Synthetic ACTH-fragment-derived neuroactive heptapeptide
Semax is a seven-amino-acid peptide researched mostly for brain recovery, cognition, and neuroprotection. Small and older human studies report signals, but the evidence does not establish a reliable focus, memory, stroke, migraine, or pain treatment.
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Depth and confidence summarize the research record—not effectiveness, safety, or a recommendation.
Small human imaging, stroke, and pain reports exist alongside extensive animal and mechanistic research, but no modern pivotal program was located.
Research depth describes how large and mature the overall record is. It does not tell you whether the results were positive.
Human findings are small, old, incompletely controlled, and not independently replicated across modern clinical outcomes.
Confidence describes how reliable and consistent the conclusions are. It can be high for one outcome and low for another.
The strongest evidence type shows what the best-supported conclusions are actually based on.
Human findings are more directly relevant than animal or laboratory results, but they still apply only to the populations and outcomes studied.
Route-specific record
These are exposures used in cited research for a specific route and population—not a suggested amount.
Half-life describes how long it takes the measured amount in the body to fall by half. It is not a dosing recommendation.
Evidence can change by administration method. Findings from one route should not automatically be applied to another.
Evidence boundary: The studies involved different populations, formulations, endpoints, and co-treatments, and often did not identify free base versus acetate. Their exposures do not form one universal nasal regimen. Amounts shown describe cited research exposure—not a dosage recommendation.
Practical starting point
Common goals and questions—not recommendations or promises of benefit.
The overview, studies, and source ledger below explain what supports each label—and where the evidence stops.
The short version
Semax is a seven-amino-acid peptide researched mostly for brain recovery, cognition, and neuroprotection. Small and older human studies report signals, but the evidence does not establish a reliable focus, memory, stroke, migraine, or pain treatment.
Evidence reviewed through July 25, 2026. Human imaging, older Russian-language clinical reports, FDA regulatory review, and animal or laboratory findings are labeled separately.
What the evidence says
A 24-person placebo-comparison fMRI study found an acute default-mode-network change, while two older stroke reports involving 110 participants each described recovery or BDNF signals. None provides a modern, independently replicated, blinded efficacy record.
This is the strongest supported conclusion in the current human evidence—not a summary of every claim made about the compound.
Whether Semax produces meaningful, reproducible clinical benefit and what its human pharmacokinetics, product-form differences, route-specific exposure, repeated-use safety, immunogenicity, bleeding risk, and interaction profile look like.
Keeping the main uncertainty visible prevents an early or promising finding from looking more settled than it is.
The evidence story
Importance shows how much an item changes the evidence story. Quality shows how much confidence the design deserves. A strong negative study can score highly on both.
Importance and quality answer different questions. A rigorous study can be highly important even when it challenges a popular claim.
Four of 12 migraine participants reported headache cessation at 90 to 120 minutes. The typical trigeminal-neuralgia group did not improve; some subjective improvement was described in dental plexalgia without a broad objective effect.
FDA found insufficient effectiveness evidence for the reviewed conditions, no human pharmacokinetic study, and no human SubQ safety data. Advisory-committee consideration does not make Semax FDA approved.
Semax bound copper, reduced copper-linked reactive oxygen species, and reduced toxicity in the cell model.
The Semax group showed a larger rostral default-mode-network subcomponent than the placebo group after administration.
The report associated Semax exposure with higher plasma BDNF and faster Barthel-index improvement, while early rehabilitation was also strongly associated with recovery.
Administration and handling
Published human reports located by FDA used intranasal Semax, with widely varying historical study exposures and incomplete identification of free base versus acetate. FDA found no human pharmacokinetic study by any route and no human subcutaneous safety or efficacy evidence. Study schedules are descriptions of research—not an approved dose, route, cycle, or self-use protocol.
No FDA-approved Semax product label, consumer reconstitution method, or official storage instruction exists in the United States. Free base and acetate are distinct substances and should not be assumed interchangeable. FDA found inconsistent naming and certificates of analysis, limited impurity and aggregate controls, and unresolved device, microbial-quality, stability, and immunogenicity questions. Supplier-reported cold-storage statements cited in the FDA briefing are not regulator-approved consumer instructions.
Primary-source ledger
2026-07-24
2026-07-01
2025-06-03 · PMID 40496623 · DOI 10.1155/bca/4226220
2021-06-11 · PMID 34201112 · DOI 10.3390/ijms22126179
2018-09-01 · PMID 30225715 · DOI 10.1007/s10517-018-4234-3
2018-01-01 · PMID 29798983 · DOI 10.17116/jnevro20181183261-68
2017-06-01 · PMID 28255762 · DOI 10.1007/s00438-017-1297-1
2006-10-30 · PMID 16996037 · DOI 10.1016/j.brainres.2006.07.108
1997-01-01 · PMID 11517472