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Peptides / Semax

Panel: recommendedACTH-based peptideNot FDA approved

Semax

Semax is a seven-amino-acid peptide developed in the Soviet Union in the 1980s. It is a modified piece of ACTH, a pituitary hormone, designed to keep effects on the brain without ACTH's hormonal effects. In Russia it is an approved nasal-drop medicine.

Reviewed for
Reduced brain blood flow, migraine, nerve pain
Committee vote
8 yes, 5 no, 1 abstain
Strongest evidence
Small human studies
Legal to compound in the US
Not yet

Effects studied or claimed

What it is promoted for, and where each effect has actually been seen

  • Recovery after strokeUsed in Russia
  • Memory, attention and mental performanceClaimed
  • Protection of nerve cellsAnimals
  • Migraine and facial nerve pain (trigeminal neuralgia)Limited reports

How it is thought to work

In animal studies it raises levels of BDNF, a protein that helps nerve cells survive and form connections, and it changes brain chemical signalling.

What the evidence shows

In animals and the lab

Many rodent studies on stroke, nerve injury and memory.

In people

Clinical use and trials in Russia for stroke and cognitive problems, mostly published in Russian. It has not been tested in large international trials.

Safety and unknowns

Russian studies describe it as well tolerated, but the data are thin by FDA standards and long-term effects have not been well studied.

FDA review

Reviewed as a nasal spray for reduced blood flow to the brain (cerebral ischemia), migraine and trigeminal neuralgia. FDA staff recommended against it. The committee voted 8 to 5 in favour.

Committee votes are advice to the FDA. A peptide can only be compounded legally once the FDA adds it to the 503A bulks list through formal rulemaking, which has no fixed deadline.

Sources

Analysis

A Russian stroke drug marketed in the West as a nootropic

Peptide Evidence IndexBiology 4.5/10In people 3/10Index 3.4, rank 8 of 15See the full index

Semax is a modified fragment of ACTH, a pituitary hormone, developed at the Institute of Molecular Genetics in Moscow. It is given as nasal drops and has been approved in Russia since the 1990s for stroke recovery and some optic nerve conditions. Outside Russia it is sold online as a focus and memory enhancer.

Much of the mechanistic interest comes from brain growth factors. In rats, a single dose of Semax raised levels of BDNF, a protein that supports nerve cell survival and learning, and its receptor in the hippocampus within hours (Dolotov and colleagues, 2006). Rodent stroke models show changes in genes linked to inflammation and blood vessel growth. Human studies exist, mainly in stroke patients, but most were published in Russian journals, were small, and are hard to assess against Western trial standards.

Our view. Semax has more human use than most peptides on this list, but almost entirely within one country's regulatory system. Claims of better memory or focus in healthy people have not been tested in rigorous trials.

Studies and reports cited

  1. Dolotov OV et al. Semax, an analog of ACTH(4-10) with cognitive effects, regulates BDNF and trkB expression in the rat hippocampus. Brain Res, 2006

Summary of published research for general information. It is not medical advice and not a recommendation to use this substance.

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General information, not medical advice. Do not buy or inject unregulated peptides.