AI illustration · not actual product photoDetails from the source.
Source-listed Semax (SKU XA10): 10mg*10vials. PriceList(1).pdf lists 63 per 10 vials but does not specify currency; the website displays $63 per 10 vials in USD per owner instruction. The source row does not establish the supplier-specific item's identity, lot quality, or approval.
- Catalogue code
- XA10
- Source specification
- 10mg*10vials
- Source document
- PriceList(1).pdf, page 1
- Photograph
- AI-generated illustration only — not an actual product photo or verified molecular depiction; owner-approved product photo still pending.
Product information is presented from supplied source materials. Inclusion on this website does not state that a product is an approved medicine or authorize human use. This is educational content, not medical advice.
Compound-level research and safety context.
Evidence below concerns the research family associated with this listing. For blends, findings about individual components do not establish evidence for the combination. This does not verify the supplier-specific vial or lot. Reviewed 2026-10-30.
What it is
Semax is described in the literature as a synthetic heptapeptide related to ACTH(4–10). It is a peptide. The catalogue’s label does not resolve whether the particular vial contains Semax free base, an acetate salt, another form, or a verified Semax substance.
Biological mechanism
Semax’s mechanism is not fully understood. Animal studies report altered brain BDNF and TrkB expression and changes in immune- and vascular-related gene expression after experimental ischemia. These are preclinical findings; they do not establish a mechanism in humans or for the catalogue vial.[5] [6]
Research focus
Human research has principally examined ischemic stroke and post-stroke rehabilitation. Laboratory and animal research has examined neurotrophic, neuroprotective, and gene-expression effects. FDA reviewed proposed uses related to cerebral ischemia, migraine, and trigeminal neuralgia, and found the evidence insufficient to support effectiveness for these proposed uses.[1] Catalogue rows, reproduced exactly from PriceList(1).pdf p.1: XA5 — *10vials, 43 per 10 vials; XA10 — *10vials, 63 per 10 vials. The PDF does not state a currency.
Potential applications in the evidence
Investigated—not established—as a research subject in acute ischemic stroke and post-stroke rehabilitation. FDA also evaluated proposed use for cerebral ischemia, migraine, and trigeminal neuralgia, but determined the available evidence insufficient to support effectiveness for those uses.[1] Do not present these as proven or approved applications.
Human evidence
A 1997 Russian-language clinical report compared 30 patients with acute ischemic stroke receiving Semax as part of combined care with 80 controls and reported improvement in some neurological measures; its abstract does not describe random allocation.[3] A 2018 Russian-language study followed 110 post-stroke patients in early- and late-rehabilitation groups with Semax and non-Semax subgroups, reporting changes in BDNF and functional measures; the abstract does not establish randomization or independent replication.[4] FDA found the evidence insufficient to support effectiveness for its reviewed uses. FDA also found no published human pharmacokinetic studies and insufficient clinical information to characterize safety. These studies do not establish efficacy or safety for this product-specific vial.[1]
Known and potential effects
The reviewed literature does not adequately characterize adverse effects. FDA noted that most clinical reports did not discuss adverse events; one report stated none occurred, which is not enough to establish safety. FDA cited a report raising a possible antithrombotic effect and potential bleeding concern, particularly in people at bleeding risk or using medicines that increase bleeding risk.[1] For some routes, FDA also raises potential immunogenicity concerns for compounded Semax products because of possible aggregation and peptide-related impurities; this is a potential product-quality-related risk, not a verified effect of this catalogue vial.[1] [2]
Safety and contraindications
Human safety evidence is insufficient. FDA identified no safety data for a proposed subcutaneous route, no published human pharmacokinetic studies, and inadequate information to characterize intranasal safety. Its review flags potential bleeding risk and, for certain routes of compounded products, immunogenicity associated with aggregation or peptide-related impurities.[1] [2] The catalogue provides no route, manufacturer, lot, formulation source, or certificate of analysis, so product-specific risks and contraindications cannot be verified. These warnings do not establish that this item is compounded. No specific contraindication list for the exact vial was verified.
U.S. FDA / regulatory status
FDA’s 2026 briefing states Semax (free base) and Semax acetate are not components of an FDA-approved drug and reports Russian registration as 0.1% and 1% nasal drops; this does not establish U.S. approval or the identity of the catalogue vial.[1] FDA reviewed Semax-related bulk substances for possible inclusion on the 503A Bulks List and proposed against inclusion; that compounding-list process is separate from drug approval. The reviewed FDA materials do not verify a final determination on the list as of 2026-10-30. No approval or jurisdictional status can be verified for this supplier-specific item.
Evidence limitations
Most human evidence located consists of older or regional Russian-language reports with limited detail in the abstracts. Randomization and independent replication are not established in the cited studies. FDA judged available evidence insufficient for the proposed uses and found the clinical safety profile insufficiently characterized.[1] Animal and molecular findings cannot be transferred as established human benefits. FDA notes that Semax common-name usage has included multiple salts or derivatives, and clinical references often do not specify whether free base or a salt was used.[1] The supplier vial’s identity, active form, manufacturer, lot, formulation source, jurisdiction, quality, route, and authorization cannot be verified. The price list alone does not establish whether the item is compounded or research-only.
Supporting sources
- FDA Evaluation of Semax-Related Bulk Drug Substances: Semax Free Base and Semax Acetate U.S. Food and Drug Administration · Official regulatory briefing document. Supports: Molecular identity uncertainty; FDA review of clinical evidence, effectiveness, human safety, potential bleeding and immunogenicity concerns, Russian registration, and distinction from FDA approval and 503A Bulks List evaluation.
- Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks U.S. Food and Drug Administration · Official regulatory safety communication. Supports: FDA warning that compounded Semax may pose immunogenicity risk for certain routes due to potential aggregation and peptide-related impurities, and that human safety information is inadequate.
- Effectiveness of semax in acute period of hemispheric ischemic stroke (a clinical and electrophysiological study) PubMed, National Library of Medicine · Primary clinical study record. Supports: 1997 human clinical report involving 30 Semax-treated patients and 80 controls; reported outcomes and limitations visible in the abstract.
- The efficacy of semax in the treatment of patients at different stages of ischemic stroke PubMed, National Library of Medicine · Primary clinical study record. Supports: 2018 study of 110 post-stroke patients, rehabilitation groupings, BDNF and functional outcomes, and abstract-level design limitations.
- Semax, an analog of ACTH(4-10) with cognitive effects, regulates BDNF and trkB expression in the rat hippocampus PubMed, National Library of Medicine · Primary animal study record. Supports: Heptapeptide sequence and rat findings involving BDNF/TrkB expression; supports preclinical-mechanism distinction.
- The peptide semax affects the expression of genes related to the immune and vascular systems in rat brain focal ischemia: genome-wide transcriptional analysis BMC Genomics via PubMed Central, National Library of Medicine · Peer-reviewed primary animal study. Supports: Rat ischemia findings on immune- and vascular-related gene expression and their preclinical nature.