Legal status · United States
Is Mecasermin legal in the United States?
Written by Aaron CuhaReviewed Sep 2026
Direct answer
Yes. Mecasermin is an approved medicine in the United States, classified as "FDA-approved, prescription only". Approval covers its labeled indication and it is supplied on prescription, not over the counter. Products labeled "research use only" fall outside that approval and the label does not make human use lawful. On the evidence, 5 human studies are cited on its profile.
Mecasermin in the United States at a glance
| Classification | FDA-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. |
| FDA approval 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. |
| Human studies cited | 5 of 5 citations on the profile |
| Reviewed | Sep 2026 |
Classification and note come from the Mecasermin profile, checked against U.S. Food and Drug Administration (FDA) listings at the reviewed date.
What this means
- 01
FDA has approved Mecasermin for at least one labeled indication, so a pharmaceutical-grade product exists in the United States and is dispensed on prescription.
- 02
Approval is indication-specific. Uses outside the label are a clinical decision for a prescriber, not something the approval itself authorizes.
- 03
Unlicensed online vials, including those labeled "research use only", are not the approved product and are not covered by the approval.
What Mecasermin is
An approved medicine, and only for a rare paediatric deficiency. In 76 children with severe IGF-1 deficiency, height velocity rose from 2.8 cm per year at baseline to 8.0 cm per year in the first year, and 49 percent had hypoglycaemia. Among registry patients followed to the end of puberty, mean height moved from about 3.7 to about 2.6 standard deviations below the mean in boys: better, still short.
Mecasermin is recombinant human IGF-1, the mature 70 amino acid hormone, given by subcutaneous injection twice daily with food. It is the only entry in this batch that is an approved medicine, and it is approved for one narrow thing: growth failure in children and adolescents with severe primary IGF-1 deficiency, and in children with growth hormone gene deletion who have developed neutralising antibodies to growth hormone.
Mechanism: Mecasermin binds the IGF-1 receptor, a receptor tyrosine kinase, activating PI3K/Akt and MAPK signalling to drive cell growth, protein synthesis and, at the growth plate, linear bone growth. It also has meaningful affinity for the insulin receptor, which is the direct reason hypoglycaemia is the principal adverse effect and why the product is dosed with a meal.
Regulatory history: 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.
How FDA treats this kind of product
Approves prescription drugs by indication and polices unapproved products, including peptides sold online. Compounding pharmacies may prepare some compounds under a prescription when the FDA places them on a permitted bulk-substances category.
The classification above is the The Longevity Archive reading of U.S. Food and Drug Administration listings for Mecasermin at the reviewed date, not a legal opinion. Rules change, and importing, prescribing and possessing a compound can each be treated differently. Check the regulator directly before acting on anything here.
Mecasermin in other countries
Frequently asked questions
Is Mecasermin legal in the United States?
Yes. Mecasermin is an approved medicine in the United States, classified as "FDA-approved, prescription only". Approval covers its labeled indication and it is supplied on prescription, not over the counter. Products labeled "research use only" fall outside that approval and the label does not make human use lawful. On the evidence, 5 human studies are cited on its profile. 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.
Can I buy Mecasermin in the United States?
Only with a prescription. Mecasermin is classified as "FDA-approved, prescription only" in the United States, so it is dispensed by pharmacies against a prescription for its approved indication. Buying it from unlicensed online sellers or as a "research chemical" is outside that system and carries no regulatory protection. 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.
Is Mecasermin FDA approved?
Yes. 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.. Current US classification: "FDA-approved, prescription only". On the evidence, 5 human studies are cited on its profile.
Related compounds in the United States
Full research profile
Mechanism, cited studies, FDA status and the full legal summary for Mecasermin live on its compound profile.
Mecasermin profileThis page is general information about the regulatory status of Mecasermin in the United States, current as of Sep 2026. It is not legal advice, and classifications change; check U.S. Food and Drug Administration directly or consult 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 and does not recommend where to buy anything.