypovolemia
- Orthostatic hypotension
Drug interactions
- Topiramate or other carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide or dichlorphenamide)
- Drugs that Reduce Metformin Clearance (e.g., ranolazine, vandetanib, dolutegravir, and cimetidine)
- Alcohol
- Diuretics
- Insulin or Insulin Secretagogues (e.g., sulfonylurea)
- Drugs Affecting Glycemic Control (e.g., thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid)
- Lithium
- Drugs that Reduce Metformin Clearance (e.g., ranolazine, vandetanib, dolutegravir, and cimetidine)
Key clinical trials
- SGLT2i and KNO3 in HFpEF - The SAK HFpEF Trial (PHASE2)
- PREvention of CardIovascular and DiabEtic kidNey Disease in Type 2 Diabetes (PHASE4)
- The Assessment of Partial Guideline-Directed Medical Therapy Down Titration in Heart Failure in Remission. (PHASE4)
- SAVE-Care (Sodium Glucose Cotransporter-2 Inhibitors [SGLT2i] As Novel Gout Care) Trial (PHASE4)
- Vascular Complications in Patients Undergoing Peripheral Revascularization and Taking SGLT-2 Inhibitors
- SGLT2i Therapy in Islet Transplantation (SIT) (PHASE4)
- SGLT2i Improve Left Atrial Function in Patients With Paroxysmal Atrial Fibrillation, Hypertension and Abnormal Glucose Metabolism (PHASE2)
- The Cardiovascular Effect of GLP-1 Agonist, SGLT2 Inhibitor and Their Combination
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Synjardy CI brief — competitive landscape report
- Synjardy updates RSS · CI watch RSS
- Hotel Dieu de France Hospital portfolio CI