Last reviewed 2026-04-22 · How we verify

Comparator monotherapy empagliflozin

Empagliflozin inhibits sodium-glucose cotransporter 2 (SGLT2) in the kidney to increase urinary glucose excretion and lower blood glucose.

Comparator monotherapy empagliflozin is a marketed drug developed by The George Institute, with a key composition patent expiring in 2028. A key strength of empagliflozin is its established market presence, leveraging its mechanism to address primary indications effectively. The primary risk is the patent expiry in 2028, which could lead to increased competition from generics.

At a glance

Mechanism of action

SGLT2 is responsible for reabsorbing filtered glucose in the proximal tubule of the nephron. By blocking this transporter, empagliflozin prevents glucose reabsorption, allowing excess glucose to be excreted in urine. This mechanism reduces blood glucose levels independently of insulin secretion or action, and also produces osmotic diuresis and modest weight loss.

Approved indications

• Type 2 diabetes mellitus
• Heart failure with reduced ejection fraction
• Chronic kidney disease

Common side effects

• Genital mycotic infections
• Urinary tract infections
• Polyuria
• Diabetic ketoacidosis
• Volume depletion

Key clinical trials

• Polydiuretic Therapy for HFpEF, a Randomised Controlled Trial (PHASE4)
• Empagliflozin (BI 10773) in Type Two Diabetes (T2D) Patients, Open Label Extension (PHASE2)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Comparator monotherapy empagliflozin CI brief — competitive landscape report
• Comparator monotherapy empagliflozin updates RSS · CI watch RSS
• The George Institute portfolio CI