Legal status by country
Is Metreleptin legal?
Written by Aaron CuhaReviewed Sep 2026
How Metreleptin 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 | Approved only for generalised lipodystrophy, with a boxed warning for neutralising antibodies and T-cell lymphoma, under a restricted distribution programme. Explicitly not approved for general obesity. | None recorded | None recorded | None recorded |
US FDA status: FDA-approved as Myalept for complications of leptin deficiency in generalised lipodystrophy. Carries a boxed warning for anti-metreleptin antibodies with neutralising activity and for T-cell lymphoma risk, and is subject to a restricted distribution programme. Not approved for obesity or partial lipodystrophy.. Reviewed Sep 2026.
Related compounds
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.