Legal status by country
Is Empagliflozin legal?
Written by Aaron CuhaReviewed Sep 2026
How Empagliflozin is classified in the United States, United Kingdom, Australia and Canada, side by side. Each country has its own page with a direct answer, the regulator's approval status and what the classification means in practice.
All four countries, side by side
| Attribute | United States · FDA | United Kingdom · MHRA | Australia · TGA | Canada · Health Canada |
|---|---|---|---|---|
| Status | Approved | Approved | Approved | Approved |
| Classification | FDA-approved, prescription only | Licensed, prescription only (MHRA) | TGA-registered, prescription only | Health Canada approved, prescription only |
| Note | Taking it to slow ageing is off label. No regulator anywhere has reviewed an ageing indication for this drug. | Licensed for diabetes, heart failure and chronic kidney disease. | None recorded | None recorded |
US FDA status: FDA approved for type 2 diabetes, for reducing cardiovascular death in adults with type 2 diabetes and established cardiovascular disease, for heart failure across the ejection fraction range, and for chronic kidney disease. Not approved for ageing, longevity or healthspan.. Reviewed Sep 2026.
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General information current as of Sep 2026, not legal advice. Classifications change; confirm with the regulator or a lawyer for a specific situation. Educational use only. This database summarizes published research. It is not medical advice and contains no dosing protocols or recommendations for personal use. The Longevity Archive has no vendor relationships.