Legal status · United States
Is Stamulumab legal in the United States?
Written by Aaron CuhaReviewed Sep 2026
Direct answer
No. Stamulumab is not an approved medicine in the United States; its classification is "Not approved; research use only". Nothing containing it is authorized for any use in people. Vials labeled "for research use only" are not exempt: that label does not make human use lawful. On the evidence, 3 human studies are cited on its profile.
Stamulumab in the United States at a glance
| Classification | Not approved; research use only |
|---|---|
| Note | Development discontinued after the 2008 phase 1/2 trial. Not available in any form. |
| FDA approval status | Never approved. Development did not continue past this trial. |
| Human studies cited | 3 of 3 citations on the profile |
| Reviewed | Sep 2026 |
Classification and note come from the Stamulumab profile, checked against U.S. Food and Drug Administration (FDA) listings at the reviewed date.
What this means
- 01
No product containing Stamulumab is approved by FDA for any use in the United States, so nothing on the market is authorized for people.
- 02
"Research use only" is a vendor label, not a legal category that permits human use. It does not exempt a product from medicines law.
- 03
Importing, supplying or promoting it for human use can fall under medicines legislation in the United States. This page is general information, not legal advice.
What Stamulumab is
The first anti-myostatin antibody ever given to humans, in 116 adults with muscular dystrophy in 2008. It was safe, it showed a hint of muscle growth, and it did not improve strength or function.
Every myostatin drug on this site descends from this trial. Wyeth, later Pfizer, took the first neutralising antibody against myostatin into adults with three forms of muscular dystrophy and published it in 2008.
Mechanism: A neutralising monoclonal antibody against myostatin, also called GDF-8, a member of the transforming growth factor beta family secreted by skeletal muscle. Myostatin binds activin type II receptors and signals through SMAD2 and SMAD3 to suppress muscle protein synthesis and satellite cell activation.
Regulatory history: Never approved. Development did not continue past this trial.
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 Stamulumab 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.
Stamulumab in other countries
Frequently asked questions
Is Stamulumab legal in the United States?
No. Stamulumab is not an approved medicine in the United States; its classification is "Not approved; research use only". Nothing containing it is authorized for any use in people. Vials labeled "for research use only" are not exempt: that label does not make human use lawful. On the evidence, 3 human studies are cited on its profile. Note: Development discontinued after the 2008 phase 1/2 trial. Not available in any form.
Can I buy Stamulumab in the United States?
No approved product exists to buy. In the United States Stamulumab is classified as "Not approved; research use only", so there is no licensed pharmacy product. Vendors selling it "for research use only" are not selling it for human use, and that label does not change its legal status. This site does not list or recommend vendors. Note: Development discontinued after the 2008 phase 1/2 trial. Not available in any form.
Is Stamulumab FDA approved?
No. FDA status: Never approved. Development did not continue past this trial.. Current US classification: "Not approved; research use only". On the evidence, 3 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 Stamulumab live on its compound profile.
Stamulumab profileThis page is general information about the regulatory status of Stamulumab 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.