{"id":"semax","name":"Semax","aliases":["ACTH(4-7)-Pro-Gly-Pro","heptapeptide nootropic"],"url":"https://lyoresearch.com/compounds/semax","class":{"id":"nootropic-peptides","name":"Nootropic and sleep peptides","url":"https://lyoresearch.com/classes/nootropic-peptides"},"summary":"Semax is a seven-amino-acid peptide derived from ACTH, developed in Russia in the 1980s and registered there for stroke and cognitive indications. It is not approved in the EU, US or UK. The human literature is almost entirely Russian-language, largely uncontrolled or poorly reported by international standards, and has not been replicated by independent groups — which is why the cognitive and stroke claims sit at grade D despite the registration.","overall_grade":"D","overall_grade_meaning":"no human evidence","human_trials":"Russian-language, largely uncontrolled","regulatory_status":"Not approved (outside Russia)","molecule":{"formula":"C37H51N9O10S","molecular_weight":"813.9","cas":"80714-61-0","pubchem_cid":9811102,"note":null},"pharmacokinetics":{"basis":"animal","route":"Intranasal","half_life":"No human pharmacokinetic data; rat intranasal kinetics only","licensed_regimen":null,"product":null,"source":{"title":"Kinetics of Semax penetration into the brain and blood of rats after intranasal administration (Russian)","url":"https://pubmed.ncbi.nlm.nih.gov/16523722/"}},"outcomes":[{"outcome":"Cognitive performance","grade":"D","grade_meaning":"no human evidence","effect_size":"not measurable","adverse":false,"human_studies":"Russian-language, mostly uncontrolled","evidence":"Small studies, often without blinding or a comparison group, published outside the indexed international literature. No independent replication.","references":[{"citation":"Searches of PubMed and trial registries for Semax human trials outside Russia.","where":"LYO literature search, September 2026","url":"https://pubmed.ncbi.nlm.nih.gov/?term=Semax+randomized+controlled+trial"}]},{"outcome":"Stroke recovery","grade":"D","grade_meaning":"no human evidence","effect_size":"not measurable","adverse":false,"human_studies":"Russian trials, not independently replicated","evidence":"The basis of the Russian registration. Not reproduced in trials meeting international reporting standards.","references":[{"citation":"Searches of PubMed and trial registries for Semax human trials outside Russia.","where":"LYO literature search, September 2026","url":"https://pubmed.ncbi.nlm.nih.gov/?term=Semax+randomized+controlled+trial"}]},{"outcome":"Anxiety / stress","grade":"D","grade_meaning":"no human evidence","effect_size":"not measurable","adverse":false,"human_studies":"None controlled internationally","evidence":"Claims derive from animal work and from the related peptide Selank.","references":[]},{"outcome":"Safety in humans","grade":"D","grade_meaning":"no human evidence","effect_size":"not measurable","adverse":true,"human_studies":"No systematic international data","evidence":"Long Russian clinical use is reassuring but not equivalent to pharmacovigilance data.","references":[]}],"regions":[{"region":"European Union","status":"Unauthorised in the EU","note":"Authorised in Russia only. Supplying it for human use in the EU is an offence under national medicines law."},{"region":"United States","status":"Not approved; compounding under review","note":"Removed from FDA's Category 2 list on 22 April 2026; the Pharmacy Compounding Advisory Committee recommended it for the 503A bulks list in July 2026 (recommended 24 July 2026). Not on the list yet and not an approved drug. Sold otherwise as an unapproved 'research chemical'."},{"region":"United Kingdom","status":"Unlicensed medicine","note":"No MHRA licence; supply for human use is an offence."},{"region":"Australia","status":"Schedule 4, unapproved","note":"Prescription-only substance not on the ARTG. Possession without a prescription is an offence; imports without a prescription are seized."},{"region":"Canada","status":"Not authorised","note":"No Drug Identification Number; selling it is illegal. Residents cannot import prescription drugs by mail."},{"region":"Sport (WADA)","status":"Not on the list","note":"Approved in Russia, so S0 does not apply, and it is not named."}],"faq":[{"q":"Semax is approved in Russia — doesn't that count?","a":"It counts as a regulatory fact, not as evidence of effect at the standard LYO grades on. The trials behind the registration are largely unavailable in the indexed international literature and have not been independently replicated."},{"q":"Does Semax improve memory or focus?","a":"No trial meeting international standards has tested it. The claims come from small Russian studies and from animal work."}],"references":[{"cite":"Searches of PubMed and trial registries for Semax human trials outside Russia.","where":"LYO literature search, September 2026","url":"https://pubmed.ncbi.nlm.nih.gov/?term=Semax+randomized+controlled+trial","note":"No randomised trials meeting international reporting standards were identified."}],"last_reviewed":"2026-09-02","literature_searched_to":"2026-09-02","changelog":[{"date":"2026-09-02","note":"Initial publication. Graded D on absence of internationally reported controlled evidence; Russian registration noted separately."}],"license":"CC BY 4.0 — cite as “LYO Research” with a link.","methodology":"https://lyoresearch.com/methodology"}