Regulatory landscape

Approved in Russia, unapproved in the West

Semax occupies an unusual regulatory position: a registered drug in Russia, and in the US a substance with no FDA approval that is still marketed through clinics and online sellers. Understanding why explains a lot about the whole evidence picture.

This unit maps where Semax is approved, traces its approval history, sets out what can and cannot be said about its status in the US, EU, UK, and Australia, and explains the regulatory gap without pretending it means the drug is either safe or unsafe.