Older regional stroke and rehabilitation studies report neurological/functional signals and BDNF changes, but this evidence does not establish healthy-person cognitive enhancement.
Regulatory status
Not FDA/EMA-approved; US compounding status has been under FDA review.
Main limitations
Healthy-person cognitive enhancement, broad neuroprotection, long-term compounded-route safety or an approved regimen.
Safety
Safety data outside regional clinical experience are limited; FDA has highlighted insufficient safety information for compounded Semax.
i
Older regional stroke and rehabilitation studies report neurological/functional signals and BDNF changes, but this evidence does not establish healthy-person cognitive enhancement.
What the evidence actually supports
✓Cognition hub should distinguish human signal from strength/modernity of evidence.
✓Separate stroke rehabilitation evidence from nootropic marketing.
✓Do not translate this evidence into healthy-person cognitive-enhancement claims.
✓Page should pair older efficacy reports with current safety uncertainty.
What is not established / key limitations
×Modern large healthy-population RCT evidence is lacking; regional use does not establish universal approval.
×The study does not establish healthy-person cognitive enhancement.
×No modern large multinational placebo-controlled outcome programme establishes routine stroke efficacy.
×No adequate subcutaneous safety dataset and limited modern human PK/safety information.
Selected study & evidence records
Semax during rehabilitation after ischemic stroke
2018 · Clinical comparative rehabilitation study · n=110
Semax exposure was associated with higher BDNF and faster/final Barthel-index improvement in the study groups.
Safety data outside regional clinical experience are limited; FDA has highlighted insufficient safety information for compounded Semax.
FDA says compounded Semax has no or limited safety information for proposed routes and may pose immunogenicity/impurity risks.
Technical details
Mechanism / biologyProposed neurotrophic/neuroprotective signalling with effects on melanocortin-related and gene-expression pathways.
Route / formulation boundaryDo not convert regional clinical use into a general cognitive-enhancement claim.
Identity / data-quality noteUse the canonical compound identity and studied formulation when interpreting evidence.
Dosing evidence statusVerified dosing evidence added. Published human intranasal research range. See dosing_evidence records for route, regimen, population, duration and source.
Identifiers & alternate namesnasal SEMAX
Evidence rule: WhichPeps keeps human, animal, laboratory, regulatory and product/formulation evidence distinct. Common names help people find the page; they do not change the underlying scientific identity.