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Approved in Russia for stroke recovery and cognitive decline since 1994 — with a research tradition that runs deep but hasn't crossed into Western regulatory evidence.
Semax has one of the longest track records of any peptide on this page — three decades of Russian clinical use for serious neurological conditions. It's also never been reviewed by the FDA. Both facts are worth holding at once.
Semax is a synthetic peptide derived from a fragment of ACTH (adrenocorticotropic hormone), developed and approved in Russia in 1994 for acute ischemic stroke, post-stroke cognitive recovery, age-related cognitive decline, and certain optic nerve conditions. It has never been submitted for FDA review and has no approval status anywhere in the Western regulatory system.
Semax is thought to influence brain-derived neurotrophic factor (BDNF) signaling and modulate neurotransmitter systems involved in attention and memory, which underlies its use for cognitive and neurological recovery in the Russian literature.
Semax has a deeper published clinical history than most compounds on this page — including real human data in serious conditions like acute stroke, most notably a widely cited 1997 study (Gusev) — plus smaller studies in healthy volunteers looking at cognitive effects. The catch is consistent with Selank: this evidence comes from an older Russian research tradition, uses methodology that predates current Western trial standards, and has not been independently replicated by Western research groups. More clinical history than most investigational peptides here; still not equivalent to Western-standard trial evidence.
The Russian clinical literature, spanning genuine acute-stroke use, generally reports a favorable safety profile. Without independent Western replication, a modern safety profile by US regulatory standards isn't established, which is why this belongs under provider supervision with explicit acknowledgment of that evidence gap — not self-directed use, and not for anyone with unevaluated neurological or cardiovascular conditions.
Semax's three-decade Russian clinical history — including use in acute stroke — makes it one of the more clinically seasoned compounds on this page. It still hasn't been reviewed by US regulators or independently replicated in Western trials, and that gap deserves the same honesty here that we give every other peptide.
Regulatory status as of 2026-07-20.
This article is for educational purposes only and is not medical advice. It does not establish a provider-patient relationship. FDA-approval status and clinical information are summarized in general terms and may change; consult a licensed healthcare provider and current prescribing information before making any medical decision. Bioaminex does not sell or dispense Semax or any medication.