AEDP
Evidence Grade D — Primarily preclinical. 13 published studies, mostly animal models. 0 registered clinical trials.
Cortagen is a synthetic tetrapeptide from the Khavinson bioregulator programme, originally isolated from bovine brain extract and proposed to target brain tissue. No controlled human clinical trials have been conducted and it has no approval from any major regulatory agency. The evidence consists of animal studies from the originating research group.
13 published studies: 2 human, 11 animal, 2 in-vitro, 0 reviews
Cortagen has no marketing authorisation from any major regulatory agency. No controlled human clinical trials have been conducted. The evidence base consists of animal studies published primarily by the originating research group.
Cortagen is part of the Khavinson bioregulator peptide programme, which proposes that short peptides derived from organ extracts can regulate gene expression in corresponding tissues. This theoretical framework has not been evaluated through FDA or EMA regulatory processes. Products available through unregulated channels lack pharmaceutical quality assurance.
Research from the Khavinson group proposes that Cortagen interacts with DNA sequences in gene promoter regions, potentially modulating gene expression. This 'bioregulation' theory posits that short peptides can influence chromatin structure. These proposals come from a specific theoretical framework that has not been independently validated through conventional drug development processes.
Nearly all research originates from Khavinson's institute or affiliated Russian groups. No pharmacokinetic data, no dose-response studies in humans, and no independent Western validation exist. The strongest mechanistic evidence is a gene expression microarray study, but this was performed in mouse heart tissue rather than brain. As with other Khavinson bioregulator peptides, the question of how a four-amino-acid peptide achieves tissue-specific gene regulation remains unresolved. Products from unregulated channels lack pharmaceutical quality assurance.
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.
Pinealon has no marketing authorisation from any major regulatory agency. No controlled human clinical trials have been conducted. The evidence base consists of in vitro cell studies and animal experiments published primarily by the originating research group. As with other Khavinson bioregulator peptides, the proposed mechanisms and the underlying theoretical framework have not been evaluated through conventional Western regulatory processes. Products available through unregulated channels lack pharmaceutical quality assurance.
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.
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.
