Cortagen
Evidence: DExperimental / Early Research
Evidence Snapshot
What this grade covers
A for canonical sequence identity; C/D for cell and animal findings (nerve-injury, brain-ischemia, and gene-expression studies); D/E for human nerve repair, neuroprotection, cognition, approval, safety, or dosing.
Regulatory Context
No FDA-approved Cortagen product or verified human clinical trial was identified. Cortagen is distinct from Cortexin, a complex polypeptide preparation.
Research Takeaway
Cortagen is the synthetic tetrapeptide Ala-Glu-Asp-Pro (AEDP), developed from brain-cortex peptide research; it is not Cortexin, Cerebrolysin, Pinealon/EDR, Semax, Selank, Dihexa, or another short peptide.
Evidence boundary: Evidence from the source extract or neighboring neuropeptides does not automatically transfer to AEDP.
See all 6 evidence claims →Quick Summary
Cortagen is a synthetic tetrapeptide identified as Ala-Glu-Asp-Pro (AEDP), developed from research on the distinct brain-cortex extract Cortexin. Its direct evidence is preclinical, including rodent nerve-injury, ischemia, and gene-expression studies.
Mechanism & Research Overview
Cortagen has been studied in experimental models for effects on gene expression, nerve regeneration, and metabolic responses to ischemia. No validated human target, pharmacokinetic profile, or clinical effect has been established.
Evidence Claims
Individual scientific statements drawn from the sources cited below, each shown with the specific evidence boundary that statement does not establish.
Supported
Cortagen is the synthetic tetrapeptide Ala-Glu-Asp-Pro (AEDP), developed from brain-cortex peptide research; it is not Cortexin, Cerebrolysin, Pinealon/EDR, Semax, Selank, Dihexa, or another short peptide.
Does not establish
Evidence boundary: Evidence from the source extract or neighboring neuropeptides does not automatically transfer to AEDP.
Supported
In mice, short-course Cortagen exposure altered expression of numerous cardiac transcripts in microarray analysis, demonstrating a measurable systemic transcriptional effect in an animal model.
Does not establish
Evidence boundary: Mouse-heart transcriptomic changes do not establish a therapeutic cardiovascular effect in humans.
Supported
Cortagen has produced tissue-specific effects in organotypic culture experiments, including effects on explants derived from brain cortex.
Does not establish
Evidence boundary: Organotypic explant growth is a preclinical endpoint and cannot be translated directly into neurological recovery claims.
Supported
Cortagen has shown immunologic effects in experimental systems, including changes in interleukin-2 mRNA and age-dependent macrophage/lymphocyte-activating-factor responses.
Does not establish
Evidence boundary: These findings are cellular/animal observations, not evidence of clinical immune enhancement.
Sources: Cortagen and IL-2 Gene Expression in Mouse Splenocytes
Supported
A published Cortagen paper states in its background that therapeutic effects had been observed in humans after peripheral-nerve trauma, but that statement is not itself a controlled human trial and must not be treated as proof of clinical efficacy.
Does not establish
Evidence boundary: Secondary/background assertions require the underlying human study before they can support a clinical-efficacy claim.
Supported
Cortagen should remain classified as a preclinical/experimental peptide for MitoCore purposes because the verified source set does not establish a modern, replicated human therapeutic evidence base.
Does not establish
Evidence boundary: This is an evidence-grade conclusion, not a claim that no historical human use has ever occurred.
Sources: Elucidation of the effect of brain cortex tetrapeptide Cortagen on gene expression in mouse heart by microarray; Cortagen and IL-2 Gene Expression in Mouse Splenocytes
Safety & Evidence Limitations
Considerations reported in the sources cited on this page — not a complete list of every possible risk, and not medical advice.
Safety Consideration
No verified human clinical evidence was located.Safety Consideration
Animal nerve-injury and ischemia findings do not establish neurologic benefit or safety in people.Safety Consideration
A study that evaluates Cortagen together with Cortexin cannot isolate the effect of Cortagen.Safety Consideration
Product identity, route-specific safety, immunogenicity, and long-term toxicology are inadequately characterized.Safety Consideration
Important uncertainties include: CNS delivery and brain penetration; neuroexcitation, agitation, anxiety, sleep disruption, or seizure risk; effects on neuronal differentiation and synaptic networks; unknown cardiovascular, autonomic, hepatic, renal, reproductive, pregnancy, pediatric, and developmental effects; unknown interaction with stroke therapies, antiseizure drugs, antidepressants, stimulants, or sedatives; peptide identity, stereochemistry, terminal groups, counterion, purity, aggregation, immunogenicity, sterility, and endotoxins; and lack of long-term or repeated-course safety data.
Research Areas Being Studied
Research areas discussed on this page reflect the Experimental / Early Research category and the sources cited below.
Findings Reported in Studies
Educational summary only — reported in cited studies, not a claim of proven benefit.
No Human Study Findings Listed Yet
See preclinical, regulatory, and review sources below.
Study Tables by Evidence Type
Human Studies & Clinical Data
No Human Studies & Clinical Data Listed Yet
This section will be updated as sources are added.
Animal / Cell / Preclinical Data
| Title | Year | Population / Model | Dose / Duration / Finding | Safety Notes | Source |
|---|---|---|---|---|---|
| Cortexin and Cortagen as correcting agents in functional and metabolic disorders in chronic brain ischemia | 2011 | Rat model of chronic brain ischemia | Cortexin and Cortagen were studied in a rodent ischemia model, with reported functional and metabolic changes. | Combined-product animal study; effects cannot automatically be attributed solely to Cortagen. | |
| Elucidation of the effect of brain cortex tetrapeptide Cortagen on gene expression in mouse heart by microarray | 2004 | Mouse heart gene-expression analysis | The paper identifies Cortagen as Ala-Glu-Asp-Pro and reports gene-expression changes in mouse heart. | Preclinical molecular data; does not establish neurologic or cardiovascular clinical benefit. | |
| The delayed effect of Cortagen on restoration of injured nerve function | 2002 | Rat peripheral-nerve injury model | The study evaluated delayed functional recovery after Cortagen exposure in injured nerves. | Animal study with limited safety characterization. | |
| Effect of tetrapeptide Cortagen on regeneration of sciatic nerve | 2000 | Rats after sciatic-nerve transection and repair | The authors reported increased growth rate and conduction velocity in regenerating nerve fibers.
| Animal injury model; the source-reported dose is not human-use guidance. | |
| Cortagen and IL-2 Gene Expression in Mouse Splenocytes | An in-vitro study reported that Cortagen/AEDP altered IL-2 mRNA gene expression in mouse splenocytes. This molecular finding does not establish a validated human immune target, clinical immune benefit, or tissue specificity. | ||||
| Short Peptides and Neuronal Differentiation of Human Periodontal Stem Cells | An in-vitro stem-cell study reported effects of short peptides, including AEDP, on neuronal differentiation of human periodontal stem cells. This cell finding does not establish human neurogenesis, cognitive benefit, or clinical tissue specificity. |
Regulatory Documents & Official Trial Registries
| Title | Year | Population / Model | Dose / Duration / Finding | Safety Notes | Source |
|---|---|---|---|---|---|
| FDA 503A Bulk Drug Substances Categories, Updated May 14, 2026 | 2026 | Cardiogen, Cortagen, Pinealon, and Vesugen were not identified in FDA's current 503A nominated bulk-drug-substance category document, updated May 14, 2026. Absence from that document is not approval, a safety determination, or authorization to compound. | |||
| ClinicalTrials.gov Search Portal | No modern registered interventional development program for Cardiogen, Cortagen, Pinealon, or Vesugen was identified in the reviewed ClinicalTrials.gov searches. |
Review Articles / Secondary Sources
| Title | Year | Population / Model | Dose / Duration / Finding | Safety Notes | Source |
|---|---|---|---|---|---|
| Peptide regulation of gene expression: a systematic review | 2021 | Systematic review of short-peptide gene-expression studies | The review summarizes proposed DNA and gene-expression effects of short peptides, including organ-labeled bioregulators. | Secondary source dominated by one research program; independent validation remains limited. | |
| Peptide regulation of cell differentiation | 2020 | Review of short-peptide differentiation studies | The review discusses AEDP and other short peptides in cell-differentiation models. | Secondary source; not evidence of human clinical effectiveness. |
Anecdotal Reported Patterns — Not Medical Advice
Anecdotal Reported Patterns — Not Medical Advice
Reported dosing patterns are included for educational context only. They are self-reported, unverified, not medical advice, and not instructions for human use. Community-submitted patterns are not yet available in this Phase 1 prototype; this section is a placeholder reserved for moderated, aggregated community data.
Lab Markers to Discuss With a Clinician
Educational topics only — not self-monitoring instructions.
FAQ
Disclaimer
Educational information only. This page summarizes published and official research and does not provide medical advice, a recommendation, or instructions for human use.
Educational use only. This content is provided for informational and research-summary purposes only. It is not medical advice, not a treatment recommendation, not a dosing guide, and not a substitute for care from a licensed medical professional. Nothing here is intended to diagnose, treat, cure, prevent, or mitigate disease. Reported dosing patterns, when shown elsewhere on the site, must be labeled either as Study / Trial Dosing or Anecdotal Reported Patterns — Not Medical Advice. Community reports are self-reported, unverified, and not scientific proof.
Community-reported experiences, once enabled, must be displayed only as moderated, anonymized, or aggregated data. They are anecdotal, self-reported, unverified, and should never be presented as proof of safety, efficacy, or expected results.
Content status: Published. Last updated 2026-07-30.
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