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Terminus Peptides
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Research profile · Peptide

Cortagen

Also known as Ala-Glu-Asp-Pro

Animal — evidence level 2 of 4: Animal evidenceExperimental — UK regulatory status: Experimental — not authorised for human use in the UK

Overview

A synthetic tetrapeptide from the Russian peptide bioregulator programme, with no human clinical studies of any design.

Category
Peptide
Highest evidence level identified
Animal evidence
Last scientifically reviewed
20 August 2026
Last regulatory review
20 August 2026

Mechanism under investigation

Cortagen is a synthetic tetrapeptide from the same St Petersburg programme as pinealon and epitalon, designed as a defined-sequence analogue of an older bovine brain-cortex extract used in Russian neurology. The proposed mechanism is the same peptide bioregulator hypothesis — that short peptides enter the nucleus and modulate transcription of tissue-relevant genes, with reported effects on chromatin structure and cytokine gene expression. As with the related compounds, this remains a hypothesis generated and largely tested within the originating group.

Research areas

  • Nerve regeneration models
  • Ageing research

These are fields in which the compound has been investigated. Listing a field is not a statement that anything was demonstrated within it.

Current evidence

In-vitro evidence

Cells, tissues or biochemical systems outside a living organism.

Present, and the most consistent tier. Reported effects on interleukin-2 gene expression in rat splenocytes and on thymocyte signalling. Chromatin work in cultured lymphocytes from donors aged 75 to 88 reports activation of ribosomal genes and decondensation of densely packed chromatin. That work uses human donor cells in culture — it is laboratory evidence, not a clinical study, and is frequently miscited as the latter.

Animal evidence

Studies in living non-human animals.

Present. The most-cited single finding is increased growth rate and conduction velocity in regenerating fibres after sciatic nerve transection in rats, with a follow-up reporting delayed effects on functional recovery. Separate work reports preserved antioxidant activity in brain tissue in a rat chronic cerebral ischaemia model, and gene expression profiling in mouse heart.

Human observational evidence

Studies observing people without assigning an intervention.

Absent. No observational human study was found. The chromatin studies use human donor lymphocytes in culture, which is laboratory evidence rather than observation of treated people.

Clinical-trial evidence

Studies assigning an intervention to human participants.

Absent. No randomised or controlled human trial was identified, and no registered trials exist. A search of ClinicalTrials.gov returns one apparent result, but it is an unrelated study of a nutritional formula and is a false positive.

Study limitations

  • Single-programme literature. Around 53 per cent of indexed records carry the programme’s founder as an author, with most of the remainder authored by long-term collaborators at the same institute. No independent replication of the headline nerve-regeneration finding was identified.
  • No registered clinical trials and no human clinical studies of any design. The entire evidence base is laboratory and small-animal work.
  • The literature is small and largely dormant, with the core findings dating from 2000 to 2006 and little since.
  • Key papers appear in journals with limited international visibility, several indexed without identifiers, and animal studies typically report small group sizes without pre-registration, blinding or power calculations.
  • The human-cell chromatin findings are frequently cited as though they were human clinical evidence. They are cell-culture experiments on donor lymphocytes and cannot support claims about effects in people.

UK regulatory context

Experimental — not authorised for human use in the UK

A compound appearing in research literature that holds no UK authorisation for human use in any indication.

Source: The Human Medicines Regulations 2012, regulation 46 — prohibition on sale or supply of an unauthorised medicinal product (opens legislation.gov.uk in a new tab) (legislation.gov.uk)

Regulatory classification is jurisdiction-specific. A compound authorised elsewhere is not thereby authorised in the UK, and a supplier’s description of a substance does not determine how it is classified in law. See safety and regulation for the framework and the authoritative sources.

Safety and interpretation

There is no human safety data: no clinical trials of any design, no registered studies, and no pharmacovigilance, since the compound holds no marketing authorisation in any identified jurisdiction. The animal studies were small, short and designed to detect efficacy rather than harm, so their failure to report adverse effects carries little weight as safety evidence.

References