Semax Spray 10 mg

One-Peptides SEMAX 10 mg — ACTH(4-10) analogue nasal spray for laboratory research

Semax nasal spray 10 mg is a research reagent (Research Use Only), intended solely for laboratory research and scientific applications. It is neither a medicine nor a dietary supplement and is not intended for use in humans or animals, nor for diagnosis or therapy. In the European Union, Semax is not authorised as a medicinal product. The fact that a registered intranasal medicine of the same name exists in Russia relates to a separate regulatory framework and does not change the status of this reagent in the One Peptides catalogue.

Semax belongs to the family of regulatory peptides originating from the Russian neuropeptide school. It was developed at the Institute of Molecular Genetics of the Russian Academy of Sciences as a synthetic analogue of a fragment of the adrenocorticotropic hormone — specifically the ACTH(4-10) sequence — augmented with a Pro-Gly-Pro tripeptide that slows its enzymatic breakdown. The same institution that developed Semax stands behind its Russian authorisation in the form of nasal drops and spray, used in neurology in the context of ischaemia and cognitive function. For the research world this signifies something important: the form administered across the nasal mucosa carries a genuine laboratory heritage rather than a purely theoretical one.

The nasal spray format here is not a matter of convenience but of research logic. Neuropeptides such as Semax cross the blood–brain barrier poorly after conventional administration, which is why the nose–brain axis (the route by which molecules can reach the central nervous system while bypassing this barrier) is of particular interest to scientists working on neuropeptides. A pre-dissolved solution in a spray applicator makes it possible to reproduce under model conditions precisely the route of administration that has been studied for decades — without the powder reconstitution step.

Semax is a synthetic heptapeptide with the sequence Met-Glu-His-Phe-Pro-Gly-Pro (MEHFPGP) and a molecular weight of approximately 813 Da, being an analogue of the ACTH(4-10) fragment. In the scientific literature it is studied as a compound with nootropic and neuroprotective properties, acting on the expression of BDNF and its trkB receptor in animal models.

What Semax is — sequence and class

Semax is a molecule with a transparent structure: seven amino-acid residues arranged in a chain that links the active fragment of a natural hormone with a stabilising motif. The first four residues (Met-Glu-His-Phe) correspond to the ACTH(4-7) fragment, yet without the steroidogenic hormonal activity characteristic of full ACTH. The attached Pro-Gly-Pro tripeptide performs a protective function — it impedes rapid degradation of the peptide by peptidases, which in models translates into a longer presence of the molecule in the biological environment.

This construction means that Semax is sometimes classified as a regulatory peptide with a neurotropic profile. Unlike the parent ACTH, it does not exhibit significant action on the hypothalamic–pituitary–adrenal axis, and it draws the attention of researchers chiefly because of its effect on the neurotrophin system observed in experimental work.

Chemical characteristics

Mechanism of action in research

The best-documented thread in the literature concerning Semax is its effect on the neurotrophin system, and especially on brain-derived neurotrophic factor (BDNF) and its trkB receptor. In the work of Dolotov et al. it was shown that administration of Semax modulated the expression of BDNF and trkB in the rat brain — an observation that set the direction for further research on this peptide and its potential effect on neuronal plasticity in models.

1. BDNF is one of the most important signalling molecules responsible in the organism for neuronal survival, differentiation and the formation of connections. If one imagines a neuronal network as a garden, BDNF acts within it rather like a fertiliser supporting the growth and maintenance of plants. The effect of Semax on this system observed in research is precisely the reason why the peptide is analysed in the context of neuroprotection and cognitive processes — always, however, as a subject of research, not as an agent with a confirmed effect in humans.
2. The second pillar of knowledge about the mechanism comes from gene-expression analyses. Medvedeva et al. analysed the transcriptional profile of nervous tissue after exposure to Semax in a model of ischaemia, describing changes in groups of genes linked to the neuroprotective response, the immune system and the vascular system. Such an approach, based on a broad read-out of gene activity, helps to understand which biological pathways respond to the presence of the peptide under conditions of experimental ischaemia.
3. Beyond the neurotrophins, the literature also features threads concerning the modulation of attention and learning processes, studied mainly in behavioural rodent models. Levitskaya et al. described the effects of Semax in behavioural tests, placing the peptide within the strand of research into its presumed nootropic profile. All of these observations belong to the domain of basic science — they describe what happens in a model, not in a person taking the substance.

Nasal spray format — research context

The choice of the intranasal route for a neuropeptide is not accidental. The blood–brain barrier effectively protects the central nervous system, but by the same token impedes the access of large, polar molecules — and peptides are among these. Intranasal administration opens an alternative route: through the olfactory epithelium and the nerves in the nasal cavity, molecules may theoretically travel towards brain structures with partial bypassing of the bloodstream and the blood–brain barrier. This nose–brain axis has for years been the subject of research into the administration of neuropeptides.

Semax is here one of the most frequently cited examples, because it was developed in Russia in the intranasal form from the outset. This is a historical precedent that lends the spray form a genuine methodological justification — a research model can reproduce the same route of administration described in the original works. The pre-dissolved solution simplifies sample preparation, eliminating the reconstitution step and the variability associated with it.

A clear distinction must nevertheless be drawn between two things. The intranasal precedent from Russian clinical practice is an argument for the reasonableness of the format in research, not an invitation to use the reagent in humans. The spray format here serves the convenient modelling of the nose–brain route under laboratory conditions — and nothing beyond that.

Semax RUO vs the Russian intranasal medicine

The same three letters on a label can denote two entirely different regulatory entities. The comparison below sets out the difference.

The conclusion is straightforward: the research reagent in the One Peptides catalogue and the Russian neurological preparation are two distinct categories. In the European Union, Semax does not function as an authorised medicine, and this product remains a research material — regardless of how advanced its status may be in other markets.

Applications in scientific research

Semax is a research tool used in several related areas of brain science. The most common laboratory contexts include:

• Neurotrophin pharmacology — studying the effect of the peptide on the expression of BDNF, the trkB receptor and related neurotrophic factors in the nervous tissue of animal models.
• Models of neuroprotection and ischaemia — analysing the response of nervous tissue to the peptide under conditions of experimental restriction of blood supply, including profiling of the expression of protective-response genes.
• Models of attention and memory — behavioural tests in rodents serving to characterise the presumed nootropic profile.
• Research into the nose–brain route — using the intranasal format as a model of the transport of neuropeptides to the central nervous system bypassing the blood–brain barrier.

All of the applications listed are exploratory in nature and refer to model systems. They describe how the compound is studied — and not any suggestion of any use in humans.

One Peptides quality specification

The value of a research reagent stems from its reproducibility and documentation. Each batch of Semax nasal spray from One Peptides meets the following standards:

• HPLC purity ≥98% — high-performance liquid chromatography confirms the peptide content and a low level of impurities.
• MS identity confirmation — mass spectrometry verifies the molecular weight and sequence conformity.
• COA per batch — a certificate of analysis accompanying each batch, documenting the control results.
• Cold chain 2–8°C — a cold chain maintained in distribution to preserve the stability of the peptide in solution.
• Batch traceability — full batch traceability enabling the history of the material to be reconstructed.

Such a set of controls is the standard for work in which the result of an experiment must be reproducible, and in which differences between samples cannot stem from unknown reagent quality.

Safety and limitations

In published studies, Semax was described as a compound well tolerated in the models used, with no reports of significant toxicity under typical experimental conditions. The proper perspective on the strength of the evidence must nevertheless be retained.

Most of the clinical and preclinical data come from Russian centres, and outside that area there is a lack of large, independent randomised controlled trials (RCT) that would confirm the observations in a broader population according to the standards adopted in the EU or the USA. Nor does extensive data on long-term safety exist beyond the context mentioned. From the laboratory point of view, this means that Semax remains chiefly a research tool with a profile described mainly within one scientific tradition.

As an RUO reagent, this product requires handling in accordance with the principles of good laboratory practice — by qualified personnel, under conditions intended for work with research materials. It is not intended for any use in humans or animals beyond the strictly scientific.

Regulatory status and WADA

In the European Union, Semax is offered solely as a research reagent (Research Use Only) and holds no authorisation as a medicinal product nor the status of a dietary supplement. The pharmaceutical authorisation covering the intranasal form relates exclusively to the Russian market and does not extend to the EU area — these are two independent legal frameworks.

On the World Anti-Doping Agency (WADA) list of prohibited substances and methods, Semax does not currently appear as a substance named explicitly. The regulatory status of peptide compounds is, however, periodically revised, which is why those operating in areas covered by anti-doping regulations should verify the current version of the WADA list themselves on each occasion.

Frequently asked questions

What is Semax and what does it mean that it is an ACTH(4-10) analogue?
Semax is a synthetic heptapeptide with the sequence MEHFPGP and a weight of approximately 813 Da. The term “ACTH(4-10) analogue” means that its core corresponds to a fragment of the adrenocorticotropic hormone (residues 4-10), augmented with a stabilising Pro-Gly-Pro tripeptide. Unlike full ACTH, it does not exhibit significant hormonal activity on the adrenal glands, and in research it is analysed with regard to neurotropic properties.

What does research say about the effect of Semax on BDNF and neuroprotection?
In animal models, Semax modulated the expression of BDNF and the trkB receptor (Dolotov et al., 2006), and gene-expression analyses described changes linked to the neuroprotective response under conditions of ischaemia (Medvedeva et al., 2014). These are observations from basic research concerning model systems — they do not describe effects in humans and do not constitute claims of any medicinal action.

How does RUO differ from the Russian intranasal medicine of the same name?
The RUO reagent is intended solely for laboratory research and holds no medicinal authorisation. The Russian intranasal preparation is a medicinal product authorised in that market with neurological indications. These are two distinct regulatory categories — in the European Union, Semax is not authorised as a medicine, and the product offered remains a research material.

Why was the nasal spray format chosen?
Neuropeptides cross the blood–brain barrier poorly, which is why the nose–brain axis is the subject of research into their transport to the central nervous system. The nasal spray format makes it possible to reproduce under model conditions the intranasal route of administration in which Semax was developed from the outset. The pre-dissolved solution simplifies sample preparation by eliminating the reconstitution step.

What about the stability and storage of the product?
Semax is supplied as a pre-dissolved solution and requires the maintenance of a cold chain within the range of 2–8°C to preserve the stability of the peptide. Each batch is covered by a certificate of analysis and by traceability, and handling of the material should take place in accordance with the principles of good laboratory practice.

Bibliography

1. Dolotov OV et al. (2006). Semax, an analog of ACTH(4-10), regulates expression of BDNF and trkB in the rat brain
2. Medvedeva EV et al. (2014). The peptide semax affords neuroprotection — gene expression analysis
3. Levitskaya NG et al. (2004). Effects of Semax in a model — behavioral physiology
4. Ashmarin IP et al. (1997). Semax — synthetic analog of ACTH(4-10): pharmacological characteristics (DOI not verified — no link)

This material is for informational purposes only and describes a reagent intended for laboratory research (Research Use Only). Semax nasal spray is neither a medicine nor a dietary supplement and in the European Union is not authorised as a medicinal product. The product is not intended for use in humans or animals, nor for diagnosis, prophylaxis or therapy. Any observations cited derive from research on model systems and do not constitute claims of an effect in humans. The intranasal preparation authorisation that exists in Russia relates to a separate regulatory framework and does not change the status of this reagent.