Legal status by country
Is FGF21 legal?
Written by Aaron CuhaReviewed Sep 2026
How FGF21 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 | Not approved | Not approved | Not approved | Not approved |
| Classification | Investigational, not approved | Investigational, not licensed | Investigational, not registered | Investigational, not approved |
| Note | Native FGF21 is not a product. The analogues efruxifermin, pegozafermin and efimosfermin are investigational. | None recorded | None recorded | None recorded |
US FDA status: Not FDA-approved. Native FGF21 is not a drug. No FGF21 analogue (efruxifermin, pegozafermin, efimosfermin) had a Drugs@FDA record on 11 September 2026; efruxifermin and pegozafermin are in phase 3.. 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.