Evidence Grade D — Primarily preclinical. 13 published studies, mostly animal models. 0 registered clinical trials.
Medically reviewed by a licensed medical professional
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.
Cortagen is also known by these brand and alternate names:
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.
PeptideTrace tracks 0 registered clinical trials for Cortagen sourced from ClinicalTrials.gov.
No trials registered on ClinicalTrials.gov for this compound.
Cortagen is a Khavinson bioregulator tetrapeptide isolated from bovine cerebral cortex extract (Cortexin), designed to target brain tissue. Its sequence is Ala-Glu-Asp-Pro (AEDP), with molecular formula C17H26N4O9 and molecular weight 430.41 g/mol (CAS: 335591-03-2; PubChem CID: 18439621). Cortagen differs from the better-known Epitalon (AEDG) by only the fourth residue, proline versus glycine, yet research suggests distinct tissue-specificity targeting cerebral cortex rather than pineal gland. Available as a white lyophilized powder that is water-soluble. Research administration routes include subcutaneous injection and oral. Not approved by any Western regulatory agency. The parent complex Cortexin is a registered pharmaceutical in Russia.
Per Khavinson's bioregulation theory, research suggests Cortagen penetrates nuclear membranes and binds preferentially to the DNA sequence AACC in gene promoter regions, modulating chromatin accessibility. Lezhava et al. reported Cortagen may increase ribosomal gene activity and reactivate genes repressed by age-related heterochromatin condensation. Anisimov et al. (2004) profiled 15,247 gene clones using NIA 15K cDNA microarray in mouse hearts and found Cortagen modulated genes related to membrane transport, DNA synthesis, and upregulated mitochondrial genes (16S rRNA, COX3, ND5). Research suggests Cortagen decreases lipid peroxidation products and protein carbonyl groups (approximately 15% reduction in neural cells) through indirect upstream modulation, notably showing no direct antioxidant effects in vitro.
Turchaninova et al. (2000) showed Cortagen increased growth rate and conduction velocity of regenerating sciatic nerve fibers in rats. Adriani et al. (2009) demonstrated that in mice, acute and sub-chronic Cortagen produced motor stimulation with no side effects on emotional-affective profiles. Zarubina and Shabanov (2011) showed that in chronic brain ischemia rats, Cortagen accelerated behavioral recovery and prevented excessive lipid peroxidation. No randomized, controlled human clinical trials are indexed in Western databases. Cortexin (the parent complex) is a registered pharmaceutical in Russia for neurological indications. Cortagen as a standalone synthetic peptide is sold primarily as a research 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.
Compare prices from 8 vendor listings
View pricing data across vendors and countries for Cortagen
Cerebrolysin has been studied in over 200 clinical trials involving more than 15,000 patients, primarily for stroke and Alzheimer's disease. The largest stroke trial (CASTA, 1,070 patients) showed no significant benefit on its primary endpoint. A Cochrane systematic review concluded that evidence was insufficient to support its routine use in stroke or dementia. Cerebrolysin is approved in some non-FDA/non-EMA jurisdictions for neurological conditions. Its clinical evidence base, despite being extensive in volume, has not met the standards required for FDA or EMA approval. The undefined molecular composition makes batch-to-batch consistency and quality standardisation inherently challenging compared to defined single-entity pharmaceuticals.
P21 has no marketing authorisation. No human clinical trials have been conducted. The evidence base consists entirely of studies in transgenic Alzheimer's disease mouse models, conducted primarily by a single research group. Animal studies reported behavioural and biochemical changes in AD mouse models following chronic oral administration. The translation of results from transgenic mouse models of Alzheimer's disease to human disease has historically been extremely poor — the vast majority of compounds showing efficacy in such models have failed in human trials. Products available through unregulated channels lack pharmaceutical quality assurance.
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.
This content is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional before making decisions about your health.
