Semax nasal drops
Evidence Grade C — Moderate human evidence. 202 published studies, 45 human. 0 registered clinical trials.
Semax is a synthetic peptide derived from a fragment of ACTH, developed in Russia in the 1980s. It is used clinically in Russia as a nasal spray for stroke recovery and cognitive conditions but has never been evaluated by the FDA, EMA, or other major Western regulatory agencies. The clinical evidence is predominantly Russian-language.
202 published studies: 45 human, 144 animal, 12 in-vitro, 9 reviews
Semax is approved in Russia for stroke recovery and cognitive conditions. It has not been approved by the FDA, EMA, or other major Western regulatory agencies, and the clinical evidence base has not undergone Western regulatory review.
Published clinical studies are predominantly Russian. The largest published study (110 stroke patients) reported correlations between treatment and BDNF levels. The evidence does not meet the standards typically required for FDA or EMA approval. Its regulatory status is limited to Russia and certain former Soviet states.
Research suggests Semax may interact with neurotrophic factor pathways, including upregulation of BDNF expression. These proposed mechanisms are based primarily on animal studies and a limited number of human studies conducted predominantly in Russia. The evidence has not been evaluated through FDA or EMA regulatory review processes.
Research suggests Semax has been in clinical use in Russia since 1996, with the largest published study involving 110 stroke patients. The Alzheimer's Drug Discovery Foundation assessed Semax and concluded that well-conducted published studies are lacking. Most clinical studies are available only as Russian-language abstracts, making full quality assessment difficult. No randomised, double-blind, placebo-controlled trials have been published in English-language journals. Reported side effects include nasal discolouration (about 10% of patients) and blood sugar elevation in people with diabetes. Widespread Russian use suggests an acceptable safety profile in that context, but data meeting Western regulatory standards are absent.
No trials registered on ClinicalTrials.gov for this compound.
The information on this page is provided for educational and research reference purposes only. This is not medical advice. Always consult a qualified healthcare professional before making any health-related decisions.
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Selank is approved in Russia for anxiety-related conditions. It has not been approved by the FDA, EMA, or other major Western regulatory agencies. The key clinical study (62 patients) compared Selank to a benzodiazepine in generalised anxiety disorder and reported comparable effects. Published clinical studies are predominantly Russian and have not undergone Western regulatory review. The evidence base does not meet FDA or EMA approval standards. Its regulatory status is limited to Russia and certain former Soviet states.
Dihexa has no marketing authorisation. No human clinical trials have been conducted. The foundational research by the originating laboratory faces serious integrity concerns: a key paper (McCoy et al., 2013) received an expression of concern for image manipulation, and a second paper (Benoist et al., 2014) was retracted after institutional investigation found falsified and fabricated data. These integrity issues fundamentally undermine the evidence base for dihexa. Products available through unregulated channels are based on research that has been formally questioned or retracted by the scientific community. This compound carries unique evidence quality concerns beyond the standard limitations of other research compounds.
