Legal status by country
Is Leptin legal?
Written by Aaron CuhaReviewed Sep 2026
How Leptin 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 | Not approved | Not approved | Approved |
| Classification | FDA-approved, prescription only | Prescription only; check current MHRA status | Prescription only; check current TGA status | Health Canada approved, prescription only |
| Note | Myalept, generalised lipodystrophy only, dispensed through the MYALEPT REMS programme. Not indicated for obesity, partial lipodystrophy, HIV-related lipodystrophy or liver disease. | Myalepta received EU marketing authorisation on 30 July 2018 (EMA, orphan medicine). The current MHRA entry was not checked live in this session. | The TGA database could not be reached in this session; Australian registration of metreleptin was not verified. | Myalepta, DINs 02544555, 02544563 and 02544571, Chiesi, status Marketed since 2024, Schedule D (biologic). |
US FDA status: Metreleptin (Myalept) FDA-approved 24 February 2014 (BLA 125390, Chiesi) as an adjunct to diet for complications of leptin deficiency in congenital or acquired generalised lipodystrophy; Drugs@FDA marketing status Prescription on 11 September 2026. Boxed warning for neutralising anti-metreleptin antibodies and T-cell lymphoma; REMS restricted. Not indicated for obesity. Native leptin is not a product.. 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.