Legal status · Record reviewed
Semax has no single legal status. It depends on the product and how it is supplied.
Registered in Russia; no FDA-approved U.S. product or final 503A listing was identified as reviewed August 30, 2026.
Pharmacy mixing (compounding): FDA had placed it in Category 2 for possible safety risks, and the request was then withdrawn (FDA page dated April 22, 2026).
Sports: we have no current sports-rule review for it yet.
Rules for buying, selling, and prescribing also depend on how a product is made and sold, and on state law.
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Approved outside the U.S. only
A regulator in another country allowed a product. The record found no FDA-approved product in the United States.
What the record says: Registered in Russia; no FDA-approved U.S. product or final 503A listing was identified as reviewed August 30, 2026
Nomination withdrawn
FDA had placed it in Category 2 for possible safety risks. The person who asked FDA to allow it in compounding then withdrew the request. FDA still lists its safety concerns and has not made a final decision. A withdrawn request is neither a ban nor an approval.
Source: FDA's page of bulk drug substances that may present significant safety risks. FDA marks it current as of . We checked it on .
Not assessed
This editorial review did not determine sport eligibility. Athletes must check the current prohibited list, Global DRO, and their governing body.
Check the current World Anti-Doping Agency list and your sport's rules before you compete.
Other names in this record: Heptapeptide Semax.
What it is, what studies in people show, and what is still unknown.
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