Semax

Classification

Synthetic ACTH fragment analogue (nootropic research)

Approval status

Investigational · Not approved for human use

Research status

Used as a registered product in some jurisdictions outside ICH-aligned TGA/FDA/EMA pathways; not an FDA/TGA approved nootropic. Treat as investigational in Australia.

Molecular formula

Insufficient reliable evidence identified.

Molecular weight

Insufficient reliable evidence identified.

Sequence

Met-Glu-His-Phe-Pro-Gly-Pro (ACTH(4–10) analogue with Pro-Gly-Pro)

Primary biological target

Proposed melanocortin-related and neurotrophic signalling. Mechanism not yet fully established outside regional product use.

Half-life

Insufficient reliable evidence identified.

Routes investigated

Intranasal (regional clinical use), Parenteral in experimental literature

Human evidence level

C — Limited or early human evidence

A peptide studied mainly in Russian clinical and experimental literature for neurological and cognitive research. It is not an approved cognitive medicine on the ARTG.

Synthetic ACTH fragment analogue developed in Russian clinical research programmes.

Proposed mechanism

Proposed mechanism: Semax is reported to influence BDNF-related and melanocortin-adjacent pathways in experimental systems. Mechanism not yet fully established by FDA/EMA labelling. Human data are largely regional and not equivalent to a modern Western NDA package.

Human pharmacology is less standardised in English-language Phase 3 programmes than for Western approved peptide drugs.

• Ischaemic stroke / cognition (regional literature)

  C · Limited or early human evidence

  Early human research in regional literature has examined stroke and cognitive settings. Quality and generalisability vary.^[1]

Investigational findings are not proven clinical benefits unless an authority has labelled that indication.

Overall human evidence grade: C · Limited or early human evidence

A body of clinical reports exists largely outside ICH-standard global registration packages. Quality and bias vary. Not a substitute for TGA-evaluated nootropic medicines (of which few exist).

Animal, cell and in-vitro findings are listed separately from human effects.

Rodent studies report BDNF and behavioural effects; translation is uncertain.

This section does not provide personalised medical dosing. Values are those reported in papers or protocols. Animal mg/kg doses are not converted to human doses.

Doses reported in human studies

Insufficient reliable evidence identified.

Preclinical / animal study dosing

Insufficient reliable evidence identified.

Intranasal regional products exist; ICH-standard PK for Australian registration was not identified.

Nasal irritation possible with intranasal use; a complete ICH AE table was not identified.

Unknowns. Compounded research sprays are not regional registered products.

Contraindications. Not for self-administration. Not approved for human use in Australia.

Australia — TGA

Not an established ARTG nootropic peptide.

United States — FDA

Not approved.

European Union — EMA

Not centrally authorised as a cognitive peptide drug.

1. [1] A nootropic ACTH(4-10) analogue Semax: studies in healthy volunteers and patients

   Asmarin IP et al. / related Semax clinical reports A nootropic ACTH(4-10) analogue Semax: studies in healthy volunteers and patients Neurosci Res Commun / Russian clinical literature. 1997. PMID 9448131

   PMID 9448131