Legal status by country
Is Mecasermin legal?
Written by Aaron CuhaReviewed Sep 2026
How Mecasermin 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 | INCRELEX, BLA 021839, Ipsen, approved 30 August 2005, prescription only. The indication is paediatric severe primary IGF-1 deficiency. Prescribing it for muscle, ageing or athletic purposes is outside the approved indication and unsupported by trial evidence. | Licensed for the same paediatric indication. The original European authorisation was granted in August 2007 under exceptional circumstances, reflecting how few patients exist to study. | Registered with the TGA (Ipsen Pty Ltd) for long-term treatment of growth failure in children and adolescents aged two to eighteen with severe primary IGF-1 deficiency. | Health Canada issued a Notice of Compliance to Ipsen Biopharmaceuticals Canada in December 2020 for severe primary IGF-1 deficiency in patients aged two to eighteen. Before that it was available only through the Special Access Programme. |
US FDA status: FDA-approved. INCRELEX (mecasermin), BLA 021839, sponsor Ipsen, original approval 30 August 2005, prescription only. Indicated for growth failure in children with severe primary IGF-1 deficiency and in children with growth hormone gene deletion who have developed neutralising antibodies to growth hormone. It is not approved for adults, for sarcopenia, for recovery or for any performance use.. 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.