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. Its legal category is "FDA-approved, prescription only". The approval covers the use on its label. It is given out on prescription, not sold over the counter. Products labeled "research use only" are not covered by that approval, and that label does not make them legal to use in people. On the evidence, 1 completed human trial is cited on its profile.
- People given it
- 76
- Found nothing
- 0
Legal category
FDA-approved, prescription only
INCRELEX, BLA 021839, Ipsen, approved 30 August 2005, prescription only. It is approved for children with a severe IGF-1 shortage. Prescribing it for muscle, ageing or sport is outside its approved use, and no trials back that use.
Reviewed Sep 2026. This is a legal category, not legal advice.
A "research use only" label on a vial does not make it legal to use on people.
Mecasermin in the United States at a glance
| Legal category | FDA-approved, prescription only |
|---|---|
| Note | INCRELEX, BLA 021839, Ipsen, approved 30 August 2005, prescription only. It is approved for children with a severe IGF-1 shortage. Prescribing it for muscle, ageing or sport is outside its approved use, and no trials back that use. |
| FDA approval status | FDA-approved. INCRELEX (mecasermin), BLA 021839, made by Ipsen, first approved 30 August 2005, prescription only. It is for children who are not growing because of a severe IGF-1 shortage that is not caused by low growth hormone. It is also for children missing the growth hormone gene whose immune system has started blocking growth hormone treatment. It is not approved for adults, for age-related muscle loss, for recovery or for any performance use. |
| Studies in people | 5 of 5 sources on the profile |
| Reviewed | Sep 2026 |
The legal category and note come from the Mecasermin profile. We checked them against U.S. Food and Drug Administration (FDA) listings on the reviewed date.
What this means
- 01
FDA has approved Mecasermin for at least one use named on its label. So a proper pharmacy-grade product exists in the United States, and pharmacies hand it out on prescription.
- 02
Approval covers only the uses named on the label. Any other use is a prescriber's call. The approval itself does not cover it.
- 03
Unlicensed vials sold online, including those labeled "research use only", are not the approved product. The approval does not cover them.
What Mecasermin is
An approved medicine, but only for a rare condition in children. In 76 children with a severe shortage of IGF-1, growth sped up from 2.8 cm a year to 8.0 cm a year in the first year, and 49 percent had low blood sugar. Children followed to the end of puberty moved a good way up the height chart but stayed well short of average.
Mecasermin is a lab-made copy of human IGF-1, the finished 70 amino acid form of the hormone. It is given as a shot under the skin, twice a day with food.
How it works: Mecasermin locks onto the IGF-1 receptor on cells. That switches on growth signals inside the cell, called PI3K/Akt and MAPK.
Approval history: FDA-approved. INCRELEX (mecasermin), BLA 021839, made by Ipsen, first approved 30 August 2005, prescription only. It is for children who are not growing because of a severe IGF-1 shortage that is not caused by low growth hormone. It is also for children missing the growth hormone gene whose immune system has started blocking growth hormone treatment. It is not approved for adults, for age-related muscle loss, for recovery or for any performance use.
How FDA treats this kind of product
Approves prescription drugs, each for a named use. It also acts against unapproved products, including peptides sold online. Compounding pharmacies, which mix drugs to order, may make some compounds with a prescription. That only applies when the FDA puts the compound in a category of bulk ingredients it allows.
The legal category above is how The Longevity Archive reads U.S. Food and Drug Administration listings for Mecasermin on the reviewed date. It is not a legal opinion. Rules change. Bringing a compound into the country, prescribing it and owning it can each be treated differently. Check with the agency before you act on anything here.
Mecasermin in sport and the military
Whether Mecasermin is banned in sport is set by the World Anti-Doping Code and by military rules, not by its legal status in the United States. Before you compete or get tested, look up Mecasermin by name on the Prohibited List, or look up a named product in Global DRO. Under the World Anti-Doping Code, category S0 bans, at all times, any drug-like substance that meets two tests. No other section of the List covers it. And no government health regulator anywhere has a current approval for it as a treatment in people. Many substances that are approved somewhere are banned by name in another section. So approval does not mean a substance is allowed in sport.
- WADA Prohibited List
- Global DRO (check a named product)
- USADA (US athletes)
- Operation Supplement Safety (US service members)
The rules you compete or serve under decide this, not this page.
Mecasermin in other countries
Frequently asked questions
Is Mecasermin legal in the United States?
Yes. Mecasermin is an approved medicine in the United States. Its legal category is "FDA-approved, prescription only". The approval covers the use on its label. It is given out on prescription, not sold over the counter. Products labeled "research use only" are not covered by that approval, and that label does not make them legal to use in people. On the evidence, 1 completed human trial is cited on its profile. Note: INCRELEX, BLA 021839, Ipsen, approved 30 August 2005, prescription only. It is approved for children with a severe IGF-1 shortage. Prescribing it for muscle, ageing or sport is outside its approved use, and no trials back that use.
Can I buy Mecasermin in the United States?
Only with a prescription. In the United States, Mecasermin has the legal category "FDA-approved, prescription only". Pharmacies hand it out with a prescription, for the use it is approved for. Buying it from unlicensed sellers online, or as a "research chemical", is outside that system. You get none of the protection the regulator gives. Note: INCRELEX, BLA 021839, Ipsen, approved 30 August 2005, prescription only. It is approved for children with a severe IGF-1 shortage. Prescribing it for muscle, ageing or sport is outside its approved use, and no trials back that use.
Is Mecasermin FDA approved?
Yes. FDA status: FDA-approved. INCRELEX (mecasermin), BLA 021839, made by Ipsen, first approved 30 August 2005, prescription only. It is for children who are not growing because of a severe IGF-1 shortage that is not caused by low growth hormone. It is also for children missing the growth hormone gene whose immune system has started blocking growth hormone treatment. It is not approved for adults, for age-related muscle loss, for recovery or for any performance use.. Current US legal category: "FDA-approved, prescription only". On the evidence, 1 completed human trial is cited on its profile.
Related compounds in the United States
Full research profile
How Mecasermin works, the studies we cite, FDA status and the full legal summary are all on its compound profile.
Mecasermin profileThis page is general information about the legal status of Mecasermin in the United States, current as of Sep 2026. It is not legal advice. Legal status changes. For your own situation, check with U.S. Food and Drug Administration or ask a lawyer. Educational use only. This database summarizes published research and is not medical advice. Where a dose appears it is a record of what a trial or clinic ran, or what people describe doing, with its source attached. Nothing here is a recommendation for personal use. Sellers named on the price pages are ranked by certificate tier, then price, and any affiliate income is disclosed there. Naming a seller is not a recommendation to buy or use anything.